Alinity m STI Assay

K202977 · Abbott Molecular, Inc. · QEP · Apr 29, 2022 · Microbiology

Device Facts

Record IDK202977
Device NameAlinity m STI Assay
ApplicantAbbott Molecular, Inc.
Product CodeQEP · Microbiology
Decision DateApr 29, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 866.3393
Device ClassClass 2
AttributesReal-World Evidence

Real-World Evidence

SubmissionDeviceSponsorRWD SourcesRWE Use SummaryKey Tags
K202977 · Apr 29, 2022Alinity m STI AssayAbbott Molecular, Inc.Prospective clinical study of subjects seeking routine STI testing at 33 clinical sitesClinical performance (sensitivity and specificity) of the Alinity m STI assay was established by comparing results from prospectively collected clinical specimens against a composite comparator algorithm of FDA-cleared NAATs.Prospective clinical study; Clinical performance; Sensitivity and specificity; Urogenital specimens; Extragenital specimens

Clinical Evidence

Study DesignPopulationComparatorKey Endpoints
Urogenital Specimens Clinical Study; Prospective multicenter clinical study; Follow-up/Duration: 10 months7,099 subjects (3,401 females and 3,698 males) seeking testing for STIs; Sample Size: 7,099; Number of Sites: 33Composite algorithm of FDA-cleared NAATsClinical sensitivity and specificity for CT, NG, TV, and MG
Extragenital Specimens Clinical Study; Prospective multicenter clinical study2,390 subjects (sexually active men and women, 15-77 years old); Sample Size: 2,390; Number of Sites: 8Composite Comparator (CC) of three FDA-cleared NAATsClinical sensitivity and specificity for CT and NG in oropharyngeal and rectal specimens

Indications for Use

The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes: CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs NG: vaginal swabs (clinician-collected and self-collected in a clinical setting). endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.

Device Story

Alinity m STI Assay is a real-time PCR test for qualitative detection of CT (rRNA), NG (DNA), TV (rRNA), and MG (rRNA). Input: endocervical/vaginal/oropharyngeal/rectal swabs, urine, or PreservCyt specimens. Operation: automated on Alinity m System; magnetic microparticle-based nucleic acid extraction; RT-PCR assembly; amplification/detection; result calculation. Output: qualitative report of presence/absence of target organisms. Used in clinical laboratories; operated by trained technicians. Healthcare providers use results to guide STI diagnosis and treatment. Benefits: rapid, automated, high-throughput detection of multiple STI pathogens from diverse specimen types.

Clinical Evidence

Multicenter clinical study (N=7,099) evaluated urogenital specimens; extragenital study (N=2,373) evaluated oropharyngeal/rectal specimens. Performance compared to composite comparator/NAATs. Urogenital sensitivity/specificity generally >94%. Extragenital sensitivity/specificity generally >93%. Bench testing included LoD, inclusivity, cross-reactivity, interference, precision, and carryover.

Technological Characteristics

Real-time PCR assay; automated nucleic acid extraction using magnetic microparticles; targets CT (rRNA), NG (DNA), TV (rRNA), MG (rRNA); includes internal control (armored RNA) and cellular control (beta-globin); utilizes Alinity m System for thermal cycling and fluorescence detection; closed-system automated workflow; requires Alinity m multi-Collect Specimen Collection Kit.

Indications for Use

Indicated for symptomatic and asymptomatic individuals to aid in diagnosis of CT, NG, TV, and MG infections. Specimen types include vaginal swabs (clinician/self-collected), endocervical swabs, male/female urine, gynecological specimens in PreservCyt, oropharyngeal swabs, and rectal swabs.

Regulatory Classification

Identification

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) and their associated resistance markers in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist that are not detected by the device.

Special Controls

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) must comply with the following special controls: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device: alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including, but not limited to. Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate; (iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing. (iv) Limiting statements indicating that: (A)a negative test result does not preclude the possibility of infection; (B) the test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe procedures in any one of these steps can lead to incorrect results; and (D)if appropriate (e.g., recommended by CDC, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type. (v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that: (A)negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present; (B) detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora; (C) detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and (D) therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy. (4) Design verification and validation must include: (i) Detailed device description documentation, including, but not limited to, methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported result). (ii) Detailed documentation of analytical studies including but not limited to, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate. (iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses. (iv) A detailed description of the impact of any software, including, but not limited to, software applications and hardware-based devices that incorporate software, on the device's functions.

*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate; (iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing; (iv) Limiting statements indicating that: (A) A negative test result does not preclude the possibility of infection; (B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and (D) If appropriate ( *e.g.,* recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type; and(v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that: (A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present; (B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora; (C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and (D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy. (4) Design verification and validation must include: (i) Detailed device description documentation, including methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result ( *e.g.,* how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate. (iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses. (iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.

Predicate Devices

Submission Summary (Full Text)

