New Delhi: Mylab Discovery Solutions on Wednesday announced that its ‘Pathocatch’ covid-19 antigen rapid testing kit has received a commercial approval from the Indian Council of Medical Research, making it the first Indian firm to get the nod.
“After bringing an affordable RT-PCR test to reduce dependence on foreign kits, we launched Compact XL to accelerate COVID-19 testing. Now, with the approval for an antigen testing kit, we will cover whole spectrum of COVID-19 testing and leave no stone unturned to fight this pandemic," Mylab managing director Hasmukh Rawal was quoted as saying in a statement.
Mylabs said its antigen test is priced at ₹450 per unit. In comparison, Mylab’s RT-PCR test kits are priced around ₹1,000 per unit.
Antigens are molecules related to a particular pathogen which are capable of stimulating an immune response. An antigen test detects the presence of the molecule, thereby diagnosing exposure to the virus and, with it, the disease.
They are also different from antibody tests, which indicate whether a person has prior exposure to the novel coronavirus, which has given them immunity.
Mylabs is one of three suppliers of antigen test kits, the other two being manufactured by South Korea based firm SD Biosensor and Belgium-based Coris Bioconcept, according to data on the Indian Council of Medical Research website.
As per the government guidelines, a person who is found positive in the antigen test will be considered as covid-19 positive, while those who get a negative result in antigen test are then tested with RT-PCR test, which is the gold standard for the disease, for confirmation.
The protocol was made because, while antigen tests are cheaper and give results faster than RT-PCR test, they are generally less accurate, and there is especially concern of false negatives, that an actual covid-19 patient’s result might be shown as negative in an antigen test.
Information on the false positive and negative data of Mylab’s antigen testing kits could not be ascertained.