COBAS CT/NG V2.0 TEST
Device Facts
| Record ID | K132270 |
|---|---|
| Device Name | COBAS CT/NG V2.0 TEST |
| Applicant | Roche Molecular Systems, Inc. |
| Product Code | LSL · Microbiology |
| Decision Date | Dec 2, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3390 |
| Device Class | Class 2 |
Intended Use
The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals. The cobas® PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test. The cobas® PCR Urine Sample Kit is used to collect and transport urine specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test.
Device Story
Automated in vitro nucleic acid amplification test (NAAT) for qualitative detection of C. trachomatis and N. gonorrhoeae DNA. Inputs: urogenital specimens (urine, vaginal/endocervical swabs, PreservCyt). Process: automated sample preparation (cobas x 480) followed by real-time PCR amplification and detection (cobas z 480) using TaqMan FRET probes. Internal control added during prep monitors entire process. Used in clinical settings; operated by laboratory personnel. Output: qualitative test results based on PCR cycle threshold analysis. Assists clinicians in diagnosing chlamydial and gonococcal infections, enabling timely treatment and management.
Clinical Evidence
Clinical performance established in multi-center US studies (archived and prospective samples). Evaluated sensitivity/specificity against Patient Infected Status (PIS) defined by reference NAATs. CT sensitivity: 93.7-98.4%; specificity: 98.8-99.8%. NG sensitivity: 95.6-100.0%; specificity: 99.1-100.0%. Reproducibility study performed across sites, operators, and days; total CVs ranged 1.4-2.6%.
Technological Characteristics
Real-time PCR assay using TaqMan FRET probes. Targets: CT cryptic plasmid/ompA gene and NG genomic DNA. Automated sample prep (cobas x 480) and amplification/detection (cobas z 480). Compatible with cobas PCR Media and PreservCyt solution. Software-controlled workflow.
Indications for Use
Indicated for qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae DNA in urogenital specimens (male/female urine, self-collected/clinician-collected vaginal swabs, endocervical swabs, cervical specimens in PreservCyt). For use in symptomatic and asymptomatic individuals as an aid in diagnosis.
Regulatory Classification
Identification
Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
Predicate Devices
- cobas® CT/NG Test (K110923)
Related Devices
- K202408 — cobas CTNG for use on cobas 6800/8800 systems · Roche Molecular Systems, Inc. · Jan 21, 2021
- K240217 — cobas® liat CT/NG nucleic acid test · Roche Molecular Systems, Inc. · Jan 17, 2025
- K173887 — cobas CT/NG for use on cobas 6800/8800 systems · Roche Molecular Systems, Inc. · Mar 21, 2018
Submission Summary (Full Text)
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Roche Molecular Systems, Inc. Pleasanton, CA 94588-2722
cobas® CT/NG Test Section 5: 510(k) Summary 510(k) Summary Report
K 132270
DEC - 2 2013
# cobas® CT/NG v2.0 Test 510(k) Summary
| | Roche Molecular Systems, Inc. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | 4300 Hacienda Drive |
| Submitted by: | Pleasanton, CA 94588-2722<br>Phone Number: (925) 730-8046<br>Fax Number: (925) 730-8128 |
| Contact: | Wilk von Gustedt |
| Date of Preparation: | July 16, 2013 |
| Device Trade Name: | cobas® CT/NG v2.0 Test |
| Common Name: | Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG) Test |
| Type of Test: | Nucleic Acid Amplification Test, DNA, Chlamydia trachomatis (CT) and<br>Neisseria gonorrhoea (NG), qualitative |
| Classification Names: | Chlamydia serological reagents<br>Neisseria spp. Direct serological test reagents<br>Real Time Nucleic Acid Amplification System |
| Regulations: | 866.3120<br>866.3390<br>862.2570 |
| Product codes: | MKZ (DNA Probe, Nucleic Acid Amplification, Chlamydia)<br>LSL (DNA Reagents, Neisseria)<br>OOI: Real Time Nucleic Acid Amplification System |
| Panel: | Microbiology |
| Predicate Device-Assay: | cobas® CT/NG Test (K110923) |
| Predicate Devices-Collection Kits: | cobas® PCR Female Swab Sample Kit and the cobas® PCR Urine Sample<br>Kit, previously cleared with the cobas® CT/NG Test (K110923) |
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દિ
・・
## TABLE OF CONTENTS
| 1. | Device Description | | | 5 |
|----|---------------------------------------------------------------------|--|--|----|
| 2. | Intended Use | | | 6 |
| 3. | Technological Characteristics | | | 6 |
| 4. | Non-Clinical Performance Evaluation | | | 8 |
| | 4.1. Analytical Sensitivity | | | 8 |
| | 4.2. Inclusivity. | | | 9 |
| | 4.3. Analytical Specificity. | | | 11 |
| | 4.4. Interference. | | | 14 |
| | 4.5. Precision | | | 17 |
| 5. | Clinical Performance | | | 20 |
| | 5.1. Reproducibility. | | | 20 |
| | 5.1.1. C. trachomatis (Table 12, Table 13, Table 14, and Table 15). | | | 21 |
| | 5.1.2. N. gonorrhoeae (Table 16. Table 17, Table 18, Table 19). | | | 26 |
| | 5.2. Clinical Specimen Study | | | 30 |
| | 5.2.1. Study Design. | | | 30 |
| | 5.2.2. Determination of Patient Infected Status | | | 31 |
| | 5.2.3. Study Results | | | 32 |
| | 5.2.4. Chlamydia trachomatis (CT) | | | 33 |
| | 5.2.5. Neisseria gonorrhoeae (NG) | | | 39 |
| | 5.2.6. Prevalence | | | 44 |
| | 5.2.7. Positive and Negative Predictive Value. | | | 44 |
| 6 | Conclusion | | | 45 |
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## List of Tables
| Table 1: | Comparison of the cobas® CT/NG v2.0 Test with the Predicate Device | 7 |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| Table 2: | cobas® CT/NG v2.0 Test Limit of Detection for CT serovar D and serovar I | 9 |
| Table 3: | cobas® CT/NG v2.0 Test Limit of Detection for NG strain 2948 (ATCC<br>19424) and Strain 6693 | 9 |
| Table 4: | Summary of CT Serovars/Variant Inclusivity Verification Results. | 10 |
| Table 5: | Summary of NG Strains Inclusivity Verification Results. | 11 |
| Table 6: | Microorganisms Tested for Analytical Specificity | 12 |
| Table 7: | List of Microorganisms Tested below 1 x 10⁶ Units/mL for Analytical<br>Specificity. | 14 |
| Table 8: | Results from Endogenous Interference Testing for Albumin, Bilirubin,<br>Glucose, and pH. | 16 |
| Table 9: | Results from Endogenous Interference Testing for Whole Blood. PBMC, and<br>Mucus | 16 |
| Table 10: | Panel Design for In-House Precision Study | 17 |
| Table 11: | In-House Precision Study Hit Rate Analysis | 18 |
| Table 12: | <i>C. trachomatis:</i> Overall Mean, Standard Deviations, and Coefficients of<br>Variation (%) for Cycle Threshold, Estimated From Valid Samples of<br>Positive Sample Type Panel Members. | 22 |
| Table 13: | <i>C. trachomatis:</i> Percent Agreement by Panel Member Overall and for<br>Site/Instrument, Operator. and Day - PCR Media/Urine | 23 |
| Table 14: | <i>C. trachomatis:</i> Percent Agreement by Panel Member Overall and for<br>Site/Instrument, Operator, and Day - PCR Media/Swab | 24 |
| Table 15: | <i>C. trachomatis:</i> Percent Agreement by Panel Member Overall and for<br>Site/Instrument, Operator, and Day - PreservCyt | 25 |
| Table 16: | <i>N. gonorrhoeae:</i> Overall Mean. Standard Deviations, and Coefficients of<br>Variation (%) for Cycle Threshold, Estimated From Valid Samples of<br>Positive Sample Type Panel Members. | 26 |
| Table 17: | <i>N. gonorrhoeae:</i> Percent Agreement by Panel Member Overall and for<br>Site/Instrument, Operator, and Day - PCR Media/Urine | 27 |
| Table 18: | <i>N. gonorrhoeae:</i> Percent Agreement by Panel Member Overall and for<br>Site/Instrument, Operator, and Day - PCR Media/Swab | 28 |
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| Table 19: <i>N. gonorrhoeae:</i> Percent Agreement by Panel Member Overall and for<br>Site/Instrument. Operator, and Day - PreservCyt | 29 |
|---------------------------------------------------------------------------------------------------------------------------------------|----|
| Table 20: Determination of Female Patient Infected Status. | 31 |
| Table 21: Determination of Male Patient Infected Status | 32 |
| Table 22: CT: Clinical Performance Compared With Patient Infected Status by Gender<br>and Sample Type, and Symptom Status. | 33 |
| Table 23: CT: Positive/Negative Analysis for Female Patient Infected Status. | 35 |
| Table 24: CT: Positive/Negative Analysis for Male Patient Infected Status | 39 |
| Table 25: NG: Clinical Performance Compared With Patient Infected Status by<br>Gender, Sample Type, and Symptom Status. | 40 |
| Table 26: NG: Positive/Negative Analysis for Female Patient Infected Status | 42 |
| Table 27: NG: Positive/Negative Analysis for Male Patient Infected Status. | 44 |
| Table 28: Positive Predictive Value and Negative Predictive Value for Hypothetical CT<br>Prevalence | 45 |
| Table 29: Positive Predictive Value and Negative Predictive Value for Hypothetical<br>NG Prevalence. | 45 |
.
