BENGALURU: The Union Health Ministry has banned the use of Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria. A gazette notification, dated March 23, prohibits the manufacture, sale and distribution of these kits.
The order observed that these kits as a form of serological testing are not practical for routine diagnosis of acute Malaria owing to the time required for the development of the antibody, the persistence of antibodies after clearance of an active infection and the fact that serology does not detect current infection, but only measures past exposure.
Malaria antibody detection is performed using the indirect fluorescent antibody test for a patient who is infected with Plasmodium.The false positive rate in endemic areas is also high as patients with fever due to other reasons, who test negative by antigen detection, test positive by Antibody Detecting Rapid Diagnostic Tests.
“The only tests used in diagnosis are Antigen Detecting Rapid Diagnostic Tests and blood smear examination, and, therefore, there will not be any problem faced for malaria diagnosis by banning the Antibody Detecting Rapid Diagnostic Tests,” the order said.The matter was examined by an expert committee appointed by the central government and the committee recommended that the said drug was found to have no therapeutic justification.