Rajasthan complaint against firms making corona antigen test kits

JAIPUR: Expressing concern over the quality of antigen test kits being used across the country to diagnose Covid, the state government has asked the Indian Council of Medical Research (ICMR) to follow up with companies involved in manufacture of the kits and direct them to improve its quality.
Health department principal secretary Akhil Arora wrote to Balram Bhargava, secretary to the department of health research, ministry of health and director general, ICMR, requesting that the testing strategy be reviewed. He mentioned that they had validated rapid antigen test kits through the department of microbiology, SMS Medical College, and found that the sensitivity of rapid antigen test taking RT-PCR as gold standard was 48.6% for Covid and only 33% for influenza-like-illness (ILI) cases.
Arora stressed upon the need for reviewing the testing strategy referring to the ICMR’s advisory issued on June 14 on use of rapid antigen detection test and also the advisory issued on June 23 on newer additional strategies for Covid testing wherein ICMR had recommended the use of rapid point-of-care (PoC) antigen detection test (for diagnosis along with RT-PCR), while communicating that specificity of the test ranged from 99.3 to 100% and sensitivity of thee test ranged from 50.6% to 84%. However, during validation, the sensitivity was found much less at SMS Medical College.
“With this low sensitivity, the state’s technical committee has rightly advised against the use of rapid antigen test at large or in hospital settings. In case of asymptomatic cases who are negative with rapid antigen test in a hospital setting, there is risk of transmission of infection through them to other patients and to healthcare services providers. In case of symptomatic cases who are negative with rapid antigen test in a hospital setting, they will have to be subjected to a confirmatory RT-PCR test, which implies increase of time for testing, and also another test,” Arora wrote.