School of Bioscience and Bioengineering, South China University of Technology, Panyu District, Guangzhou 510006, China; Department of Molecular Biology and Biotechnology, School of Biological Sciences, University of Cape Coast, Cape Coast, Ghana; National Engineering Laboratory of Rapid Diagnostic Tests, Guangzhou Wondfo Biotech Co Ltd, Science City, Lizhishan Rd No 8, Luogang District, Guangzhou 510663, China
Wang, J., School of Bioscience and Bioengineering, South China University of Technology, Panyu District, Guangzhou 510006, China; Dzakah, E.E., School of Bioscience and Bioengineering, South China University of Technology, Panyu District, Guangzhou 510006, China, Department of Molecular Biology and Biotechnology, School of Biological Sciences, University of Cape Coast, Cape Coast, Ghana, National Engineering Laboratory of Rapid Diagnostic Tests, Guangzhou Wondfo Biotech Co Ltd, Science City, Lizhishan Rd No 8, Luogang District, Guangzhou 510663, China; Kang, K., School of Bioscience and Bioengineering, South China University of Technology, Panyu District, Guangzhou 510006, China, National Engineering Laboratory of Rapid Diagnostic Tests, Guangzhou Wondfo Biotech Co Ltd, Science City, Lizhishan Rd No 8, Luogang District, Guangzhou 510663, China; Ni, C., School of Bioscience and Bioengineering, South China University of Technology, Panyu District, Guangzhou 510006, China; Tang, S., National Engineering Laboratory of Rapid Diagnostic Tests, Guangzhou Wondfo Biotech Co Ltd, Science City, Lizhishan Rd No 8, Luogang District, Guangzhou 510663, China; Wang, J., National Engineering Laboratory of Rapid Diagnostic Tests, Guangzhou Wondfo Biotech Co Ltd, Science City, Lizhishan Rd No 8, Luogang District, Guangzhou 510663, China
Background: Misdiagnosis of malaria by commercial rapid diagnostic tests (RDTs) is a major cause of concern in the diagnosis of malaria. This retrospective study was aimed at assessing the relative performance of four RDTs with emphasis on the detection of two Plasmodium vivax antigens: aldolase and lactate dehydrogenase (LDH). Methods. Three commercially available Plasmodium LDH or aldolase antigen detection kits (One Step Malaria P.f/P.v, ParaHit Total ver. 1.0, SD Bioline Malaria) and an anti-P. vivax aldolase-specific monoclonal antibody (mAb) pair 1C3-12 F10 were evaluated with P. vivax positive as well as non-P. vivax samples and healthy samples using blood smear examination as standard. Each test was read according to the manufacturer's instructions. Results: MAb 1C3-12 F10 pair targeting P. vivax-specific aldolase exhibited very good specificity and sensitivity of 100 and 97.4%, respectively. Positive predictive value (PPV) and negative predictive value (NPV) of 100 and 99.5%, respectively, were also observed. The anti-P. vivax LDH in the One-Step Malaria P.f/P.v test showed sensitivity, specificity, PPV and NPV of 93.5, 98.0, 88.9 and 98.8%, respectively. ParaHit Total ver. 1.0 targeting the pan-aldolase antigen showed sensitivity, specificity of 97.4 and 99.6%, respectively. PPV and NPV were both 99.5%. SD Bioline had sensitivity, specificity, PPV and NPV of 93.5, 100, 100 and 98.8%, respectively. The overall sensitivity and specificity of all four RDTs were acceptable, especially for the aldolase detection tests. Five (6.5%) of the P. vivax-positive samples (n = 77) that were confirmed by microscopic examination as well as the two aldolase detection RDTs (mAb 1C3-12 F10 and ParaHit Total ver.1.0) were undetected by the two LDH detection RDTs (One Step Malaria P.f/P.v and SD Bioline). Similarly, two positive samples (2.6%) that were positively confirmed by the LDH detection RDTs were also undetected by the aldolase detection test kits. Conclusion: Aldolase and LDH antigens perform differently in different P. vivax samples; hence there is a high risk of misdiagnosis when monoclonal antibodies are used against only one particular antigen in the test. A combination of both aldolase and LDH in RDTs for the rapid diagnosis of P. vivax will enhance the sensitivity of the assay and reduce misdiagnosis. © 2014 Dzakah et al.; licensee BioMed Central Ltd.
fructose bisphosphate aldolase; lactate dehydrogenase; monoclonal antibody; monoclonal antibody 1C3 12 F10; unclassified drug; fructose bisphosphate aldolase; lactate dehydrogenase; monoclonal antibody; parasite antigen; protozoon antibody; antigen detection; article; blood smear; controlled study; diagnostic test accuracy study; human; intermethod comparison; major clinical study; malaria rapid test; microscopy; nonhuman; parasite identification; Plasmodium falciparum; Plasmodium malariae; Plasmodium vivax; Plasmodium vivax malaria; predictive value; retrospective study; sensitivity and specificity; blood; comparative study; diagnostic test; diagnostic use; evaluation study; hospital information system; immunoassay; Malaria, Vivax; procedures; Antibodies, Monoclonal; Antibodies, Protozoan; Antigens, Protozoan; Diagnostic Tests, Routine; Fructose-Bisphosphate Aldolase; Humans; Immunoassay; L-Lactate Dehydrogenase; Malaria, Vivax; Point-of-Care Systems; Retrospective Studies; Sensitivity and Specificity