Visby Medical™ Sexual Health Test

Description

CLIA waived point-of-care PCR test for the detection of Chlamydia, Gonorrhea, and Trichomoniasis in 28 minutes. Test, talk, and treat in the same visit.

• CLIA Waived point-of-care PCR test for Chlamydia, Gonorrhea, and Trichomoniasis.
• Instrument-free, portable, and scalable, run as many tests as you have power adapters.
• 28 minute test time with ~97% accuracy.
• Test, talk and treat in the same visit.
• No capital investment, service contracts or maintenance agreements.
• CT (PPA: 97.4%, NPA: 97.8%); NG (PPA: 97.8%, NPA: 99.1%); TV (Sens: 99.3%, Spec: 96.7%).
• For self-collected vaginal swab samples.
• Room temperature storage.
• 20 tests per case.
• Required for use with the Visby Medical™ Power Adapter (PS-000288) and Visby Medical™ Sexual Health Collection Kit (PS-000715).
• Zeptometrix external controls NATCTNGTV-POS-IVD, NATCTNGTV-NEG-IVD are recommended, refer to Instructions for use.

Specifications

• Clia Complexity: Waived
• Format: Kit
• Sensitivity: CT (PPA: 97.4%), NG (PPA: 97.8%), TV (Sens: 99.3%)
• Type: PCR Test
• For Use With (Application): Self-Collected Vaginal Swab Specimens
• Specificity: CT (NPA: 97.8%), NG (NPA: 99.1%), TV (Spec: 96.7%)