Ramparany Lovasoa, Ramirez José, Nizou Jacques-Yves, Le Saux David, Richard Vincent, Talarmin Antoine
Institut Pasteur de Madagascar, BP 1274, Antananarivo 101, Madagascar.
Clin Vaccine Immunol. 2011 Mar;18(3):414-7. doi: 10.1128/CVI.00502-10. Epub 2011 Jan 12.
Cardiac troponin I (cTnI) is a sensitive and specific marker of acute coronary syndromes and myocardial damage. During the past few years, it has become the preferred biochemical marker of myocardial infarction. However, due to the sensitivity required for its detection, only automated systems can be used in developed countries. However, these are rather expensive and unaffordable for most laboratories in developing countries. Many manufacturers have therefore proposed rapid immunochromatographic tests to detect cTnI. The aim of this study was to assess the limit of detection (LOD) and performance of four rapid immunochromatographic tests available in Madagascar. The four tests evaluated were Hexagon Troponin, Nadal troponin I cassette, Troponitest+, and Amicheck-Trop. Amicheck-Trop had a sensitivity and negative predictive value of about 80%, whereas for the three others, they were about 20%. The specificity of Amicheck-Trop of 87.3% was lower than the specificities of the other tests (98% to 100%). These differences were explained by the limits of detection of the tests: 0.3 to 0.4 ng/ml for Amicheck-Trop but only 1.8 to 2 ng/ml for the three other tests. It was concluded that Amicheck-Trop could be useful in the management of acute myocardial infarction or myocarditis in sparsely equipped laboratories in developing countries.
心肌肌钙蛋白I（cTnI）是急性冠状动脉综合征和心肌损伤的敏感且特异的标志物。在过去几年中，它已成为心肌梗死的首选生化标志物。然而，由于其检测所需的灵敏度，在发达国家仅能使用自动化系统。然而，这些系统相当昂贵，发展中国家的大多数实验室难以负担。因此，许多制造商提出了用于检测cTnI的快速免疫层析试验。本研究的目的是评估马达加斯加现有的四种快速免疫层析试验的检测限（LOD）和性能。所评估的四种试验分别是Hexagon Troponin、Nadal肌钙蛋白I检测盒、Troponitest+和Amicheck-Trop。Amicheck-Trop的灵敏度和阴性预测值约为80%，而其他三种试验的灵敏度和阴性预测值约为20%。Amicheck-Trop的特异性为87.3%，低于其他试验的特异性（98%至100%）。这些差异可通过试验的检测限来解释：Amicheck-Trop的检测限为0.3至0.4 ng/ml，而其他三种试验的检测限仅为1.8至2 ng/ml。得出的结论是，Amicheck-Trop在发展中国家设备简陋的实验室中对急性心肌梗死或心肌炎的管理可能有用。
