MICHIGAN INNOVATIVE DIAGNOSTICS

Nine-target molecular panel intended to identify common causes of sexually transmitted infection, including gonorrhea/chlamydia, trichomoniasis, syphilis, genital herpes, chancroid, and bacterial-vaginosis-associated organisms, from a first-catch urine specimen.

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LIS PANEL CODE: (MID) Unisex Urine STI PCR (STI) Panel

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INDIVIDUAL LIS TEST CODES INCLUDED WITHIN PANEL: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginalis, Atopobium vaginae, Haemophilus ducreyi, HHV-1 (Herpes Simplex), HHV-2 (Herpes Simplex)

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CPT CODE: 87494 (CT/NG) + 87661 (TV) + 87528 (HSV) + 87798 (infectious agent, not otherwise specified, amplified probe technique) x remaining organisms

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ALIASES: STI PCR, Comprehensive STI Urine PCR, 9-Target STI Panel

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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: First-Catch Urine (not midstream/clean-catch)

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- Container: Sterile, Preservative-Free Urine Cup

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- Minimum Volume Required: 5 mL

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- Storage/Handling: Patient should not have urinated for at least 1 hour prior to collection. Transport specimen at room temperature; refrigerate on receipt. 

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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: N/A

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REJECTION REASONS: Clean-Catch/Midstream Urine, Contaminated Container, QNS, Stability Violation, Unlabeled/Mislabeled Specimen, Incorrect Container

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EXPECTED FINDINGS:​​

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Chlamydia trachomatis: Not Detected

Neisseria gonorrhoeae: Not Detected

Trichomonas vaginalis: Not Detected​

Treponema pallidum: Not Detected

Gardnerella vaginalis: Not Detected

Atopobium vaginae: Not Detected

Haemophilus ducreyi: Not Detected

HHV-1 (Herpes Simplex): Not Detected

HHV-2 (Herpes Simplex): Not Detected

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