Aptima Trichomonas vaginalis Assay

K231316 · Hologic, Inc. · OUY · Nov 6, 2023 · Immunology

Device Facts

• Record ID: K231316
• Device Name: Aptima Trichomonas vaginalis Assay
• Applicant: Hologic, Inc.
• Product Code: OUY · Immunology
• Decision Date: Nov 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3860
• Device Class: Class 2

Indications for Use

The Aptima Trichomonas vaginalis (TV) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther system. The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs, clinician-collected and patient-collected vaginal swabs (in a clinical setting), female and male urine, and specimens collected in PreservCyt Solution.

Device Story

Aptima Trichomonas vaginalis (TV) assay is an automated NAAT for qualitative detection of TV rRNA. Input samples include clinician/patient-collected vaginal swabs, endocervical swabs, and male/female urine. The Panther System performs target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA). Labeled DNA probes bind to RNA amplicons; luminometer measures photon signals as Relative Light Units (RLU). Used in clinical settings; operated by laboratory personnel. Software automatically interprets RLU to provide negative, positive, or invalid results. Results aid clinicians in diagnosing trichomoniasis, facilitating timely patient treatment and management.

Clinical Evidence

Prospective, multicenter clinical study (n=3820 subjects, 5502 specimens). Evaluated patient-collected vaginal swabs, female urine, and male urine. Compared against composite comparator method (CCA) or patient infected status (PIS). Results: Vaginal swab sensitivity 98.8% (95% CI: 95.6-99.7), specificity 99.4% (95% CI: 99.0-99.7). Male urine sensitivity 100% (95% CI: 91.6-100), specificity 99.8% (95% CI: 99.5-99.9). Female urine PPA 100% (95% CI: 97.6-100), NPA 100% (95% CI: 99.8-100).

Technological Characteristics

Nucleic acid amplification test (NAAT) using target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA). Automated processing on the Panther System. Analyte: Trichomonas vaginalis ribosomal RNA. No calibration required. Internal control for PCR function included. Software-based automated interpretation of RLU signals.

Indications for Use

Indicated for symptomatic or asymptomatic individuals to aid in the diagnosis of trichomoniasis via detection of Trichomonas vaginalis rRNA in clinician-collected endocervical swabs, clinician-collected/patient-collected vaginal swabs, and male/female urine.

Regulatory Classification

Identification

A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused by Trichomonas vaginalis.

Special Controls

*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of*Trichomonas vaginalis;* Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.

Predicate Devices

• Aptima Trichomonas vaginalis assay (K122062)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K231316

B Applicant

Hologic, Inc.

C Proprietary and Established Names

Aptima Trichomonas vaginalis Assay

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OUY | Class II | 21 CFR 866.3860 - Trichomonas Vaginalis Nucleic Acid Assay | MI - Microbiology |

## II Submission/Device Overview:

### A Purpose for Submission:

The Aptima Trichomonas vaginalis assay on the Panther System was previously cleared under K122062 for use with the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs, clinician-collected vaginal swabs, and specimens collected in PreservCyt Solution. Clearance of this pre-market submission adds patient-collected vaginal swab, and male and female urine from symptomatic and asymptomatic individuals as additional acceptable specimen types for use with the Aptima Trichomonas vaginalis (TV) assay on the Panther system.

### B Measurand:

Trichomonas vaginalis ribosomal RNA

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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C Type of Test:

Automated, nucleic acid amplification test (NAAT) for qualitative detection of ribosomal RNA (rRNA). The Aptima Trichomonas vaginalis assay involves the technologies of target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA).

III Intended Use/Indications for Use:

A Intended Use(s):

The Aptima Trichomonas vaginalis (TV) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther System.

The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs, clinician-collected and patient-collected vaginal swabs (in a clinical setting), female and male urine, and specimens collected in PreservCyt Solution.