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#### DEVICE DESCRIPTION 1.
The changes between the previously cleared cobas® CT/NG Test (K110923) and the currently submitted cobas® CTNG v2.0 Test are limited to the modification of the sample preparation workflow which requires a system software update related to the cobas 4800 system. There are no changes for the reagents or the design between the cobas® CT/NG v2.0 Test and the cobas® CT/NG Test. The Roche Molecular Systems (RMS) cobas® CT/NG v2.0 Test consists of six reagent kits:
- cobas® 4800 System Sample Preparation Kit .
- cobas 4800 CT/NG v2.0 Amplification/Detection Kit .
- cobas® 4800 CT/NG Controls Kit .
- cobas 4800 System Wash Buffer Kit .
- cobas® 4800 System Control Diluent Kit .
- cobas® 4800 System Liquid Cytology Preparation Kit .
Sample Collection Kits to be used for the cobas CT/NG v2.0 Test are:
- cobas® PCR Female Swab Sample Kit •
- cobas® PCR Urine Sample Kit .
- PreservCyt® (Hologic, Inc.) .
The cobas® CTNG v2.0 Test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) is based on two major processes: (1) automated sample preparation to obtain nucleic acids, including CT and NG DNA; (2) simultaneous PCR amplification of target DNA sequences using both CT and NG specific complementary primer pairs and real-time detection of cleaved fluorescent-labeled CT and NG specific oligonucleotide detection probes. Internal control. containing CT and NG DNA. is added to all samples during automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process.
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The cobas 4800 System utilizes the cobas x 480 Instrument for automated sample preparation, and the cobas z 480 Analyzer for automated amplification and detection. The cobas® 4800 system software integrates the sample preparation with nucleic acid amplification and detection to generate test results.
#### INTENDED USE 2.
The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
The coloas® PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test.
The cobas® PCR Urine Sample Kit is used to collect and transport urine specimens. The cohuse PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test.
#### 3. TECHNOLOGICAL CHARACTERISTICS
The primary technological characteristics and intended use of the RMS cobas® CT/NG v2.0 Test are substantially equivalent to other legally marketed nucleic acid amplification tests intended for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).
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As indicated in Table 1, the RMS cobas® CT/NG v2.0 Test is substantially equivalent to significant characteristics of the identified predicate device, the currently cleared cobase CT/NG Test (K110923).
| | Submitted Device:<br>RMS cobas® CT/NG v2.0 Test | Predicate Device:<br>RMS cobas® CT/NG Test<br>(K110923) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Qualitative in vitro diagnostic test for the<br>direct qualitative detection of Chlamydia<br>trachomatis and/or Neisseria gonorrhoeae<br>in patient specimens | Same |
| Sample Types | Male urine<br>Female urine<br>Endocervical swabs<br>Clinician-collected vaginal swabs<br>Patient-collected vaginal swabs<br>Cervical specimens in PreservCyt®<br>Solution | Male urine<br>Patient-collected vaginal swabs |
| Subject Status | Asymptomatic and symptomatic | Asymptomatic and symptomatic |
| Sample Collection Devices | Urine collection kit<br>Female swab collection kit | Urine collection kit<br>Female swab collection kit |
| CT Analyte Targets | CT cryptic plasmid DNA<br>CT ompA gene | CT cryptic plasmid DNA<br>CT ompA gene |
| NG Analyte Targets | NG genomic DNA | NG genomic DNA |
| Sample Preparation<br>Procedure | Semi-automated | Semi-automated |
| Amplification Technology | Real-time PCR | Real-time PCR |
| Detection Chemistry | Paired reporter and quencher<br>fluorescence labeled probes (TaqMan<br>Technology) using fluorescence<br>resonance energy transfer (FRET) | Paired reporter and quencher<br>fluorescence labeled probes (TaqMan<br>Technology) using fluorescence<br>resonance energy transfer (FRET) |
| Result Analysis | Based on PCR cycle threshold analysis | Based on PCR cycle threshold analysis |
| | | Table 1: Comparison of the cobas® CT/NG v2.0 Test with the Predicate Device | | | | |
|--|--|-----------------------------------------------------------------------------|--|--|--|--|
|--|--|-----------------------------------------------------------------------------|--|--|--|--|
In summary, the intended use, technology, and functionality of the cobas CT/NG v2.0 Test are substantially equivalent to the predicate device.
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Roche Molecular Systems, Inc. Pleasanton, CA 94588-2722
#### NON-CLINICAL PERFORMANCE EVALUATION 4.
All performance related testing summarized in this report was performed using the cobas® CT/NG v2.0 Test with the exception of the Analytical Specificity study (Section 4.3 below) which is based on the currently cleared cobas® CT/NG Test (K110923). The changes between the previously cleared cobas® CT/NG Test (K110923) and the currently submitted cobas® CT/NG v2.0 Test are limited to the modification of the sample preparation workflow which requires a system software update related to the cobas 4800 system. There are no changes for the reagents or the design between the cobas® CT/NG v2.0 Test and the cobas® CT/NG Test. Therefore it was concluded that data for the cobas® CT/NG Test can also be used to demonstrate performance of the cobas® CT/NG v2.0 Test for Analytical Specificity.
#### Analytical Sensitivity 4.1.
The analytical sensitivity (Limit of Detection or LOD) for the cobas 8 CTNG v2.0 Test was determined by analyzing dilutions of quantified CT and NG cultures of CT and NG were diluted into negative urine specimens stabilized in cobas PCR Media, negative endocervical swab specimen in cobas® PCR Media, negative vaginal swab specimen in col>ass® PCR Media, and negative PreservCyt® specimen to determine the LOD for each specimen tvpc. All levels for each specimen type were analyzed using the full cobas 8 CT/NG v2.0 Test workflow with 3 unique lots of cobas CT/NG v2.0 Test reagents. In the course of the study, a total of 5 unique lots of reagents were used. The LOD of the test is defined as the target concentration which can be detected as positive in ≥ 95% of the replicates tested.
