Malaria rapid test kit mis­used

■ THE RDT COSTS range from `250 to `300 per test. ■ THE RDT MAKES re­sults avail­able in 15 to 30 min­utes. ■ CON­CERNS ARE be­ing raised as there are dif­fer­ent vari­a­tions of RDT prod­ucts in the mar­ket.

Deccan Chronicle - - City - KANIZA GARARI | DC

Rapid di­ag­nos­tic tests for malaria are be­ing ex­ten­sively mar­keted and used and these are show­ing false pos­i­tives as only a mi­cro­scope-based test can val­i­date and con­firm the load of par­a­sites, drug con­trollers said.

Mis­use of these di­ag­nos­tic kits and heavy mar­ket­ing has led to com­plaints to the drug con­troller depart­ment about these kits and there has been a de­mand to reg­u­late it.

A se­nior drug con­troller on con­di­tion of anonymity said, “The man­u­fac­tur­ers are mak­ing low-cost malaria an­ti­body IVD kits for rapid di­ag­nos­tic tests of the dis­ease. These are be­ing heav­ily re­lied upon but they do not give the ex­act par­a­site load. The 100 per cent sen­si­tiv­ity to de­tect malaria is not present in these kits.”

Ac­cord­ing to the World Health Or­gan­i­sa­tion, only a mi­cro­scope-based test can val­i­date and con­firm the par­a­site load in the hu­man blood to con­firm malaria.

The WHO stan­dards state that par­a­site load of 50 to 100 per mi­cron of blood can help to con­firm but by a mi­cro­scope­based test only. The rapid di­ag­nos­tic an­ti­body kits were to man­age malaria med­i­cally once con­firmed to un­der­stand the load of the var­i­ous par­a­sites.

The RDT’s are for spe­cific anti­gens ei­ther p fal­ci­parum or p vi­vax and other mul­ti­ple species which cause the in­fec­tion.

Dr Mo­hammed Rafi, se­nior gen­eral physi­cian with Os­ma­nia Gen­eral Hos­pi­tal said, “The RDT is used as the first step and then the blood sam­ples are sent for mi­cro­scopic test­ing. The first test­ing is done to start the malaria treat­ment. The load of the virus is as­cer­tained in the mi­cro­scopic test. Only those pa­tients who come from ar­eas which are not iden­ti­fied as malaria zones are not start­ing the treat­ment. The RDT so far has helped to con­trol and man­age the dis­ease prop­erly.”

A se­nior drug con­trol of­fi­cer ex­plained, “We have got com­plaints that the man­u­fac­tur­ers are us­ing fewer an­ti­bod­ies in the test­ing kit which is lead­ing to re­duced costs. Due to this rea­son, there is a doubt that there is im­proper screen­ing of malaria. In the ur­ban ar­eas, the tests are be­ing re­con­firmed but in ru­ral ar­eas, there are no con­fir­ma­tion tests and that is lead­ing to wrong treat­ment.”

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