B Indication(s) for Use:

Same as Intended Use

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

D Special Instrument Requirements:

PANTHER System automated analyzer

IV Device/System Characteristics:

A Device Description:

The Aptima Trichomonas vaginalis (Aptima TV) assay is a nucleic acid amplification test, intended for the in vitro qualitative detection of ribosomal RNA from Trichomonas vaginalis (TV) in clinician-collected and patient-collected vaginal swabs, clinician-collected endocervical swabs, male and female urine, and specimens collected in PreservCyt solution. The assay involves the technologies of target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA). Assay test results are automatically interpreted by the Panther system Aptima TV assay software. A test result may be negative, positive, or invalid as determined by total RLU in the detection step. The current Aptima TV assay is similar to the assay cleared earlier (K122062) for use on the Panther System. There are no changes to the Aptima TV assay reagents and accessories. The Aptima Urine Specimen Collection Kit is required for the collection of male or female urine specimens. The Aptima Multitest Swab Specimen Collection Kit is intended to be used for collection and transport of clinician and patient collected vaginal swabs.

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## B Principle of Operation:

The Aptima TV assay utilizes target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA). The TMA reaction amplifies a specific region of the small ribosomal subunit from TV via DNA and RNA intermediates and generates RNA amplicon molecules. Detection of the rRNA amplification product sequences is achieved using nucleic acid based HPA. A labeled DNA probe combines with amplicon to form stable RNA: DNA hybrids. During the detection step, light emitted from the labeled RNA: DNA hybrids is measured as photon signals in a luminometer and are reported as Relative Light Units (RLU). Please refer to the decision summary of K122062 for detailed description.

## C Instrument Description Information:

1. Instrument Name:
Panther System

2. Specimen Identification:
By handheld barcode reader and manual entry.

3. Specimen Sampling and Handling:
Fully automated

4. Calibration:
The Aptima TV assay requires no calibration. The PANTHER System undergoes Preventive Maintenance every 12 months, which includes luminometer calibration.

5. Quality Controls:
The Aptima Trichomonas vaginalis Controls Kit includes 5 vials each of Positive and Negative Controls which are ready to use.

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

Aptima Trichomonas vaginalis assay (Panther System)

### B Predicate 510(k) Number(s):

K122062

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K122062 | K231316 |
| --- | --- | --- |
| Device Trade Name | Aptima Trichomonas vaginalis Assay (Panther System) | Aptima Trichomonas vaginalis Assay (Panther System) |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Aptima Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther system. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, and specimens collected in PreservCyt Solution. | The Aptima Trichomonas vaginalis (TV) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther System. The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs, clinician-collected and patient-collected vaginal swabs (in a clinical setting), female and male urine, and specimens collected in PreservCyt Solution. |
| Assay principle | Target Capture (TC), Transcription-Mediated Amplification (TMA), Hybridization Protection Assay (HPA) | Same |
| Instrumentation | PANTHER System automated analyzer | Same |
| Analyte | Trichomonas vaginalis rRNA | Same |
| Amplification technology | Technology of target | Same |

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| | capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) to streamline specimen processing, amplify target rRNA and detect amplicon. | |
| --- | --- | --- |
| Test interpretation | Automated test interpretation | Same |
| Controls | Assay contains an internal control for PCR function. | Same |
| Organism detected | Trichomonas vaginalis | Same |
| General Device Characteristic Differences | | |
| Specimen type | Female specimens: • Vaginal swab (Clinician collected) • Endocervical swab • Gynecological specimens in PreservCyt solution | Female specimens: • Vaginal swab (Clinician collected) • Vaginal swab (Patient collected in clinical settings) • Endocervical swab • Gynecological specimens in PreservCyt solution • Urine
Male Specimens: • Urine |

VI Standards/Guidance Documents Referenced:
- Class II Special Controls Guideline for Industry and Food and Drug Administration Staff - Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Reproducibility of the Aptima TV assay on the Panther system was previously evaluated using samples prepared in specimen transport medium (STM) and in PreservCyt Solution, reviewed under K122062.

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For this submission, Aptima TV assay reproducibility on the Panther system was evaluated by testing panel members created using unique pools of negative urine specimens with Urine Transport Medium (UTM) spiked with varying concentrations of a stock solution of lysed TV organisms diluted in UTM. Final TV concentrations ranged from 0.003 TV/mL to 1 TV/mL. The study was conducted at two external US laboratories and at Hologic, using two lots of assay reagents and a total of six operators (two at each site), testing each sample in three replicates. At each site, testing was performed over at least 6 days. The summary of reproducibility results is presented in Table 1 below.

