Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India.
Independent Malaria Technical Expert, New Delhi, India.
Am J Trop Med Hyg. 2024 Feb 13;110(3):431-435. doi: 10.4269/ajtmh.23-0339. Print 2024 Mar 6.
Since 2010, malaria rapid diagnostic tests (RDTs) are widely used to detect malaria. The Indian Council of Medical Research-National Institute of Malaria Research performed lot testing (LT) according to WHO procedures since 2016. Lot testing is performed to evaluate the lot-to-lot variation in performance of malaria RDTs. Four sets of positive quality control (QC) panels for P. falciparum (Pf) and P. vivax (Pv) and 10 negative panels tested RDTs. RDTs were reported as pass, failed, or deferred on the basis of WHO criteria. In the past 5 years, 275 lots containing 15,488 RDT kits for malaria diagnosis were subjected to LT. The monovalent RDTs (n = 1,216), based on either Pf histidine rich protein 2 (HRP2) or Pan-Plasmodium lactate dehydrogenase (Pan-pLDH) antigens, showed 90.4% sensitivity and 100% specificity, whereas RDTs based on HRP2 + Pan-pLDH or HRP2 + pLDH (n = 13,924) had sensitivity 95.6% and specificity 99.5%, respectively. RDTs based on PfHRP2 + Pv-pLDH + Pan-pLDH (n = 348) had 100% sensitivity and specificity. In a comparison between HRP2 + pLDH or HRP2 + Pan-pLDH to HRP2 + pLDH + Pan-pLDH RDTs, it was found that the sensitivity of PfHRP2 with Pan-pLDH RDTs (n = 2,382) was only 83%. Of the 275 lots analyzed, 15 lots of PfHRP2 with Pan-pLDH were deferred. The QC panel for Pf revealed a faint Pan band in the tested lots, which is a cause for concern. The results of deferred lots were reported to concerned government agencies. Quality-compromised RDTs may lead to an incorrect diagnosis. It is critical to have a QC system in place for effective malaria management.
自 2010 年以来，疟疾快速诊断检测（RDT）已被广泛用于检测疟疾。自 2016 年以来，印度医学研究理事会-国家疟疾研究所按照世卫组织程序进行了大量检测（LT）。进行 lot 测试是为了评估疟疾 RDT 性能的批间变化。使用 4 组针对 Pf（恶性疟原虫）和 Pv（间日疟原虫）的阳性质量控制（QC）面板以及 10 个阴性面板来测试 RDT。根据世卫组织标准，RDT 报告为通过、失败或延期。在过去的 5 年中，有 275 批包含 15488 个疟疾诊断 RDT 试剂盒接受了 LT。单价 RDT（n=1216），基于 Pf 组氨酸丰富蛋白 2（HRP2）或泛疟乳酸脱氢酶（Pan-pLDH）抗原，显示出 90.4%的敏感性和 100%的特异性，而基于 HRP2+Pan-pLDH 或 HRP2+pLDH（n=13924）的 RDT 具有 95.6%的敏感性和 99.5%的特异性。基于 PfHRP2+Pv-pLDH+Pan-pLDH（n=348）的 RDT 具有 100%的敏感性和特异性。在 HRP2+pLDH 或 HRP2+Pan-pLDH 与 HRP2+pLDH+Pan-pLDH RDT 之间的比较中，发现基于 PfHRP2+Pan-pLDH 的 RDTs（n=2382）的敏感性仅为 83%。在分析的 275 批中，有 15 批 PfHRP2+Pan-pLDH 被延期。Pf 的 QC 面板在测试的批次中显示出微弱的 Pan 条带，这令人担忧。延期批次的结果已报告给有关政府机构。质量受损的 RDT 可能导致不正确的诊断。建立有效的疟疾管理质量控制系统至关重要。
