Ponce Carlos, Ponce Elisa, Vinelli Elizabeth, Montoya Alberto, de Aguilar Vilma, Gonzalez Antonio, Zingales Bianca, Rangel-Aldao Rafael, Levin Mariano J, Esfandiari Javan, Umezawa Eufrosina S, Luquetti Alejandro O, da Silveira José Franco
Laboratorio Central de Referencia para Enfermedad de Chagas y Leishmaniasis, Secretaria de Salud, Tegucigalpa, Honduras.
J Clin Microbiol. 2005 Oct;43(10):5065-8. doi: 10.1128/JCM.43.10.5065-5068.2005.
In this study we compared the performance of the Chagas Stat-Pak rapid immunochromatographic test with a standard enzyme-linked immunosorbent assay (ELISA) in the serodiagnosis of Chagas' disease in Central America. Out of 3,400 blood donor samples, 156 (4.6%) were positive in both assays. Three sera out of 2,084 samples from reference laboratories were negative with the rapid test but positive with the ELISA (99.8% agreement). Agreement of 100% between the two tests was observed with 339 additional sera from patients with cardiopathies and 175 sera from potential blood donors in emergency surgical cases occurring on weekends or at night. In conclusion, Chagas Stat-Pak showed 99.6% and 99.9% sensitivity and specificity, respectively, when assayed with 5,998 serum samples. It is a sensitive and specific alternative to the ELISA, as required in medical emergencies and blood screenings in Central America.
在本研究中，我们比较了Chagas Stat-Pak快速免疫层析试验与标准酶联免疫吸附测定（ELISA）在中美洲恰加斯病血清诊断中的性能。在3400份献血者样本中，两种检测方法均呈阳性的有156份（4.6%）。来自参考实验室的2084份样本中有3份血清快速检测呈阴性，但ELISA检测呈阳性（一致性为99.8%）。对于另外339份心脏病患者血清以及175份周末或夜间急诊手术潜在献血者的血清，两种检测方法的一致性为100%。总之，用5998份血清样本进行检测时，Chagas Stat-Pak的灵敏度和特异性分别为99.6%和99.9%。它是ELISA的一种敏感且特异的替代方法，适用于中美洲的医疗紧急情况和血液筛查。
