Al Awaji Nisreen Naser, Ahmedah Hanadi Talal, Alsaady Isra Mohammed, Bawaked Rowaedh Ahmed, Alraey Mohammed A, Alasiri Ahmed Ayed, Alfaifi Abdullah Mofareh, Alshehri Hamdan Ali, Alserihi Raed, Yasin Elrashed B
Department of Health Communication Sciences, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, P.O Box 84428, Riyadh 11671, Saudi Arabia.
Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, King Abdulaziz University, Rabegh, Saudi Arabia.
Saudi J Biol Sci. 2021 Jun;28(6):3433-3437. doi: 10.1016/j.sjbs.2021.03.007. Epub 2021 Mar 14.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a disease called COVID-19. COVID-19 is primarily diagnosed using molecular techniques mainly real-time reverse transcriptase PCR. Reliable and accurate serologic assays for COVID-19, are an important tool for surveillance and epidemiologic studies. In this study, the IgG/IgM Rapid Test Cassette and the Prima COVID-19 IgG/IgM Rapid Test for the detection of SARS-CoV-2 antibodies in blood, serum and plasma samples collected from patients up to 48 days after symptom onset in Saudi Arabia were validated. Overall, both tests showed poor performance and cannot be utilised for COVID-19 diagnosis as a point of care test or to determine seroprevalence.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引发一种名为COVID-19的疾病。COVID-19主要通过分子技术进行诊断，主要是实时逆转录聚合酶链反应。用于COVID-19的可靠且准确的血清学检测方法，是监测和流行病学研究的重要工具。在本研究中，对从沙特阿拉伯症状出现后48天内患者采集的血液、血清和血浆样本中检测SARS-CoV-2抗体的IgG/IgM快速检测试剂盒和Prima COVID-19 IgG/IgM快速检测进行了验证。总体而言，这两种检测方法表现不佳，不能作为即时检测用于COVID-19诊断或确定血清阳性率。
