RealTime MTB

CE Marked

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). 

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Description
 

Leading Science

  • 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.

Design
 

Development Philosophy

The Abbott RealTime MTB assay is engineered to address the MTB detection challenges.

Assay design developed based on Abbott Molecular's RealTime legacy.

  • Reliable detection of eight members of the MTB complex
  • High sensitivity and specificity even in smear negative, culture positive samples
  • Dual target assay design

Automated workflow from extraction to amplification and detection.

  • Flexible throughput ranging from low to high volume testing
  • Inactivation reagent minimizes risk of infection during sample handling 

Committed to reducing the burden of infectious disease.

Specifications
 
 
 
Abbott RealTime MTB
Sensitivity culture positive samples 93%
Sensitivity in smear negative culture positive samples 81%
Specificity 97%
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

Ordering Info

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