(53 days)
The GEN-PROBE® APTIMA® Adapter Kit is to be used to test male urethral specimens collected with the GEN-PROBE® PACE® Specimen Collection Kit for Urethral or Conjunctival Specimens or female endocervical specimens collected with the GEN-PROBE PACE Specimen Collection Kit for Endocervical Specimens in the APTIMA Assays.
The APTIMA Adapter Kit is specifically formulated to allow testing of specimens collected with the GEN-PROBE PACE collection devices in the APTIMA Combo 2 Assay. The APTIMA Adapter Kit provides a diluent for PACE specimens. The diluent is identical to the transport media provided in both the PACE and APTIMA collection kits. The APTIMA Adapter Kit can only be used in conjunction with the GEN-PROBE PACE Specimen Collection Kits for testing in the APTIMA Combo 2 Assay. The description provided pertains to the test application (the APTIMA Combo 2 Assay).
Here's a breakdown of the acceptance criteria and study details for the GEN-PROBE® APTIMA® Adapter Kit, based on the provided document:
Acceptance Criteria and Device Performance
The study aimed to establish the equivalence of the APTIMA Adapter Kit with the APTIMA Combo 2 Unisex Swab Collection Kit. While explicit "acceptance criteria" in terms of specific percentages were not stated before the results, the implication is that high levels of agreement between the two methods would demonstrate equivalence.
| Metric (Agreement between Adapter Kit and Unisex Swab Kit) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| C. trachomatis (CT) Results Percent Agreement | High level of agreement | 97.7% (95% C.I.: 95.6% - 98.9%) |
| N. gonorrhoeae (GC) Results Percent Agreement | High level of agreement | 98.7% (95% C.I.: 97.0% - 99.6%) |
The study concluded that the results demonstrate that using the APTIMA Adapter Kit with specimens collected in the PACE Specimen Collection Kits yield equivalent APTIMA Combo 2 Assay results when compared to specimens collected with the APTIMA Combo 2 Assay, Unisex Swab Specimen Collection Kits. This statement confirms the device met the implicit acceptance criteria of demonstrating equivalence.
Study Details
1. Sample sizes used for the test set and data provenance:
- Male subjects: 154
- Female subjects: 232
- Total test results analyzed: 772 (for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC))
- Data Provenance: The specimens were collected from subjects attending STD and Family Planning clinics. The document does not explicitly state the country of origin, but given the submission is to the FDA (USA), it is highly probable the data is from the USA. The study design comparing two collection methods for the same patients suggests a prospective collection for this specific study, although the underlying APTIMA Combo 2 Assay itself would have been validated with clinical data (which could be retrospective). This specific study focuses on the adapter kit's performance in a comparative manner.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the number of experts or their qualifications used to establish ground truth. This is a study comparing two specimen collection methods with the same assay, rather than comparing an assay to a gold standard. The "ground truth" implicitly relies on the established accuracy of the APTIMA Combo 2 Assay itself.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method. The study design compares results from paired swab specimens using two different collection kits with the same assay.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI or imaging device, nor is it a multi-reader study. The device is an adapter kit for a diagnostic assay.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The APTIMA Combo 2 Assay itself, with the adapter kit, operates as a standalone diagnostic test for detecting C. trachomatis and N. gonorrhoeae rRNA. The "algorithm" here refers to the assay's biochemical processes and detection methods (TMA and DKA), which yield qualitative results (positive/negative) without human interpretation of raw data beyond reading the instrument's output. The study here validates the specimen collection component in conjunction with this standalone assay.
6. The type of ground truth used (expert consensus, pathology, outcome data, etc):
- The "ground truth" in this comparative study is the results obtained from specimens collected with the APTIMA Combo 2 Unisex Swab Collection Kit. The study aims to show that using the PACE kit with the adapter yields equivalent results to this existing, presumably validated, collection method. The underlying ground truth for the APTIMA Combo 2 Assay itself would likely be a combination of culture results (historically considered the gold standard for N. gonorrhoeae), and molecular methods, as culture is no longer the gold standard for C. trachomatis. The document mentions amplification methods (like APTIMA Combo 2) are more sensitive than culture for C. trachomatis.
7. The sample size for the training set:
- The document does not provide information about a separate training set. This kit adapts an existing, validated assay. The study cited is a clinical validation study for the adapter kit's use with the existing assay.
8. How the ground truth for the training set was established:
- As no training set is mentioned for this specific adapter kit validation, this information is not available in the document.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.