Table 1: Aptima TV Assay Reproducibility Study

| Sample | Conc TV/mL | N | Agreed | Agrmt (%) | Mean RLU | Between Sites | | Between Operators | | Between Lots | | Between Runs | | Within Runs | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| Neg | N/A | 108 | 108 | 100 | 1.0 | 0.2 | 24.6 | 0.0 | 0.0 | 0.3 | 28.3 | 0.0 | 0.0 | 0.7 | 72.3 | 0.8 | 81.4 |
| HNeg | 0.002 | 107 | 107 | 100 | 33.1 | 15.9 | 48.1 | 4.9 | 14.8 | 0.0 | 0.0 | 7.1 | 21.6 | 9.3 | 28.0 | 20.3 | 61.5 |
| MPos | 0.03 | 108 | 108 | 100 | 621.9 | 27.2 | 4.4 | 33.5 | 5.4 | 37.3 | 6.0 | 100.6 | 16.2 | 69.4 | 11.2 | 134.9 | 21.7 |
| HPos | 1.00 | 108 | 108 | 100 | 1208.3 | 28.8 | 2.4 | 0.0 | 0.0 | 0.0 | 0.0 | 140.4 | 11.6 | 41.5 | 3.4 | 149.2 | 12.3 |

Agrmt=Agreement with expected result, HNeg=High negative, HPos=High positive, MPos=Moderate positive, Neg=Negative, Conc= Concentration units, TV/mL = trichomonads/mL

# 2. Linearity:

Aptima TV assay is a qualitative assay, therefore a linearity study is not applicable.

# 3. Analytical Specificity/Interference:

# Analytical Specificity-Cross Reactivity and Microbial Interference

Analytical specificity of the Aptima TV assay was evaluated for cross-reactivity by testing various microorganisms, including common flora of the genitourinary tract, opportunistic organisms, and closely related organisms. Testing was conducted in urine in UTM with 25 replicates of each panel comprising of three different microorganisms per panel. The list of organisms and the concentrations tested are provided in Table 2. The Aptima TV Assay was also evaluated for microbial interference by testing the same organisms (Table 2) in urine in STM spiked with TV lysate to a final concentration of $0.01\mathrm{TV / mL}$ . This microorganism is found in the gastrointestinal tract and not likely to be found in cervical, urine, or vaginal samples. Please refer to K122062 for the cross-reactivity/microbial interference studies conducted for previously claimed matrices in support of Aptima TV assay.

Table 2: Microorganisms Tested in the Aptima TV Assay with Urine

| Microorganism | Concentration | Microorganism | Concentration |
| --- | --- | --- | --- |
| Acinetobacter Iwoffii | 1x106CFU/mL | HPV 16 | 2.5x106copies/mL |
| Actinomyces israelii | 1x106CFU/mL | HPV 6 | 2.5x106copies/mL |
| Atopobium vaginae | 1x106CFU/mL | Klebsiella pneumoniae | 1x106CFU/mL |

