Local Company Develops Leptospirosis Test Pack

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Penang-based Medical Innovation Ventures Sdn. Bhd. (Mediven) announced that its real-time PCR diagnostic kit for Leptospirosis 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 & Javanica and additional tropical serovars like Copenhageni, Hardjo Pratjino, Celledoni & Djasmiman that are commonly found in tropical countries.

Costa et al. estimated in 2015 that leptospirosis cause 1.03 million cases and 58,900 deaths each year on a global scale. These estimates mark leptospirosis as a leading zoonotic cause of morbidity and mortality. One of the reasons that this disease is difficult to diagnose is that it has about 250 pathogenic serovars, making it difficult to distinguish leptospirosis clinical signs from those of other endemic diseases and hence, there is poor availability of effective diagnostic tools for early detection.

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. The patient is asymptomatic for 3–4 days until the second phase begins with another episode of fever. In the second phase, meningitis of the brain may occur.

90% of cases of the disease are mild leptospirosis with the remainder having severe disease, which develops during the second stage or occurs as a single progressive illness. In the advanced form of the disease, known as Weil’s disease, the patient suffers liver damage, kidney failure and bleeding. Additionally, the heart and brain can be affected.

“The infection is often incorrectly diagnosed due to the nonspecific symptoms; and the fact that most kits test for antibodies, which are reactions of the human body to the disease after exposure, makes early detection of the test problematic. GenoAmp Real Time PCR Leptospirosis on the other hand, tests for the DNA of the offending pathogen, making early diagnosis possible. Within less than 3 hours from collection of the samples, the kit can test for the infecting pathogen. The kit has already been clinically validated as the preferred molecular assay for the screening of Leptospirosis in several public health labs and hospitals in Southeast Asia. This CE-IVD marking means that the kits can be offered in more regions, especially in Europe,” said Mr Ariff Ismail, the Executive Director of Mediven.

“We have conducted verification tests of the kit with good results. We look forward to using the kit.” said Dr Muhammad Nazri Bin Aziz, M.D., MPath. (Microbiology), Consultant Medical Microbiologist at Lablink, KPJ.

The GenoAmp Real Time PCR Leptospirosis test is available at Geneflux BioScience Sdn Bhd in Puchong, Malaysia, several private and public labs in South East Asia and will be made available in stages in hospitals as well.

CE-IVD is a globally recognized mark in the diagnostic industry. With this new CE-IVD marked product, Mediven can aim for faster growth in emerging markets. Mediven is a developer and manufacturer of molecular and rapid tests with ISO13485 certified facilities based in Malaysia. The company was awarded the BioNexus status by the Malaysian BioEconomy (previously the Malaysian Biotechnology Corporation) in January 2015 for its technological innovations in the field of IVD.

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