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Evaluation of the analytical performance of six rapid diagnostic tests for the detection of viral hepatitis B and C in Lubumbashi, Democratic Republic of Congo.
Journal of Virological Methods ( IF 3.1 ) Pub Date : 2020-08-26 , DOI: 10.1016/j.jviromet.2020.113961
Arsène T Kabamba 1 , Claude M Mwamba 2 , Géraldine Dessilly 3 , François Dufrasne 3 , Benoit M Kabamba 3 , Albert O Longanga 4
Affiliation  

Rapid diagnostic tests (RDTs) are widely used in Lubumbashi for the diagnosis of viral hepatitis B and C. To date, there are no works that have been carried out in Lubumbashi to independently assess the performance of such tests. This study aimed at assessing the effectiveness of RDTs for the detection of HBsAg and anti-HCV antibodies in order to identify infected blood donors in Lubumbashi. A total of 300 serum samples (100 HBsAg positive samples; 100 anti-HCV positive samples and 100 HBsAg and anti-HCV negative samples) were tested simultaneously using the 6 locally used RDTs and as gold standard the chemiluminescent assays for HBsAg and the RT-TMA for HCV detection.

The six evaluated RDTs demonstrated a sensitivity and a negative predictive value (NPV) of 100 % whereas the specificity and positive predictive value (PPV) varied from 46 % to 98.1 %. SB BioLine HBsAg test performed best in this study with 100 % of sensitivity, 97.1 % of specificity, 100 % of NPV and 96.9 % of PPV. Furthermore, sensitivity, specificity, NPV and PPV for SB BioLine HCV test were as follows: 100 %, 98.1 %, 100 % and 93.9 %. Therefore, SD BioLine tests (HBsAg, HCV) would be selected as the first line RDTs for the detection and the diagnostic of hepatitis B and C. They can prevent blood-borne transmission of HBV and HCV in areas with limited incomes as Lubumbashi.



中文翻译:

评估刚果民主共和国卢本巴希市六种快速诊断测试检测乙型和丙型病毒性肝炎的分析性能。

快速诊断测试(RDT)在卢本巴希(Lubumbashi)中广泛用于诊断乙型和丙型病毒性肝炎。迄今为止,卢本巴希(Lubumbashi)尚未开展任何工作来独立评估此类测试的性能。这项研究旨在评估RDTs检测HBsAg和抗HCV抗体的有效性,以鉴定卢本巴希(Lubumbashi)受感染的献血者。使用6个本地使用的RDT同时检测了300份血清样品(100份HBsAg阳性样品; 100份抗HCV阳性样品以及100份HBsAg和抗HCV阴性样品),并且作为金标准,对HBsAg和RT-进行化学发光测定TMA用于HCV检测。

六个评估的RDT显示出100%的敏感性和阴性预测值(NPV),而特异性和阳性预测值(PPV)从46%到98.1%不等。SB BioLine HBsAg测试在本研究中表现最佳,灵敏度为100%,特异性为97.1%,NPV为100%,PPV为96.9%。此外,SB BioLine HCV检测的敏感性,特异性,NPV和PPV如下:100%,98.1%,100%和93.9%。因此,SD BioLine检测(HBsAg,HCV)将被选作检测和诊断乙型和丙型肝炎的一线RDT。它们可以防止收入有限的地区(如卢本巴希)的HBV和HCV血源性传播。

更新日期:2020-09-02
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