The CE-IVD DiagCor GenoFlow DR-MTB Array Test is a PCR-DNA hybridization assay, based on the “Flow-through hybridization” technology, designed to detect wild-type Mycobacterium tuberculosis (MTB) and Mycobacterium tuberculosis resistant to Rifampin (RIF) and Isoniazid (INH) in liquefied, decontaminated and concentrated human respiratory specimens, including sputum and brochial alveolar lavages (BAL).
The DiagCor GenoFlow DR-MTB Array Test is a highly efficient and sensitive assay that can give accurate results in 4 hours. The assay uses specific primer sets for sensitive amplification of MTB DNA from the 16S rRNA sequence of the MTB genome. After PCR amplification, PCR amplicons are detected with the highly efficient “Flow-through” hybridization.
Multi-drug resistant MTB poses a strong threat to the general population as delayed treatment contributes to morbidity, motility and transmission. The DiagCor GenoFlow DR-MTB Array Test can help clinicians to identify drug-resistant MTB early. The assay has 7 wild-type probes to detect the wild-type MTB covering the rpoB and katG genes. There are 9 probes detecting the hotspot mutations in the two genes. These mutation probes cover 91% and 63% of all rpoB mutations and katG mutations that cause resistance to Rifampin (RIF) and Isoniazid (INH).
The assay provides an internal control which detects a sequence in the human beta-globin gene to monitor the sample adequacy, DNA extraction and PCR amplification. This minimizes the chance of false negativity.
In molecular laboratories with thermal cycler, setting up the test is simple. Generally a “Flow-through” hybridization device is the only required new instrumentation. No additional data interpretation device is required.