Performance of SD Bioline Malaria Ag Pf/Pan rapid test in the diagnosis of malaria in South-Kivu, DR Congo

INTRODUCTION: Use of malaria rapid diagnostic tests (RDTs) has improved the management of this disease. We evaluated the validity of the SD-Bioline Malaria-Ag-Pf/Pan™ (Batch 60952) RDT supplied by the Malaria Control Program of the DRCongo. METHODS: cChildren (n = 460) aged below 5 years seen in curative care (CC) for suspected malaria and in pre-school consultation (PSC) in two rural centers underwent clinical evaluation and capillary blood collection for microscopic reading of thick smear (TS) and thin film (BF), and for RDT. Sensitivity (Se), specificity (Sp), positive (PPV) and negative (NPV) predictive values of the RDT, and the corresponding accuracy and Youden indices were determined using microscopic data as reference. Results were compared using the Chi-square test. RESULTS: Microscopy showed malaria infection in 53.8% of CC and in 10.8% of PSC children. Similar results were obtained using the RDT (CC: 47.1%; PSC: 18.3%; P > 0.05 vs. microscopy). Se of the RDT was 82.1%, Sp 92.0%, PPV 88.5% and NPV 87.4%. RDT positivity was significantly (p < 0.01) associated with some symptoms (chills, profuse sweating) and with a recent history of malaria attack. In addition, Se of the RDT depended on parasitemia and decreased at low parasite denstity. CONCLUSION: SD-Bioline Malaria-Ag-Pf/Pan™ RDT has a relatively good sensitivity and specificity but seems useful only for high parasitemia. Negative SD Bioline Malaria Ag Pf/Pan™ RDT should be complemented with microscopy when clinical signs suggest malaria.