Diagnostic Performance of Conventional and Ultrasensitive Rapid Diagnostic Tests for Malaria in Febrile Outpatients in Tanzania
Diagnostic Performance of Conventional and Ultrasensitive Rapid Diagnostic Tests for Malaria in Febrile Outpatients in Tanzania
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DOI：
10.1093/infdis/jiy676
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发表时间：
2019-05-01
影响因子：
6.4
通讯作者：
Felger, Ingrid
中科院分区：
文献类型：
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作者：
Hofmann, Natalie E.;Moniz, Clara Antunes;Felger, Ingrid
背景资料。一种新的超灵敏疟疾快速诊断试验(US-RDT)已被开发用于改进的活动性恶性疟原虫感染检测。这种US-RDT在临床诊断和发热管理中的有效性还没有被评估。对在坦桑尼亚门诊就诊的3000名发热儿童和515名成人的US-RDT和传统RDT(co-RDT)的诊断性能进行了回顾性比较。用超灵敏的定量聚合酶链式反应(US-qPCR)测定寄生虫密度，用酶联免疫吸附试验测定HRP2浓度。与联合RDT相比，US-RDT发现的额外恶性疟原虫阳性患者很少(276例检测到寄生虫阳性患者)，只有略高的敏感度(75%比73%)，使用US-qPCR作为金标准(检测到357例寄生虫阳性患者)。两种RDTs的特异度均为99%。另外11例US-RDT检测阳性的患者中，有5例US-qPCR检测结果为阴性。在寄生虫密度为>；100条寄生虫/亩L的感染中，几乎所有感染(99%[236/239])的HRP2浓度都超过了联合RDT的检测限值(每毫升血液中HRP2含量为3653pg)。在寄生虫密度为100pg/亩L时，有29例(25%)和24例(20%)的hrp2浓度超过了US-RDT(793pg/mL)和co-RDT的检测范围。使用us-RDT而不是co-RDT进行疟疾临床诊断既没有优势，也没有风险。在发热患者中，只有一小部分感染的特征是寄生虫密度或HRP2浓度在使用us-RDT将比co-RDT具有显著优势的范围内。
Background. A novel ultrasensitive malaria rapid diagnostic test (us-RDT) has been developed for improved active Plasmodium falciparum infection detection. The usefulness of this us-RDT in clinical diagnosis and fever management has not been evaluated.Methods. Diagnostic performance of us-RDT was compared retrospectively to that of conventional RDT (co-RDT) in 3000 children and 515 adults presenting with fever to Tanzanian outpatient clinics. The parasite density was measured by an ultrasensitive qPCR (us-qPCR), and the HRP2 concentration was measured by an enzyme-linked immunosorbent assay.Results. us-RDT identified few additional P. falciparum-positive patients as compared to co-RDT (276 vs 265 parasite-positive patients detected), with only a marginally greater sensitivity (75% vs 73%), using us-qPCR as the gold standard (357 parasite-positive patients detected). The specificity of both RDTs was > 99%. Five of 11 additional patients testing positive by us-RDT had negative results by us-qPCR. The HRP2 concentration was above the limit of detection for co-RDT (> 3653 pg of HRP2 per mL of blood) in almost all infections (99% [236 of 239]) with a parasite density > 100 parasites per mu L of blood. At parasite densities < 100 parasites/mu L, the HRP2 concentration was above the limits of detection of us-RDT (> 793 pg/mL) and co-RDT in 29 (25%) and 24 (20%) of 118 patients, respectively.Conclusion. There is neither an advantage nor a risk of using us-RDT, rather than co-RDT, for clinical malaria diagnosis. In febrile patients, only a small proportion of infections are characterized by a parasite density or an HRP2 concentration in the range where use of us-RDT would confer a meaningful advantage over co-RDT.