{0} # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: ### A 510(k) Number K202977 ### B Applicant Abbott Molecular, Inc. ### C Proprietary and Established Names Alinity m STI Assay ### D Regulatory Information #### 1. Regulation section 21 CFR 866.3393: Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) #### 2. Classification Class II #### 3. Product Codes QEP: Nucleic Acid Detection System For Non-Viral Microorganism(s) Causing Sexually Transmitted Infections LSL: DNA-Reagents, Neisseria MKZ: DNA Probe, Nucleic Acid Amplification, Chlamydia OUY: *Trichomonas vaginalis* nucleic acid assay OOI: Instrumentation for clinical multiplex test systems #### 4. Panel Microbiology (83) ## II Submission/Device Overview: ### A Purpose for Submission: To obtain market clearance for a new device. {1} # **B Measurand:** *Chlamydia trachomatis* (CT) ribosomal RNA *Neisseria gonorrhoeae* (NG) genomic DNA *Trichomonas vaginalis* (TV) ribosomal RNA *Mycoplasma genitalium* (MG) ribosomal RNA # **C Type of Test:** Qualitative, real time polymerase chain reaction (PCR) assay. # **III Intended Use/Indications for Use:** # **A Intended Use(s):** See Indications for Use below. # **B Indication(s) for Use:** The Alinity m STI Assay is an *in vitro* polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from *Chlamydia trachomatis* (CT), DNA from *Neisseria gonorrhoeae* (NG), ribosomal RNA from *Trichomonas vaginalis* (TV), and ribosomal RNA from *Mycoplasma genitalium* (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes: CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs NG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if *M. genitalium* infection is suspected. K202977 - Page 2 of 65 {2} **C Special Conditions for Use Statement(s):** Rx - For Prescription Use Only **D Special Instrument Requirements:** Alinity m System **IV Device/System Characteristics:** **A Device Description:** The Alinity m System is a fully integrated instrument that can process 300 samples per day (in approximately 8 hours) from first sample aspiration to the last test result. The Alinity m System supports random access to assays as well as continuous loading of samples, reagents and commodities. The system includes a touchscreen where the operator directs the system to execute various tasks, and a barcode scanner for sample identification. Samples can be loaded on the system in any order, and the system will schedule them to be processed based on system defined criteria. The system pipettor robot dispenses and aspirates liquids, as appropriate for each reaction. Sample handling and reagent transport is performed by a handler robot. The instrument performs the following functions automatically: - Isolation of nucleic acid from specimens - Amplification of specific nucleic acid targets by PCR - Detection of the amplified product - Analysis of the response data to produce qualitative results The extraction of nucleic acids includes cell lysis and adsorption onto magnetic microparticles, followed by multiple washing cycles and finally elution of the purified nucleic acids. The extracted material is mixed with a master mix for amplification in a PCR reaction which includes target specific probes labelled with different fluorophores allowing for detection of multiple targets in one reaction. The system software analyzes generated signals and reduces the data to determine the final qualitative result for the STI analytes. All stages of the Alinity m STI Assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. Alinity m STI Assay requires the following: 1. AMP Kit, which consists of two distinct reagent plates: - Alinity m STI AMP TRAY 1 (4 trays x 96 tests) - Alinity m STI ACT TRAY 2 (4 trays x 96 tests) 2. Alinity m Multi-Collect Specimen Collection Kit, with the following components: - One Transport Tube filled with 1.4 mL Alinity m Transport Buffer - One individually packaged Sterile Specimen Collection Swab - One disposable Transfer Pipette 3. Alinity m STI CTRL Kit includes two assay controls in liquid format provided in single-use tubes. K202977 - Page 3 of 65 {3} - Alinity STI Negative Control (12 tubes x 0.47mL) - Alinity STI Positive Control (12 tubes x 0.47mL) 4. Alinity m Sample Prep Kit 1 is used to isolate nucleic acids from biological samples for analysis in PCR tests and consists of: - Alinity m Elution Buffer 1 which contains nuclease, protease free molecular grade water, and Tween 20 and preservatives - Alinity m Microparticles 1, which contains magnetic microparticles in 6.2 M Guanidine hydrochloride solution 5. Alinity m System Solutions are required to perform the Alinity m STI assay: - Alinity m Lysis Solution - Alinity m Ethanol Solution - Alinity m Diluent Solution - Alinity m Vapor Barrier Solution # Specimen Collection Endocervical, vaginal, oropharyngeal, and rectal swabs, female urine and male urine specimens must be collected using the Alinity m multi-Collect Specimen Collection Kit, according to the instructions for use. Gynecological specimens in PreservCyt Solution (Hologic Inc.) must be collected and handled according to the manufacturer's instructions. For PreservCyt specimens, only the aliquot taken from the PreservCyt vial prior to cytology processing must be transferred to an Alinity m Transfer Tube for processing on the Alinity m System. # Results The Alinity m System automatically reports qualitative results for each analyte (CT, NG, TV, or MG) based on the amplification cycle number (CN) after the fluorescent signal is detected by the Alinity m System. Each result is either reported as "Positive", if the CN is less than or equal to a fixed assay cutoff cycle for that signal, or as "Negative", if the CN is not generated, or the CN is greater than the assay cutoff cycle. Interpretation of Results | Assay | Result | Interpretation | | --- | --- | --- | | CT | CT Positive | CT Target Detected | | CT | CT Negative | CT Target Not Detected | | NG | NG Positive | NG Target Detected | | NG | NG Negative | NG Target Not Detected | | TV | TV Positive | TV Target Detected | | TV | TV Negative | TV Target Not Detected | | MG | MG Positive | MG Target Detected | | MG | MG Negative | MG Target Not Detected | K202977 - Page 4 of 65 {4} # **B Principle of Operation:** The Alinity m STI assay utilizes real-time polymerase chain reaction (PCR) to amplify and detect *Chlamydia trachomatis* ribosomal RNA sequences, *Neisseria gonorrhoeae* DNA sequences, *Trichomonas vaginalis* ribosomal RNA sequences, *Mycoplasma genitalium* ribosomal RNA sequences, and human DNA sequences that have been extracted from urogenital specimens, including endocervical swab, vaginal swab, male and female urine, and gynecological specimens preserved in ThinPrep PreservCyt Solution, as well as extragenital specimens, including rectal and oropharyngeal swabs. Nucleic acids from specimens collected with the Alinity m multi-Collect Specimen Collection Kit, are extracted using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash and elution. After multiple washes of the microparticles, the resulting purified nucleic acid is then combined with Alinity m STI activation reagent and Alinity m STI amplification/ detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to prevent evaporation during the thermal cycling of the PCR. The reaction vessel is then transferred to an amplification / detection unit for reverse transcription, PCR amplification, and real-time fluorescence detection of CT, NG, TV, and MG amplified target nucleic acids. The Alinity m System's data analysis software processes the generated fluorescence for each assay reaction and automatically calculates and reports assay results. # Internal Controls: The Alinity m STI assay incorporates an endogenous human DNA sequence, referred to as Cellular Control (CC), by including primers and probes in the amplification reagents to detect and amplify the single copy human gene, β-globin. The CC functions to ensure that the sample was adequate and to monitor the sample extraction and amplification efficiency. In addition, a defined, consistent quantity of exogenous internal control (IC) is present in each PCR reaction and is measured on the Alinity m System to confirm that no PCR inhibitors are present in the sample. The IC is comprised of an armored RNA sequence unrelated to the Alinity m STI assay target sequences. The Cellular Control and Internal Control are both used to demonstrate assay validity. If the cycle number (CN) value for either one of these controls exceeds the specified range, a Flag or Message Code is displayed for the associated specimen: - For Positive Specimens: If the IC CN or CC CN is out of range, but the analyte(s) in that sample is Positive, the sample will yield a Positive result. An IC Flag or CC Flag will be reported next to the positive result. - For Negative Specimens: If the IC CN or CC CN is out of range and the analyte(s) in that sample is not Positive, no result will be reported for the analyte(s) and a Message Code will be generated. In addition, the test system is designed to minimize the possibility of nucleic acid contamination on the Alinity m System by the following features: K202977 - Page 5 of 65 {5} - Aerosol barrier pipette tips which are used for all pipetting; the pipette tips are discarded after use. - PCR amplification and detection are carried out automatically in a sealed reaction vessel. - Disposal of the reaction vessel is performed automatically by the Alinity m System. External Quality Controls: The Alinity m STI CTRL Kit includes Negative and Positive assay controls in liquid format provided in single-use tubes. It is recommended that both controls are tested, at the minimum frequency of once every 24 hours to ensure that instrument and reagent performance remains satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. The controls do not indicate if bacterial cells have been adequately lysed, therefore, additional controls, including those for cell lysis, may be tested in