The LOD for the CT serovar D and serovar 1 cultures in urine specimens stabilized in cobas PCR Media, endocervical swab specimen in cobas® PCR Media, vaginal swab specimen in cobas® PCR Media, and PreservCyt® specimen are shown in Table 2. The LOD for NG strain 2948 (ATCC 19424) and strain 6693 in urine specimens stabilized in cobas® PCR Media, cndocervical swab specimen in cobas® PCR Media, vaginal swab specimen in cobas® PCR Media. and negative PreservCvt® specimen are shown in Table 3. When analyzed separately. male and female urine results were statistically equivalent for both CT and NG cultures.
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#### cobas® CT/NG v2.0 Test Limit of Detection for CT scrovar D and serovar I Table 2:
| Specimen Types | <i>C. trachomatis</i> serovar D | | | <i>C. trachomatis</i> serovar I | | |
|--------------------|---------------------------------|----------------------|----------------|---------------------------------|------------------------|----------------|
| | Levels<br>Tested* | Replicates/<br>Level | LOD<br>(EB/mL) | Levels<br>Tested* | Replicates/<br>Level** | LOD<br>(EB/mL) |
| Urine (Female) | 6 | 60 | 40 | 6 | 60 | 10 |
| Urine (Male) | 6 | 60 | 40 | 6 | 60 | 20 |
| Endocervical Swabs | 6 | 59-60** | 200 | 6 | 60 | 100 |
| Vaginal Swabs | 6 | 60 | 300 | 6 | 60 | 70 |
| PreservCyt® | 6 | 60 | 200 | 6 | 59-60** | 50 |
* Testing included one negative level with 24-48 replicates
** One replicate was not processed by the cobas® x 480 due to insufficient sample volume
## cobas® CT/NG v2.0 Test Limit of Detection for NG strain 2948 (ATCC 19424) Table 3: and Strain 6693
| Specimen Types | <i>N. gonorrhoeae</i> strain 2948 | | | <i>N. gonorrhoeae</i> strain 6693 | | |
|--------------------|-----------------------------------|-------------------|--------------|-----------------------------------|---------------------|--------------|
| | Levels Tested* | Replicates/ Level | LOD (CFU/mL) | Levels Tested* | Replicates/ Level** | LOD (CFU/mL) |
| Urine (Female) | 6 | 60 | 0.2 | 7 | 60 | 0.4 |
| Urine (Male) | 6 | 60 | 0.2 | 7 | 60 | 0.6 |
| Endocervical Swabs | 6 | 59-60** | 2 | 6 | 60 | 2 |
| Vaginal Swabs | 6 | 60 | 3 | 6 | 60 | 1.5 |
| PreservCyt® | 6 | 60 | 1 | 6 | 59-60** | 1 |
* Including one negative level with 24-72 replicates
** One replicate was not processed by the cobas x 480 due to insufficient sample volume
#### 4.2. Inclusivity
The sensitivity of the cobas CT/NG v2.0 Test was determined for 13 additional CT serovars, the Swedish variant CT strain (nvCT), and an additional 43 independently isolated strains of NG. Panels were prepared by spiking each CT culture stock into specimen type specific CT/NG negative pools to approximately 0.5 and 1.5 times the LOD of CT serovar D as determined in the LOD studies. Each NG culture was spiked into CT/NG negative pools to approximately 1.5 times the LOD of NG strain 2948 (ATCC 19424) as determined in the LOD studies. At least 20 replicates were tested for each CT and NG levels that did not produce a 95% or greater hit rate at the levels tested, a higher concentration was prepared and tested.
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A total of 13 CT serovars and one nvCT (Swedish variant) strain were evaluated. The minimum concentration from which all of the CT serovars returned a hit rate of ≥ 95% was 60 EB/mL for urine stabilized in cobas PCR Media; 300 EB/mL for endocervical specimen in cobas PCR Media; 150 EB/mL for vaginal specimen in cobas PCR Media; and 100 EB/mL for cervical specimen collected in PreservCyt Solution (Table 4).
A total of 43 strains of NG were evaluated. The minimum concentration from which all of the . NG strains returned a hit rate of ≥ 95% was 1 CFU/mL for urine stabilized in cobas PCR Media; 10 CFU/mL for endocervical specimen in cobas PCR Media; 10 CFU/mL for vaginal specimen in cobas PCR Media; and 5 CFU/mL for cervical specimen collected in PreservCyt Solution (Table 5).
| | Results for C. trachomatis | | | | | | | |
|----------------------------|----------------------------|------------|--------------------|---------------|---------------|---------------|-------------|---------------|
| Serovar Type or<br>Variant | Urine | | Endocervical Swabs | | Vaginal Swabs | | PreservCyt® | |
| | EB/mL | % Hit Rate | EB/mL | % Hit<br>Rate | EB/mL | % Hit<br>Rate | EB/mL | % Hit<br>Rate |
| A | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| B | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| Ba | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| C | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| E | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| F | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| G | 20 | 100% | 100 | 95% | 150 | 100% | 100 | 100% |
| H | 20 | 100% | 100 | 95% | 150 | 100% | 100 | 100% |
| J | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| K | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| LV Type 1 | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| LV Type 2 | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| LV Type 3 | 20 | 100% | 100 | 100% | 150 | 100% | 100 | 100% |
| nvCT | 60 | 100% | 300 | 100% | 150 | 95% | 100 | 100% |
| Table 4: Summary of CT Serovars/Variant Inclusivity Verification Results | | | |
|--------------------------------------------------------------------------|--|--|--|
|--------------------------------------------------------------------------|--|--|--|
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| Numbers of<br>NG Strains | Urine | | Numbers of<br>NG Strains | Endocervical Swabs | |
|--------------------------|---------------|------------|--------------------------|--------------------|------------|
| 34 | 0.3 | ≥ 95% | 39 | 3 | ≥ 95% |
| 9 | 1 | 100% | 4 | 10 | 100% |
| Total = 43 | | | Total = 43 | | |
| Numbers of | Vaginal Swabs | | Numbers of NG | PreservCyt | |
| NG Strains | CFU/mL | % Hit Rate | Strains | CFU/mL | % Hit Rate |
| 42 | 4.5 | ≥ 95% | 40 | 1.5 | 100% |
| 1 | 10 | 100% | 3 | 5 | 100% |
| Total = 43 | | | Total = 43 | | |
#### Summary of NG Strains Inclusivity Verification Results Table 5:
#### 4.3. Analytical Specificity
A panel of 184 bacteria, fungi and viruses, including those commonly found in the female urogenital tract, as well as representatives of N. cineria, N. flava, N. lactamica, N. perflava and N. subflava and other phylogenetically unrelated organisms, were tested to assess analytical specificity. The organisms tested are listed in Table 6. All organisms were tested at concentrations of at least 1 x 106 Units*/mL except those organisms listed in Table 7. All organisms were spiked into CT/NG negative cobas® PCR Media, pooled negative urine stabilized in cobas " PCR Media, pooled negative vaginal specimen in cobas® PCR Media, and pooled negative PreservCyt® specimen spiked with CT and NG cultures at 3 times the limit of detection. Results indicated that none of these organisms interfered with detection of CT and NG or produced a false positive result in the CT/NG negative matrices.
