India has prohibited the use of the antibody detecting rapid diagnostic tests for routine diagnosis of malaria.
The union health ministry has also banned the manufacture for sale, sale and distribution of these test kits with immediate effect.
The ministry said the use of antibody detecting rapid diagnostic tests offer no solution to diagnose malaria because serological testing is not practical for routine diagnosis of acute infections, going by the time required for development of antibody.
Also, the antibodies may persist even after clearance of an active infection. The expert committee appointed by the government is of the opinion that serology does not detect ongoing infection but measures past exposure, stated the government notification issued on March 23, 2018.
These tests are used rampantly due to low cost and free availability. The false positive rate in the endemic areas is also high.
Antigen detecting rapid diagnostic tests and blood smear examination are reliable tests for malaria diagnosis, according to the guidance.