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Expanded Vaginosis Panel (Aptima)

Alternate Name: VGExpnd(Aptima)

SAL Code:

4222

Turn Around Time:

1-3 Days

Setup:

M-F

Department:

Molecular Diagnostics

Performing Laboratory:

Sherman Abrams Laboratory

Specimen Requirements:

Primary Tube:

APTIMA

Primary Substance:

Vaginal

Temperature

Period

Stable Ambient:

10 Days

Stable Fridge:

10 Days

Stable Frozen:

Not acceptable

Rejection Criteria:

Only Vaginal swab specimens collected using the Aptima Miltitest Swab Specimen Collection Kit are acceptable for testing with the Aptima BV and Aptima CT/TV Assay. Specimens will be rejected if the transport tube contains no swab, more then one swab, a cleaning swab, or any swab not provided by Hologic, Inc..

Clinical Info:

Clinical Information
Aptima BV Assay is a qualitative molecular assay used to support the diagnosis of Bacterial vaginosis by detects ribosomal RNA from bacterial groups associated with BV, including Lactobacillus species, Gradnerella vaginalis, and Atopobium vaginae. This assay applies applies an algorithm to generate a single positive or negative BV result.

The Aptima CV/TV Assay is a qualitative molecular assay used to detected RNA from organisms associated with volvovaginal candidiasis and Trichomoniasis including Candida species group, Candida glabrata and Trichomoniasis vaginalis. Differentiation of Candida glabrata is clinically important because this organism may demonstrate reduced susceptibility to standard antifungal therapy.

Additional Information:

This test is intended to be used as an aid in the diagnosis of the most common causes of vaginosis in women with a clinical presentation consistent with this disorder. The Bacterial Vaginosis test detects the three most common causes of bacterial vaginosis (Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus species). It is also used to determine the most frequent causes of vulvovaginal candidiasis, the Candida species, including the frequently antifungal resistant Candida glabrata. Finally, the test also detects the three common sexually transmitted infections, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Sample Collection:

Vaginal swab: Collect vaginal fluid sample using the Aptima® swab by touching the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

Test Limitations:

Test Limitation
- Testing should be performed only by personal trained in the assay procedure.
-The assays have been validated only for vaginal swab specimens and not for home-collected samples.
- Proper collection, transport, and processing are essential for accurate results.
- A negative result does not completely exclude infection or bacterial vaginosis.
- The assays are qualitative and do not quantify organism burden.
-Residual nucleic acid may remain detectable after treatment; therefore, the assay should not be used to assess treatment effectiveness or response.
- Result should be interpreted in conjunction with clinical findings and other laboratory data.
- Performance has not been established in patients younger then 14 years of age.
-Certain medication or substances, may interfere with testing, including mucus vaginal moisturizing gel, and tioconazole.
- A positive result indicates the presence of target RNA and does not confirm that viable organisms are present

Specimen Handling Instructions:

Swab specimens may be stored at 2 C to 30 C for up to 7 days after the receipt date.

Test Information:

Components:

Component Name CPT Loinc
Bacterial Vaginosis, Vaginal 46999-9
Candida glabrata, Vaginal 94421-5
Candida spp, Vaginal 94422-3
Chlamydia trachomatis, Vaginal 87491 43304-5
Neisseria gonorrhoeae, Vaginal 43305-2
Trichomonas vaginalis, Vaginal 6568-0