accordance with local, state, and/or federal regulations or accreditation requirements and internal quality control policy. Valid results for all control levels must be obtained before specimen results are reported. V Substantial Equivalence Information: A Predicate Device Name(s): Abbott RealTime CT/NG (Predicate for CT/NG) Hologic Aptima Combo 2 Assay (Predicate for CT/NG in PreservCyt Samples) Becton Dickinson MAX CT/GC/TV (Predicate for TV) Hologic Aptima Mycoplasma genitalium Assay (Predicate for MG) B Predicate 510(k) Number(s): K140354 K190515 K151589 DEN180047 C Comparison with Predicate(s): Testing for CT and NG | Device & Predicate Device(s): | K202977 | K140354 | K190515 | | --- | --- | --- | --- | | Device Trade Name | Alinity m STI Assay | Abbott RealTime CT/NG | Aptima Combo 2 Assay (for Gynecological Specimens) | | General Device Characteristic Similarities and Differences | | | | | Intended Use/Indications For Use | The Alinity m STI Assay is an *in vitro* polymerase chain reaction (PCR) assay for use | The Abbott RealTime CT/NG assay is an *in vitro* polymerase chain reaction | The Aptima Combo 2 Assay is a target amplification nucleic acid probe test that | K202977 - Page 6 of 65 {6} | | with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from *Chlamydia trachomatis* (CT), DNA from *Neisseria gonorrhoeae* (NG), ribosomal RNA from *Trichomonas vaginalis* (TV), and ribosomal RNA from *Mycoplasma genitalium* (MG) to aid in the diagnosis of urogenital disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes: CT: vaginal swabs (clinician-collected and self-collected in a clinical settings), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs NG: vaginal swabs (clinician-collected and self-collected in a clinical settings), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs TV: vaginal swabs (clinician-collected and self-collected in a clinical settings), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine MG: vaginal swabs (clinician collected and self-collected in a clinical | (PCR) assay for the direct, qualitative detection of the plasmid DNA of *Chlamydia trachomatis* and the genomic DNA of *Neisseria gonorrhoeae*. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens. | utilizes target capture for the *in vitro* qualitative detection and differentiation of ribosomal RNA (rRNA) from *Chlamydia trachomatis* (CT) and/or *Neisseria gonorrhoeae* (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther System as specified. On the Panther System, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal, throat, rectal, and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt Solution, patient-collected vaginal swab specimens,^{1} and female and male urine specimens. ^{1}Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Aptima Multitest Swab Specimen Collection kit has not been evaluated for home use. | | --- | --- | --- | --- | K202977 - Page 7 of 65 {7} | | settings), endocervical swabs, and male urine A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if *M. genitalium* infection is suspected. | | | | --- | --- | --- | --- | | Assay Type | Qualitative Nucleic acid amplification | Qualitative Nucleic acid amplification | Qualitative Nucleic acid amplification | | Amplification Technology | Real Time RT-PCR | Real Time PCR | Target Capture (TC), Transcription-mediated Amplification (TMA), Dual Kinetic Assay (DKA) | | Assay Targets | CT ribosomal RNA NG genomic DNA TV ribosomal RNA MG ribosomal RNA | CT cryptic plasmid DNA NG genomic DNA | CT ribosomal RNA NG ribosomal RNA | | Specimen Types | Endocervical swabs Self-collected vaginal swabs Clinician- collected vaginal swabs Male and female urine Gynecological specimens in PreservCyt Solution Oropharyngeal swabs Rectal swabs | Endocervical swabs Self-collected vaginal swabs Clinician- collected vaginal swabs Male and female urine Male urethral swabs | Endocervical swabs Self-collected vaginal swabs Clinician- collected vaginal swabs Male and female urine Male urethral swabs Gynecological specimens in PreservCyt Solution Oropharyngeal swabs Rectal swabs | | Sample Preparation | Automated extraction and purification | Automated extraction and purification | Automated extraction and purification | | Assay Controls | • External Negative and Positive Controls • Internal Processing Control (IC) • Sample Adequacy Cellular Control (CC) | • External Negative and Positive Control • Internal Cutoff Control • Internal Processing Control | • External Negative and Positive Controls | | Specimen Collection Kit(s) | Alinity m multi-Collect Specimen Collection Kit | Abbott multi-Collect Specimen Collection Kit | • Aptima Multitest Swab Specimen Collection Kit | K202977 - Page 8 of 65 {8} | | | | - • Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens - • Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens | | --- | --- | --- | --- | ### Testing for TV and MG | Device & Predicate Device(s): | K202977 | K151589 | DEN180047 | | --- | --- | --- | --- | | Device Trade Name | Alinity m STI | BD Max CT/GC/TV | Aptima Mycoplasma genitalium Assay | | General Device Characteristic Similarities and Differences | | | | | Intended Use/Indications For Use | The Alinity m STI Assay is an *in vitro* polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from *Chlamydia trachomatis* (CT), DNA from *Neisseria gonorrhoeae* (NG), ribosomal RNA from *Trichomonas vaginalis* (TV), and ribosomal RNA from *Mycoplasma genitalium* (MG) to aid in the diagnosis of urogenital disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes: CT: vaginal swabs (clinician-collected and self-collected in a | The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from *Chlamydia trachomatis* (CT), *Neisseria gonorrhoeae* (GC) and/or *Trichomonas vaginalis* (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, | The Aptima Mycoplasma genitalium assay is an *in vitro* nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from *Mycoplasma genitalium* on the fully automated Panther system. It is intended for use as an aid in the diagnosis of *M. genitalium* urogenital infections in male and female patients suspected of *M. genitalium* infection. The assay may be used to test the following specimens: clinician-collected and self-collected vaginal swabs (in a clinical setting), clinician-collected endocervical swabs, female and male urine, clinician-collected male urethral swabs, and self-collected penile meatal | K202977 - Page 9 of 65 {9} | | clinical settings), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs NG: vaginal swabs (clinician-collected and self-collected in a clinical settings), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs TV: vaginal swabs (clinician-collected and self-collected in a clinical settings), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine MG: vaginal swabs (clinician collected and self-collected in a clinical settings), endocervical swabs, and male urine A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if *M. genitalium* infection is suspected. | gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals. | swabs (in a clinical setting). For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting *M. genitalium* than other specimen types; however, female urine or clinician-collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if *M. genitalium* infection is suspected. | | --- | --- | --- | --- | K202977 - Page 10 of 65 {10} | Assay Type | Qualitative Nucleic acid amplification | Qualitative Nucleic acid amplification | Qualitative Nucleic acid amplification | | --- | --- | --- | --- | | Amplification Technology | Real Time PCR | Real Time PCR | Target Capture (TC), Transcription-mediated Amplification (TMA), Hybridization Protection Assay (HPA) | | Assay Targets | CT ribosomal RNA NG genomic DNA TV ribosomal RNA MG ribosomal RNA | CT genomic DNA NG genomic DNA TV genomic DNA | MG ribosomal RNA (16s rRNA) | | Specimen Types | Endocervical swabs Self-collected vaginal swabs Clinician- collected vaginal swabs Male and female urine Gynecological specimens in PreservCyt Solution Oropharyngeal swabs Rectal swabs | Endocervical swabs Self-collected vaginal swabs Male and female urine | Endocervical swabs Self-collected vaginal swabs Clinician- collected vaginal swabs Male and female urine Male urethral swabs Self-collected penile meatal swabs | | Sample Preparation | Automated extraction and purification | Automated extraction and purification | Automated extraction and purification | | Assay Controls | • External Negative and • Positive Controls • Internal processing Control (IC) • Sample adequacy Cellular Control (CC) | • Internal Processing Control | • Internal Processing Control | | Specimen Collection Kit(s) | • Alinity m multi- Collect Specimen Collection Kit | • BD MAX Urine Transport Kit • BD MAX 3-in-1 Swab Collection Kit | • Aptima Multitest Swab Specimen Collection Kit • Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens • Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens | K202977 - Page 11 of 65 {11} ## **VI Standards/Guidance Documents Referenced:** AMMI/ANSI/ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. I/ANSI/ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. CLSI Guideline EP12-A2, “User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline.” Second Edition. CLSI Guideline EP15-A3, “User Verification of Precision and Estimation of Bias;Approved Guideline.” Third edition. FDA Guidance Document, “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis, 2015.” ## **VII Performance Characteristics:** ### **A Analytical Performance:** #### **1. Precision/Reproducibility:** ##### Within Laboratory Precision The within-laboratory precision of the Alinity m STI assay was evaluated by testing 13 panel members prepared in three different sample matrices that represent urogenital specimen types: urine and two contrived matrices described in section B.2. For each specimen matrix, the 13 panel members were prepared by spiking with quantified