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| Bacteroides fragilis | 1x10^6 CFU/mL | Lactobacillus acidophilus | 1x10^6 CFU/mL |
| --- | --- | --- | --- |
| Bifidobacterium adolescentis | 1x10^6 CFU/mL | Lactobacillus crispatus | 1x10^6 CFU/mL |
| Campylobacter jejuni | 1x10^6 CFU/mL | Listeria monocytogenes | 1x10^6 CFU/mL |
| Candida albicans | 1x10^6 CFU/mL | Mobiluncus curtisii | 1x10^6 CFU/mL |
| Chlamydia trachomatis | 1x10^6 IFU/mL | Mycoplasma genitalium | 2.5 x10^6 copies/mL |
| Clostridium difficile | 1x10^6 CFU/mL | Mycoplasma hominis | 1x10^6 CFU/mL |
| Corynebacterium genitalium | 1x10^6 CFU/mL | Neisseria gonorrhoeae | 1x10^6 CFU/mL |
| Cryptococcus neoformans | 1x10^6 CFU/mL | Pentatrichomonas hominis | 1x10^6 cells/mL |
| Cytomegalovirus | 2x10^5 TCID50/mL | Peptostreptococcus magnus | 1x10^6 CFU/mL |
| Dientamoeba fragilis* | 1x10^6 CFU/mL | Prevotella bivia | 1x10^6 CFU/mL |
| Enterobacter cloacae | 1x10^6 CFU/mL | Propionibacterium acnes | 1x10^6 CFU/mL |
| Enterococcus faecalis | 1x10^6 CFU/mL | Proteus vulgaris | 1x10^6 CFU/mL |
| Escherichia coli | 1x10^6 CFU/mL | Pseudomonas aeruginosa | 1x10^6 CFU/mL |
| Gardnerella vaginalis | 1x10^6 CFU/mL | Staphylococcus aureus | 1x10^6 CFU/mL |
| Haemophilus ducreyi | 1x10^6 CFU/mL | Staphylococcus epidermidis | 1x10^6 CFU/mL |
| Herpes simplex virus I | 2x10^5 TCID50/mL | Streptococcus agalactiae | 1x10^6 CFU/mL |
| Herpes simplex virus II | 2x10^5 TCID50/mL | Trichomonas tenax | 1x10^6 cells/mL |
| HIV-1 | 2.5x10^6 copies/mL | Ureaplasma urealyticum | 1x10^6 CFU/mL |

## Interfering Substances

The analytical performance of the Aptima TV assay was evaluated in the presence of a panel of potentially interfering substances that may be found in urine samples. Each potential interferent was organized in panels comprising of representatives of personal lubricant, personal deodorant, antifungal agents, and representatives of spermicide and intravaginal hormone (Table 3). Additionally, porcine mucin (used to simulate the major biological component of cervical mucus), seminal fluid from 25 subjects, whole blood, glacial acetic acid and commercially prepared Kova-Trol I were used to evaluate the interference from endogenous substances (commercially available Kova-Trol I is a ready-to-use liquid control at clinically high concentrations). Each potential interferent was spiked into urine/ UTM diluted samples, containing TV organisms at the concentration of 0.01 TV/mL, to a final indicated concentration (vol/vol, V/V or wt/vol, W/V), as shown in Table 3. Additionally, each interferent was spiked into urine/ UTM with no TV present. Tests for all interference substances, with the exception of glacial acetic acid, mucin and astroglide lubricant, generated expected results, demonstrating that the substances listed at the concentrations shown in Table 3, do not interfere with the Aptima TV assay. Glacial acetic acid, mucin and astroglide lubricant interfered with performance of TV detection at concentration of 0.01 TV/mL causing false negative results. However, these substances did not interfere with TV detection when tested at higher concentrations, i.e., of 0.3 TV/mL when tested in the presence of astroglide lubricant, and 1 TV/mL when tested in the presence of mucin and glacial acetic acid. Please refer to K122062 for the interference studies conducted for previously claimed matrices in support of Aptima TV assay.

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Table 3: Substances evaluated in the Interference Study with Urine

| Product Category | Product Brand or Type | Concentration |
| --- | --- | --- |
| Lubricant (V/V) | KY Warming Liquid, KY Sensitive Touch Target Lubricant Liquid, Astroglide KY Sensitive Jelly * | 1% |
| Spermicide (W/V) | Gynol II Jelly Max Strength; Conceptrol VCF Vaginal Contraceptive Film Encare Inserts | 1% |
| Anti-fungal (W/V) | Monistat 3 Combo, CVS Clotrimazole 3, Target Vagicaine Cream, Vagisil Maximum Strength, Tarqet Miconazole ? | 1% |
| Deodorant Spray/Powder (W/V) | Summer's Eve Powder, Vagisil Powder Summer's Eve, Spray New Freshness Spray, FDS Spray | 1% |
| Intravaginal Hormone (W/V) | Estrace Vaginal Cream (estradiol), CrinoneGel (progesterone) Endometrin tablets (progesterone) Vagifem tablets (estradiol) | 1% |
| Seminal Fluid (V/V) | Samples from 25 subjects | 10% |
| Mucus (W/V) * | Porcine Mucin | 10% |
| Whole Blood (V/V) | N/A | 100% in place of urine |
| Glacial Acetic Acid (V/V) * | EMD Chemicals, Alfa Aesar (retest at 1 TVmL) | 1% |
| Urine Metabolites | KOVA-Trol I High Abnormal with Urobilinogen | 100% in place of urine |

* These substances interfered with performance of Aptima TV assay at the indicated tested concentrations and resulted in false positives in urine -UTM samples containing 0.01 TV/mL.

