Health Ministry bans Antibody Detecting Rapid Diagnostic Tests for Routine Diagnosis of Malaria

Health Ministry bans Antibody Detecting Rapid Diagnostic Tests for Routine Diagnosis of Malaria

NEW DELHI:
The Union Health Ministry has prohibited the use of the Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria in public interest and hence the ministry has also prohibited the manufacture for sale, sale and distribution of the test kits used in ‘Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria’ with immediate effect.

“The matter was examined by an Expert Committee appointed by the central government which recommended that the said drug is found to have no therapeutic justification. Now the Central Government is satisfied that it is necessary and expedient to prohibit the use of the Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria in public interest; hereby prohibits the manufacture for sale, sale and distribution of the test kits used in ‘Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria’ with immediate effect”, the ministry in its notification said.

The Ministry has now indicated that the use of antibody detecting rapid diagnostic tests is not the solution to diagnose malaria. This is because serological testing is not practical for routine diagnosis of the acute parasite infectious disease going by the time required for development of antibody. 

The reason to issue the guidance banning the use of antibody detecting rapid diagnostic tests is the persistence of antibodies even after clearance of an active infection. The government’s expert committee sees that serology does not detect current infection but measures past exposure. 

Malaria antibody detection is performed using the indirect fluorescent antibody test for a patient who is infected with Plasmodium. Because of the time required for development of antibody and also the persistence of antibodies, serologic testing is not practical for routine diagnosis of acute malaria, stated the government notification issued on March 23, 2018. 

There is a rampant use of Antibody Detecting Rapid Diagnostic Tests due to low cost and free availability of these tests. The false positive rate in the endemic areas is also high as patients with fever due to other reasons, test negative by antigen detection and test positive by Antibody Detecting Rapid Diagnostic Tests. The only 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, stated the guidance. 

Globally too microscopic examination of blood films is accepted as the current universal gold standard for the diagnosis of malaria. 

Last year, the government had made a framework to eliminate malaria nationally by the year 2030. The game plan spanning between 2016–2030, is through surveillance with population-based reporting from all health centres and use of preventive measures.

Although the best discovered drug artemisinin used for treating malaria is now beginning to show drug resistance, India is gearing up to get rid of the disease by seeking to destroy both the parasite and mosquito. On the occasion of the World Malaria Day observed annually on April 25, the irony is that India contributes 70% of malaria cases and 69% of malaria fatalities in the South-East Asia Region, as per the WHO data. 

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