External quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting
External quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting
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DOI：
10.1186/1475-2875-9-359
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发表时间：
2010-12-13
期刊：
影响因子：
3
通讯作者：
Jacobs, Jan
中科院分区：
文献类型：
--
作者：
Gillet, Philippe;Mukadi, Pierre;Jacobs, Jan
背景：疟疾快速诊断测试（RDTs）越来越多地被用作疟疾诊断工具，无论是在地方性和非地方性环境中。本研究报告了在非地方性环境中开展的RDTs外部质量评估（EQA）会议的结果。方法：在室温运输过程中对抗原稳定性进行验证后，使用疟疾rdt将3份临床样品和一份调查问卷分别送往比利时和卢森堡大公国临床实验室。参与者被要求以观察（RDT控制线和测试线的可见性）和解释（向临床医生报告）的形式报告RDT的结果。此外，与会者还被邀请填写一份关于RDTs在疟疾诊断战略中的地位的调查问卷。结果：共有128/133家采用随机对照试验的临床实验室（96.2%）参与。使用了六个三波段和一个四波段RDT品牌。分析错误很少，包括(i)未识别无效的RDT结果（1.6%）和（ii）未诊断恶性疟原虫（0.8%）。较小的错误与RDT检测结果解释有关，包括(i)在恶性疟原虫和非恶性疟原虫的情况下报告“RDT阳性”而没有进行物种鉴定（分别为16.9%和6.5%）和（ii）在报告中添加错误评论（3.2%）。其中一些错误与不正确的RDT包装说明书有关，例如(i)没有报告恶性疟原虫和间日疟原虫混合感染的可能性（分别为35.5%和18.5%）和（ii）在存在泛种抗原系时将间日疟原虫解释为非恶性疟原虫（4.0%）。调查问卷显示，48.8%的参与者加工过
Background: Malaria rapid diagnostic tests (RDTs) are increasingly used as a tool for the diagnosis of malaria, both in endemic and in non-endemic settings. The present study reports the results of an external quality assessment (EQA) session on RDTs in a non-endemic setting.Methods: After validation of antigen stability during shipment at room temperature, three clinical samples and a questionnaire were sent to clinical laboratories in Belgium and the Grand Duchy of Luxembourg using malaria RDTs. Participants were asked to report the results of the RDTs as observations (visibility of the RDT control and test lines) and interpretations (report as formulated to the clinician). In addition, participants were invited to fill in a questionnaire on the place of RDTs in the diagnostic strategy of malaria.Results: A total of 128/133 (96.2%) of clinical laboratories using RDTs participated. Six three-band and one four-band RDT brands were used. Analytical errors were rare and included (i) not recognizing invalid RDT results (1.6%) and (ii) missing the diagnosis of Plasmodium falciparum (0.8%). Minor errors were related to RDT test result interpretation and included (i) reporting "RDT positive" without species identification in the case of P. falciparum and non-falciparum species (16.9% and 6.5% respectively) and (ii) adding incorrect comments to the report (3.2%). Some of these errors were related to incorrect RDT package insert instructions such as (i) not reporting the possibility of mixed species infection in the case of P. falciparum and Plasmodium vivax (35.5% and 18.5% respectively) and (ii) the interpretation of P. vivax instead of non-falciparum species at the presence of a pan-species antigen line (4.0%). According to the questionnaire, 48.8% of participants processed