Kumudesh calls on NMRA to come up with protocol to validate rapid antigen test kits

By Rathindra Kuruwita

The National Medicines Regulatory Authority (NMRA) should come up with a protocol on validating rapid antigen test kits, President of the College of Medical Laboratory Science, Ravi Kumudesh said yesterday. 

Kumudesh told The Island, “The sample to validate these kits must be chosen randomly. Given that these antigen tests only detect those with a high viral load, someone can do the tests among people they suspect to have high viral loads to come up with a favourable result.”

Kumudesh said that there were close to 200 companies that produced rapid antigen test kits. Contrary to some claims, the World Health Organization (WHO) had not given approval for two companies cited here, Kumudesh said.

“WHO approved these considering the situation in the US. In the US presidential election was drawing near and COVID19 cases were exploding. That’s why these two US-based kits were mentioned, but the WHO never said other kits were bad. Therefore, we have no reason to ignore kits from China, India and Germany”.

Replacing PCR tests with rapid antigen testing would create a large number of false data and wrong mapping of the COVID hotspots,  Kumudesh said. 

He said that given the current health crisis, they were not opposed to the use of rapid antigen test kits.

“In the broader context rapid antigen testing is like a straw given to a desperate drowning man but we are in a position where even this straw might come in handy. We believe that the sensitivity of the test, based on peer reviewed research conducted by other countries, to be around 50-60%. The Health Ministry must create an algorithm, identify areas where PCR testing can’t be done and use the rapid tests there. It would be good even if we can get some results in an area where PCR testing is impossible but it will be a mess if we try to substitute rapid antigen testing for PCR testing.”