I work in a non endemic region of India. I have diagnosed many patients of malaria presenting with fever after travel to endemic regions using these kits.
Malaria antigen test kits had become a reliable tool for ruling out falciparum malaria among tourists with pyrexia and seizures.
An expert committee recommended banning the kits to curb increasing malaria cases in endemic regions.
Govt of India has now banned entire production and sale of these kits in India. People in non endemic regions are not now well trained in slide and microscopy methods. Sudden ban of kits can also be counterproductive.
Do you think that this was a wise step?
What was your experience with these kits?
Dear Vivek.....there are two types of kits available in the market one that detect malaria antigen in the blood and another detecting malaria antibodies in the blood. Please check...I think Govt of India has banned malaria antibodies detecting kits (due to problem of large number of false positives) and not the antigen detecting test kit. Kits that detect malaria antigen in the human blood will continue to be be available as usual. Hence, don't worry unduly and be happy
You must compare the results with good microscopic results as the reference methods.
Dear Vivek.....there are two types of kits available in the market one that detect malaria antigen in the blood and another detecting malaria antibodies in the blood. Please check...I think Govt of India has banned malaria antibodies detecting kits (due to problem of large number of false positives) and not the antigen detecting test kit. Kits that detect malaria antigen in the human blood will continue to be be available as usual. Hence, don't worry unduly and be happy
Dear Anil
That was a great explanation!
Thankyou for clarifying my doubts.
If that is true then the notification by the govt should have written it explicitly in their notification.
I will also check the details.
Vivek
Agree with Dr Prakash.
Here is the news item, wherein Govt of India has banned antibody detecting Rapid Diagnostic kits of malaria.
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Government bans antibody rapid test kits for malaria
The Union Health Ministry has banned the use of of Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria.
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Published: 05th April 2018 05:54 AM | Last Updated: 05th April 2018 05:54 AM | A+A A-
By Express News Service
BENGALURU: The Union Health Ministry has banned the use of Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria. A gazette notification, dated March 23, prohibits the manufacture, sale and distribution of these kits.
The order observed that these kits as a form of serological testing are not practical for routine diagnosis of acute Malaria owing to the time required for the development of the antibody, the persistence of antibodies after clearance of an active infection and the fact that serology does not detect current infection, but only measures past exposure.
Malaria antibody detection is performed using the indirect fluorescent antibody test for a patient who is infected with Plasmodium.The false positive rate in 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 will not be any problem faced for malaria diagnosis by banning the Antibody Detecting Rapid Diagnostic Tests,” the order said.The matter was examined by an expert committee appointed by the central government and the committee recommended that the said drug was found to have no therapeutic justification.
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