6 BIOTECHNOLOGY
Novel molecular diagnostics solutions meet demand for fast, accurate testing
The first real-time tests for tuberculosis and drug resistant tuberculosis and a way to measure the viral load or amount of hepatitis B virus in a blood sample are among the advances in molecular diagnostic technology. Sean Ottewell reports.
Les premiers tests en temps réel pour le dépistage de la tuberculose et de la tuberculose résistante aux médicaments et une méthode permettant de mesurer la charge virale ou la quantité de virus de l’hépatite B sont parmi les avancées de la technologie du diagnostic moléculaire. Un reportage de Sean Ottewell.
Die ersten Echtzeit-Tests für Tuberkulose und medikamentenresistente Tuberkulose sowie die Methode, die virale Belastung oder Menge an Hepatitis-B-Viren in einer Blutprobe zu messen, gehören zu den großen Fortschritten der molekulardiagnostischen Technologie. Sean Ottewell berichtet.
T
Fig. 1. QIAsymphony is designed to transform work in the emerging field of molecular diagnostics.
he emergence and spread of drug-resistant mycobacterium tuberculosis
(TB) threatens global TB control
efforts, and there is an urgent need for new diagnostic tests that rapidly identify drug sensitivity profiles of TB strains.
To help address these concerns, Seegene has introduced Anyplex MDR-TB screening test, which it says is the first real-time PCR molecular diagnostic capable of simultaneous detection of TB and genetic mutations leading to multi- drug resistant TB (MDR-TB) within four hours.
According to the World Health Organisation (WHO), TB strains that are resistant to all major anti-TB drugs have been documented in every country by the non-governmental organisation recent survey. A
particularly dangerous form of drug- resistant TB is multi-drug resistant TB (MDR-TB), which is defined as the disease caused by TB bacilli resistant to, among others, the two most powerful anti-TB drugs, isoniazid (INH) and rifampicin (Rif).Te rate for successful MDR-TB treatment is extremely low and the progress of the disease is faster than normal TB, resulting in 40-50 per cent of mortality rate. Rates of MDR-TB are troublingly high in some countries, especially in the former Soviet Union, and threaten TB infectious disease control efforts. WHO estimates that more than 440 000 people are infected with MDR-TB.
Using Anyplex MDR-TB screening test, healthcare workers will be able to quickly determine whether or not a patient is infected with a strain of TB that is resistant to INH and Rif. Te Anyplex MDR-TB is a real-time detection test of M. tuberculosis that quickly and comprehensively determines the levels of targets in a patient’s various sample types, and identifies mutations of drug resistant genes to better inform a diagnosis.
Because genetic mutations that lead to antibiotic resistance are minute and sit close together, so far conventional PCR or conventional real-time PCR tests are not able to discriminate these mutations accurately within the same test procedure. In contrast, the Anyplex MDR-TB test can detect the mutations of drug resistant genes to Rif (rpoB: D516V/Y, H526D/Y, S531L) and INH (katG: S315T (2 cases); inhA promoter: -15(C/T)).
According to Seegene, the unprecedented speed and accuracy of the Anyplex MDR-TB tests will enable doctors and clinicians
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