stocks of whole organisms in combinations of the four target organisms CT, NG, TV, and MG. The following target concentrations were evaluated for each organism: LoD (targeting the limit of detection), low positive (targeting 2x claimed LoD), high positive (targeting ≥ 5x LoD), and a high negative (targeting 0.3x LoD); a negative panel member consisted of unspiked matrix. Each panel member was tested in two replicates, twice each day for 12 days, on three Alinity m Systems with three reagent lots, for a total of 144 replicates. Three operators performed the testing. The results were evaluated for % agreement with expected results. Additionally, the mean, standard deviation and % CV were calculated for each component of variability (within-run, between run, between day, between lot/instrument, and overall/total) for each panel member, for each matrix, and for each of the four target organisms. **Precision Panel Composition** | Panel Member | CT | NG | TV | MG | | --- | --- | --- | --- | --- | | 1 | Negative | Negative | Negative | Negative | | 2 | Low Positive | Negative | Negative | Negative | | 3 | Negative | Low Positive | Negative | Negative | K202977 - Page 12 of 65 {12} | 4 | Negative | Negative | Low Positive | Negative | | --- | --- | --- | --- | --- | | 5 | Negative | Negative | Negative | Low Positive | | 6 | Low Positive | Low Positive | Low Positive | Low Positive | | 7 | High Positive | Low Positive | Low Positive | Low Positive | | 8 | Low Positive | High Positive | Low Positive | Low Positive | | 9 | Low Positive | Low Positive | High Positive | Low Positive | | 10 | Low Positive | Low Positive | Low Positive | High Positive | | 11 | High Positive, | High Positive | High Positive | High Positive | | 12 | Near LoD | Near LoD | Near LoD | Near LoD | | 13 | High Negative | High Negative | High Negative | High Negative | ### *Data Analysis* The data was analyzed for percent agreement with expected results (positive or negative); the summary of the qualitative analysis is as follows. #### For CT: - For the panel members with CT concentration at near LoD or above (Panel Member 2, 6-12), the positive percent agreement with expected results was 100% (3456/3456), 95% CI: (99.9%-100%) across instruments, lots and matrices. - For the High Negative Panel Member 13, the CT positivity rate ranged from 27.8% to 61.1% across instruments, lots and matrices. - For the panel members without CT Target (Panel Member 1, 3-5), 1726 samples returned the expected negative results, for the overall negative percent agreement of 99.9% (1726/1728), 95% CI (99.6%-100%), across instruments, lots and matrices. #### For NG: - For the panel members with NG concentration at near LoD or above (Panel Member 3, 6-12), the positive percent agreement with expected results was 100% (3456/3456), 95% CI: (99.9%-100%), across instruments, lots and matrices. - For the High Negative Panel Member 13, the NG positivity rate ranged from 45.1% to 84.7% across instruments, lots and matrices. - For the panel members without NG target (Panel Member 1, 2, 4, 5), all samples returned the expected negative results, for the overall negative percent of 100% (1728/1728), 95% CI: (99.8%-100%), across instruments, lots and matrices. #### For TV: - For the panel members with TV concentration at near LoD or above (Panel Member 4, 6-12), the positive percent agreement with expected results was 99.97% (3455/3456), 95% CI: (99.8%-100%), across instruments, lots and matrices. - For the High Negative Panel Member 13, the TV positivity rate ranged from 23.6% to 93.8% across instruments, lots and matrices. - For the panel members without TV target (Panel Member 1, 2, 3, 5), the negative percent agreement was 99.8% (1724/1728), 95% CI: (99.4%-99.9%), across instruments, lots and matrices. K202977 - Page 13 of 65 {13} For MG: - For the panel members with MG concentration at near LoD or above (Panel Member 5-12), the positive percent agreement with expected results was 100% (3456/3456), 95% CI: (99.9%-100%), across instruments, lots and matrices. - For the High Negative Panel Member 13, the MG positivity rate ranged from 45.1% to 77.1% across instruments, lots and matrices. - For the panel members without MG target (Panel Member 1, 2, 3, 5), the negative percent agreement was 100% (1728/1728), 95% CI: (99.8%-100%), across instruments, lots and matrices. Additionally, the analysis of each variance component was performed for each positive target (near LoD and above) based on the generated signal (CN), using the random effects ANOVA model. The point estimates of the means, standard deviations (SD), and percent coefficient of variation (%CV) were reported. The SD and %CV were calculated for each component of variability. The total assay variability was defined as the sum of the within-run (residual error) component, the between-run component, the between-day component and between-instrument component estimates of variability. The summary of the within-laboratory precision data is shown below. K202977 - Page 14 of 65 {14} ## Within-lab Precision: CT Results | Matrix | Panel Description | N^{a} | n^{b} | Agreement (n/N) | Mean CN | Within-Run Component | | Between-Run Component | | Between-Day Component | | Within-Laboratory^{c} | | Between-Instrument/Lot Component | | Total^{d} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | CT High Pos (NG, TV & MG High Pos) | 144 | 144 | 100.0% | 16.62 | 0.191 | 1.2 | 0.133 | 0.8 | 0.133 | 0.8 | 0.655 | 3.9 | 0.094 | 0.6 | 0.662 | 4.0 | | | CT High Pos (NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 17.03 | 0.162 | 1.0 | 0.138 | 0.8 | 0.138 | 0.8 | 0.457 | 2.7 | 0.229 | 1.3 | 0.511 | 3.0 | | | CT at 2X LOD Claim (TV High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.18 | 0.246 | 0.8 | 0.121 | 0.4 | 0.121 | 0.4 | 0.613 | 2.0 | 0.160 | 0.5 | 0.634 | 2.1 | | | CT at 2X LOD Claim (NG High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.65 | 0.171 | 0.6 | 0.125 | 0.4 | 0.125 | 0.4 | 0.352 | 1.1 | 0.232 | 0.8 | 0.422 | 1.4 | | | CT at 2 X LOD Claim (MG High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.37 | 0.213 | 0.7 | 0.069 | 0.2 | 0.069 | 0.2 | 0.311 | 1.0 | 0.231 | 0.8 | 0.388 | 1.3 | | | CT at 2X LOD Claim (NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.80 | 0.380 | 1.2 | 0.079 | 0.3 | 0.079 | 0.3 | 0.489 | 1.6 | 0.321 | 1.0 | 0.585 | 1.9 | | | CT at 2X LOD Claim (CT only) | 144 | 144 | 100.0% | 30.23 | 0.180 | 0.6 | 0.165 | 0.5 | 0.165 | 0.5 | 0.287 | 0.9 | 0.177 | 0.6 | 0.337 | 1.1 | | | CT at LOD Claim | 144 | 144 | 100.0% | 31.73 | 0.164 | 0.5 | 0.112 | 0.4 | 0.112 | 0.4 | 0.404 | 1.3 | 0.204 | 0.6 | 0.453 | 1.4 | | | CT at Sub-LOD (High Negative) | 144 | 76 | 52.8% | 37.08 | 0.522 | 1.4 | 0.101 | 0.3 | 0.101 | 0.3 | 0.630 | 1.7 | 0.240 | 0.6 | 0.675 | 1.8 | | | CT Negative^{e} | 576 | 575 | 99.8% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | CT High Pos (NG, TV & MG High Pos) | 144 | 144 | 100.0% | 16.94 | 0.219 | 1.3 | 1.645 | 9.7 | 1.645 | 9.7 | 1.659 | 9.8 | 0.253 | 1.5 | 1.679^{f} | 9.9^{f} | | | CT High Pos (NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 16.97 | 0.083 | 0.5 | 0.046 | 0.3 | 0.046 | 0.3 | 0.103 | 0.6 | 0.109 | 0.6 | 0.150 | 0.9 | | | CT at 2X LOD Claim (TV High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.58 | 0.102 | 0.3 | 0.000 | 0.0 | 0.000 | 0.0 | 0.116 | 0.4 | 0.113 | 0.4 | 0.162 | 0.5 | | | CT at 2X LOD Claim (NG High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.53 | 0.102 | 0.3 | 0.037 | 0.1 | 0.037 | 0.1 | 0.125 | 0.4 | 0.140 | 0.5 | 0.188 | 0.6 | | | CT at 2 X LOD Claim (MG High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 29.62 | 0.113 | 0.4 | 0.027 | 0.1 | 0.027 | 0.1 | 0.119 | 0.4 | 0.137 | 0.5 | 0.181 | 0.6 | | | CT at 2X LOD Claim (NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.60 | 0.163 | 0.5 | 0.071 | 0.2 | 0.071 | 0.2 | 0.183 | 0.6 | 0.170 | 0.6 | 0.249 | 0.8 | | | CT at 2X LOD Claim (CT only) | 144 | 144 | 100.0% | 29.71 | 0.084 | 0.3 | 0.022 | 0.1 | 0.022 | 0.1 | 0.090 | 0.3 | 0.105 | 0.4 | 0.138 | 0.5 | | | CT at LOD Claim | 144 | 144 | 100.0% | 30.51 | 0.230 | 0.8 | 0.036 | 0.1 | 0.036 | 0.1 | 0.236 | 0.8 | 0.117 | 0.4 | 0.264 | 0.9 | | | CT at Sub-LOD (High Negative) | 144 | 88 | 61.1% | 36.60 | 0.543 | 1.5 | 0.193 | 0.5 | 0.193 | 0.5 | 0.576 | 1.6 | 0.298 | 0.8 | 0.649 | 1.8 | | | CT Negative^{e} | 576 | 575 | 99.8% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | $^{a}$ N:Total number of replicates $^{b}$ n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. $^{c}$ Within-Laboratory includes Within-Run, Between-Run and Between-Day Components. $^{d}$ Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components. $^{e}$ The negative panel included 4 panel members negative for CT $^{f}$ Two samples had cellular control (CC) failures and very late target CNs. Because the Alinity m STI assay reports positive results even if the CC fails, the CNs from these replicates were included in the total SD and %CV. Without those samples, the total SD was 0.143 and the total %CV was 0.9. Page 15 of 65 {15} # Within-lab Precision: NG Results | Matrix | Panel Description | N^{a} | N^{b} | Agreement (n/N) | Mean CN | Within-Run Component | | Between-Run Component | | Between-Day Component | | Within- Laboratory^{c} | | Between- Instrument/Lot Component | | Total^{d} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | NG High Pos (CT, TV & MG High Pos) | 144 | 144 | 100.0% | 21.89 | 0.183 | 0.8 | 0.138 | 0.6 | 0.138 | 0.6 | 0.322 | 1.5 | 0.209 | 1.0 | 0.384 | 1.8 | | | NG High Pos (CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 22.41 | 0.230 | 1.0 | 0.206 | 0.9 | 0.206 | 0.9 | 0.416 | 1.9 | 0.193 | 0.9 | 0.458 | 2.0 | | | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.95 | 0.287 | 0.9 | 0.044 | 0.1 | 0.044 | 0.1 | 0.391 | 1.3 | 0.140 | 0.5 | 0.415 | 1.3 | | | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.72 | 0.245 | 0.