HLL Lifecare Limited, a Central government enterprise under the Ministry of Health and Family Welfare, has developed the rapid antibody diagnostic kit for COVID-19.
The kit is one-step novel coronavirus IgM/IgG antibody detection from the human serum, plasma and/or whole blood obtained from the patient with signs and symptoms of respiratory infection.
This device is designed to aid in the rapid differential diagnosis of COVID-19 virus infection in large population screening in our country during the current pandemic situation and this shall support in the management of control and treatment of coronavirus disease.
The test result can be obtained from the patient sample within 15-20 minutes. This will help those people whose symptoms do not show up initially and thus in which areas the coronavirus is moving more quickly. Further, if the antibodies test negative then the RT-PCR test is done if it comes positive then the patient is further sent for isolation.
The principle of 'MakeSure' COVID-19 IgM/IgG antibody test kit is based on antibody capture immunochromatographic assay for the simultaneous detection of IgM and IgG antibodies to COVID-19 virus in human serum, plasma and/or whole blood samples.
The kit has been manufactured at HLL's rapid diagnostic kit manufacturing facility at Manesar and has been validated and approved by the NIV, Pune and the ICMR for use in India.HLL is the first Indian government company received the approval from the ICMR for manufacturing and supplying the rapid antibody kit for COVID-19 detection.
The kit manufactured by HLL will be marketed under the brand name of "MakeSure" -- COVID IgM/IgG antibody detection.
HLL is planning to manufacture two lakh kits for supplying to various government units within the next 10 days.