Roche Diagnostics has announced the launch of a tuberculosis test for South Africa.
The kit detects different species of Mycobacterium from human sputum samples using the Lightcycler 2.0 instrument.
The diagnosis of tuberculosis in South Africa relies on smear microscopy and culture methods.
Smear microscopy allows for direct detection of acid-fast bacilli (AFB) in the specimen and makes it possible to identify the most infectious patients.
Although it provides rapid results and is inexpensive, it is limited by its lack of sensitivity and specificity.
Based on the Lightcycler system, Roche Applied Science has developed a Lightcycler assay that overcomes these problems.
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 Laboratories), South Africa, and at the University Hospital in Regensburg, Germany.
The test enables differentiation between Mycobacterium tuberculosis, Mycobacterium avium, and Mycobacterium kansasii in a single PCR run, and is claimed to provide laboratories with reliable, accurate and objective results within hours.
Replacing the AFB smear test will also reduce false negative results obtained by microscopy.
Use of the test will result in fewer cultures being performed, leading to 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.
Roche is currently evaluating which other countries would also be suitable candidates for the test.
