Evaluation of the Performance of the COVID-19 Rapid Antigen Tests in a Tertiary Level Hospital in Bangladesh

Bangabandhu Sheikh Mujib Medical University Journal Pub Date : 2023-10-13 DOI:10.3329/bsmmcj.v1i2.68872

Mohammad Jahidur Rahman Khan, Ruksana Raihan, Arifa Akram, Sumon Roy, Md Shahidul Islam, Mahjabin Alam, Md Sabir Hossain, Nurul Karim, Farha Matin Juliana, Mohammad Rezaul Quader, Farhana Khatoon Khatoon, Ashikuzzaman Suzan, Farzana Mim, Sharmin Rahman, Md Hanif Howlader, Selim Reza

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Abstract

The tests providing high sensitivity and specificity are essential to identify and manage COVID-19 patients.There is aheavy demand for low-cost rapid antigen tests (RATs) for COVID-19 with a decent diagnostic value. Globally,several RATs for COVID-19 have been developed, but their clinical efficacy has not been well recognized.Thepurpose of the study was to evaluate the performance of RATs. We conducted this prospective observational study atShaheed Suhrawardy Medical College hospital from February 2021 to April 2021 in Dhaka, Bangladesh. This studyincluded the patients admitted in this hospital at the COVID-19 isolation unit or referred from the triage facility of theoutdoor department of this hospital suspected as COVID-19 case. Two nasopharyngeal samples were collectedsimultaneously. We used one sample on the spot for the RATs and the other was sent to the adjacent ShaheedSuhrawardy Medical College COVID-19 RT-PCR laboratory for real-time reverse transcription PCR (RT-PCR). Theperformance of the RATs was evaluated by consuming the real-time RT-PCR results as a reference. In thisinvestigation, SARS-CoV-2 was identified in 84 (30.7%) of the 223 patients who participated. Of these 84 patients, 9(10.7%) were asymptomatic. The overall sensitivity and specificity of RATs were 78.6% and 99.3%, respectively. Thesensitivity was 81.3% in symptomatic cases and 55.6% in asymptomatic cases. There were 18 false-negativespatients,including 3 asymptomatic cases, who had a low viral load (cycle threshold(Ct) > 30). When the Ct value was up to24, the detection rate of RATs was 100%. The detection rate was 42.3% when the Ct was >29. When symptoms beganwithin three days, the detection rate was 92.3%. When the start of symptoms was over 7 days, the detection rate was33.3%. RATs for COVID-19 used in this study delivered an acceptable performance in patients with high viral loadand within the first week of the onset of symptoms. This method can be a supplementary method to RT- PCR for thediagnosis of symptomatic COVID-19 patients. Bangabandhu Sheikh Mujib Med. Coll. J. 2022;1(2):58-64

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孟加拉国某三级医院COVID-19快速抗原检测效果评价

具有高灵敏度和特异性的检测对于识别和管理COVID-19患者至关重要。对具有良好诊断价值的低成本快速抗原检测(rat)的需求很大。在全球范围内，已经开发了几种针对COVID-19的大鼠，但其临床疗效尚未得到很好的认可。本研究的目的是评价rat的性能。我们于2021年2月至2021年4月在孟加拉国达卡的shaheed Suhrawardy医学院医院进行了这项前瞻性观察研究。本研究纳入了在该院COVID-19隔离病房住院的患者或从该院室外分诊设施转诊的疑似COVID-19病例。同时采集两组鼻咽标本。一份样本现场检测，另一份样本送往邻近的ShaheedSuhrawardy医学院COVID-19 RT-PCR实验室进行实时反转录PCR (RT-PCR)。通过消耗实时RT-PCR结果作为参考来评估rat的性能。在本次调查中，参与调查的223例患者中有84例(30.7%)被鉴定出SARS-CoV-2。在84例患者中，9例(10.7%)无症状。总的敏感性和特异性分别为78.6%和99.3%。有症状者敏感性为81.3%，无症状者敏感性为55.6%。假阴性患者18例，其中3例无症状，病毒载量低(周期阈值(Ct) >30)。当Ct值> 24时，rat的检出率为100%。Ct = 29时，检出率为42.3%。当症状在3天内出现时，检出率为92.3%。当症状开始超过7 d时，检出率为33.3%。本研究中使用的COVID-19大鼠在病毒载量高的患者和症状出现的第一周内表现良好。该方法可作为RT- PCR诊断有症状的COVID-19患者的补充方法。Bangabandhu Sheikh Mujib Med. col。j . 2022; 1 (2): 58 - 64

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Bangabandhu Sheikh Mujib Medical University Journal

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12 weeks