* All bacteria were quantified as Colony Forming Units (CFU) except Chlanndophila pneumoniae as Inclusion Forming Units (IFU). Treponema pallidum and HBV were quantified as DNA copies. Adenovirus was quantified as Plaque Forming Units (PFU). CMV, EBV, HSV-1 and HSV-2 were quantified as Viral Particles (VP). HCV and HIV-1 were quantified in International Units (IU). Trichomonas vaginalis, HPV16 and HPV18 were quantified as cells/mL.
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ﻟﺴﻤﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
#### Microorganisms Tested for Analytical Specificity Table 6:
| Achromobacter xerosis | Helicobacter pylori | Neisseria sicca |
|-------------------------------------|-----------------------------------------------|------------------------------------|
| Acinetobacter calcoaceticus | Hepatitis B virus (HBV) | Neisseria subflava |
| Acinetobacter lwoffi | Hepatitis C virus (HCV) | Neisseria subflava 6458 |
| Acinetobacter sp. genospecies 3 | Human immunodeficiency virus | Neisseria subflava 6617 |
| Actinomyces israelii | Human papillomavirus type 16<br>(CaSki cells) | Neisseria subflava 6618 |
| Actinomyces pyogenes | Human papillomavirus type 18<br>(HeLa cells) | Neisseria subflava 7441 |
| Adenovirus | Herpes Simplex Virus (HSV-1) | Neisseria subflava 7452 |
| Aerococcus viridans | Herpes Simplex Virus (HSV-2) | Neisseria weaveni |
| Aeromonas hydrophila | Kingella dentifricans | Pantoea agglomerans |
| Alcaligenes faecalis | Kingella kingae | Paracoccus denitrificans |
| Bacillus subtilis | Klebsiella oxytoca | Pasteurella maltocida |
| Bacillus thuringiensis | Klebsiella pneumoniae ss ozaenae | Pediococcus acidilactica |
| Bacteroides caccae | Lactobacillus acidophillus | Peptostreptococcus anaerobius |
| Bacteroides fragilis | Lactobacillus brevis | Peptostreptococcus asacharolyticus |
| Bacteroides ureolyticus | Lactobacillus crispatus | Peptostreptococcus magnus |
| Bifidobacterium adolescentis | Lactobacillus delbrueckii subsp.<br>lactis | Plesiomonas shigelloides |
| Bifidobacterium breve | Lactobacillus jensenii | Prevotella bivia |
| Bifidobacterium longum | Lactobacillus lactis lactis | Prevotella corporis |
| Branhamella catarrhalis | Lactobacillus oris | Prevotella intermedia |
| Brevibacterium linens | Lactobacillus parabuchneri | Propionibacterium acnes |
| Campylobacter gracilis | Lactobacillus vaginalis | Proteus mirabilis |
| Campylobacter jejuni | Lactococcus lactis cremoris | Proteus vulgaris |
| Candida albicans | Legionella bozemnii | Providencia stuartii |
| Candida glabrata | Legionella pneumophila | Pseudomonas aeruginosa |
| Candida guilliermondi | Listeria monocytogenes | Pseudomonas fluorescens |
| Candida krusei | Micrococcus luteus | Pseudomonas putida |
| Candida parapsilosis | Mobiluncus curtisii subsp. curtisii | Rahnella aquatilis |
| Candida tropicalis | Mobiluncus curtisii subsp. holmesii | Rhizobium radiobacter |
| Chlamydophila pneumoniae | Mobiluncus mulieris | Rhodospirillum rubrum |
| Chromobacter violaceum | Moraxella catarrhalis | Ruminococcus productus |
| Chryseobacterium<br>meningosepticum | Moraxella lacunata | Saccharomyces cerevisiae |
| Citrobacter braakii | Moraxella osloensis | Salmonella choleraesuis |
| Citrobacter freundii | Morganella morganii | Salmonella minnesota |
| Clostridium innocuum | Mycobacterium avium | Salmonella typhimurium |
| Clostridium perfringens | Mycobacterium gordonae | Serratia denitrificans |
| Clostridium sporogenes | Mycobacterium smegmatis | Serratia marcescens |
| Corynebacterium genitalium | Mycoplasma genitalium | Staphylococcus aureus |
| Corynebacterium renale | Mycoplasma hominis | Staphylococcus epidermidis |
| Corynebacterium xerosis | Mycoplasma pneumoniae | Staphylococcus saprophyticus |
| Cryptococcus neoformans | Neisseria cinerea 832 | Streptococcus agalactiae |
| Cytomegalovirus | Neisseria cinerea 3306 | Streptococcus anginosus |
| Deinococcus radiodurans | Neisseria cinerea 3307 | Streptococcus bovis |
| Deinococcus radiopugnans | Neisseria cinerea 3308 | Streptococcus dysgalactiae |
| Derxia gummosa | Neisseria cinerea 6317 | Streptococcus equinis |
| Edwardsiella tarda | Neisseria dentrificans | Streptococcus mitis |
| Eikenella corrodens | Neisseria elongata subsp.<br>niroreducans | Streptococcus mutans |
| Enterobacter aerogenes . | Neisseria flava | Streptococcus pneumoniae |
| Enterobacter cloacae | Neisseria flavescens | Streptococcus pyogenes |
| Enterococcus avium | Neisseria kochi | Streptococcus salivarius |
| Enterococcus faecalis | Neisseria lactamica | Streptococcus sanguis |
| Enterococcus faecium | Neisseria meningitidis 135 | Streptomyces griseinus |
| Epstein Barr Virus | Neisseria meningitidis Serogroup A | Treponema pallidum |
| Erwinia herbicola | Neisseria meningitidis Serogroup B | Trichomonas vaginalis |
| Erysipelothrix rhusiopathiae | Neisseria meningitidis Serogroup C | Ureaplasma urealyticum |
| Escherichia coli | Neisseria meningitidis Serogroup D | Veillonela parvula |
| Ewingella americana | Neisseria meningitidis Serogroup Y | Vibrio parahaemolyticus |
| Flavobacterium meningosepticum | Neisseria mucosa | Weissella paramesenteroides |
| Fusobacterium nucleatum | Neisseria perflava 837 | Yersinia enterocolitica |
| Gardnerella vaginalis | Neisseria perflava 911 | |
| Gemella haemolysans | Neisseria perflava 6339 | |
| Gemella morbillorum | Neisseria perflava 6340 | |
| Haemophilus ducreyi | Neisseria perflava 6341 | |
| Haemophilus influenzae | Neisseria polysaccharea | |
{12}------------------------------------------------
{13}------------------------------------------------
| | | Concentration Tested in Listed Matrix* | | | |
|----------------------------------------------------|---------------------|----------------------------------------|------------------------------|------------------------------------|--|
| Microorganism Tested | cobas®<br>PCR Media | Negative Urine<br>Specimen | Negative Vaginal<br>Specimen | Negative<br>PreservCyt<br>Specimen | |
| Adenovirus | | 8x105 PFU/mL | 8x105 PFU/mL | 8x105 PFU/mL | |
| Cytomegalovirus (CMV) | 1x104 VP/mL | | | | |
| Chlamydophila pneumoniae | 1x105 IFU/mL | 1.1x104 IFU/mL | 1.1x104 IFU/mL | 1.1x104 IFU/mL | |
| Gemella morbillorum | | 4.5 x 104 CFU/mL | 4.5 x 104 CFU/mL | 4.5 x 104 CFU/mL | |
| Hepatitis C virus (HCV) | | 5.6 x 104 IU/mL | 5.6 x 104 IU/mL | 5.6 x 104 IU/mL | |
| Human papillomavirus (HPV)<br>type 16 (SiHa cells) | | 1x104 cells/mL | 1x104 cells/mL | 1x104 cells/mL | |
| Human papillomavirus (HPV)<br>type 18 (HeLa cells) | | 1x104 cells/mL | 1x104 cells/mL | 1x104 cells/mL | |
| Neisseria cinerea 3307 | | | 4x105 CFU/mL | 4x105 CFU/mL | |
| Prevotella bivia | | 9x104 CFU/mL | 9x104 CFU/mL | 9x104 CFU/mL | |
| Prevotella corporis | | | 1.4x105 CFU/mL | 1.4x105 CFU/mL | |
| Treponema pallidum | Not Tested | 1x105 copies/mL | 1x105 copies/mL | 1x105 copies/mL | |
| Trichomonas vaginalis | | | 6.5x105 cells/mL | 6.5x105 cells/mL | |
### Table 7: List of Microorganisms Tested below 1 x 10° Units/mL for Analytical Specificity
*Gray cells indicate concentration tested was ≥ 1 x 10° Units/mL in that matrix
#### 4.4. Interference
Interference testing was performed using CT/NG negative urine specimen stabilized in cobass PCR Media, endocervical swab specimen in cobas® PCR Media, vaginal swab specimen in cobas® PCR Media, and PreservCyt® specimen spiked with CT and NG cultures at ~ 3 x LOD for each target. Twenty-three over-the-counter (OTC) products and prescription medications, as well as whole blood, and PBMC cells were tested for interference. Additionally, cervical mucus was tested in swabs samples, and albumin, bilirubin, glucose, and pH were tested for interference in the urine specimen type.
