尼日利亚SARS-CoV-2快速诊断检测的性能评估：一项横断面研究。
Performance evaluation of SARS-CoV-2 rapid diagnostic tests in Nigeria: A cross-sectional study.
作者信息
Omonkhua Akhere A, Faneye Adedayo, Akinwande Kazeem S, Evaezi Okpokoro, Shehu Nathan Y, Onayade Adedeji, Ochu Chinwe Lucia, Popoola Mustapha, Emmanuel Nnadi, Ojo Temitope, Ohonsi Cornelius, Abubakar Abdullahi, Odeh Elizabeth, Akinduti Paul, Folarin Onikepe, Bimba John Samson, Igumbor Ehimario, Elimian Kelly, Edem Victory Fabian, Pam D Luka, Olusola Tunde, Ntoimo Loretta, Olugbile Michael, Opayele Adewale Victor, Kida Ibrahim, David Shwe, Onyeaghala Augustine, Igbarumah Isaac, Maduka Omosivie, Mahmoud Magaji A, El-Fulatty Abdul Rahman, Olaleye David O, Simon Omale, Osaigbovo Iriagbonse Iyabo, Obaseki Darlington Ewaen, Tolulupe Afolaranmi, Happi Christian, Jibrin Yusuf Bara, Okonofua Friday, Eliya Timan, Simji Gomerep, Abi Izang Joy, Ameh Emmanuel, Maigari Ibrahim Mahmood, Alhaji Sulaiman, Adetifa Ifedayo, Salako Babatunde, Bogoro Suleiman, Ihekweazu Chikwe, Odaibo Georgina N
机构信息
Centre of Excellence in Reproductive Health Innovation (CERHI), University of Benin, Benin City, Nigeria.
Department of Medical Biochemistry, University of Benin, Benin City, Nigeria.
出版信息
PLOS Glob Public Health. 2024 Jul 15;4(7):e0003371. doi: 10.1371/journal.pgph.0003371. eCollection 2024.
The COVID-19 pandemic challenged health systems globally. Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detecting the presence of SARS-CoV-2 in clinical samples. Rapid diagnostic test (RDT) kits for COVID-19 have been widely used in Nigeria. This has greatly improved test turnover rates and significantly decreased the high technical demands of RT-PCR. However, there is currently no nationally representative evaluation of the performance characteristics and reliability of these kits. This study assessed the sensitivity, specificity, and predictive values of ten RDT kits used for COVID-19 testing in Nigeria. This large multi-centred cross-sectional study was conducted across the 6 geo-political zones of Nigeria over four months. Ten antigen (Ag) and antibody (Ab) RDT kits were evaluated, and the results were compared with RT-PCR. One thousand, three hundred and ten (1,310) consenting adults comprising 767 (58.5%) males and 543 (41.5%) females participated in the study. The highest proportion, 757 (57.7%), were in the 20-39 years' age group. In terms of diagnostic performance, Lumira Dx (61.4, 95% CI: 52.4-69.9) had the highest sensitivity while MP SARS and Panbio (98.5, 95% CI: 96.6-99.5) had the highest specificity. For predictive values, Panbio (90.7, 95% CI: 79.7-96.9) and Lumira Dx (81.2, 95% CI: 75.9-85.7) recorded the highest PPV and NPV respectively. Ag-RDTs had better performance characteristics compared with Ab-RDTs; however, the sensitivities of all RDTs in this study were generally low. The relatively high specificity of Ag-RDTs makes them useful for the diagnosis of infection in COVID-19 suspected cases where positive RDT may not require confirmation by molecular testing. There is therefore the need to develop RDTs in-country that will take into consideration the unique environmental factors, interactions with other infectious agents, and strains of the virus circulating locally. This may enhance the precision of rapid and accurate diagnosis of COVID-19 in Nigeria.
新冠疫情给全球卫生系统带来了挑战。逆转录聚合酶链反应（RT-PCR）是检测临床样本中是否存在严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的金标准。用于新冠病毒检测的快速诊断测试（RDT）试剂盒在尼日利亚已被广泛使用。这极大地提高了检测周转率，并显著降低了RT-PCR对高技术的要求。然而，目前尚无对这些试剂盒性能特征和可靠性的全国代表性评估。本研究评估了在尼日利亚用于新冠病毒检测的十种RDT试剂盒的敏感性、特异性和预测值。这项大型多中心横断面研究在尼日利亚的六个地理政治区域进行，为期四个月。对十种抗原（Ag）和抗体（Ab）RDT试剂盒进行了评估，并将结果与RT-PCR进行比较。1310名同意参与研究的成年人，其中包括767名（58.5%）男性和543名（41.5%）女性。比例最高的757名（57.7%）在20至39岁年龄组。在诊断性能方面，Lumira Dx（61.4，95%置信区间：52.4-69.9）具有最高的敏感性，而MP SARS和Panbio（98.5，95%置信区间：96.6-99.5）具有最高的特异性。在预测值方面，Panbio（90.7，95%置信区间：79.7-96.9）和Lumira Dx（81.2，95%置信区间：75.9-85.7）分别记录了最高的阳性预测值（PPV）和阴性预测值（NPV）。与抗体RDT试剂盒相比，抗原RDT试剂盒具有更好的性能特征；然而，本研究中所有RDT试剂盒的敏感性普遍较低。抗原RDT试剂盒相对较高的特异性使其可用于新冠疑似病例的感染诊断，在这些病例中，RDT检测呈阳性可能不需要通过分子检测进行确认。因此，有必要在国内开发RDT试剂盒，充分考虑当地独特的环境因素、与其他感染因子的相互作用以及当地流行的病毒毒株。这可能会提高尼日利亚新冠病毒快速准确诊断的精准度。
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