For In Vitro Diagnostic Use
The Abbott RealTime MTB assay is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of MTB complex DNA in smear positive or smear negative specimen of sputum or bronchial alveolar lavage and N-acetyl-L-cysteine (NALC)-prepared sediments prepared from sputum and broncial alveolar lavage collected from individuals suspected of having tuberculosis (TB).Instructions for Use View Ordering Information
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.
The Abbott RealTime MTB assay is engineered to address the MTB detection challenges.
Assay design developed based on Abbott Molecular's RealTime legacy.
Automated workflow from extraction to amplification and detection.
Committed to reducing the burden of infectious disease.
|Abbott RealTime MTB|
|Sensitivity culture positive samples||93%|
|Sensitivity in smear negative culture positive samples||81%|
|Limit of Detection (LoD)||17 CFU/mL|
|Target region||IS 6110 and PAB|
|Reported results||MTB detected, MTB not detected|
|Subspecies||Eight members of MTB complex
M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, M. caprae, M/ pinnipedil, M. canetti
|Internal control||Proceed with each sample|
|Specimen type||Sputum or bronchial alveolar lavages, or the NALC sediment of sputum or bronchial alveolar lavages|
|Input volume||0.8 mL of inactivated sample|
|Sample preparation||m2000sp or manual|
Creates efficiency from the lab tube through patient result. Includes m2000rt and m2000sp
Resistance detection within a single assay for the two most important first-line MTB drugs
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