Of the 23 products tested, Metronidazole Vaginal Gel and Vagisil Satin produced invalid and/or false negative results in the urine panel samples. Replens® vaginal moisturizer produced invalid and/or false negative results in urine and endocervical swab panel samples. No interference from any of the other products was observed with the other sample matrices tested.
{14}------------------------------------------------
The levels of albumin, bilirubin, glucose, and pH shown in Table 8 and the levels of whole blood, mucus and PBMC cells shown in Table 9 represent maximum allowable concentrations which will not interfere with the cobas® CT/NG v2.0 Test performance.
{15}------------------------------------------------
loche Molecular Systems,
Teasanton, CA 94588-2722
cobas® CT/NG v2.0 Tes
ction 5: 510(k) Summary Repor
sults from Endogenous Interference Testing for Albumin, Bilirubin, Glucose, and Table 8:
.
| Specimer | Albumin (w/v | | Bilirubin (w/v | | Glucose | | pH | |
|----------|-------------------------|-------------------------|-------------------------------|--------------------------|-------------------------|--------------------------|--------------------------------|--------------------------|
| Type | Concentration<br>Tested | nterference<br>Observed | Concentration<br>Tested | Interference<br>Observed | Concentration<br>Fested | interference<br>Observer | Concentration<br>ested<br>1 | Interference<br>Observer |
| Urine | 0%, 1%, 2%, 5% | None | 0%,0.05%,0.10%<br>0.25%,0.50% | None | 1%<br>0%, 0.5%, | None | Alkaline (pH9)<br>Acidic (pH4) | None |
# lesults from Endogenous Interference Testing for Whole Blood, PBMC, and Muc Table 9:
| Specimen Type | Whole Blood (v/v) | | PBMC (cells/mL) | | Mucus | |
|---------------------|--------------------------------|-----------------------|---------------------------------|-----------------------|----------------------|-----------------------|
| | Concentration Tested | Interference Observed | Concentration Tested | Interference Observed | Concentration Tested | Interference Observed |
| Urine | 0%, 0.10%, 0.25%,<br>0.50%, 1% | > 0.25% | 0, 1.0+E05, 1.0+E06,<br>1.0+E07 | > 1.0+E05 | Not Tested | Not Tested |
| Endocervical Swab | 0%, 3%, 5%, 10% | None | 0, 1.0+E05, 1.0+E06,<br>1.0+E07 | > 1.0+E06 | Routine Level * | None |
| Vaginal Swab | 0%, 3%, 5%, 10% | None | 0, 1.0+E05, 1.0+E06,<br>1.0+E07 | > 1.0+E06 | Routine Level * | None |
| Cervical PreservCyt | 0%, 3%, 5%, 10% | > 3% | 0, 1.0+E05, 1.0+E06,<br>1.0+E07 | None | Routine Level * | None |
outine Level = Quantity of cervical mucus equivalent to amount normally removed prior to samp
{16}------------------------------------------------
#### 4.5. Precision
Precision of the cobas CT/NG v2.0 Test was examined in-house using a test panel composed of CT and NG cultures diluted into pools of CT and NG negative urine specimen stabilized in cobas PCR Media, vaginal swab specimen in cobas® PCR Media, and PreservCvt® specimen. The precision panel was designed to include negative samples as well as samples with CT and/or NG concentrations at and above the LOD of the cobas® CT/NG v2.0 Test. Additionally, samples with high CT or NG titers were examined for suppression of low titer target in the adjacent channel. Testing was done with three unique lots of cobas® CT/NG v2.0 Test reagents, three instruments, over 12 days. A description of the precision panels is shown in Table 10 and the study performance in % hit rates is shown in Table 11. All positive panel levels vielded the anticipated hit rates, with the exception of panel member 3 in urine which resulted in a hit rate of 83%. All negative panel levels tested negative throughout the study.
