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Agappe Diagnostics Ltd, a leading In-Vitro medical device company, has received nod from Indian Council of Medical Research (ICMR) and Central Drugs Standards Control Organisation for the commercial production of new Covid-19 test kits.
The test kit is based on the latest diagnostic tool, which is quicker, affordable, compact, and capable of delivering accurate results. It is also capable of making Covid-19 screening accessible to large segments of the population, particularly in the rural areas, the company said and claimed that Agappe will be the first medical devices manufacturing company to go in for commercial production of the test kits.
Agappe will roll out the new test kit and the reagents from its manufacturing facilities in Kochi under the brand name MISPA LUME and Lumescreen-nCov respectively.
MISPA LUME will be based on the RT-LAMP (Reverse Transcription Loop-mediated Isothermal Amplification). The RT-LAMP technology carries the reaction at a constant temperature, unlike PCR (Polymerase chain reaction) testing. This technology is a significant improvement from PCR as it is more economical and quicker with a high correlation of results with PCR.
MISPA LUME can provide a confirmatory diagnostic test for N gene of SARS-CoV-2. The process is designed in such a way that the Covid positive sample can be identified in 10 minutes after starting the assay. The assay can be used for mass testing because of the low turn-around-time (TAT) for positive samples.
Agappe’s MISPA LUME is focused on accurate results at the shortest turnaround time. For the public health sector, which is struggling to manage the large turnout of patients, larger accurate testing capacity will help the Government to reach out to the weaker sections of the population and conserve resources to meet the demands of critical patients, the company added.
The firm has two manufacturing facilities in Kochi and a wholly-owned subsidiary in Switzerland. It has a wide range of products in the Pre-Analytical and Analytical segment.
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