- High sensitivity and specificity even in smear negative, culture positive samples, for reliable detection of eight members of the MTB complex
- Inactivation reagent minimizes risk of infection during sample handling
The assay is intended for use in conjunction with clinical presentation and other laboratory markers for use as an aid in diagnosis TB infections. mPLUS extended reagent use available.
Performance characteristics of the Abbott RealTime MTB assay were established by testing prospective and achieved specimens (sputum, NALC sediments) from subjects with symptoms suggesting of active TB collected from both US and non-US populations. Each specimen was divided as needed to perform testing using smear microscopy, culture and Abbott RealTime MTB. Smear microscopy and/or culture were performed at or near the collection site. Abbott RealTime MTB test results were compared to culture status for calculation of assay sensitivity and specificity. The results were also stratified by acid-fast-bacilli (AFB) smear status for additional sensitivity status.