| Abstract: | ABSTRACT: BACKGROUND: Rapid diagnostic tests (RDTs) are central to fulfilling the WHO's recommendation for parasitologic confirmation of all suspected cases of malaria. RDT performance may be compromised when exposed to the high temperature conditions typical of most malaria endemic regions. However, a systematic method to monitor RDT quality and performance in endemic countries is lacking at the present time. Current methods to monitor RDT performance in the field include comparing results from RDTs to diagnoses made by light microscopy and observing health workers perform tests. These methods are not substitutes for direct quality control. In this study, the suitability of dried Plasmodium falciparuminfected blood as quality control samples for malaria RDTs was evaluated. METHODS: Three cultured strains of P. falciparum at 200 and 2,000 parasites/mul were tested on 10 brands of RDT. After baseline testing to determine initial reactivity, aliquots of parasite-infected blood were air dried, stored at 35 degreesC, room temperature (~25 degreesC) or 4 degreesC for one, four and 12 weeks and were then tested on the 10 RDTs after rehydration. Extended stability testing of dried blood stored at 4 degreesC was done using P. falciparum strain 3D7 at 1,000 and 2,000 parasites/mul. RESULTS: All dried blood samples at 2,000 parasites/mul retained reactivity (100 % sensitivity) at all three temperatures and time points for all nine RDT brands that detect histidine-rich protein-2 (HRP2). The dried blood samples with 200 parasites/mul were detected by six of the nine HRP2-based RDTs at all storage temperatures and time points. The sensitivity for two of the three remaining HRP2-based RDTs was 100 % up to four weeks of storage at all temperatures but dropped to 87.5 % at week 12. Of the four RDTs that detect plasmodium lactate dehydrogenase (pLDH) in a pan-specific manner, alone or in combination with HRP2, the detection of pLDH in samples with 2,000 parasites/muL was 100 % for two RDTs and 80 % for the other two RDTs. The mean level for detection of pLDH at 200 parasites/mul was low (29 %), with a range of 0 % to100%, which was partly attributable to weak initial baseline reactivity. Reactivity of dried 3D7 at 1,000 and 2,000 parasites/mul stored at 4 degreesC was retained at 100 % for up to 52 weeks for both HRP2 and pLDH. CONCLUSIONS: In the absence of native or recombinant positive control antigens, well-standardized P. falciparum-infected dried blood samples can be used as positive control samples for monitoring RDT performance, particularly with HRP2-detecting tests. |