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.318 | 1.0 | 0.197 | 0.6 | 0.374 | 1.2 | | | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.37 | 0.291 | 0.9 | 0.207 | 0.7 | 0.207 | 0.7 | 0.433 | 1.4 | 0.022 | 0.1 | 0.434 | 1.4 | | | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.24 | 0.212 | 0.7 | 0.144 | 0.5 | 0.144 | 0.5 | 0.346 | 1.1 | 0.093 | 0.3 | 0.359 | 1.1 | | | NG at 2X LOD Claim (NG only) | 144 | 144 | 100.0% | 31.23 | 0.189 | 0.6 | 0.000 | 0.0 | 0.000 | 0.0 | 0.241 | 0.8 | 0.083 | 0.3 | 0.255 | 0.8 | | | NG at LOD Claim | 144 | 144 | 100.0% | 32.32 | 0.217 | 0.7 | 0.149 | 0.5 | 0.149 | 0.5 | 0.384 | 1.2 | 0.126 | 0.4 | 0.404 | 1.3 | | | NG at Sub-LOD (High Negative) | 144 | 119 | 82.6% | 37.80 | 0.849 | 2.2 | 0.191 | 0.5 | 0.191 | 0.5 | 0.870 | 2.3 | 0.527 | 1.4 | 1.017 | 2.7 | | | NG Negative^{e} | 576 | 576 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | NG High Pos (CT, TV & MG High Pos) | 144 | 144 | 100.0% | 21.31 | 0.135 | 0.6 | 0.117 | 0.6 | 0.117 | 0.6 | 0.194 | 0.9 | 0.232 | 1.1 | 0.303 | 1.4 | | | NG High Pos (CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 22.07 | 0.165 | 0.7 | 0.184 | 0.8 | 0.184 | 0.8 | 0.342 | 1.5 | 0.134 | 0.6 | 0.367 | 1.7 | | | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.45 | 0.179 | 0.6 | 0.092 | 0.3 | 0.092 | 0.3 | 0.238 | 0.8 | 0.126 | 0.4 | 0.270 | 0.9 | | | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.32 | 0.159 | 0.5 | 0.166 | 0.5 | 0.166 | 0.5 | 0.289 | 0.9 | 0.136 | 0.4 | 0.319 | 1.0 | | | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.40 | 0.173 | 0.5 | 0.258 | 0.8 | 0.258 | 0.8 | 0.323 | 1.0 | 0.000 | 0.0 | 0.323 | 1.0 | | | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.33 | 0.192 | 0.6 | 0.119 | 0.4 | 0.119 | 0.4 | 0.276 | 0.9 | 0.171 | 0.5 | 0.324 | 1.0 | | | NG at 2X LOD Claim (NG only) | 144 | 144 | 100.0% | 31.49 | 0.173 | 0.6 | 0.096 | 0.3 | 0.096 | 0.3 | 0.205 | 0.6 | 0.196 | 0.6 | 0.283 | 0.9 | | | NG at LOD Claim | 144 | 144 | 100.0% | 32.16 | 0.201 | 0.6 | 0.103 | 0.3 | 0.103 | 0.3 | 0.243 | 0.8 | 0.127 | 0.4 | 0.274 | 0.9 | | | NG at Sub-LOD (High Negative) | 144 | 122 | 84.7% | 36.76 | 0.730 | 2.0 | 0.198 | 0.5 | 0.198 | 0.5 | 0.757 | 2.1 | 0.266 | 0.7 | 0.802 | 2.2 | | | NG Negative^{e} | 576 | 576 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | PreservCyt | NG High Pos (CT, TV & MG High Pos) | 144 | 144 | 100.0% | 21.28 | 0.147 | 0.7 | 0.177 | 0.8 | 0.177 | 0.8 | 0.230 | 1.1 | 0.162 | 0.8 | 0.281 | 1.3 | | | NG High Pos (CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 24.04 | 0.191 | 0.8 | 0.063 | 0.3 | 0.063 | 0.3 | 0.205 | 0.9 | 0.232 | 1.0 | 0.310 | 1.3 | | | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.66 | 0.181 | 0.6 | 0.082 | 0.3 | 0.082 | 0.3 | 0.199 | 0.6 | 0.129 | 0.4 | 0.237 | 0.8 | | | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.91 | 0.164 | 0.5 | 0.086 | 0.3 | 0.086 | 0.3 | 0.198 | 0.6 | 0.220 | 0.7 | 0.296 | 1.0 | | | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.80 | 0.253 | 0.8 | 0.081 | 0.3 | 0.081 | 0.3 | 0.278 | 0.9 | 0.134 | 0.4 | 0.309 | 1.0 | | | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.35 | 0.219 | 0.7 | 0.103 | 0.3 | 0.103 | 0.3 | 0.242 | 0.8 | 0.195 | 0.6 | 0.311 | 1.0 | | | NG at 2X LOD Claim (NG only) | 144 | 144 | 100.0% | 31.18 | 0.224 | 0.7 | 0.109 | 0.4 | 0.109 | 0.4 | 0.266 | 0.9 | 0.250 | 0.8 | 0.365 | 1.2 | | | NG at LOD Claim | 144 | 144 | 100.0% | 32.87 | 0.272 | 0.8 | 0.185 | 0.6 | 0.185 | 0.6 | 0.329 | 1.0 | 0.153 | 0.5 | 0.363 | 1.1 | | | NG at Sub-LOD (High Negative) | 144 | 65 | 45.1% | 37.31 | 0.613 | 1.6 | 0.332 | 0.9 | 0.332 | 0.9 | 0.698 | 1.9 | 0.232 | 0.6 | 0.735 | 2.0 | | | NG Negative^{e} | 576 | 576 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | a N: total number of replicates b n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. c Within-Laboratory includes Within-Run, Between-Run and Between-Day Components. d Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components. e The negative panel included 4 panel members negative for NG {16} ## Within-lab Precision: TV Results | Matrix | Panel Description | N^{a} | N^{b} | Agreement (n/N) | Mean CN | Within-Run Component | | Between-Run Component | | Between-Day Component | | Within- Laboratory^{c} | | Between- Instrument/Lot Component | | Total^{d} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | TV High Pos (CT, NG & MG High Pos) | 144 | 144 | 100.0% | 9.85 | 0.274 | 2.8 | 0.178 | 1.8 | 0.178 | 1.8 | 0.706 | 7.2 | 0.256 | 2.6 | 0.751 | 7.6 | | | TV High Pos (CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 9.85 | 0.353 | 3.6 | 0.204 | 2.1 | 0.204 | 2.1 | 0.758 | 7.7 | 0.357 | 3.6 | 0.837 | 8.5 | | | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.30 | 0.245 | 0.9 | 0.101 | 0.4 | 0.101 | 0.4 | 0.360 | 1.3 | 0.295 | 1.1 | 0.465 | 1.7 | | | TV at 2X LOD Claim (NG High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.60 | 0.186 | 0.7 | 0.175 | 0.6 | 0.175 | 0.6 | 0.397 | 1.4 | 0.353 | 1.3 | 0.531 | 1.9 | | | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.58 | 0.224 | 0.8 | 0.061 | 0.2 | 0.061 | 0.2 | 0.461 | 1.7 | 0.297 | 1.1 | 0.548 | 2.0 | | | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | 144 | 143 | 99.3% | 27.84 | 0.210 | 0.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.368 | 1.3 | 0.341 | 1.2 | 0.502 | 1.8 | | | TV at 2X LOD Claim (TV only) | 144 | 144 | 100.0% | 27.22 | 0.266 | 1.0 | 0.000 | 0.0 | 0.000 | 0.0 | 0.393 | 1.4 | 0.375 | 1.4 | 0.543 | 2.0 | | | TV at LOD Claim | 144 | 144 | 100.0% | 28.73 | 0.355 | 1.2 | 0.190 | 0.7 | 0.190 | 0.7 | 0.520 | 1.8 | 0.321 | 1.1 | 0.611 | 2.1 | | | TV at Sub-LOD (High Negative) | 144 | 34 | 23.6% | 33.89 | 0.956 | 2.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.978 | 2.9 | 0.355 | 1.0 | 1.041 | 3.1 | | | TV Negative^{e} | 576 | 574 | 99.7% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | TV High Pos (CT, NG & MG High Pos) | 144 | 144 | 100.0% | 10.44 | 0.267 | 2.6 | 1.679 | 16.1 | 1.679 | 16.1 | 1.704 | 16.3 | 0.583 | 5.6 | 1.801^{f} | 17.3^{f} | | | TV High Pos (CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 10.13 | 0.170 | 1.7 | 0.025 | 0.2 | 0.025 | 0.2 | 0.221 | 2.2 | 0.371 | 3.7 | 0.432 | 4.3 | | | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.31 | 0.376 | 1.3 | 0.159 | 0.5 | 0.159 | 0.5 | 0.409 | 1.4 | 0.295 | 1.0 | 0.504 | 1.7 | | | TV at 2X LOD Claim (NG High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.11 | 0.192 | 0.7 | 0.093 | 0.3 | 0.093 | 0.3 | 0.265 | 0.9 | 0.330 | 1.1 | 0.423 | 1.5 | | | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.24 | 0.200 | 0.7 | 0.161 | 0.6 | 0.161 | 0.6 | 0.280 | 1.0 | 0.298 | 1.0 | 0.409 | 1.4 | | | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 28.94 | 0.338 | 1.2 | 0.165 | 0.6 | 0.165 | 0.6 | 0.402 | 1.4 | 0.275 | 0.9 | 0.487 | 1.7 | | | TV at 2X LOD Claim (TV only) | 144 | 144 | 100.0% | 26.99 | 0.190 | 0.7 | 0.054 | 0.2 | 0.054 | 0.2 | 0.207 | 0.8 | 0.264 | 1.0 | 0.336 | 1.2 | | | TV at LOD Claim | 144 | 144 | 100.0% | 29.75 | 0.334 | 1.1 | 0.055 | 0.2 | 0.055 | 0.2 | 0.352 | 1.2 | 0.259 | 0.9 | 0.437 | 1.5 | | | TV at Sub-LOD (High Negative) | 144 | 135 | 93.8% | 33.55 | 0.378 | 1.1 | 0.000 | 0.0 | 0.000 | 0.0 | 0.411 | 1.2 | 0.151 | 0.5 | 0.438 | 1.3 | | | TV Negative^{e} | 576 | 575 | 99.8% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | PreservCyt | TV High Pos (CT, NG & MG High Pos) | 144 | 144 | 100.0% | 9.11 | 0.182 | 2.0 | 0.152 | 1.7 | 0.152 | 1.7 | 0.238 | 2.6 | 0.394 | 4.3 | 0.460 | 5.1 | | | TV High Pos (CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 8.54 | 0.166 | 1.9 | 0.099 | 1.2 | 0.099 | 1.2 | 0.193 | 2.3 | 0.356 | 4.2 | 0.405 | 4.7 | | | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 26.98 | 0.291 | 1.1 | 0.126 | 0.5 | 0.126 | 0.5 | 0.317 | 1.2 | 0.368 | 1.4 | 0.486 | 1.8 | | | TV at 2X LOD Claim (NG High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.41 | 0.216 | 0.8 | 0.206 | 0.8 | 0.206 | 0.8 | 0.304 | 1.1 | 0.376 | 1.4 | 0.483 | 1.8 | | | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 26.59 | 0.166 | 0.6 | 0.063 | 0.2 | 0.063 | 0.2 | 0.180 | 0.7 | 0.315 | 1.2 | 0.363 | 1.4 | | | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 28.11 | 0.289 | 1.0 | 0.124 | 0.4 | 0.124 | 0.4 | 0.314 | 1.1 | 0.248 | 0.9 | 0.401 | 1.4 | | | TV at 2X LOD Claim (TV only) | 144 | 144 | 100.0% | 27.88 | 0.128 | 0.5 | 0.101 | 0.4 | 0.101 | 0.4 | 0.201 | 0.7 | 0.331 | 1.2 | 0.388 | 1.4 | | | TV at LOD Claim | 144 | 144 | 100.0% | 29.01 | 0.452 | 1.6 | 0.000 | 0.0 | 0.000 | 0.0 | 0.466 | 1.6 | 0.247 | 0.9 | 0.527 | 1.8 | | | TV at Sub-LOD (High Negative) | 144 | 85 | 59.0% | 33.95 | 0.352 | 1.0 | 0.000 | 0.0 | 0.000 | 0.0 | 0.373 | 1.1 | 0.096 | 0.3 | 0.385 | 1.1 | Page 17 of 65 {17} TV Negativeᵃ 576 575 99.8% ᵃ N: Total number of replicates. ᵇ n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. ᶜ Within-Laboratory includes Within-Run, Between-Run and Between-Day Components. ᵈ Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components. ᵉ The negative panel included 4 panel members negative for TV. ᶠ Two samples had cellular control (CC) failures and very late target CNs. Because the Alinity m STI Assay reports positive results even if the CC fails, the CNs from these replicates were included in the total SD and %CV. Without those samples, the total SD was 0.402 and the total %CV was 3.9 Page 18 of 65 {18} ## Within-lab Precision: MG Results | Matrix | Panel Description | N^{a} | N^{b} | Agreement (n/N) | Mean CN | Within-Run Component | | Between-Run Component | | Between-Day Component | | Within-Laboratory^{c} | | Between-Instrument/Lot Component | | Total^{d} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | MG High Pos (CT, NG & TV High Pos) | 144 | 144 | 100.0% | 20.57 | 0.199 | 1.0 | 0.149 | 0.7 | 0.149 | 0.7 | 0.660 | 3.2 | 0.423 | 2.1 | 0.784 | 3.8 | | | MG High Pos (CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 21.63 | 0.219 | 1.0 | 0.098 | 0.5 | 0.098 | 0.5 | 0.352 | 1.6 | 0.472 | 2.2 | 0.589 | 2.7 | | | MG at 2X LOD Claim (TV High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.39 | 0.315 | 1.0 | 0.148 | 0.5 | 0.148 | 0.5 | 0.692 | 2.2 | 0.443 | 1.4 | 0.822 | 2.6 | | | MG at 2X LOD Claim (NG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.76 | 0.242 | 0.8 | 0.182 | 0.6 | 0.182 | 0.6 | 0.438 | 1.4 | 0.498 | 1.6 | 0.663 | 2.1 | | | MG at 2X LOD Claim (CT High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.74 | 0.242 | 0.8 | 0.112 | 0.4 | 0.112 | 0.4 | 0.517 | 1.6 | 0.440 | 1.4 | 0.679 | 2.1 | | | MG at 2X LOD Claim (CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.77 | 0.672 | 2.1 | 0.000 | 0.0 | 0.000 | 0.0 | 0.758 | 2.4 | 0.559 | 1.8 | 0.942 | 3.0 | | | MG at 2X LOD Claim (MG only) | 144 | 144 | 100.0% | 31.73 | 0.139 | 0.4 | 0.087 | 0.3 | 0.087 | 0.3 | 0.305 | 1.0 | 0.376 | 1.2 | 0.484 | 1.5 | | | MG at LOD Claim | 144 | 144 | 100.0% | 32.90 | 0.317 | 1.0 | 0.126 | 0.4 | 0.126 | 0.4 | 0.589 | 1.8 | 0.530 | 1.6 | 0.792 | 2.4 | | | MG at Sub-LOD (High Negative) | 144 | 111 | 77.1% | 38.85 | 1.084 | 2.8 | 0.125 | 0.3 | 0.125 | 0.3 | 1.364 | 3.5 | 0.000 | 0.0 | 1.364 | 3.5 | | | MG Negative^{e} | 576 | 576 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | MG High Pos (CT, NG & TV High Pos) | 144 | 144 | 100.0% | 19.85 | 0.404 | 2.0 | 1.826 | 9.2 | 1.826 | 9.2 | 1.870 | 9.4 | 0.574 | 2.9 | 1.956^{f} | 9.9^{f} | | | MG High Pos (CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 20.58 | 0.141 | 0.7 | 0.081 | 0.4 | 0.081 | 0.4 | 0.163 | 0.8 | 0.382 | 1.9 | 0.415 | 2.0 | | | MG at 2X LOD Claim (TV High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.90 | 0.141 | 0.5 | 0.017 | 0.1 | 0.017 | 0.1 | 0.153 | 0.5 | 0.337 | 1.1 | 0.370 | 1.2 | | | MG at 2X LOD Claim (NG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.76 | 0.158 | 0.5 | 0.038 | 0.1 | 0.038 | 0.1 | 0.182 | 0.6 | 0.324 | 1.1 | 0.371 | 1.2 | | | MG at 2X LOD Claim (CT High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.86 | 0.123 | 0.4 | 0.072 | 0.2 | 0.072 | 0.2 | 0.147 | 0.5 | 0.307 | 1.0 | 0.340 | 1.1 | | | MG at 2X LOD Claim (CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.72 | 0.199 | 0.6 | 0.130 | 0.4 | 0.130 | 0.4 | 0.243 | 0.8 | 0.327 | 1.1 | 0.407 | 1.3 | | | MG at 2X LOD Claim (MG only) | 144 | 144 | 100.0% | 31.31 | 0.137 | 0.4 | 0.079 | 0.3 | 0.079 | 0.3 | 0.160 | 0.5 | 0.252 | 0.8 | 0.298 | 1.0 | | | MG at LOD Claim | 144 | 144 | 100.0% | 31.55 | 0.248 | 0.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.248 | 0.8 | 0.270 | 0.9 | 0.367 | 1.2 | | | MG at Sub-LOD (High Negative) | 144 | 94 | 65.3% | 35.95 | 0.409 | 1.1 | 0.263 | 0.7 | 0.263 | 0.7 | 0.487 | 1.4 | 0.171 | 0.5 | 0.516 | 1.4 | | | MG Negative^{e} | 576 | 576 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | $^{a}$ N: Total number of replicates $^{b}$ n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. $^{c}$ Within-Laboratory includes Within-Run, Between-Run and Between-Day Components. $^{d}$ Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components $^{e}$ The negative panel included 4 panel members negative for MG. $^{f}$ Two samples had cellular control (CC) failures and very late target CNs. Because the Alinity m STI Assay reports positive results even if the CC fails, the CNs from these replicates were included in the total SD and %CV. Without those samples, the total SD was 0.361 and the total %CV was 1.8. ## Reproducibility The Alinity m STI Assay Reproducibility panel consisted of 13 primary panel members, prepared in urine and other matrices, as described above for the Within-laboratory Precision study. The reproducibility testing was conducted at three clinical sites over five days of testing, using two lots of Alinity m STI reagents, with each sample tested in 5 replicates. The summary of the results is shown below. Page 19 of 65 {19} ## Reproducibility Analysis: CT Results | Matrix | Panel Description | N^{a} | n^{b} | Agreement (n/N) | Mean CN | Within-Run/Day Component | | Between-Run/Day Component | | Between-Lot Component | | Between-Site Component | | Total^{c} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | CT High Pos (NG, TV & MG High Pos) | 150 | 150 | 100.0% | 19.31 | 0.405 | 2.1 | 0.278 | 1.4 | 0.144 | 0.7 | 0.956 | 5.0 | 1.084 | 5.6 | | | CT High Pos (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 19.18 | 0.224 | 1.2 | 0.272 | 1.4 | 0.143 | 0.7 | 0.697 | 3.6 | 0.794 | 4.1 | | | CT at 2X LOD Claim (MG High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 31.50 | 0.243 | 0.8 | 0.209 | 0.7 | 0.114 | 0.4 | 0.592 | 1.9 | 0.683 | 2.2 | | | CT at 2X LOD Claim (TV High Pos, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.81 | 0.285 | 0.9 | 0.272 | 0.9 | 0.128 | 0.4 | 0.774 | 2.4 | 0.878 | 2.8 | | | CT at 2X LOD Claim (NG High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.47 | 0.189 | 0.6 | 0.270 | 0.9 | 0.000 | 0.0 | 0.609 | 1.9 | 0.692 | 2.2 | | | CT at 2X LOD Claim (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.34 | 0.200 | 0.6 | 0.262 | 0.8 | 0.063 | 0.2 | 0.561 | 1.8 | 0.654 | 2.1 | | | CT at 2X LOD Claim (CT only) | 150 | 150 | 100.0% | 31.29 | 0.182 | 0.6 | 0.244 | 0.8 | 0.148 | 0.5 | 0.402 | 1.3 | 0.526 | 1.7 | | | CT at LOD Claim | 150 | 149 | 99.3% | 32.05 | 0.344 | 1.1 | 0.157 | 0.5 | 0.245 | 0.8 | 0.464 | 1.4 | 0.647 | 2.0 | | | CT at Sub-LOD (High Negative) | 150 | 54 | 36.0% | 36.85 | 0.543 | 1.5 | 0.016 | 0.0 | 0.572 | 1.6 | 0.550 | 1.5 | 0.962 | 2.6 | | | CT Negative^{d} | 600 | 600 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | CT High Pos (NG, TV & MG High Pos) | 150 | 150 | 100.0% | 16.80 | 0.185 | 1.1 | 0.075 | 0.4 | 0.151 | 0.9 | 0.000 | 0.0 | 0.250 | 1.5 | | | CT High Pos (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 16.95 | 0.120 | 0.7 | 0.049 | 0.3 | 0.123 | 0.7 | 0.000 | 0.0 | 0.179 | 1.1 | | | CT at 2X LOD Claim (MG High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 29.59 | 0.147 | 0.5 | 0.097 | 0.3 | 0.133 | 0.4 | 0.000 | 0.0 | 0.221 | 0.7 | | | CT at 2X LOD Claim (TV High Pos, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.71 | 0.428 | 1.4 | 0.000 | 0.0 | 0.115 | 0.4 | 0.000 | 0.0 | 0.443 | 1.5 | | | CT at 2X LOD Claim (NG High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.53 | 0.159 | 0.5 | 0.104 | 0.4 | 0.130 | 0.4 | 0.000 | 0.0 | 0.230 | 0.8 | | | CT at 2X LOD Claim (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.57 | 0.130 | 0.4 | 0.091 | 0.3 | 0.111 | 0.4 | 0.000 | 0.0 | 0.193 | 0.7 | | | CT at 2X LOD Claim (CT only) | 150 | 150 | 100.0% | 29.45 | 0.129 | 0.4 | 0.088 | 0.3 | 0.133 | 0.5 | 0.000 | 0.0 | 0.206 | 0.7 | | | CT at LOD Claim | 150 | 150 | 100.0% | 30.47 | 0.222 | 0.7 | 0.069 | 0.2 | 0.169 | 0.6 | 0.000 | 0.0 | 0.288 | 0.9 | | | CT at Sub-LOD (High Negative) | 150 | 54 | 36.0% | 36.94 | 0.900 | 2.4 | 0.000 | 0.0 | 0.940 | 2.5 | 0.000 | 0.0 | 1.301 | 3.5 | | | CT Negative^{d} | 600 | 595 | 99.2% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | $^{a}$ N: Total number of replicates $^{b}$ n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. $^{c}$ Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components. $^{d}$ The negative panel included 4 panel members negative for CT Page 20 of 65 {20} ## Reproducibility Analysis: NG Results | Matrix | Panel Description | N^{a} | n^{b} | Agreement (n/N) | Mean CN | Within- Run/Day Component | | Between- Run/Day Component | | Between-Lot Component | | Between-Site Component | | Total^{c} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | NG High Pos (CT, TV & MG High Pos) | 150 | 150 | 100.0% | 24.85 | 0.513 | 2.1 | 1.162 | 4.7 | 0.547 | 2.2 | 0.448 | 1.8 | 1.453 | 5.8 | | | NG High Pos (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 26.05 | 0.436 | 1.7 | 1.136 | 4.4 | 0.594 | 2.3 | 0.974 | 3.7 | 1.668 | 6.4 | | | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 150 | 148 | 98.7% | 35.29 | 0.764 | 2.2 | 1.073 | 3.0 | 0.540 | 1.5 | 1.058 | 3.0 | 1.774 | 5.0 | | | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 34.70 | 0.735 | 2.1 | 1.089 | 3.1 | 0.160 | 0.5 | 0.760 | 2.2 | 1.526 | 4.4 | | | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 150 | 149 | 99.3% | 34.68 | 0.662 | 1.9 | 1.018 | 2.9 | 0.401 | 1.2 | 0.911 | 2.6 | 1.570 | 4.5 | | | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 150 | 147 | 98.0% | 35.37 | 1.004 | 2.8 | 1.093 | 3.1 | 0.679 | 1.9 | 1.037 | 2.9 | 1.934 | 5.5 | | | NG at 2X LOD Claim (NG only) | 150 | 145 | 96.7% | 35.84 | 0.767 | 2.1 | 0.677 | 1.9 | 0.796 | 2.2 | 1.025 | 2.9 | 1.652 | 4.6 | | | NG at LOD Claim | 150 | 141 | 94.0% | 36.20 | 0.931 | 2.6 | 1.110 | 3.1 | 0.526 | 1.5 | 0.870 | 2.4 | 1.770 | 4.9 | | | NG at Sub-LOD (High Negative) | 150 | 14 | 9.3% | 37.82 | 0.000 | 0.0 | 0.735 | 1.9 | 0.617 | 1.6 | 0.443 | 1.2 | 1.056 | 2.8 | | | NG Negative^{d} | 600 | 600 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | NG High Pos (CT, TV & MG High Pos) | 150 | 150 | 100.0% | 21.77 | 0.259 | 1.2 | 0.172 | 0.8 | 0.112 | 0.5 | 0.000 | 0.0 | 0.331 | 1.5 | | | NG High Pos (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 22.51 | 0.289 | 1.3 | 0.268 | 1.2 | 0.000 | 0.0 | 0.197 | 0.9 | 0.440 | 2.0 | | | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 31.63 | 0.316 | 1.0 | 0.159 | 0.5 | 0.155 | 0.5 | 0.139 | 0.4 | 0.411 | 1.3 | | | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.44 | 0.275 | 0.9 | 0.159 | 0.5 | 0.147 | 0.5 | 0.000 | 0.0 | 0.350 | 1.1 | | | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.68 | 0.294 | 0.9 | 0.262 | 0.8 | 0.000 | 0.0 | 0.136 | 0.4 | 0.417 | 1.3 | | | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.54 | 0.306 | 1.0 | 0.246 | 0.8 | 0.000 | 0.0 | 0.111 | 0.4 | 0.408 | 1.3 | | | NG at 2X LOD Claim (NG only) | 150 | 150 | 100.0% | 31.78 | 0.285 | 0.9 | 0.180 | 0.6 | 0.117 | 0.4 | 0.108 | 0.3 | 0.373 | 1.2 | | | NG at LOD Claim | 150 | 150 | 100.0% | 32.49 | 0.336 | 1.0 | 0.185 | 0.6 | 0.053 | 0.2 | 0.116 | 0.4 | 0.405 | 1.2 | | | NG at Sub-LOD (High Negative) | 150 | 80 | 53.3% | 36.95 | 0.934 | 2.5 | 0.000 | 0.0 | 0.126 | 0.3 | 0.163 | 0.4 | 0.956 | 2.6 | | | NG Negative^{d} | 600 | 600 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | PreservCyt | NG High Pos (CT, TV & MG High Pos) | 150 | 150 | 