| | CT | | NG | |
|--------------|-------------------|-----------------------------|-------------------|-----------------------------|
| Panel Member | Level | Anticipated Hit Rate<br>(%) | Level | Anticipated Hit Rate<br>(%) |
| 1 | Negative | 0 | Negative | 0 |
| 2 | Negative | 0 | High Negative | 20-80 |
| 3 | High Negative | 20-80 | Negative | 0 |
| 4 | Low Positive | ≥ 90 | Low Positive | ≥ 90 |
| 5 | Moderate Positive | ≥ 99 | Low Positive | ≥ 90 |
| 6 | Low Positive | ≥ 90 | Moderate Positive | ≥ 99 |
| 7 | Low Positive | ≥ 90 | High Positive | ≥ 99 |
| 8 | High Positive | ≥ 99 | Low Positive | ≥ 90 |
| 9 | High Positive | ≥ 99 | High Positive | ≥ 99 |
| | Table 10: Panel Design for In-House Precision Study |
|--|-----------------------------------------------------|
| | |
{17}------------------------------------------------
cobas® CT/NG v2.0 Tess
Section 5: 510(k) Summary
510(k) Summary Repor
Roche Molecular Systems, Inc
Pleasanton, CA 94588-2722
able 11: In-House Precision Study Hit Rate Analysi
| Panel Matrix | Target<br>Panel<br>Member | CT<br>Mean | CT<br>Positive | CT<br>Valid | CT<br>% Hit<br>Rate | CT<br>95% CI | NG<br>Mean | NG<br>Positive | NG<br>Valid | NG<br>% Hit<br>Rate | NG<br>95% CI |
|--------------------------------------------|---------------------------|------------|----------------|-------------|---------------------|--------------|------------|----------------|-------------|---------------------|--------------|
| Urine stabilized<br>in cobas® PCR<br>Media | 1 | N/A | 0 | 48 | 0 | 0 - 7.4% | N/A | 0 | 48 | 0 | 0 - 7.4% |
| | 2 | N/A | 0 | 48 | 0 | 0 - 7.4% | 36.9 | 32 | 48 | 67 | 51.6 - 79.6% |
| | 3 | 37.9 | 40 | 48 | 83 | 69.8 - 92.5% | N/A | 0 | 48 | 0 | 0 - 7.4% |
| | 4 | 35.5 | 48 | 48 | 100 | 92.6 - 100% | 36.2 | 48 | 48 | 100 | 92.6 - 100% |
| | 5 | 34.6 | 48 | 48 | 100 | 92.6 - 100% | 36.1 | 48 | 48 | 100 | 92.6 - 100% |
| | 6 | 35.4 | 48 | 48 | 100 | 92.6 - 100% | 35.1 | 48 | 48 | 100 | 92.6 - 100% |
| | 7 | 36.1 | 48 | 48 | 100 | 92.6 - 100% | 18.4 | 48 | 48 | 100 | 92.6 - 100% |
| | 8 | 18.0 | 48 | 48 | 100 | 92.6 - 100% | 36.7 | 48 | 48 | 100 | 92.6 - 100% |
| | 9 | 18.3 | 48 | 48 | 100 | 92.6 - 100% | 18.0 | 48 | 48 | 100 | 92.6 - 100% |
| Vaginal swab in<br>cobas® PCR<br>Media | 1 | N/A | 0 | 48 | 0 | 0 - 7.4% | N/A | 0 | 48 | 0 | 0 - 7.4% |
| | 2 | N/A | 0 | 48 | 0 | 0 - 7.4% | 37.6 | 29 | 48 | 60 | 45.3 - 74.2% |
| | 3 | 36.9 | 22 | 48 | 46 | 31.4 - 60.8% | N/A | 0 | 48 | 0 | 0 - 7.4% |
| | 4 | 36.5 | 48 | 48 | 100 | 92.6 - 100% | 37.1 | 48 | 48 | 100 | 92.6 - 100% |
| | 5 | 35.8 | 48 | 48 | 100 | 92.6 - 100% | 37.2 | 48 | 48 | 100 | 92.6 - 100% |
| | 6 | 36.7 | 47 | 48 | 98 | 88.9 - 99.9% | 36.5 | 48 | 48 | 100 | 92.6 - 100% |
| | 7 | 36.6 | 47 | 48 | 98 | 88.9 - 99.9% | 18.6 | 48 | 48 | 100 | 92.6 - 100% |
| | 8 | 21.6 | 48 | 48 | 100 | 92.6 - 100% | 36.8 | 48 | 48 | 100 | 92.6 - 100% |
| | 9 | 21.2 | 48 | 48 | 100 | 92.6 - 100% | 18.1 | 48 | 48 | 100 | 92.6 - 100% |
| Matrix | Target<br>Panel<br>Member | CT<br>Mean | CT<br>Positive | CT<br>Valid | CT<br>% Hit Rate | CT<br>95% CI | NG<br>Mean | NG<br>Positive | NG<br>Valid | NG<br>% Hit Rate | NG<br>95% CI |
| | 1 | N/A | 0 | 47 | 0 | 0 - 7.5% | N/A | 0 | 47 | 0 | 0 - 7.5% |
| | 2 | N/A | 0 | 47 | 0 | 0 - 7.5% | 36.0 | 26 | 47 | 55 | 40.1 - 69.8% |
| | 3 | 36.4 | 26 | 47 | 55 | 40.1 - 69.8% | N/A | 0 | 47 | 0 | 0 - 7.5% |
| | 4 | 35.0 | 48 | 48 | 100 | 92.6 - 100% | 34.7 | 47 | 48 | 98 | 88.9 - 99.9% |
| PreservCyt® | 5 | 33.7 | 47 | 47 | 100 | 92.5 - 100% | 34.8 | 47 | 47 | 100 | 92.5 - 100% |
| | 6 | 34.7 | 48 | 48 | 100 | 92.6 - 100% | 33.5 | 48 | 48 | 100 | 92.6 - 100% |
| | 7 | 34.8 | 48 | 48 | 100 | 92.6 - 100% | 18.9 | 48 | 48 | 100 | 92.6 - 100% |
| | 8 | 18.9 | 48 | 48 | 100 | 92.6 - 100% | 34.3 | 48 | 48 | 100 | 92.6 - 100% |
| | 9 | 18.8 | 48 | 48 | 100 | 92.6 - 100% | 17.7 | 48 | 48 | 100 | 92.6 - 100% |
{18}------------------------------------------------
Roche Molecular Systems, Inc.
Pleasanton, CA 94588-2722
510(k) Premarket Notification
Print Date: November 18, 2013
{19}------------------------------------------------
#### CLINICAL PERFORMANCE 5.
The clinical performance characteristics of the cobas® CT/NG v2.0 Test were established in three multi-center clinical investigations conducted in the United States. One study evaluated the reproducibility at one internal and two external testing sites and two studies evaluated the sensitivity, specificity, and predictive values of the cobas CT/NG v2.0 Test on clinical specimens tested at 7 external testing sites.
One clinical investigation used archived endocervical specimens, self-collected and clinician collected vaginal specimens, endocervical specimens in PreservCyt Solution and male and female urine specimens, from symptomatic and asymptomatic males and females, collected during the clinical evaluation of the cobas® CT/NG Test (archived samples). A sccond investigation was performed using prospectively collected endocervical specimens, cliniciancollected vaginal specimens, female urine specimens, and cervical specimens in PrescryCvt Solution from asymptomatic women (prospective fresh samples). Specimen collection for these studies took place at 18 collection sites in the US, which included family planning and Obstetrics/Gynecology (OB/GYN) clinics, and sexually transmitted disease clinics.
#### Reproducibility 5.1.
A Reproducibility Study was performed across, testing site, operator, run, and day for the cobase CT/NG v2.0 Test for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using 3 panels prepared from negative vaginal swabs collected in cobas® PCR Media, negative urine stabilized in cobas® PCR Media and negative cervical specimens collected in PreservCvt® Solution. The 5 panel members for each matrix type contained single target levels of CT and NG at 1 x LOD and 3 x LOD plus one CT/NG negative level. Testing was performed at two external sites and one in-house site. A run for cobas® PCR Media (urine and swab) included 3 replicates of each of 5 panel members and 1 negative control (32 total tests). A run for the PreservCyt® Solution panel included 3 replicates of each of 5 panel members and 1 positive and 1 negative control (17 total tests). The 2 operators at each site performed 1 run per day each, for, a total of 5 days of testing per operator per panel type (10 days of testing total for each panel type). Testing was performed with 1 reagent lot.
{20}------------------------------------------------
Roche Molecular Systems, Inc. Pleasanton, CA 94588-2722
Overall, 127 runs were performed: 62 were for urine and swab panels (which were run together) and 65 were for PreservCyt panels. Sixty valid runs were obtained for each media type. Two failed runs occurred for the urine and swab panels, and 5 failed runs occurred for the PreservCvt panels. Failed runs were attributed to protocol deviations and instrument errors. A total of 900 tests were performed on the 5 panel members for each panel type. There was 1 invalid test result in the PreservCyt panel type, and 1 failed test result each in the swab, urine and PreservCyt panels. These failed tests were due to instrument errors.
All valid test results were included in the analyses of the percent agreement for CT and NG for each panel type separately. There were no false positive results for cither analvic (CT and NG) for all panel types for negative panel members, thus giving negative percent agreement (NPA) of 100% for each analyte.
C. trachomatis (Table 12, Table 13, Table 14, and Table 15) 5.1.1.
Tuble 12 below presents the total standard deviation (SD) and total percent coefficient of variation (CV [%]) for each panel type, respectively. Across all panel types, the total CV (%) ranged from 1.4% to 2.6%.