4. Assay Reportable Range:

Aptima TV assay is a qualitative assay; therefore, a measuring range study is not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

The stability of urine specimens was evaluated in an analytical study which used individual negative female urine specimens spiked with freshly cultured TV and replicates tested at baseline and after storage. The study results demonstrated urine samples are stable when stored neat for 24 hours at 30°C and when stored in UTM for 30 days at 30°C or up to 24 months at -20°C.

6. Detection Limit:

The limit of detection (LoD) for the Aptima TV assay was determined by testing two quantified (TV/mL) strains of TV spiked into negative pools of female urine matrix. One batch of each cultured TV strain, ATCC #30236 (metronidazole-sensitive strain) and ATCC #50138 (metronidazole-resistant strain) were used in this study. Results demonstrated greater than 95% positivity for both strains of TV at 0.01 TV/mL in urine specimen matrix. Please refer to K122062 for the Detection Limit studies conducted for previously claimed matrices in support of Aptima TV assay.

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7. Assay Cut-Off:

Please refer to K122062 for the carry-over studies conducted in support of the Aptima TV assay on the Panther instrument.

8. Accuracy (Instrument):

Not applicable.

9. Carry-Over:

Please refer to K122062 for the carry-over studies conducted in support of the Aptima TV assay.

## B Comparison Studies:

1. Method Comparison with Predicate Device:

See Clinical Studies section below.

2. Matrix Comparison:

Not applicable.

## C Clinical Studies:

### Clinical Performance

The clinical performance of the Aptima TV assay on the Panther system with urine (male and female) and self-collected vaginal specimens, was evaluated in a prospective, multicenter clinical study.

Symptomatic and asymptomatic men and women were enrolled at 11 geographically and ethnically diverse US clinical sites, including obstetrics and gynecology, family planning, and STI clinics.

Up to five specimens were collected from each female subject (four patient-collected vaginal swabs, one first-catch urine), and one first catch urine specimen was collected from each male subject. All specimens were collected by the subject at the clinical sites.

Of the specimens collected, 5922 were processed in valid Aptima TV assay runs. Of these, 225 samples generated invalid results upon initial testing (invalid rate of 3.8%, 95% CI: 3.3%-4.3%); after retesting, 89 samples remained invalid.

The clinical performance of the Aptima TV assay with vaginal swabs and female and male urine was evaluated testing each sample with up to three FDA-cleared NAATs for detection of TV. Specimens were categorized as "infected" (patient infected status, PIS) for vaginal swabs and male urine and as "positive" (composite comparator algorithm, CCA) for female urine if a positive result occurred in at least two of the comparator NAAT results, and as "not infected"/

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"negative" if at least two of the comparator results were negative; the third (tie-breaker) NAAT was only required if the first two NAAT results were discordant. Specimens that could not be categorized as infected/positive or not infected/negative due to missing results from the comparator assays were excluded from the performance analyses.

A total of 5502 specimens from 3820 evaluable subjects were included in the analyses comparing Aptima TV assay results to the PIS or CCA interpretation: 1785 patient- collected vaginal swabs, 1782 female urine specimens, and 1935 male urine specimens.

Performance characteristics of the Aptima TV assay, are shown below in Table 4 and 5.

