MICHIGAN INNOVATIVE DIAGNOSTICS

Molecular assay that aids in diagnosing the three most common causes of infectious vaginitis: (1) bacterial vaginosis, (2) vulvovaginal candidiasis, and (3) trichomoniasis, all from a single vaginal swab in symptomatic patients.

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LIS PANEL CODE: (MID) Basic Vaginitis PCR (BVP) Panel​

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INDIVIDUAL LIS TEST CODES INCLUDED WITHIN PANEL: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Gardnerella vaginalis, Candida albicans

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CPT CODE: 87494 (CT/NG) + 87661 (TV) + 87481 (Candida) + 87798 (GV)

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ALIASES: BVP PCR, Vaginitis Panel PCR

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METHODOLOGIES: Real-Time Reverse Transcription PCR (RT-PCR), Multiplex Amplified Probe Technique

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Laboratory Developed Test (LDT): Performance characteristics determined by Michigan Innovative Diagnostics. This test has not been cleared or approved by the FDA.

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SPECIMEN:

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- Type: Vaginal Swab

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- Container: Flocked E-Swab (Sterile Swab with Liquid Amies Transport Medium)

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- Minimum Volume Required: N/A (Single Swab)

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- Storage/Handling: Collect prior to use of lubricant. Refrigerate if testing will be delayed beyond same day.

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- Stability:   

 

Room Temperature (20-25 °C): 1 day

Refrigerated (2-8 °C): 7 days

Frozen (-20 °C or colder): Not Accepted​

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- Turnaround Time: 24 - 48 hours from receipt.

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Special Instructions: Intended for symptomatic patients only; not validated for asymptomatic screening. Results should be interpreted alongside clinical presentation, as BV- and Candida-associated organisms can be commensal.

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REJECTION REASONS: Non-Vaginal Source, Contamination, QNS, Stability Violation, Unlabeled/Mislabeled Specimen, Expired Container, Incorrect Container

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EXPECTED FINDINGS:​​

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Chlamydia trachomatis: Not Detected

Neisseria gonorrhoeae: Not Detected

Trichomonas vaginalis: Not Detected​

Gardnerella vaginalis: Not Detected

Candida albicans: Not Detected

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