Percent agreement for the CT-positive panel members was 100% for 3 X LOD CT of all 3 panel types and also for the 1 X LOD CT of urine panel type. For the remaining 1 X LOD CT. percent agreement was 96.7% for swab and 98.9% for PreservCyt panel types. (Table 13 through Table 15.)
{21}------------------------------------------------
.
# Table 12: C. trachomatis: Overall Mean, Standard Deviations, and Coefficients of Variation (%) for Cycle Threshold, Estimated From Valid Samples of Positive Sample Type Panel Members
| | | | Standard Deviation [SD] and Percent Coefficient of Variation [CV(%)] | | | | | | | | | | | |
|----------------------------|-------------|------------|----------------------------------------------------------------------|----------------|------|-----------------|------|-----------------|------|----------------------|------|---------------------------------|------|-------|
| Panel<br>Member | n¹/<br>N | Mean<br>Ct | | Within-<br>Run | | Between-<br>Run | | Between-<br>Day | | Between-<br>Operator | | Between-<br>Site/<br>Instrument | | Total |
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| | | | PCR Media/Urine | | | | | | | | | | | |
| 1 X LOD CT,<br>Negative NG | 180/<br>180 | 37.11 | 0.54 | 1.5% | 0.00 | 0.0% | 0.23 | 0.6% | 0.13 | 0.4% | 0.22 | 0.6% | 0.64 | 1.7% |
| 3 X LOD CT,<br>Negative NG | 180/<br>180 | 35.77 | 0.38 | 1.1% | 0.18 | 0.5% | 0.15 | 0.4% | 0.00 | 0.0% | 0.21 | 0.6% | 0.50 | 1.4% |
| | | | PCR Media/Swab | | | | | | | | | | | |
| 1 X LOD CT,<br>Negative NG | 174/<br>180 | 36.99 | 0.82 | 2.2% | 0.17 | 0.5% | 0.00 | 0.0% | 0.00 | 0.0% | 0.00 | 0.0% | 0.84 | 2.3% |
| 3 X LOD CT,<br>Negative NG | 180/<br>180 | 36.11 | 0.42 | 1.2% | 0.24 | 0.7% | 0.14 | 0.4% | 0.14 | 0.4% | 0.00 | 0.0% | 0.53 | 1.5% |
| | | | PreservCyt Solution | | | | | | | | | | | |
| 1 X LOD CT,<br>Negative NG | 177/<br>179 | 35.21 | 0.88 | 2.5% | 0.00 | 0.0% | 0.28 | 0.8% | 0.00 | 0.0% | 0.00 | 0.0% | 0.93 | 2.6% |
| 3 X LOD CT,<br>Negative NG | 180/<br>180 | 33.81 | 0.68 | 2.0% | 0.03 | 0.1% | 0.18 | 0.5% | 0.15 | 0.4% | 0.00 | 0.0% | 0.72 | 2.1% |
1 n is the number of positive tests, which contribute Ct values to the analysis. N is the total number of valid tests for the panel member.
{22}------------------------------------------------
| Panel<br>Member | Ct<br>SD | Ct CV<br>% | Overall | Percent Agreement* | | | |
|-----------------------------|----------|------------|---------|--------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | | | | Site / Instrument | Operator | Day | |
| 1 X LOD CT,<br>Negative NG | 0.64 | 1.7 | 100.0 | 180/180 | 1 100.0 60/60<br>2 100.0 60/60<br>3 100.0 60/60 | 1 100.0 30/30<br>2 100.0 30/30<br>3 100.0 30/30<br>4 100.0 30/30<br>5 100.0 30/30<br>6 100.0 30/30 | 1 100.0 36/36<br>2 100.0 36/36<br>3 100.0 36/36<br>4 100.0 36/36<br>5 100.0 36/36 |
| 3 X LOD CT,<br>Negative NG | 0.50 | 1.4 | 100.0 | 180/180 | 1 100.0 60/60<br>2 100.0 60/60<br>3 100.0 60/60 | 1 100.0 30/30<br>2 100.0 30/30<br>3 100.0 30/30<br>4 100.0 30/30<br>5 100.0 30/30<br>6 100.0 30/30 | 1 100.0 36/36<br>2 100.0 36/36<br>3 100.0 36/36<br>4 100.0 36/36<br>5 100.0 36/36 |
| Negative CT,<br>1 X LOD NG | n/a | n/a | 100.0 | 180/180 | 1 100.0 60/60<br>2 100.0 60/60<br>3 100.0 60/60 | 1 100.0 30/30<br>2 100.0 30/30<br>3 100.0 30/30<br>4 100.0 30/30<br>5 100.0 30/30<br>6 100.0 30/30 | 1 100.0 36/36<br>2 100.0 36/36<br>3 100.0 36/36<br>4 100.0 36/36<br>5 100.0 36/36 |
| Negative CT,<br>3 X LOD NG | n/a | n/a | 100.0 | 179/179 | 1 100.0 60/60<br>2 100.0 59/59<br>3 100.0 60/60 | 1 100.0 30/30<br>2 100.0 30/30<br>3 100.0 30/30<br>4 100.0 29/29<br>5 100.0 30/30<br>6 100.0 30/30 | 1 100.0 36/36<br>2 100.0 36/36<br>3 100.0 35/35<br>4 100.0 36/36<br>5 100.0 36/36 |
| Negative CT,<br>Negative NG | n/a | n/a | 100.0 | 180/180 | 1 100.0 60/60<br>2 100.0 60/60<br>3 100.0 60/60 | 1 100.0 30/30<br>2 100.0 30/30<br>3 100.0 30/30<br>4 100.0 30/30<br>5 100.0 30/30<br>6 100.0 30/30 | 1 100.0 36/36<br>2 100.0 36/36<br>3 100.0 36/36<br>4 100.0 36/36<br>5 100.0 36/36 |
## Table 13: C. trachomatis: Percent Agreement by Panel Member Overall and for Site/Instrument, Operator, and Day - PCR Media/Urine
* For negative samples, percent agreement = (number of negative results/total valid results) x 100;
for positive samples, percent agreement = (number of positive results/total valid results) x 100.
Ct = cycle threshold; SD = standard deviation; CV = coefficient of variation; LOD = limit of detection;
n/a = not applicable; CT = C. trachomatis; NG = N. gonorthoeae; n/a = not applicable.
