LIMITATIONS OF THE TEST
1. As with all diagnostic tests, the test result must always be correlated with clinical findings.
2. The results of test are to be interpreted within the epidemiological, clinical and therapeutic context. When it seems indicated, the parasitological techniques of reference should be considered (microscopic examination of the thick smear and thin blood films).
3. Any modification to the above procedure and/or use of other reagents will invalidate the test procedure.
4. The device and buffer of different lots must not be mixed and used.
5. In case of infection due to P.vivax or P.falciparum, or due to mixed infection by these species, the pan malaria band will also be positive. Hence differentiation of infection due to P.ovale or P. malariae cannot be done.
6. While monitoring therapy, if the reaction of the test remains positive with the same intensity after 5-10 days, post treatment, the possibility of a resistant strain of malaria has to be considered.
7. Usually , the Pv and pan bands turn negative after successful anti malarial therapy. However, since treatment duration and medication used affect the clearance of parasites, the test should be repeated after 5-10 days of start of treatment.
8. In P.falciparum malaria infection, HRP-2 is not secreted in gametogony stage. Hence, in “ Carriers”, the HRP-2 band may be absent.
9. HRP-2 levels, post treatment persist upto 15 days, the pan band can be used to monitor success of therapy, in P.falciparum malaria cases.
10. In a few cases, where the HRP-2 band is positive and the pan malaria band is negative, it may indicate a case of post treatment malaria. However, such a reaction pattern may also be obtained in a few cases of untreated malaria. Retesting after 2 days is advised, in such cases.