Pan-Plasmodium band sensitivity for Plasmodium falciparum detection in combination malaria rapid diagnostic tests and implications for clinical management.

Pan-Plasmodium band sensitivity for Plasmodium falciparum detection in combination malaria rapid diagnostic tests and implications for clinical management.
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DOI:
10.1186/s12936-015-0629-z
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发表时间:
2015-03-18
期刊:
影响因子:
3
通讯作者:
Cunningham J
Cunningham J
中科院分区:
医学3区
文献类型:
--
作者:
Gatton ML;Rees-Channer RR;Glenn J;Barnwell JW;Cheng Q;Chiodini PL;Incardona S;González IJ;Cunningham J

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疟疾快速诊断试验(RDTs)适用于病例管理,但在流行地区,持续的抗原血症是HRP 2检测RDTs的一个问题。有人建议,组合RDT上的pan-pLDH测试条带可用于区分持续性抗原血症与活动性恶性疟原虫感染,然而,这假设所有活动性感染在RDT的两个条带上均产生阳性结果,这一断言尚未得到证实。在这项研究中,对WHO-FIND疟疾RDT产品检测计划期间产生的数据进行了审查,以调查18种组合RDT中单个检测条带对恶性疟原虫的反应性。针对多个仅野生型恶性疟原虫样品测试每种产品。通过定量ELISA测量HRP 2、pLDH和醛缩酶的抗原水平。当以200个寄生虫/μL对恶性疟原虫样本进行检测时,92%的RDT呈阳性;其中57%在恶性疟原虫和泛带上,而43%仅在恶性疟原虫带上呈阳性。抗原浓度与条带阳性之间存在相关性; ≥4 ng/mL的HRP 2在95%以上的恶性疟原虫条带中产生阳性结果,而≥45 ng/mL的pLDH需要至少90%的pan条带呈阳性。在活动性恶性疟原虫感染中,组合RDT通常返回阳性HRP 2条带与阴性pan-pLDH条带组合,并且当两条条带均为阳性时,通常pan-LDH条带较弱。因此,如果将存在HRP 2条带而不存在泛条带解释为仅由持续性抗原血症引起,则可能漏诊活动性感染。
Malaria rapid diagnostic tests (RDTs) are appropriate for case management, but persistent antigenaemia is a concern for HRP2-detecting RDTs in endemic areas. It has been suggested that pan-pLDH test bands on combination RDTs could be used to distinguish persistent antigenaemia from active Plasmodium falciparum infection, however this assumes all active infections produce positive results on both bands of RDTs, an assertion that has not been demonstrated. In this study, data generated during the WHO-FIND product testing programme for malaria RDTs was reviewed to investigate the reactivity of individual test bands against P. falciparum in 18 combination RDTs. Each product was tested against multiple wild-type P. falciparum only samples. Antigen levels were measured by quantitative ELISA for HRP2, pLDH and aldolase. When tested against P. falciparum samples at 200 parasites/μL, 92% of RDTs were positive; 57% of these on both the P. falciparum and pan bands, while 43% were positive on the P. falciparum band only. There was a relationship between antigen concentration and band positivity; ≥4 ng/mL of HRP2 produced positive results in more than 95% of P. falciparum bands, while ≥45 ng/mL of pLDH was required for at least 90% of pan bands to be positive. In active P. falciparum infections it is common for combination RDTs to return a positive HRP2 band combined with a negative pan-pLDH band, and when both bands are positive, often the pan band is faint. Thus active infections could be missed if the presence of a HRP2 band in the absence of a pan band is interpreted as being caused solely by persistent antigenaemia.
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