Rapid Diagnostic Tests - NVBDCP

Quality Assurance of Malaria Diagnostic tests
PREFACE
Malaria microscopy for diagnosis of malaria is a time tested “Gold Standard” test. However,
it has certain constraints. A lot of research and development has been going on to develop
alternative methods for laboratory diagnosis of malaria. Rapid diagnostic tests have been
developed validated and field tested. These RDTs detect HRPII of P. falciparum and pLDH
of P. vivax in patient’s blood by the principle of immunocbromatography. Being a relatively
new technology it is required that all laboratory personnel /field workers involved in malaria
diagnosis be trained in RDTs. Further, there are many variables like quality of test kits,
storage and transport, performance of test and internal quality control which can affect the
test results. There is no proper quality assurance programme so far under the Directorate of
NVBDCP to ensure the quality of the results produced.
This document entitled, Manual on Quality Assurance of Laboratory Diagnosis of
Malaria by Rapid Diagnostic Tests has been developed to be used as a bench manual by
laboratory personnel to perform RDTs and its quality assurance. The manual gives details of
all aspects of RDTs, preparation of quality control panels and practice of quality assurance.
I am confident that this document will be very helpful in implementing the quality assurance
for laboratory diagnosis of malaria using RDTs and training of the laboratory personnel to
ensure accurate and reliable results.
Dr. G.P.S. Dhillion
Director, NVBDCP
SOP- Rapid Diagnostic Tests
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