[Field evaluation of SD(BIOLINE) malaria antigen Plasmodium falciparum/Plasmodium vivax rapid test kit]

Abstract

Four hundred and seventy-five patients with fever within 48 h were detected for Plasmodium using double blind field trials in China-Myanmar border from June to December 2011. The result showed that 202 of 475 were positive by SD(BIOLINE) kits, with 98 positive of Plasmodium falciparum and 104 positive of Plasmodium vivax. By microscope examination, 206 were positive. Taking the result of microscope examination as the reference standard, the general sensitivity and specificity were 98.1% (202/206) and 97.8% (263/269) respectively, and the general coincidence rate of SD(BIOLINE) kits with microscopy was 97.9% (465/475). The sensitivity and specificity of P. falciparum were 99.0% (98/99) and 97.8% (263/269) respectively, and the coincidence rate of SD(BIOLINE) with microscopy was 98.1% (361/368). The sensitivity and specificity of P. vivax were 97.2% (104/107) and 100% (269/269), and the coincidence rate of SD(BIOLINE) with microscopy was 99.2% (373/376). Therefore, the test results of SD(BIOLINE) are stable with a high specificity and sensitivity.