Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POC)

INTENDED USE
The Multiplo® Complete Syphilis (TP/nTP) Antibody Test is a single-use, manually performed, visually interpreted qualitative immunoassay based on MedMira’s Rapid Vertical Flow Technology® (RVF). The test is intended for the simultaneous detection of treponemal (TP) and non-treponemal (nTP) antibodies to Treponema pallidum in human fingerstick whole blood. The test is intended for use by healthcare professionals as an aid in the diagnosis of syphilis, including primary, secondary, early latent, and late latent stages of infection, when used in conjunction with patient history, physical examination, and other laboratory findings.

Results from the treponemal (TP) and non-treponemal (nTP) components are intended to be interpreted in conjunction with patient history, physical examination, and other laboratory findings. The nTP component provides additional clinical interpretive information and demonstrates high sensitivity in the presence of higher non-treponemal antibody activity (e.g., corresponding to RPR titers ≥1:8). A non-reactive nTP result does not exclude primary syphilis or other treatable infection and should not be used in isolation.

The test is not intended to differentiate between treated and untreated infections, nor is it intended for use as the sole basis for diagnosis or for screening of pregnant individuals. All reactive results should be confirmed with standard serologic methods according to local guidelines.

Видео Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POC) канала MedMira Inc.