{23}------------------------------------------------
| Table 14: C. trachomatis. Percent Agreement by Panel Member Overall and for |
|-----------------------------------------------------------------------------|
| Site/Instrument, Operator, and Day - PCR Media/Swab |
| Panel<br>Member | Ct<br>SD | Ct CV<br>% | Overall | Site / Instrument | Operator | Day |
|-----------------------------|----------|------------|------------------|-------------------|------------------|------------------|
| 1 X LOD CT,<br>Negative NG | 0.84 | 2.3 | 96.7<br>174/180 | 1 98.3<br>59/60 | 1 96.7<br>29/30 | 1 100.0<br>36/36 |
| | | | | 2 95.0<br>57/60 | 2 100.0<br>30/30 | 2 97.2<br>35/36 |
| | | | | 3 96.7<br>58/60 | 3 96.7<br>29/30 | 3 97.2<br>35/36 |
| | | | | | 4 93.3<br>28/30 | 4 94.4<br>34/36 |
| | | | | | 5 96.7<br>29/30 | 5 94.4<br>34/36 |
| | | | | | 6 96.7<br>29/30 | |
| 3 X LOD CT,<br>Negative NG | 0.53 | 1.5 | 100.0<br>180/180 | 1 100.0<br>60/60 | 1 100.0<br>30/30 | 1 100.0<br>36/36 |
| | | | | 2 100.0<br>60/60 | 2 100.0<br>30/30 | 2 100.0<br>36/36 |
| | | | | 3 100.0<br>60/60 | 3 100.0<br>30/30 | 3 100.0<br>36/36 |
| | | | | | 4 100.0<br>30/30 | 4 100.0<br>36/36 |
| | | | | | 5 100.0<br>30/30 | 5 100.0<br>36/36 |
| | | | | | 6 100.0<br>30/30 | |
| Negative CT,<br>1 X LOD NG | n/a | n/a | 100.0<br>180/180 | 1 100.0<br>60/60 | 1 100.0<br>30/30 | 1 100.0<br>36/36 |
| | | | | 2 100.0<br>60/60 | 2 100.0<br>30/30 | 2 100.0<br>36/36 |
| | | | | 3 100.0<br>60/60 | 3 100.0<br>30/30 | 3 100.0<br>36/36 |
| | | | | | 4 100.0<br>30/30 | 4 100.0<br>36/36 |
| | | | | | 5 100.0<br>30/30 | 5 100.0<br>36/36 |
| | | | | | 6 100.0<br>30/30 | |
| Negative CT,<br>3 X LOD NG | n/a | n/a | 100.0<br>180/180 | 1 100.0<br>60/60 | 1 100.0<br>30/30 | 1 100.0<br>36/36 |
| | | | | 2 100.0<br>60/60 | 2 100.0<br>30/30 | 2 100.0<br>36/36 |
| | | | | 3 100.0<br>60/60 | 3 100.0<br>30/30 | 3 100.0<br>36/36 |
| | | | | | 4 100.0<br>30/30 | 4 100.0<br>36/36 |
| | | | | | 5 100.0<br>30/30 | 5 100.0<br>36/36 |
| | | | | | 6 100.0<br>30/30 | |
| Negative CT,<br>Negative NG | n/a | n/a | 99.4<br>178/179 | 1 100.0<br>60/60 | 1 100.0<br>30/30 | 1 100.0<br>36/36 |
| | | | | 2 100.0<br>59/59 | 2 100.0<br>30/30 | 2 100.0<br>35/35 |
| | | | | 3 98.3<br>59/60 | 3 100.0<br>29/29 | 3 97.2<br>35/36 |
| | | | | | 4 100.0<br>30/30 | 4 100.0<br>36/36 |
| | | | | | 5 96.7<br>29/30 | 5 100.0<br>36/36 |
| | | | | | 6 100.0<br>30/30 | |
* For negative samples, percent agreement = (number of negative results/total valid results) x 100;
for positive samples, percent agreement = (number of positive results/total valid results) x 100.
Ct = cycle threshold; SD = standard deviation; CV = coefficient of variation; LOD = limit of delection; n/a = not applicable; CT = C. trachomatis; NG = N. gonorthoeae; n/a = not applicable.
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| Panel<br>Member | Ct<br>SD | Ct CV<br>% | Overall | | Site / Instrument | | Operator | | Day | | | | |
|-----------------------------|----------|------------|---------|---------|-------------------|-------|----------|---|-------|-------|---|-------|-------|
| 1 X LOD CT,<br>Negative NG | 0.93 | 2.6 | 98.9 | 177/179 | 1 | 98.3 | 59/60 | 1 | 96.7 | 29/30 | 1 | 100.0 | 36/36 |
| | | | | | 2 | 98.3 | 58/59 | 2 | 100.0 | 30/30 | 2 | 100.0 | 36/36 |
| | | | | | 3 | 100.0 | 60/60 | 3 | 96.7 | 29/30 | 3 | 97.2 | 35/36 |
| | | | | | 4 | | | 4 | 100.0 | 29/29 | 4 | 100.0 | 35/35 |
| | | | | | 5 | | | 5 | 100.0 | 30/30 | 5 | 97.2 | 35/36 |
| | | | | | 6 | | | 6 | 100.0 | 30/30 | | | |
| 3 X LOD CT,<br>Negative NG | 0.72 | 2.1 | 100.0 | 180/180 | 1 | 100.0 | 60/60 | 1 | 100.0 | 30/30 | 1 | 100.0 | 36/36 |
| | | | | | 2 | 100.0 | 60/60 | 2 | 100.0 | 30/30 | 2 | 100.0 | 36/36 |
| | | | | | 3 | 100.0 | 60/60 | 3 | 100.0 | 30/30 | 3 | 100.0 | 36/36 |
| | | | | | 4 | | | 4 | 100.0 | 30/30 | 4 | 100.0 | 36/36 |
| | | | | | 5 | | | 5 | 100.0 | 30/30 | 5 | 100.0 | 36/36 |
| | | | | | 6 | | | 6 | 100.0 | 30/30 | | | |
| Negative CT,<br>1 X LOD NG | n/a | n/a | 100.0 | 179/179 | 1 | 100.0 | 60/60 | 1 | 100.0 | 30/30 | 1 | 100.0 | 35/35 |
| | | | | | 2 | 100.0 | 60/60 | 2 | 100.0 | 30/30 | 2 | 100.0 | 36/36 |
| | | | | | 3 | 100.0 | 59/59 | 3 | 100.0 | 30/30 | 3 | 100.0 | 36/36 |
| | | | | | 4 | | | 4 | 100.0 | 30/30 | 4 | 100.0 | 36/36 |
| | | | | | 5 | | | 5 | 100.0 | 29/29 | 5 | 100.0 | 36/36 |
| | | | | | 6 | | | 6 | 100.0 | 30/30 | | | |
| Negative CT,<br>3 X LOD NG | n/a | n/a | 100.0 | 180/180 | 1 | 100.0 | 60/60 | 1 | 100.0 | 30/30 | 1 | 100.0 | 36/36 |
| | | | | | 2 | 100.0 | 60/60 | 2 | 100.0 | 30/30 | 2 | 100.0 | 36/36 |
| | | | | | 3 | 100.0 | 60/60 | 3 | 100.0 | 30/30 | 3 | 100.0 | 36/36 |
| | | | | | 4 | | | 4 | 100.0 | 30/30 | 4 | 100.0 | 36/36 |
| | | | | | 5 | | | 5 | 100.0 | 30/30 | 5 | 100.0 | 36/36 |
| | | | | | 6 | | | 6 | 100.0 | 30/30 | | | |
| Negative CT,<br>Negative NG | n/a | n/a | 100.0 | 180/180 | 1 | 100.0 | 60/60 | 1 | 100.0 | 30/30 | 1 | 100.0 | 36/36 |
| | | | | | 2 | 100.0 | 60/60 | 2 | 100.0 | 30/30 | 2 | 100.0 | 36/36 |
| | | | | | 3 | 100.0 | 60/60 | 3 | 100.0 | 30/30 | 3 | 100.0 | 36/36 |
| | | | | | 4 | | | 4 | 100.0 | 30/30 | 4 | 100.0 | 36/36 |
| | | | | | 5 | | | 5 | 100.0 | 30/30 | 5 | 100.0 | 36/36 |
| | | | | | 6 | | | 6 | 100.0 | 30/30 | | | |
# Table 15: C. trachomatis. Percent Agreement by Panel Member Overall and for Site/Instrument, Operator, and Day - PreservCyt
* For negative samples, percent agreement = (number of negative results/total valid results) x 100; for positive samples, percent agreement = (number of positive results/total valid results) x 100.
Ct = cycle threshold; SD = standard deviation; CV = coefficient of variation; LOD = limit of detection; CT = C. trachomatis; NG = N. gonorrhoeae; n/a = not applicable.
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#### N. gonorrhoeae (Table 16, T…
