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Vaginal Pathogens by Nucleic Acid Testing (8000100056)
Test Mnemonic:
Specimen Requirements:
Test Included:

Bacterial Vaginosis, Candida spp., Candida glabrata, and Trichomonas vaginalis

Collection:

Follow the directions in the Aptima Multitest Collection kit.

Container:

Aptima Multitest Collection Kit.

Storage/Transport:

Aptima Multitest Collection tube - room temperature.

Stability:

Aptima samples - 30 days room temperature or refrigerated.

Causes for Rejection:

Failure to use Aptima Multitest Collection Kit; samples from non-approved sources.

Specimen container unlabeled or labeled incorrectly. No date or time of collection or no collector information on order. Leaking containers. Improperly collected samples.

Reference Range:

Negative

Turnaround Time:

Test is batch tested three days per week.

Methodology:

Nucleic acid amplification by real-time transcription-mediated amplification, target capture, and fluorescent probe hybridization. 

Performed:
Lab:

Clinical Microbiology

Synonyms:

Bacterial vaginosis, Candida, Trichomonas vaginalis, Trichomonas, Vaginitis, Vaginosis, Trich, BV, Wet mount, Wet Prep

Clinical Indication:

This test is for use from patients with symptoms of vaginitis/vaginosis. Performance with other specimen types has not been established.

Patient Preparation :

Female - vaginal collection.

CPT 4 Code:

87801, 87481, 87661

Note:

Reliable results are dependent on adequate specimen collection.

This test detects Trichomonas vaginalis, Candida glabrata, and other Candida species (C. albicans, C. parapsilosis, C. dublinensis, and C.tropicalis). The assay does not differentiate among organisms in the Candida species group. 

The Bacterial Vaginosis result is determined based on relative amounts of the following target organisms: Lactobacillus, (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. A single qualitative result is generated. This assay does not report individual organisms. 

A positive result obtained from a patient after therapeutic treatment cannot be interpreted as indicating the presence of viable organisms. For patients on whom a false positive result may have adverse psychosocial impact, retesting is advised.

Indeterminate: Unable to generate a valid test result on this specimen. Please submit a new specimen for repeat testing if clinically indicated. 

This testing has not been validated for medico-legal purposes (sexual abuse in peri-pubertal and pre-pubertal children, sexual assault, and legal cases). 

Results from this testing should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.
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