Two MTB Resistance Tests in One Assay
The Abbott RealTime MTB RIF/INH Resistance assay provides:
The Abbott RealTime MTB RIF/INH Resistance assay is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of Rifampicin (RIF) and Isoniazid (INH) resistance in MTB positive samples. The assay will be used to test specimens of sputum or bronchial alveolar lavage and N-acetyl-L-cysteine (NALC)-prepared sediments prepared from sputum and bronchial alveolar lavage. The assay is intended for use in conjunction with clinical presentation and other laboratory markers for use as an aid in identifying MTB RIF and/or INH resistant MTB strains.
Clinical Sensitivity and Specificity
Performance characteristics of the Abbott RealTime MTB RIF/INH Resistance assay were established by testing 233 MTB positive patient specimens from non-US populations; 138 sputum specimens and 95 N-Acetyl-L-Cysteine (NALC) of sputum specimens. RIF and INH susceptibility were determined by Drug Susceptibility Tests (DST). RIF results were obtained for all three assays (DST, Abbott and the RIF comparator) for 216 specimens. INH results were obtained for all three assays (DST, Abbott and the INH comparator) for 220 specimens. Three MTB INH drug sensitive samples by DST were reported as MTB INH drug resistant in both Abbott RealTime MTB RIF/INH Resistance and the INH comparator and therefore not included in the analysis. DNA sequencing was performed for clinical specimens with discrepant results between Abbott RealTime MTB RIF/INH Resistance and DST test, but was not used to impact the sensitivity and specificity analyses.
The Abbott RealTime MTB RIF/INH Resistance assay design had been developed based on Abbott Molecular’s RealTime legacy and commitment to reducing the burden of infectious disease. Abbott RealTime MTB RIF/INH Resistance assay offers the most efficient workflow from low to high volume by mPLUS extended reagent use and introduces a new automated reflex process.
Abbott RealTime MTB RIF/INH Resistance assay offers flexibility, including:
|Abbott RealTime MTB RIF/INH Resistance|
|Clinical sensitivity||Rifampicin 94.8%; isoniazid 88.3%|
|Clinical specificity||Rifampicin 100%; isoniazid 94.3%|
|Limit of Detection (LoD)||60 CFU/mL (probit analysis 32.37 CFU/mL with 95% probability)|
|Target Region||Probes targeting rpoB for Rifampicin resistance and katG and inhA upper promoter region for Isoniazid resistance|
|Reported results||Rif R-, Rif R det; INH R-, INH High R, INH Low R (see package insert for further details)|
|Subspecies coverage||Eight members of MTB complex
M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, M. caprae, M. pinnipedii, M. canetti
|Internal control||Processed with each sample|
|Specimen type||Sputum or bronchial alveolar lavage, or the NALC sediment of sputum or bronchial alveolar lavage, or already extracted DNA of MTB-positive specimens|
|Input volume||0.8 mL of inactivated specimen if extraction is needed, optional use of already extracted DNA of MTB-positive specimen|
|Sample preparation||Extraction: m2000sp or manual
Optional use of automated reflex with m2000sp allows use of already extracted DNA of MTB-positive specimen
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