Health Ministry bans antibody rapid test kits for malaria
New Delhi: Through a recent notification, Ministry of Health and Family Welfare has 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 order comes after the Central Government was satisfied that the use of Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria as serological testing is not practical for routine diagnosis of acute Malaria due to the time required for the development of antibody.
In the gazette the Ministry made the following observations
The matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said drug is found to have no therapeutic justification. The committee recommended and the Central Government agreed to prohibit the use of the Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria in public interest.
The Central Government concluded:
Attached is the notice below
The order comes after the Central Government was satisfied that the use of Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria as serological testing is not practical for routine diagnosis of acute Malaria due to the time required for the development of antibody.
In the gazette the Ministry made the following observations
- Malaria antibody detection is performed using the indirect fluorescent antibody test for a patient who is infected with Plasmodium, and 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;
- 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, 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 would not be any problems faced for malaria diagnosis by banning the Antibody Detecting Rapid Diagnostic Tests;
The matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said drug is found to have no therapeutic justification. The committee recommended and the Central Government agreed to prohibit the use of the Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria in public interest.
The Central Government concluded:
"In exercise of the powers conferred by section 26A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the Central Government 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."
Attached is the notice below
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