PCR detection of mycobacterium tuberculosis complex and its resistances against isoniazid and rifampicin

• High sensitivity and specificity for resistance to first-line drugs
• Test result available after approximately 4 hours
• Control bands on each test strip document correct DNA isolation, amplification, and hybridization
• Can be automated
• Evaluation and documentation using the AID scanner and software
• CE IVD

The incidence of multidrug resistant and extremely drug resistant strains of Mycobacterium tuberculosis is a serious threat to worldwide TB control. Multidrug-resistant tuberculosis (MDR-TB) is caused by strains resistant to at least Isoniazid (INH) and Rifampin (RIF), the two most powerful first-line Anti-TB drugs.

Strains, which cause extensively drug-resistant TB (XDR-TB), are not only resistant to INH and RIF but also to at least any Fluoroquinolone (FQ) and one of the second-line injectable drugs Amikacin, Kanamycin and Capreomycin.

Resistant TB is more difficult to treat than drug-susceptible TB, there are stronger adverse effects, therapy is more expensive and the patient is more likely to stay infectious for a longer period of time.

Rapid tests that detect resistances are necessary for early initiation of effective therapy. Culture tests can take several weeks.