Molecular Test Provides Solution for Tuberculosis Discrimination

A real time polymerase chain reaction (rt-PCR) platform offers a total solution to tuberculosis (TB) diagnosis in one assay.

The assay detects nontuberculosis mycobacteria (NTM), and the presence of key drug resistance mutations in Mycobacterium tuberculosis (MTB), the causative agent of the disease, in a single test.

The Anyplex MTB/NTM/DR-TB test detects MTB and discriminates it from NTM in less than two hours. In the case of MTB-positive, further analysis for drug-resistance to isoniazid (INH), rifampicin (RIF), all fluoroquinolone (FQ), and the injectable drugs (amikacin, kanamycin, or capreomycin) is performed to identify whether the MTB is multi drug-resistant MTB (MDR-TB), or extensively drug-resistant MTB (XDR-TB) in less than 40 minutes. This testing process will provide an effective one-stop diagnostic workflow for prompt mycobacteria detection and treatment.

The Anyplex rt-PCR assay can be used on the following specimens: sputum, stools, pleural fluid, urine, cerebral spinal fluid, blood, bronchial washings, fresh tissue, and cultured cells. The assay will discriminate three NTMs from MTB, M. avium complex, M. kansasii and M. abscessus. The Anyplex TB assay is a product of Seegene (Seoul, South Korea) and uses a fundamental tool for blocking extension of nonspecifically primed templates generating consistently high specificity (DPO), and Real Amplicon Detection (READ) technologies. This enables the test to perform multitarget detection with high specificity and sensitivity.

There are multitudes of genetic mutations in MTB that are associated with drug resistance. To date conventional PCR methods have not been able to discriminate accurately all of these mutations. However, with Anyplex MTB/NTM/DR-TB each drug-resistant mutation targeted is amplified by the corresponding DPO primer pair and detected specifically by READ technology, which is neither a probe-based method nor a melting temperature analysis method. Anyplex MTB/NTM/DR-TB Real-time Test will not be available in the USA until regulatory clearance is obtained.

The assay was showcased July 26-28, 2011, at the Annual Meeting and Clinical Lab Expo of the American Association for Clinical Chemistry held in Atlanta (GA, USA).

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