Mycobacteria IVDs

Intended purpose

For in vitro diagnostic use. The RIDA®QUICK TB is a manual immunochromatographic rapid test for the direct quantitative detection of interferon gamma-induced protein 10 (IP-10) from human plasma samples of individuals with suspected Mycobacterium tuberculosis infection (including disease). This IVD test is intended for use in conjunction with the RIDA® TB Tubes for in vitro stimulation with specific M. tuberculosis antigens. The RIDA®QUICK TB is a diagnostic aid for the indirect detection of M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessments, radiographic examinations, and other clinical and laboratory findings. Negative results do not rule out M. tuberculosis infection and should not be used as the sole basis for diagnosis. The product is intended for professional use.