Blaming the rising number of malaria incidents to the wrong diagnosis in the private sector, the Government has banned antibody test kits (serological tests) which is being rampantly used by the private medical practitioners to detect the vector-borne disease in the country.
Intriguingly, diagnostic test for malaria based on the detection of antibodies have been commercially available for decades in the country, although no international guidelines have recommended their use.
The World Health Organisation (WHO) too does not recommend antibody based tests as it gives false results. Rather, it advises use of malaria antigen test which works by detecting antigens in the blood which are released by the parasite.
Now, in a quest to eliminate malaria by 2030 and make the country bacteria free by 2022, the Union Health Ministry has issued a notification stating that "manufacture for sale, sale and distribution of the test kits used in Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria has been prohibited. "
India accounts for 6 per cent of all malaria cases reported globally, as per the World Malaria Report 2017. Presently, antibodies tests kits are being used by the doctors mainly because of its low costs as well as easy availability.
However, Jatin Mitra from AiMeD, an Umbrella Association of Indian Manufacturers of Medical Devices, said the ban on kits using serological tests is a welcome step in the right direction and was long needed. This will discontinue the use of serological tests and replace these tests with WHO endorsed diagnostic ie antigen based test.
He said that the AIMED had been writing to the Ministry for discontinuation of the serological tests as these put the patients under greater risk.
The notification issued on March 23 states that doctors in the private sector have been frequently using antibody based kit which is otherwise not practical for routine diagnosis of acute malaria which does not detect current infection but measures past exposure.
It has been found that there is a rampant use of Antibody Detecting Rapid Diagnostic Tests due to low cost and free availability of these tests. Because of this, the false positive rate in the 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 notification further says.
Only tests that should be done are Antigen Detecting Rapid Diagnostic Tests and blood smear examination as also being done in the government hospitals.
last July, Union Minister for Health JP Nadda had released the national strategic plan for malaria elimination (2017-22) which sets elimination targets for different parts of the country depending on the prevalence of malaria there. The plan is to oust the disease by 2027 and maintain the status till 2030 and beyond. To be declared malaria-free, a country has to report zero incidence for at least three years.