New PCR Assay for Tuberculosis in South Africa

A new kit detects different species of Mycobacterium from human sputum samples. The tuberculosis (TB) test was launched for South Africa, one of the countries with the highest prevalence of tuberculosis.

A LightCycler 2.0 assay overcomes problems of lack of sensitivity and specificity associated with smear microscopy and culture methods. The LightCycler Mycobacterium detection kit was thoroughly tested in extended analytical and clinical trials together with the National Health Laboratory Services (NHLS; Pretoria and Kimberley, South Africa) and at the University Hospital in Regensburg, Germany).

Launched by Roche (Basel, Switzerland), the new assay enables differentiation between Mycobacterium tuberculosis, Mycobacterium avium, and Mycobacterium kansasii in a single polymerase chain reaction (PCR) run, and provides laboratories with accurate results within hours, significantly improving patient management. Replacing the smear test will also reduce false negative results frequently obtained by microscopy.

Use of the new test will result in fewer cultures being performed, leading to significant improvements in turnaround times for the patient. The test sequence is convenient and easy to perform; the throughput of the system suits low, medium, and high throughput sample sites.

Tuberculosis is one of the major causes of death from infectious diseases worldwide, killing nearly 2 million people each year. It is also the most common cause of death in developing countries for individuals infected with HIV, particularly among patients with sputum smear-negative pulmonary tuberculosis. The increase in the incidence of tuberculosis fueled by the HIV pandemic in sub-Saharan Africa has highlighted the urgent need for rapid diagnosis of tuberculosis.

"We are proud of our contribution in the battle against tuberculosis, which is really a plague in African countries. Every patient should get exactly what he needs to be cured--this is Roche's basic idea of Personalized Healthcare. A fast, safe test result is the backbone of this concept." said Manfred Baier, head of Roche Applied Science. Roche is currently evaluating which countries besides South Africa would also be suitable candidates for the test.

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