CDSCO to scrutinise claims made by manufacturers of malaria rapid diagnostic tests for accuracy in test results
In order to scrutinise claims made by manufacturers of
malaria rapid diagnostic tests (RDTs) to detect malaria accurately, the Central
Drugs Standard Control Organisation (CDSCO) is all set to hold a series of
meetings of stakeholders to frame a policy on the same in the interest of
patient safety.
According to experts, only a microscope based test can validate and confirm the parasite load in human blood for confirmation of having malaria based on WHO specified standards. WHO standards stipulate parasite load of 50 to 100 per micron of blood which can be confirmed by a microscope based test successfully.
While malaria RDT is a user friendly screening test done by any individual in rural and urban settings to facilitate malaria control programmes and health services, microscope based test is a confirmatory test followed by the screening test recommended for actual treatment.
Moreover, what is more of grave concern is that many doctors rely on the malaria RDT because it saves on time which otherwise takes 3 to 4 days to confirm through a microscope based test.
Some of the major players of malaria antibody IVD kits in the country are Tulip, Accurex, Oscar, Selio Healthcare and Oscar Medicare Pvt Ltd.
Drug license holders had in the past approached the central and state drug regulators to review the claims made by manufacturers of malaria antibody IVD kits of giving 100 per cent sensitivity.
Blood for the malaria antibody IVD test is commonly obtained from a finger-prick and results are available within 15 to 30 minutes. Though there are variations among the RDT products in the market, the principles of the tests are similar.
It has been given to understand that since there are no WHO standards prescribed on parasite load with reference to malaria RDT available in the market, manufacturers have stooped to the level of manufacturing RDT at low cost by using less antibodies in the kit leading to improper screening of malaria in patients especially the most vulnerable ones in rural areas and having less income, activists rue.
A malaria RDT cost today ranges between Rs. 200 to Rs. 350 in the retail market.
Malaria RDTs are actually aimed to improve quality of management of malaria infections, especially in remote areas with limited access to good quality microscopy services. WHO recommends prompt parasite-based diagnosis in all patients suspected of malaria before treatment is administered in resource limited settings.
According to experts, only a microscope based test can validate and confirm the parasite load in human blood for confirmation of having malaria based on WHO specified standards. WHO standards stipulate parasite load of 50 to 100 per micron of blood which can be confirmed by a microscope based test successfully.
While malaria RDT is a user friendly screening test done by any individual in rural and urban settings to facilitate malaria control programmes and health services, microscope based test is a confirmatory test followed by the screening test recommended for actual treatment.
Moreover, what is more of grave concern is that many doctors rely on the malaria RDT because it saves on time which otherwise takes 3 to 4 days to confirm through a microscope based test.
Some of the major players of malaria antibody IVD kits in the country are Tulip, Accurex, Oscar, Selio Healthcare and Oscar Medicare Pvt Ltd.
Drug license holders had in the past approached the central and state drug regulators to review the claims made by manufacturers of malaria antibody IVD kits of giving 100 per cent sensitivity.
Blood for the malaria antibody IVD test is commonly obtained from a finger-prick and results are available within 15 to 30 minutes. Though there are variations among the RDT products in the market, the principles of the tests are similar.
It has been given to understand that since there are no WHO standards prescribed on parasite load with reference to malaria RDT available in the market, manufacturers have stooped to the level of manufacturing RDT at low cost by using less antibodies in the kit leading to improper screening of malaria in patients especially the most vulnerable ones in rural areas and having less income, activists rue.
A malaria RDT cost today ranges between Rs. 200 to Rs. 350 in the retail market.
Malaria RDTs are actually aimed to improve quality of management of malaria infections, especially in remote areas with limited access to good quality microscopy services. WHO recommends prompt parasite-based diagnosis in all patients suspected of malaria before treatment is administered in resource limited settings.
Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=115125&sid=1
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