100.0% | 21.64 | 0.322 | 1.5 | 0.182 | 0.8 | 0.086 | 0.4 | 0.169 | 0.8 | 0.415 | 1.9 | | | NG High Pos (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 25.30 | 0.239 | 0.9 | 0.198 | 0.8 | 0.055 | 0.2 | 0.097 | 0.4 | 0.329 | 1.3 | | | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 31.08 | 0.285 | 0.9 | 0.231 | 0.7 | 0.142 | 0.5 | 0.000 | 0.0 | 0.394 | 1.3 | | | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.16 | 0.271 | 0.9 | 0.176 | 0.6 | 0.000 | 0.0 | 0.085 | 0.3 | 0.334 | 1.1 | | | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 30.39 | 0.328 | 1.1 | 0.163 | 0.5 | 0.137 | 0.5 | 0.000 | 0.0 | 0.392 | 1.3 | | | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 32.06 | 0.376 | 1.2 | 0.309 | 1.0 | 0.225 | 0.7 | 0.000 | 0.0 | 0.536 | 1.7 | | | NG at 2X LOD Claim (NG only) | 150 | 150 | 100.0% | 30.48 | 0.318 | 1.0 | 0.245 | 0.8 | 0.240 | 0.8 | 0.128 | 0.4 | 0.485 | 1.6 | Page 21 of 65 {21} | NG at LOD Claim | 150 | 150 | 100.0% | 33.10 | 0.413 | 1.2 | 0.166 | 0.5 | 0.193 | 0.6 | 0.000 | 0.0 | 0.486 | 1.5 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | NG at Sub-LOD (High Negative) | 150 | 63 | 42.0% | 37.46 | 0.742 | 2.0 | 0.000 | 0.0 | 0.323 | 0.9 | 0.000 | 0.0 | 0.810 | 2.2 | | NG Negative^{d} | 600 | 598 | 99.7% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | $^{a}$ N: total number of replicates $^{b}$ n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. $^{c}$ Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components. $^{d}$ The negative panel included 4 panel members negative for NG. Page 22 of 65 {22} ## Reproducibility Analysis: TV Results | Matrix | Panel Description | N^{a} | n^{b} | Agreement (n/N) | Mean CN | Within-Run/Day Component | | Between-Run/Day Component | | Between-Lot Component | | Between-Site Component | | Total^{c} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | TV High Pos (CT, NG & MG High Pos) | 150 | 150 | 100.0% | 11.58 | 0.606 | 5.2 | 0.387 | 3.3 | 0.000 | 0.0 | 0.979 | 8.5 | 1.215 | 10.5 | | | TV High Pos (CT, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 11.45 | 0.328 | 2.9 | 0.409 | 3.6 | 0.000 | 0.0 | 0.780 | 6.8 | 0.940 | 8.2 | | | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.61 | 0.364 | 1.2 | 0.251 | 0.8 | 0.253 | 0.8 | 0.687 | 2.2 | 0.855 | 2.7 | | | TV at 2X LOD Claim (NG High Pos, CT & MG at 2X LOD Claim) | 150 | 149 | 99.3% | 31.38 | 0.445 | 1.4 | 0.369 | 1.2 | 0.076 | 0.2 | 0.568 | 1.8 | 0.814 | 2.6 | | | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.56 | 0.397 | 1.3 | 0.206 | 0.7 | 0.321 | 1.0 | 0.692 | 2.2 | 0.884 | 2.8 | | | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.09 | 0.315 | 1.0 | 0.278 | 0.9 | 0.103 | 0.3 | 0.642 | 2.1 | 0.775 | 2.5 | | | TV at 2X LOD Claim (TV only) | 150 | 150 | 100.0% | 31.34 | 0.465 | 1.5 | 0.087 | 0.3 | 0.307 | 1.0 | 0.205 | 0.7 | 0.600 | 1.9 | | | TV at LOD Claim | 150 | 149 | 99.3% | 31.75 | 0.357 | 1.1 | 0.156 | 0.5 | 0.229 | 0.7 | 0.521 | 1.6 | 0.690 | 2.2 | | | TV at Sub-LOD (High Negative) | 150 | 56 | 37.3% | 34.88 | 0.937 | 2.7 | 0.227 | 0.7 | 0.485 | 1.4 | 0.314 | 0.9 | 1.124 | 3.2 | | | TV Negative^{d} | 600 | 596 | 99.3% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | TV High Pos (CT, NG & MG High Pos) | 150 | 150 | 100.0% | 10.43 | 0.312 | 3.0 | 0.145 | 1.4 | 0.322 | 3.1 | 0.000 | 0.0 | 0.472 | 4.5 | | | TV High Pos (CT, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 10.47 | 0.715 | 6.8 | 0.131 | 1.2 | 0.275 | 2.6 | 0.000 | 0.0 | 0.778 | 7.4 | | | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.29 | 0.494 | 1.7 | 0.283 | 1.0 | 0.116 | 0.4 | 0.000 | 0.0 | 0.581 | 2.0 | | | TV at 2X LOD Claim (NG High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.22 | 0.336 | 1.1 | 0.234 | 0.8 | 0.364 | 1.2 | 0.000 | 0.0 | 0.548 | 1.9 | | | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.33 | 0.349 | 1.2 | 0.134 | 0.5 | 0.364 | 1.2 | 0.000 | 0.0 | 0.522 | 1.8 | | | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.05 | 0.200 | 0.7 | 0.142 | 0.5 | 0.273 | 0.9 | 0.000 | 0.0 | 0.367 | 1.3 | | | TV at 2X LOD Claim (TV only) | 150 | 150 | 100.0% | 29.69 | 0.269 | 0.9 | 0.173 | 0.6 | 0.222 | 0.7 | 0.064 | 0.2 | 0.394 | 1.3 | | | TV at LOD Claim | 150 | 150 | 100.0% | 29.77 | 0.395 | 1.3 | 0.658 | 2.2 | 0.000 | 0.0 | 0.000 | 0.0 | 0.767 | 2.6 | | | TV at Sub-LOD (High Negative) | 150 | 74 | 49.3% | 34.22 | 1.272 | 3.7 | 0.918 | 2.7 | 0.522 | 1.5 | 0.000 | 0.0 | 1.653 | 4.8 | | | TV Negative^{d} | 600 | 596 | 99.3% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | PreservCyt | TV High Pos (CT, NG & MG High Pos) | 150 | 150 | 100.0% | 9.53 | 0.235 | 2.5 | 0.112 | 1.2 | 0.371 | 3.9 | 0.000 | 0.0 | 0.453 | 4.8 | | | TV High Pos (CT, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 8.96 | 0.233 | 2.6 | 0.137 | 1.5 | 0.300 | 3.3 | 0.000 | 0.0 | 0.404 | 4.5 | | | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | 150 | 150 | 100.0% | 27.32 | 0.419 | 1.5 | 0.166 | 0.6 | 0.226 | 0.8 | 0.000 | 0.0 | 0.505 | 1.8 | | | TV at 2X LOD Claim (NG High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 27.61 | 0.207 | 0.7 | 0.170 | 0.6 | 0.114 | 0.4 | 0.066 | 0.2 | 0.299 | 1.1 | | | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 26.77 | 0.559 | 2.1 | 0.262 | 1.0 | 0.229 | 0.9 | 0.000 | 0.0 | 0.658 | 2.5 | | | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 28.39 | 0.380 | 1.3 | 0.213 | 0.7 | 0.152 | 0.5 | 0.000 | 0.0 | 0.461 | 1.6 | | | TV at 2X LOD Claim (TV only) | 150 | 150 | 100.0% | 28.37 | 0.327 | 1.2 | 0.070 | 0.2 | 0.167 | 0.6 | 0.000 | 0.0 | 0.374 | 1.3 | Page 23 of 65 {23} | TV at LOD Claim | 150 | 150 | 100.0% | 29.32 | 0.599 | 2.0 | 0.000 | 0.0 | 0.184 | 0.6 | 0.081 | 0.3 | 0.632 | 2.2 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | TV at Sub-LOD (High Negative) | 150 | 44 | 29.3% | 34.77 | 1.045 | 3.0 | 0.178 | 0.5 | 0.222 | 0.6 | 0.000 | 0.0 | 1.083 | 3.1 | | TV Negative^{d} | 600 | 581 | 96.8% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | $^{a}$ N: Total number of replicates $^{b}$ n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. $^{c}$ Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components. $^{d}$ The negative panel included 4 panel members negative for TV. Page 24 of 65 {24} ## Reproducibility Analysis: MG Results | Matrix | Panel Description | N^{a} | n^{b} | Agreement (n/N) | Mean CN | Within-Run/Day Component | | Between-Run/Day Component | | Between-Lot Component | | Between-Site Component | | Total^{c} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | Urine | MG High Pos (CT, NG & TV High Pos) | 150 | 150 | 100.0% | 22.66 | 0.428 | 1.9 | 0.228 | 1.0 | 0.329 | 1.5 | 0.906 | 4.0 | 1.079 | 4.8 | | | MG High Pos (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 22.67 | 0.292 | 1.3 | 0.266 | 1.2 | 0.231 | 1.0 | 0.708 | 3.1 | 0.843 | 3.7 | | | MG at 2X LOD Claim (TV High Pos, CT & NG at 2X LOD Claim) | 150 | 150 | 100.0% | 33.73 | 0.497 | 1.5 | 0.309 | 0.9 | 0.341 | 1.0 | 0.945 | 2.8 | 1.163 | 3.4 | | | MG at 2X LOD Claim (NG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 33.18 | 0.382 | 1.2 | 0.304 | 0.9 | 0.033 | 0.1 | 0.825 | 2.5 | 0.959 | 2.9 | | | MG at 2X LOD Claim (CT High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 33.18 | 0.368 | 1.1 | 0.257 | 0.8 | 0.353 | 1.1 | 0.704 | 2.1 | 0.907 | 2.7 | | | MG at 2X LOD Claim (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 32.85 | 0.312 | 0.9 | 0.292 | 0.9 | 0.267 | 0.8 | 0.734 | 2.2 | 0.890 | 2.7 | | | MG at 2X LOD Claim (MG only) | 150 | 150 | 100.0% | 33.01 | 0.274 | 0.8 | 0.199 | 0.6 | 0.295 | 0.9 | 0.340 | 1.0 | 0.564 | 1.7 | | | MG at LOD Claim | 150 | 150 | 100.0% | 33.71 | 0.645 | 1.9 | 0.118 | 0.4 | 0.362 | 1.1 | 0.723 | 2.1 | 1.041 | 3.1 | | | MG at Sub-LOD (High Negative) | 150 | 55 | 36.7% | 40.29 | 1.021 | 2.5 | 0.076 | 0.2 | 0.854 | 2.1 | 0.000 | 0.0 | 1.333 | 3.3 | | | MG Negative^{d} | 600 | 600 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | Swab | MG High Pos (CT, NG & TV High Pos) | 150 | 150 | 100.0% | 19.73 | 0.225 | 1.1 | 0.101 | 0.5 | 0.292 | 1.5 | 0.000 | 0.0 | 0.382 | 1.9 | | | MG High Pos (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 20.64 | 0.186 | 0.9 | 0.127 | 0.6 | 0.320 | 1.6 | 0.000 | 0.0 | 0.391 | 1.9 | | | MG at 2X LOD Claim (TV High Pos, CT & NG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.03 | 0.471 | 1.5 | 0.000 | 0.0 | 0.196 | 0.6 | 0.000 | 0.0 | 0.511 | 1.6 | | | MG at 2X LOD Claim (NG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 30.80 | 0.189 | 0.6 | 0.121 | 0.4 | 0.250 | 0.8 | 0.000 | 0.0 | 0.336 | 1.1 | | | MG at 2X LOD Claim (CT High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 30.87 | 0.159 | 0.5 | 0.046 | 0.1 | 0.236 | 0.8 | 0.000 | 0.0 | 0.288 | 0.9 | | | MG at 2X LOD Claim (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 30.69 | 0.165 | 0.5 | 0.124 | 0.4 | 0.225 | 0.7 | 0.000 | 0.0 | 0.305 | 1.0 | | | MG at 2X LOD Claim (MG only) | 150 | 150 | 100.0% | 31.40 | 0.180 | 0.6 | 0.083 | 0.3 | 0.238 | 0.8 | 0.000 | 0.0 | 0.310 | 1.0 | | | MG at LOD Claim | 150 | 150 | 100.0% | 31.58 | 0.244 | 0.8 | 0.034 | 0.1 | 0.304 | 1.0 | 0.000 | 0.0 | 0.391 | 1.2 | | | MG at Sub-LOD (High Negative) | 150 | 102 | 68.0% | 36.54 | 0.571 | 1.6 | 0.151 | 0.4 | 0.048 | 0.1 | 0.164 | 0.4 | 0.614 | 1.7 | | | MG Negative^{d} | 600 | 599 | 99.8% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | $^{a}$ N: total number of replicates $^{b}$ n: Number of replicates with detectable analyte for positive panel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation. $^{c}$ Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components $^{d}$ The negative panel included 4 panel members negative for MG. Page 25 of 65 {25} # 2. Linearity: Not applicable # 3. Analytical Specificity/Interference: # Cross-reactivity in Urogenital Specimens The specificity of the Alinity m STI assay was evaluated for cross-reactivity with microorganisms potentially present at the sample collection site. The test samples were prepared by spiking microorganisms into Alinity m transport buffer containing cultured HeLa