Table 4: Clinical Performance of the Aptima TV assay Compared to PIS, by Symptom Status

| Specimen Type | Symptom Status | n | TP | FP | TN | FN | Sensitivity % (95% CI) | Specificity % (95% CI) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| PVS | Asymptomatic | 932 | 59 | 3 | 868 | 2 | 96.7 (88.8-99.1) | 99.7 (99.0-99.9) |
| | Symptomatic | 853 | 99 | 6 | 748 | 0 | 100 (96.3-100) | 99.2 (98.3-99.6) |
| | All | 1785 | 158 | 9 | 1616 | 2 | 98.8 (95.6-99.7) | 99.4 (99.0-99.7) |
| MU | Asymptomatic | 1125 | 21 | 1 | 1103 | 0 | 100 (84.5-100) | 99.9 (99.5-100) |
| | Symptomatic | 810 | 21 | 2 | 787 | 0 | 100 (84.5-100) | 99.7 (99.1-99.9) |
| | All | 1935 | 42 | 3 | 1890 | 0 | 100 (91.6-100) | 99.8 (99.5-99.9) |

PVS = patient-collected vaginal swab, MU = male urine,
TP = true positive, FP = false positive, TN = true negative, FN = false negative.

The TV specimen specific positive and negative percent agreements (PPA and NPA) between the Aptima TV assay and up to three FDA cleared NAATs with female urine specimen are shown below in Table 5.

Table 5: TV Specimen Specific Agreement for Female Urine, by Symptom Status

| Specimen Type | Symptom Status | n | CCA+ ATV+ | CCA- ATV+ | CCA- ATV- | CCA+ ATV- | PPA % (95% CI) | NPA % (95% CI) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| FU | Asymptomatic | 949 | 64 | 0 | 885 | 0 | 100 (94.3-100) | 100 (99.6-100) |
| | Symptomatic | 833 | 94 | 0 | 739 | 0 | 100 (96.1-100) | 100 (99.5-100) |
| | All | 1782 | 158 | 0 | 1624 | 0 | 100 (97.6-100) | 100 (99.8-100) |

FU = female urine, TP = true positive, FP = false positive, TN = true negative, FN = false negative,
PPA = positive percent agreement, NPA = negative percent agreement. ATV= Aptima TV assay

The sensitivity of the Aptima TV assay on the Panther system in female urine specimens was also assessed compared to three comparator NAAT results obtained by testing patient-collected vaginal swabs (PIS). The data showed that the detection of TV infection in female urine specimens by the Aptima TV assay is up to $2.4\%$ lower than when testing vaginal swab specimens when compared to PIS.

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# D Clinical Cut-Off:

Not Applicable.

# E Expected Values/Reference Range:

The positivity of $T$ vaginalis, as determined by the Aptima TV assay, during the clinical study is shown in Table 6 below.

Table 6: Positivity of T. vaginalis as Determined by the Aptima TV assay, by Sample Type, stratified by Clinical Sites

| Site | PVS | FU | MU |
| --- | --- | --- | --- |
| 1 | 0 (0/16) | 0 (0/16) | 0 (0/180) |
| 2 | 11.1 (36/325) | 10.4 (38/364) | 4.4 (16/364) |
| 3 | 8.5 (6/71) | 9.5 (7/74) | 1.7 (1/60) |
| 4 | NC (0/0) | NC (0/0) | 0 (0/13) |
| 5 | 8.8 (15/170) | 8.8 (15/171) | 2.9 (12/407) |
| 6 | 5.8 (24/416) | 5.8 (24/413) | 0.7 (2/304) |
| 7 | 6.1 (11/179) | 5.3 (10/187) | 1.3 (3/225) |
| 8 | 0 (0/38) | 0 (0/39) | 0 (0/32) |
| 9 | 10.8 (32/297) | 9.8 (25/255) | 2.4 (5/210) |
| 10 | 20.2 (37/183) | 19.8 (36/182) | 6.7 (6/89) |
| 11 | 6.7 (6/90) | 3.7 (3/81) | 0 (0/51) |
| ALL | 9.4 (167/1785) | 8.9 (158/1782) | 2.3 (45/1935) |

PVS = patient-collected vaginal swab, FU = female urine, MU = male urine, NC = not calculable.

# F Other Supportive Instrument Performance Characteristics Data:

Not applicable

# VIII Proposed Labeling:

The labeling is acceptable and supports the finding of substantial equivalence for this device.

# IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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