MICHIGAN INNOVATIVE DIAGNOSTICS

Comprehensive 32-target molecular panel combining classic BV-associated bacteria, Candida species-level identification, vaginal Lactobacillus flora markers, and STI organisms (chlamydia, gonorrhea, trichomoniasis, syphilis, herpes, chancroid, mycoplasma/ureaplasma) from a single vaginal swab.

​

LIS PANEL CODE: (MID) Extended Vaginitis PCR (EVP) Panel

​

INDIVIDUAL LIS TEST CODES INCLUDED WITHIN PANEL: Atopobium vaginae, Bacteroides fragilis, BVAB-2, Candida albicans, Candida dubliniensis, Candida glabrata, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Chlamydia trachomatis, Gardnerella vaginalis, Haemophilus ducreyi, HHV-1 (Herpes Simplex), HHV-2 (Herpes Simplex), Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii, Megasphaera Type 2, Megasphaera Type 1, Mobiluncus curtisii, Mobiluncus mulieris, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhoeae, Prevotella bivia, Staphylococcus aureus, Strep. agalactiae (Group B), Treponema pallidum, Trichomonas vaginalis, Ureaplasma urealyticum

​

CPT CODE: 87494 (CT/NG) + 87661 (TV) + 87481 (Candida) + 87528 (HSV) + 87653 (Group B Strep) + 87640 (S. aureus) + 87798 (infectious agent, not otherwise specified, amplified probe technique) x remaining organisms

​

ALIASES: EVP PCR, Extended Vaginitis Panel PCR

​

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

​

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

​

SPECIMEN:

​

- Type: Vaginal Swab

​

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

​

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

​

- Storage/Handling: Collect prior to use of lubricant. Avoid cervical specimens, as elevated sialidase activity can affect results. Refrigerate specimen if testing will be delayed.

​

- Stability:   

 

Room Temperature (20-25 °C): 1 day

Refrigerated (2-8 °C): 7 days

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

​

- Turnaround Time: 24 - 48 hours from receipt.

​

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.

​

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

​

EXPECTED FINDINGS:​​

​

Atopobium vaginae: Not Detected

Bacteroides fragilis: Not Detected

BVAB-2: Not Detected

Candida albicans: Not Detected

Candida dubliniensis: Not Detected

Candida glabrata: Not Detected

Candida krusei: Not Detected

Candida lusitaniae: Not Detected

Candida parapsilosis: Not Detected

Candida tropicalis: Not Detected

Chlamydia trachomatis: Not Detected

Gardnerella vaginalis: Not Detected

Haemophilus ducreyi: Not Detected

HHV-1 (Herpes Simplex): Not Detected

HHV-2 (Herpes Simplex): Not Detected

Lactobacillus crispatus: Not Detected

Lactobacillus gasseri: Not Detected

Lactobacillus iners: Not Detected

Lactobacillus jensenii: Not Detected

Megasphaera Type 2: Not Detected

Megasphaera Type 1: Not Detected

Mobiluncus curtisii: Not Detected

Mobiluncus mulieris: Not Detected

Mycoplasma genitalium: Not Detected

Mycoplasma hominis: Not Detected

Neisseria gonorrhoeae: Not Detected

Prevotella bivia: Not Detected

Staphylococcus aureus: Not Detected

Strep. agalactiae (Group B): Not Detected

Treponema pallidum: Not Detected

Trichomonas vaginalis: Not Detected

Ureaplasma urealyticum: Not Detected

​

​