抗体检测(免疫层析法)用于新型冠状病毒肺炎的辅助诊断及影响因素

目的探讨免疫层析法抗体检测用于新型冠状病毒肺炎(COVID-19)辅助诊断的价值及影响检测阳性率的因素。方法采用回顾性研究的方法,收集新疆新型冠状病毒肺炎(COVID-19)确诊病例的血清标本、2019年之前的人群血清及2020年新型冠状病毒流行期间的非病例血清标本及相关流行病学和样本采集信息进行分析。结果新型冠状病毒(2019-nCoV)抗体检测试剂(免疫层析法)的灵敏度为71.43%;特异度为98.41%;诊断准确率为91.67%;阳性预测值为93.75%,阴性预测值为91.18%。病例发病后7 d内采样的检出阳性率明显低于采样时间较长组;病例早期咽部排毒量不是抗体阳性检出的影响因素。结论免疫层析法试剂是新型冠状病毒诊断中对临床诊断和核酸检测诊断的良好补充,由于敏感度有待提高,应与其他方法结合使用。发病后1~18 d内的血清标本中,标本采集时间过早阳性检出率低,病例早期咽部排毒量大小不影响抗体的检出。

Antibody detection (immunochromatography) for the auxiliary diagnosis and influencing factors of COVID-19

A retrospective study was used to analyze the situation of antibody against COVID-19. The serum samples of confirmed cases of COVID-19, non-case of COVID-19 and the population serum collected before 2019 were tested in laboratory. Epidemiological information and laboratorial test results are used in combination for analysis. We found that the sensitivity of 2019-nCoV antibody detection reagent (immunochromatography) was 71.43%; the specificity was 98.41%; the diagnostic accuracy was 91.67%; the positive predictive value was 93.75% and the negative predictive value was 91.18%. Antibody detection with immunochromatography is a good complement to the clinical diagnosis and nucleic acid detection diagnosis about COVID-19. Since the sensitivity needs to be improved, it should be used in combination with other methods. The serum specimens within 1-18 days after the onset were collected. The positive detection rate of specimens collected prematurely is low, and the amount of detoxification in the throat does not affect the positive rate of antibody detection.In order to improve the detection rate of antibodies, we should collect serum samples more than 6 days after the onset to test.