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比较 CareStart 疟疾 Pf/Pan 复合检测试剂与现场显微镜法在印度尼西亚北苏门答腊诊断间日疟原虫疟疾中的表现。

Comparison of the performance of the CareStart Malaria Pf/Pan Combo test and field microscopy in the diagnosis of Plasmodium vivax malaria in North Sumatera, Indonesia.

机构信息

Department of Child Health, Medical Faculty, Universitas Sumatera Utara, Medan, 20155, Indonesia.

Medical Faculty, Universitas Sumatera Utara, Medan, 20155, Indonesia.

出版信息

Malar J. 2022 Jan 29;21(1):27. doi: 10.1186/s12936-022-04057-1.

Abstract

BACKGROUND

In areas where malaria is endemic and where trained microscopists are not available, rapid diagnostic tests (RDTs) are needed not only to allow prompt treatment without delay but also to prevent overdiagnosis and overtreatment based on clinical judgements that may lead to drug resistance. This study aimed to compare the performances of the CareStart Pf/Pan Combo test to field microscopy, which is considered to be the gold standard for malaria diagnosis.

METHODS

Any person with a fever or a history of fever within 48 h who came to the health centre was recruited for the study and tested both by the CareStart Pf/Pan test and by field microscopy. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were analysed with both methods.

RESULTS

Two-hundred study participants were enrolled: 96 (48%) were found to be positive through microscopy, while 100 (50%) participants were found to be positive through RDT. The RDT produced four false-positive results. High sensitivity and specificity were observed for the CareStart Pf/Pan test (100 and 96.15%, respectively). The CareStart Pf/Pan test also showed excellent agreement with the field microscopy results.

CONCLUSION

The Carestart Pf/Pan could be used as an alternative diagnostic test in malaria-endemic areas where facility for performing microscopy is not available.

摘要

背景

在疟疾流行地区,由于缺乏训练有素的显微镜检查人员,不仅需要快速诊断检测(RDT)以便能够及时治疗,而不延误病情,还需要避免根据临床判断进行过度诊断和过度治疗,因为这可能导致耐药性的产生。本研究旨在比较 CareStart Pf/Pan Combo 检测与现场显微镜检查的性能,后者被认为是疟疾诊断的金标准。

方法

任何有发热或 48 小时内有发热史的人都被招募到该研究中,并同时接受 CareStart Pf/Pan 检测和现场显微镜检查。使用两种方法分析了敏感性、特异性、阳性预测值、阴性预测值和准确性。

结果

共纳入 200 名研究参与者:96 名(48%)通过显微镜检查呈阳性,而 100 名(50%)参与者通过 RDT 检查呈阳性。RDT 产生了 4 个假阳性结果。CareStart Pf/Pan 检测的敏感性和特异性均较高(分别为 100%和 96.15%)。CareStart Pf/Pan 检测与现场显微镜检查结果也具有极好的一致性。

结论

在缺乏进行显微镜检查设施的疟疾流行地区,Carestart Pf/Pan 可以作为替代诊断检测方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ec1/8800299/5c76450bbb18/12936_2022_4057_Fig1_HTML.jpg

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