Mason Daniel Philippe, Kawamoto Fumihiko, Lin Khin, Laoboonchai Anintita, Wongsrichanalai Chansuda
University of California School of Medicine, San Francisco, CA, USA.
Acta Trop. 2002 Apr;82(1):51-9. doi: 10.1016/s0001-706x(02)00031-1.
In Myanmar, we tested two rapid malaria immunochromatographic kits: the OptiMAL assay for the detection of parasite lactate dehydrogenase (pLDH), and the ICT Malaria P.f./P.v. test for histidine-rich protein 2 (PfHRP2) and panmalarial antigens. A total of 229 patients were examined, of whom 133 were found to be malaria positive by Giemsa microscopy. Both OptiMAL and ICT gave lower sensitivities than previously reported. ICT sensitivity for Plasmodium falciparum and non-falciparum parasites were 86.2 and 2.9%, respectively; specificity was 76.9 and 100%, respectively. OptiMAL sensitivity for P. falciparum and non-falciparum parasites were 42.6 and 47.1%, respectively; specificity was 97.0 and 96.9%, respectively. The sensitivity of both tests for the detection of both P. falciparum and non-falciparum parasites increased with parasite density. Several explanations for these results are explored. Our results raise particular concern over batch quality variations of malaria rapid diagnostic devices (MRDDs).
在缅甸，我们检测了两种疟疾快速免疫层析试剂盒：用于检测疟原虫乳酸脱氢酶（pLDH）的OptiMAL检测法，以及用于检测富含组氨酸蛋白2（PfHRP2）和泛疟原虫抗原的ICT疟疾P.f./P.v.检测法。总共检查了229名患者，其中133名经吉姆萨显微镜检查发现疟疾呈阳性。OptiMAL和ICT的灵敏度均低于先前报道。ICT对恶性疟原虫和非恶性疟原虫的灵敏度分别为86.2%和2.9%；特异性分别为76.9%和100%。OptiMAL对恶性疟原虫和非恶性疟原虫的灵敏度分别为42.6%和47.1%；特异性分别为97.0%和96.9%。两种检测方法对恶性疟原虫和非恶性疟原虫的检测灵敏度均随寄生虫密度的增加而提高。我们探讨了这些结果的几种解释。我们的结果特别引发了对疟疾快速诊断设备（MRDDs）批次质量差异的关注。
