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Test Code BVRNA Bacterial Vaginosis, Nucleic Acid Amplification, Vaginal


Specimen Required


Specimen Type: Vaginal

Supplies: Aptima Multitest Swab Collection Kit (T584)

Container/Tube: Aptima Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Specimen must be collected using the Aptima Multitest Swab Collection Kit.

2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.

3. Place swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

4. Cap tube securely, and label tube with patient's entire name and collection date and time.

5. Maintain swab container between 2 and 30° C (refrigerate temperature is preferred) and transport within 30 days of collection. If longer storage is needed, store frozen between -20 and -70° C for up to 60 days.


Useful For

Aid for diagnosis of bacterial vaginosis

 

This test is not intended for use in medico-legal applications.

Method Name

Transcription Mediated Amplification

Reporting Name

Bacterial Vaginosis, Amplified RNA

Specimen Type

Vaginal

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Vaginal Refrigerated (preferred) 30 days APTIMA VIAL
  Frozen  60 days APTIMA VIAL
  Ambient  30 days APTIMA VIAL

Reference Values

Negative

Interpretation

Positive: Results should be interpreted alongside clinical presentation. Up to 40% of asymptomatic patients may test positive by this assay. Assay result is based on relative amounts of Lactobacillus (Lactobacillus gasseri, Lactobacillus crispatus, Lactobacillus jensenii), Gardnerella vaginalis, and Atopobium vaginae. Individual organisms are not reported.

 

Negative: A negative result does not exclude infection. Assay result is based on relative amounts of Lactobacillus (L gasseri, L crispatus, L jensenii), G vaginalis, and A vaginae.

 

Inconclusive: Repeat testing on a new sample is recommended if clinically indicated.

Clinical Reference

1. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187

2. Muzny CA, Cerca N, Elnaggar JH, Taylor CM, Sobel JD, Van Der Pol B. State of the art for diagnosis of bacterial vaginosis. J Clin Microbiol. 2023;61(8):e0083722. doi:10.1128/jcm.00837-22

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

81513

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BVRNA Bacterial Vaginosis, Amplified RNA 103590-6

 

Result ID Test Result Name Result LOINC Value
620738 Bacterial Vaginosis, Amplified RNA 103590-6