NGO files PIL against govt ban on rapid antibody kits for malaria

Days after the central government banned manufacture, distribution and sale of rapid diagnostic test kits to detect the antibody for malaria, the All Food and Drug Licence Holders Foundation (AFDLHF) has filed a public interest litigation (PIL) in court against the ban, claiming it will hamper blood donation and blood testing drives.

In the PIL, filed in the Bombay High Court on Tuesday, the NGO stated that doctors commonly use the rapid antibody test kits for initiating treatment for malaria. While these kits may not be useful for malaria treatment due to questionable accuracy, they play an important role during blood donation procedure, the petitioner said.

“The test is required for blood donation due to its availability, low price and detection of the malaria parasite within few minutes,” the petition said.

On March 23, the Union health ministry issued a notification stating use of rapid test for routine diagnosis of malaria was not accurate. An expert committee set up by the Union government opined that use of rapid test as serological test often resulted in false positives or false negatives, a condition in which test results come contrary to patient’s infection.

The ministry also observed that the test sometimes detects past infection due to presence of antibodies in body. An antibody is what body produces to fight an infection. In certain cases, antibodies continue to remain even if infection is over.

National president, AFDLHF, Abhay Pandey told The Indian Express, “Ideally, a blood donor must be tested for the malaria antibody before donating blood. If this test is banned, it will hamper the blood donation process. The alternative, an ELISA test, can take two to three hours to show results. If a blood sample is tested after donation is done and comes positive for malaria, the blood will go in waste.”

Several pathologist and technicians, however, said that all donated blood units are tested only once donation is complete across all government blood donation camps. A donated blood unit undergoes tests for five diseases- HIV, hepatitis B, hepatitis C, syphilis, and malaria. “If rapid antibody is banned, we still have antigen and smear test available,” a technician from MT Agrawal blood bank said, adding that the ban will not affect the city patients.

According to physician Dr Shahid Barmare, the ban may adversely impact rural and tribal areas where rapid tests are rampant. “In rural regions, there is dearth of technicians and pathologist to physically examine blood smears for malaria. It requires specialisation. In such places, rapid diagnostic kits are commonly used. Patients in such areas may face a problem,” he said.

In urban centres, he added, physicians and diagnostic laboratories can switch to other two methods with ease.

According to Dr Arun Thorat, incharge of state Blood Transfusion Council, state government uses rapid antigen test for detecting malaria antibody in donated blood. “The prohibition of antibody rapid test will not affect us. This test is used only by few centres,” Thorat said.