AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Bichat, Laboratoire de Parasitologie-Centre National de Référence du Paludisme, Paris, France ; Université Paris Descartes, UMR 216, Paris, France ; Institut de Recherche pour le Développement, UMR 216, Paris, France.
PLoS One. 2013 Sep 30;8(9):e75486. doi: 10.1371/journal.pone.0075486. eCollection 2013.
We compared the performance of four rapid diagnostic tests (RDTs) for imported malaria, and particularly Plasmodium falciparum infection, using thick and thin blood smears as the gold standard. All the tests are designed to detect at least one protein specific to P. falciparum (Plasmodium histidine-rich protein 2 (PfHRP2) or Plasmodium LDH (PfLDH)) and one pan-Plasmodium protein (aldolase or Plasmodium LDH (pLDH)). 1,311 consecutive patients presenting to 9 French hospitals with suspected malaria were included in this prospective study between April 2006 and September 2008. Blood smears revealed malaria parasites in 374 cases (29%). For the diagnosis of P. falciparum infection, the three tests detecting PfHRP2 showed high and similar sensitivity (96%), positive predictive value (PPV) (90%) and negative predictive value (NPV) (98%). The PfLDH test showed lower sensitivity (83%) and NPV (80%), despite good PPV (98%). For the diagnosis of non-falciparum species, the PPV and NPV of tests targeting pLDH or aldolase were 94-99% and 52-64%, respectively. PfHRP2-based RDTs are thus an acceptable alternative to routine microscopy for diagnosing P. falciparum malaria. However, as malaria may be misdiagnosed with RDTs, all negative results must be confirmed by the reference diagnostic method when clinical, biological or other factors are highly suggestive of malaria.
我们比较了四种用于输入性疟疾（尤其针对恶性疟原虫感染）的快速诊断检测试剂（RDTs）的性能，以血涂片（厚薄血涂片）为金标准。所有的检测试剂都旨在检测至少一种疟原虫特有的蛋白（恶性疟原虫 HRP2（PfHRP2）或乳酸脱氢酶（PfLDH））和一种泛疟原虫蛋白（醛缩酶或乳酸脱氢酶（pLDH））。2006 年 4 月至 2008 年 9 月，在 9 家法国医院，我们对 1311 例疑似疟疾患者进行了前瞻性研究。374 例（29%）血涂片显示有疟原虫。对于恶性疟原虫感染的诊断，三种检测 PfHRP2 的试剂具有较高且相似的敏感性（96%）、阳性预测值（PPV）（90%）和阴性预测值（NPV）（98%）。PfLDH 检测的敏感性（83%）和 NPV（80%）较低，尽管其 PPV（98%）较好。对于非恶性疟原虫的检测，针对 pLDH 或醛缩酶的检测试剂的 PPV 和 NPV 分别为 94-99%和 52-64%。因此，基于 PfHRP2 的 RDT 是诊断恶性疟原虫疟疾的常规显微镜检查的可接受替代方法。然而，由于 RDT 可能导致疟疾的误诊，因此，当临床、生物学或其他因素高度提示疟疾时，所有的阴性结果都必须通过参考诊断方法来确认。
