[SD（生物线）疟原虫恶性疟原虫/间日疟原虫快速检测试剂盒的现场评估]

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

作者信息

Liu Hui, Li Xi-Rong, Li Chun-Fu, Li Xing-Liang, Wang Heng-Ye, Nie Ren-Hua

出版信息

Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi. 2013 Apr;31(2):160-1.

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.

摘要

2011年6月至12月，在中国-缅甸边境地区采用双盲现场试验，对48小时内发热的475例患者进行疟原虫检测。结果显示，475例中202例经SD（BIOLINE）试剂盒检测为阳性，其中恶性疟原虫98例阳性，间日疟原虫104例阳性。经显微镜检查，206例为阳性。以显微镜检查结果为参照标准，总体灵敏度和特异度分别为98.1%（202/206）和97.8%（263/269），SD（BIOLINE）试剂盒与显微镜检查的总体符合率为97.9%（465/475）。恶性疟原虫的灵敏度和特异度分别为99.0%（98/99）和97.8%（263/269），SD（BIOLINE）试剂盒与显微镜检查的符合率为98.1%（361/368）。间日疟原虫的灵敏度和特异度分别为97.2%（104/107）和100%（26/269），SD（BIOLINE）试剂盒与显微镜检查的符合率为99.2%（373/376）。因此，SD（BIOLINE）试剂盒检测结果稳定，具有较高的特异度和灵敏度。