(6 days)
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 TIGRIS DTS System.
The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution.
The ATV assay is a nucleic acid amplification test intended for the in vitro qualitative detection of ribosomal RNA from T. vaginalis in patient-collected first catch urine and clinician collected vaginal swabs, endocervical swab and ThinPrep Pap Test specimens collected in Cytyc Preservcyt solution. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System automated analyzer.
There are 4 kits (1 master and 3 ancillary) that are required to perform the ATV assay on the TIGRIS DTS System. The Master Kit contains 9 reagents and 2 controls and is made up of 3 boxes. Box 1 - the Refrigerated box contains ATV amplification reagent, ATV enzyme reagent, ATV probe reagent and ATV Target Capture reagent-B. Box 2 - the Room Temperature box contains ATV amplification reconstitution solution, ATV enzyme reconstitution reagent, ATV probe reconstitution reagent, ATV selection reagent and ATV target capture reagent. Box 3-the Controls kit box contains ATV positive and negative controls. The three ancillary kits consist of the APTIMA Assay Fluids kit, the APTIMA Auto Detect Reagents kit and APTIMA System Fluids Preservative kit. In addition to the reagents provided in the kit, the assay utilizes four specimen collection kits - the APTIMA unisex swab specimen collection kit for endocervical and male urethral swab specimens, APTIMA vaginal swab specimen collection kit, APTIMA urine specimen collection kit for male and female urine specimens and the APTIMA specimen transfer kit.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the Aptima Trichomonas vaginalis (ATV) assay.
Acceptance Criteria and Device Performance for Aptima Trichomonas vaginalis (ATV) Assay
The Aptima Trichomonas vaginalis (ATV) assay is a qualitative nucleic acid amplification test (NAAT) designed for the detection of ribosomal RNA (rRNA) from T. vaginalis. Its performance was evaluated through various analytical and clinical studies.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ATV assay are implicitly defined by the reported performance characteristics which are deemed sufficient for reclassification to Class II. The primary performance metrics are related to the accuracy of T. vaginalis detection across different specimen types.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Sensitivity | High sensitivity across all claimed specimen types. | Urine: 95.2% (95% CI: 88.4-98.1) |
| Clinician-collected vaginal swab: 100% (95% CI: 96.7-100) | ||
| Endocervical swab: 100% (95% CI: 96.7-100) | ||
| PreservCyt solution liquid Pap: 100% (95% CI: 96.0-100) | ||
| Similar performance in symptomatic and asymptomatic women. | ||
| Clinical Specificity | High specificity across all claimed specimen types. | Urine: 98.9% (95% CI: 97.8-99.5) |
| Clinician-collected vaginal swab: 99.0% (95% CI: 97.9-99.5) | ||
| Endocervical swab: 99.4% (95% CI: 98.6-99.7) | ||
| PreservCyt solution liquid Pap: 99.6% (95% CI: 98.8-99.9) | ||
| Similar performance in symptomatic and asymptomatic women. | ||
| Positive Predictive Value (PPV) | High PPV, especially important for positive results. | Urine: 92.0% (95% CI: 1-96.4) |
| Clinician-collected vaginal swab: 93.3% (95% CI: 87.6-97.0) | ||
| Endocervical swab: 95.8% (95% CI: 90.7-98.6) | ||
| PreservCyt solution liquid Pap: 96.9% (95% CI: 91.4-99.3) | ||
| Negative Predictive Value (NPV) | High NPV, important for ruling out infection. | Urine: 99.4% (95% CI: 98.5-99.8) |
| Clinician-collected vaginal swab: 100% (95% CI: 99.5-100) | ||
| Endocervical swab: 100% (95% CI: 99.6-100) | ||
| PreservCyt solution liquid Pap: 100% (95% CI: 99.5-100) | ||
| Detection Limit | 100% positivity at low T. vaginalis concentrations. | 100% positivity for T. vaginalis at 0.1 TV/mL in urine, PreservCyt, and vaginal swab matrices for two T. vaginalis strains (Metronidazole-susceptible and Metronidazole-resistant). |
| Analytical Specificity | No significant cross-reactivity with common genitourinary flora or closely related organisms; minimal interference from other substances. | No cross-reactivity or significant effect on specificity with a wide range of microorganisms (Table 7 in the source document). |
| No significant interference with most tested substances (e.g., lubricants, spermicides, anti-fungal/anti-itch medications, hormones, blood, urine controls) except for porcine gastric mucus (lower signal output). | ||
| Lower signal outputs observed in the presence of Trichomonas tenax and Pentatrichomonas hominis. | ||
| Precision/Reproducibility | Consistent results from repeated testing across sites, operators, and reagent lots. | Coefficient of Variation (CV) for RLU values ranged from 4.4% to 74.1% across various panel members (high negative, moderate positive, high positive) and matrices (PreservCyt, Urine). Total CV for high positive samples was 14.1% (P) and 17.9% (U). |
| Assay Cut-off | Clear rules for test interpretation (Negative, Positive, Invalid). | Negative: Total RLU (x 1000) of 0* to /= 2400. |
| Control Acceptability | Controls must perform within specified RLU ranges. | Negative Control: Total RLU (x 1000) of 0* and =500 and |
§ 866.3860
Trichomonas vaginalis nucleic acid assay.(a)
Identification. ATrichomonas 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 byTrichomonas vaginalis .(b)
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 ofTrichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.