Govt to allow testing kits for antibody test

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The government will authorise the use of rapid testing kits for measuring antibodies in patients infected with the coronavirus.

The Directorate General of Drug Administration (DGDA) has finalised a criterion pending permission from the health ministry, Md Salauddin, director of DGDA told The Daily Star.

The health ministry formed a 14-member committee to examine the necessity of rapid test kits and the panel suggested it be used for research purposes.

On June 24, the DGDA published a notice on its website, saying kits with a minimum 90 percent sensitivity and 95 percent specificity will be approved.

Package of a rapid antibody test kit must mention that “this is not for diagnosis, but to be used only to detect antibodies”.

Following a guideline from the advisory committee, the DGDA has decided to allow production and import of rapid antibody testing kits for some specific uses.

Experts have also opined it is now time for antibody and antigen testing.

“We have been recommending the use of antibody and antigen tests for a long time and believe this is a good initiative,” Dr Jahidur Rahman, virologist and assistant professor of Shahid Suhrawardy Medical College, told The Daily Star.

Such tests are not an alternative to PCR tests, but are rather meant to supplement the process and thus reduce burden on the PCR machines.

He also said it should not be used for diagnosing the disease but for epidemiological survey. “It will help in deciding the status of the disease in the country,” Dr Jahidur added.

Meanwhile, the World Health Organization (WHO) has cautioned that there is no evidence showing serological tests can determine whether a person has immunity or is no longer at risk of re-infection.

The issue of antibody test kits received extra attention when Gonoshasthaya Kendra declared that they had developed a cost-effective and quick responding antibody test kit.

After a long trial at BSMMU, the DGDA sent an email to GK officials on Thursday, informing that their technical committee rejected the kit even after BSMMU recommendations.

 

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