The Union Health Ministry of India has banned the use of ‘antibody detecting rapid diagnostic tests’ for routine malaria diagnosis due to concerns over the practicality of the approach.
Various media sources reported that the ministry has issued an order to cease the manufacture for sale, sale and distribution of kits for these tests ‘with immediate effect’.
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The antibody detection for malaria is carried out through an indirect fluorescent antibody test in patients infected with Plasmodium, which is the known causative organism of the disease.
Issued in public interest, the prohibition is based on the observation that serological testing is not practical for routine diagnosis of the acute form of the disease because of the time required to develop the antibody.
The testing is attributed to the persistence of antibodies even after clearance of an active infection and evidence suggests that serology only measures past exposure but does not identify existing infection.
While the antibody detecting rapid diagnostic tests are preferred for their low cost and free availability, they are reported to have led to a high false positive rate in endemic areas.
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By GlobalDataThis is thought to be due to the fact that patients with fever, which is caused by factors other than malaria, test negative with antigen detection but positive while using these rapid diagnostic tests.
The government said that the ban will not impact the diagnosis of malaria sufferers as the most common tests used in diagnosis are antigen detecting rapid diagnostic tests and blood smear examination. Therefore, there would not be any problems faced for malaria diagnosis by banning the antibody detecting rapid diagnostic tests.