cells (see matrix equivalence study below). The microorganisms were tested at 10⁵ units/mL for viruses and eukaryotes and 10⁶ units/mL for bacteria. The unit of measure was specific to each microorganism. In cases where the organisms could not be procured, purified nucleic acid was used as an alternate (see footnote below). Each sample was tested in three replicates. All samples returned expected results; no cross-reactivity was observed with the organisms tested. Microorganisms Tested in the Specificity Studies | Acinetobacter lwoffii | Lactobacillus lactis | | --- | --- | | Actinomyces israelii | Lactobacillus vaginalis | | Atopobium vaginae | Listeria monocytogenes | | Bacteroides fragilis | Mobiluncus curtisii | | Bacteroides ureolyticus (Campylobacter ureolyticus) | Mobiluncus mulieris | | Bifidobacterium longum | Mycoplasma hominis* | | Candida albicans | Mycoplasma pneumoniae | | Candida glabrata | Neisseria cinerea* | | Candida parapsilosis | Neisseria elongata* | | Candida tropicalis | Neisseria flava* | | Chlamydia pneumoniae* | Neisseria flavescens* | | Chlamydia psittaci* | Neisseria lactamica* | | Clostridium difficile | Neisseria mucosa* | | Clostridium perfringens | Neisseria meningitidis Serogroup A* | | Corynebacterium genitalium | Neisseria meningitidis Serogroup B* | | Corynebacterium xerosis | Neisseria meningitidis Serogroup C* | | Cryptococcus neoformans | Neisseria meningitidis Serogroup D* | | Dientamoeba fragilis | Neisseria meningitidis Serogroup W135* | | Enterococcus faecalis | Neisseria meningitidis Serogroup Y* | | Enterobacter aerogenes | Neisseria perflava* | | Enterobacter cloacae | Neisseria polysaccharea* | | Escherichia coli | Neisseria sicca* | | Fusobacterium nucleatum | Neisseria subflava* | | Gardnerella vaginalis | Pentatrichomonas hominis | | Haemophilus ducreyi | Peptostreptococcus anaerobius | | Herpes simplex virus I | Prevotella bivia | | | Propionibacterium acnes | {26} | Herpes simplex virus II | Proteus mirabilis | | --- | --- | | Human Immunodeficiency virus 1 | Pseudomonas aeruginosa | | Human papilloma virus 16 | Staphylococcus aureus | | Kingella denitrificans | Staphylococcus epidermidis | | Klebsiella oxytoca | Streptococcus agalactiae | | Klebsiella pneumoniae | Streptococcus pyogenes | | Lactobacillus acidophilus | Trichomonas tenax | | Lactobacillus brevis | Ureaplasma parvum | | Lactobacillus jensenii | Ureaplasma urealyticum | *Haemophilus ducreyi testing performed with purified genomic DNA *Indicates microorganism tested in both target-negative and target positive samples ### Microbial Interference in Urogenital Specimens The Alinity m STI assay was also evaluated for interference with a subset of the organisms used in the cross-reactivity study above (as denoted by an asterisk in the table above), by testing samples prepared with target organisms (CT, NG, TV, MG) at low positive concentrations in the presence of the potentially interfering organisms spiked at high concentrations (10⁵ units/mL for viruses and eukaryotes and 10⁶ units/mL for bacteria). The selected organisms were those that are closely related to the STI target organisms and thus have the greatest potential for primer binding at homologous targets. All positive samples reported the expected positive results for CT, NG, TV, and MG in the presence of these microorganisms; no interference was observed. ### Cross-reactivity and Microbial Interference in Extragenital Specimens Additional testing for CT and NG was performed to evaluate potential cross-reactivity and microbial interference with organisms that may be encountered in extragenital anatomic sites (i.e., oropharynx and rectum). No cross-reactivity was observed for CT or NG with the tested organisms. A subset of the microorganisms was also assessed for interference in CT and NG positive samples, as denoted by an asterisk in the table below. The positive samples contained CT and NG organisms at 2 times the claimed LoD. The potential cross-reacting microorganisms were tested at 10⁵ units/mL for viruses and eukaryotes, and 10⁶ units/mL for bacteria. All positive samples reported positive results for CT and NG in the presence of these microorganisms. Potential Cross-Reacting Microorganisms in Extragenital Specimens | Adenovirus* | Haemophilus influenzae | Saccharomyces cerevisiae | | --- | --- | --- | | Acinetobacter baumannii | Helicobacter pylori | Salmonella enterica | | Aggregatibacter actinomycetemcomitans | Human Coronavirus* | Shigella flexneri | | Anaerococcus prevotii | Human influenza virus A | Shigella sonnei | | Arcanobacterium haemolyticum | Human influenza virus B | Streptococcus anginosus | | Bifidobacterium adolescentis | Human metapneumovirus | Streptococcus dysgalactiae* | Page 27 of 65 {27} | Bordetella pertussis | Human rhinovirus 57* | Streptococcus mitis | | --- | --- | --- | | Campylobacter jejuni* | Klebsiella oxytoca | Streptococcus mutans | | Campylobacter rectus | Listeria monocytogenes | Streptococcus pneumoniae | | Citrobacter freundii | Moraxella catarrhalis | Streptococcus pyogenes* | | Clostridium difficile | Morganella morganii | Streptococcus salivarius | | Corynebacterium diphtheriae* | Mycoplasma pneumoniae | Streptococcus sanguinis | | Entamoeba histolytica* | Norovirus | Tannerella forsythia | | Enterobacter cloacae | Parvinomas micra | Treponema denticola | | Enterococcus faecium | Plesiomonas shigelloides | Veillonella parvula | | Enterovirus | Porphyromonas gingivalis | Vibrio cholerae | | Fusobacterium necrophorum | Prevotella oralis | Vibrio parahaemolyticus | | Fusobacterium nucleatum | Providencia stuartii | Yersinia enterocolitica | | Giardia lamblia | Respiratory syncytial virus | | *Indicates microorganism tested in both CT/NG-negative and CT/NG positive samples ### Potential Interferents-Urogenital Specimens The potential for interference in the Alinity m STI Assay was assessed with 35 substances that may be found in urine, vaginal swab, endocervical swab, and/or PreservCyt samples. Substances were diluted into pooled vaginal swab, pooled gynecological PreservCyt, and/or pooled urine matrices. For each substance and matrix, both CT, NG, TV, and MG positive and negative samples were tested. The positive matrices contained CT, NG, TV, and MG organisms at 3 times the claimed assay LoD. Two different strains of each organism were used in this study (CT serovars D and E, NG strains Z433 and Z437, TV strains 30001 and MTZ, and MG strains SEA-1 and MEGA 216). Although expected positive results were obtained with all the substances at the concentrations shown in the table below, cycle number delays were observed for several substances, as indicated below, which could result in interference at lower target levels. Potential Interferents (Urogenital) | Substance | Matrix^{a} | Test Level | | --- | --- | --- | | Blood | U, S, P | 5.0% v/v | | Norforms Deodorant Suppositories | U, S, P | 0.25% w/v | | Progesterone | U, S, P | 20 ng/mL | | Beta Estradiol | U, S, P | 1.2 ng/mL | | Leukocytes | U, S, P | 10^{6} cells/mL | | Mucus | U | 0.2 % v/v | | | S, P^{b} | 0.8 % v/v | | Seminal Fluid | U^{b}, S | 5.0% v/v | | | P^{b} | 3.0% v/v | | Azithromycin | U | 12.0 μg/mL | | Doxycycline | U | 31.2 μg/mL | | Acetaminophen | U | 196.5 μg/mL | Page 28 of 65 {28} | Aspirin | U | 652.2 μg/mL | | --- | --- | --- | | Vagisil Feminine Powder | U | 0.25% w/v | | Albumin | U | 60 mg/mL | | γ-globulin | U^{b} | 60 mg/mL | | Glucose | U^{b} | 1.2 mg/mL | | Acidic urine | U | pH 4.0 | | Alkaline urine | U | pH 9.0 | | Bilirubin | U | 72.5 μg/mL | | Candida albicans (Urinary tract infection organism) | U | 3x10^{4} CFU/mL | | Staphylococcus saprophyticus (Urinary tract infection organism) | U | 3x10^{4} CFU/mL | | Escherichia coli (Urinary tract infection organism) | U | 3x10^{4} CFU/mL | | Ibuprofen | U | 495.1 μg/mL | | Phenazopyridine Hydrochloride | U | 80 μg/mL | | Clotrimazole Vaginal Cream | S, P | 0.25% w/v | | KY Jelly Personal Lubricant | S, P | 0.25% w/v | | Metronidazole | S, P | 40.1 μg/mL | | Miconazole-3 | S, P | 0.25% w/v | | Monistat-1 | S, P | 0.25% w/v | | Terconazole Vaginal Cream | S, P | 0.25% w/v | | Preparation H Hemorrhoidal Cream | S, P^{b} | 0.25% w/v | | Vagisil Anti-Itch Cream | S, P | 0.25% w/v | | Vagisil Moisturizing Gel | S, P | 0.25% w/v | | Povidone-Iodine Medicated Douche | S, P | 0.25% w/v | | Yeast Gard Douche | S, P | 0.25% w/v | | Vaginal Contraceptive Foam | S, P | 0.25% w/v | $^{a}$ U = Urine, S = Swab, P = PreservCyt $^{b}$ Cycle number delays were observed for seminal fluid, γ-globulin, and glucose in urine; cycle delays were observed for seminal fluid, mucus, and Preparation H Hemorrhoidal Cream in PreservCyt. ### Potential Interferents-Extragenital Specimens The potential for interference in the Alinity m STI Assay was assessed with 18 substances that may be found in oropharyngeal or rectal swab samples. Substances were diluted into pooled oropharyngeal swab or pooled rectal swab matrices. For each substance and matrix, both CT and NG positive and negative samples were tested. The positive matrices contained CT and NG at three times the claimed LoD. Two different strains of CT and NG were used in this study (CT serovars D and E and NG strains Z433 and Z437). The study results are shown below. Page 29 of 65 {29} # Potential Interferents (Extragenital) | Substance | Matrix^{a} | Test Level | | --- | --- | --- | | Blood | O | 5.0% v/v | | Mucus | O | 25 mg/mL | | Listerine Antiseptic Mouthwash | O | 5.0% v/v | | Mucinex Dextromethorphan Cough Suppressant | O | 100 ug/mL | | Chloraseptic Sore Throat Spray, Menthol | O | 5.0% v/v | | Abreva Cold Sore Medication | O | 5.0% w/v | | Colgate Total Whitening Toothpaste | O | 0.25% w/v | | Arm & Hammer PeroxiCare Deep Clean Toothpaste | O | 0.25% w/v | | Sensodyne Repair & Protect Sensitive Toothpaste | O^{b} | 0.25% w/v | | Preparation H Hemorrhoidal Cream | R | 0.25% w/v | | Barium Sulfate | R | 0.25% w/v | | Dulcola…
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