EVALUATION OF 3 RAPID DIAGNOSTIC TESTS (CARESTART (TM) MALARIA 3 LINE PLDH (PAN, PF), OPTIMAL-IT (R) PLDH (PAN, PF) AND CARESTART (TM) 2 LINE PLDH (PAN) FOR THE DIAGNOSIS OF MALARIA IN MYANMAR

2008 
[94.8-97.7]; Pv alone: Se 91.4% [85.3-95.2]. CareStart MalariaO 3 line: Pf: Se 93.5% [CI 95 85.4-97.3], Sp 97.4% [95.9-98.3]; non-Pf: Se 78.5% [71.1-84.4], Sp 97.8% [96.3-98.7]; Pv alone: Se 80.6% [72.9-86.5]. CareStart MalariaO 2 line: Pf: Se 89.1% [CI 95 84.2-92.6], Sp 94.7% [92.5-96.3]; Pf alone: Se 95.6% [87.7-98.5]; Pv alone: Se 91.0% [92.5-96.3]. Inter-observer agreement was excellent for all tests (kappa > 0.9). The median time for the RDTs to become negative was 2 days for the CareStartO tests and 7 days for OptiMAL-IT®. Only CareStart MalariaO 2 line passed all heat stability evaluation. Conclusion In this study OptiMAL-IT® RDT and the CareStartO 2 line pLDH (Pan) test met the 95% threshold of Se for detection of falciparum malaria set by WHO. The Se of both tests to detect vivax malaria exceeded 90%. However any decision to implement one of these tests should take into account the heat stability results, positive predictive value in the context in which it would be deployed and cost-effectiveness.
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