Shirani Kiana, Hajihashemi Milad, Mortazavi Ashkan, Assadi Alireza, Baradaran Azar, Ataei Behrooz, Badei Hossein
Department of Infectious Diseases, Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Infectious Diseases, Immunodeficiency Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Iran J Microbiol. 2024 Aug;16(4):509-514. doi: 10.18502/ijm.v16i4.16310.
SARS-CoV-2 is a newly discovered viral infection. It's still unclear how antibodies react in infected individuals, and there is not enough evidence to support the clinical use of antibody examination. This study evaluates the diagnostic value of serologic tests for diagnosing COVID-19.
32 patients for whom serologic testing was performed within 7 to 21 days from symptom onset and whether they were diagnosed with COVID-19 by both PCR and lung HRCT as gold standard tests at the same time, were included in the study.
Serologic tests (IgM / IgG) compared to PCR and lung HRCT scan to diagnose COVID-19, were 89.3% specific and 59.6% sensitive. Positive predictive value (PPV) was 95% and negative predictive value (NPV) was 37%. The diagnostic accuracy index of the serologic test was 0.745 (CI 0.651-0.838) (p-value <0.001).
Serologic testing can be a complementary alternative for SARA-CoV-2 nucleic acid RT-PCR, although it cannot replace it completely. IgG/IgM combo test kits and RT-PCR together can give more insight into the diagnosis of SARS-CoV-2.
严重急性呼吸综合征冠状病毒2(SARS-CoV-2)是一种新发现的病毒感染。目前仍不清楚抗体在感染个体中的反应情况,且尚无足够证据支持抗体检测的临床应用。本研究评估血清学检测对诊断2019冠状病毒病(COVID-19)的诊断价值。
本研究纳入了32例在症状出现后7至21天内进行血清学检测的患者,同时以聚合酶链反应(PCR)和肺部高分辨率计算机断层扫描(HRCT)作为金标准检测方法来判断他们是否被诊断为COVID-19。
与PCR和肺部HRCT扫描相比,用于诊断COVID-19的血清学检测(IgM/IgG)特异性为89.3%,敏感性为59.6%。阳性预测值(PPV)为95%,阴性预测值(NPV)为37%。血清学检测的诊断准确性指数为0.745(95%置信区间0.651 - 0.838)(p值<0.001)。
血清学检测可作为严重急性呼吸综合征冠状病毒2(SARA-CoV-2)核酸逆转录PCR检测的补充替代方法,尽管它不能完全取代该检测方法。IgG/IgM联合检测试剂盒与RT-PCR一起可更深入地了解SARS-CoV-2的诊断情况。