Thursday, 25 May 2017

Mediven obtains CE-IVD mark for Leptospirosis diagnostic kit

20 February 2017 | News | By BioSpectrum Bureau

Mediven obtains CE-IVD mark for Leptospirosis diagnostic kit

Singapore: Real-time PCR diagnostic kit for Leptospirosis developed by Malaysia based Medical Innovation Ventures has obtained CE-IVD mark.

The company's GenoAmp Real-Time PCR Leptospirosis is a multiplex PCR kit that detects pathogenic Leptospirosis in human and environmental samples. It is designed for the fast and early screening of Leptospirosis using a single reaction. "The kit is intended for rapid and early diagnosis in clinical samples such as blood and urine, as well as for use in environmental surveillance," said the company in a statement.

"The kit can be used to test for the disease within the first 3-7 days after initial symptoms, which offers a huge advantage over some of the tests currently available, which can only detect the disease after 7 days." Early detection is critical for better treatment outcome, before the progression of the disease.

GenoAmp Real-Time PCR Leptospirosis detects most of the recommended serovars by WHO, namely Canicola, Pomona, Australis, Bataviae, Pyrogenes, Tarrasovi, Icterohemorrhagiae, Hebdomadis, Ballum, Autumnalis and Javanica and additional tropical serovars like Copenhageni, Hardjo Pratjino, Celledoni & Djasmiman that are commonly found in tropical countries.

Leptospirosis is transmitted by the urine of an infected animal and is contagious as long as the urine is still moist. Leptospiral infection in humans causes a range of symptoms with some infected persons showing no symptoms at all. The disease begins suddenly with fever accompanied by chills, intense headache, muscle ache, abdominal pain, red eye, and occasionally a skin rash. There are two phases to the disease. The first symptoms appear after a period of incubation of 7-12 days. The first phase (acute or septic phase) ends after 3-7 days of illness. The disappearance of symptoms coincides with the appearance of antibodies against Leptospira in the bloodstream.

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