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| 严重急性呼吸综合征冠状病毒2咽拭子核酸检测法假阴性调查分析 |
| 常颜信1,2△,徐明霖1,3△,傅晓辉1,4,尹磊1,4,万旭英1,5,张迁1,6* |
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(1. 湖北省妇幼保健院光谷院区感染四科, 武汉 430073;
2. 海军军医大学(第二军医大学)东方肝胆外科医院胆道四科, 上海 200438;
3. 联勤保障部队桂林康复疗养中心疗养一科, 桂林 541002;
4. 海军军医大学(第二军医大学)东方肝胆外科医院胆道二科, 上海 200438;
5. 海军军医大学(第二军医大学)东方肝胆外科医院中西医结合科, 上海 200438;
6. 海军军医大学(第二军医大学)东方肝胆外科医院生物治疗科, 上海 200438
△共同第一作者
*通信作者) |
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| 摘要: |
| 目的 探讨严重急性呼吸综合征冠状病毒2（SARS-CoV-2）咽拭子核酸检测法的假阴性率，并分析其原因，为稳固我国新型冠状病毒肺炎（COVID-19）防控工作提供参考。方法 对2020年2月19日至3月20日湖北省妇幼保健院光谷院区收治的1 452例COVID-19患者的咽拭子核酸检测结果进行回顾性分析，将出院前检测结果为阳性之前的阴性结果判定为假阴性，统计假阴性患者例数。随访出院患者，筛选出院后再次核酸检测阳性（复阳）的患者，分析出院前病毒核酸检测连续阴性次数和核酸复阳的关系。结果 1 452例COVID-19患者中男592例（40.77%）、女860例（59.23%）。212例（14.60%）咽拭子核酸检测结果曾出现假阴性。共随访到28例（1.93%）出院后复阳患者，连续2次核酸检测阴性的918例患者中有24例（2.61%）复阳，高于连续3次及以上核酸检测阴性患者的复阳率（0.75%，4/534），差异有统计学意义（χ2=6.21，P=0.012 7）。结论 SARS-CoV-2咽拭子核酸检测法具有一定比例的假阴性，是患者出院后核酸复阳的原因之一。建议出院前由不同检测者进行多次、连续检测，满足连续3次及以上核酸检测阴性的出院标准可以降低复阳率。 |
| 关键词: 新型冠状病毒肺炎|严重急性呼吸综合征冠状病毒2|咽拭子核酸检测法|假阴性反应|核酸复阳 |
| DOI：10.16781/j.0258-879x.2020.06.0592 |
| 投稿时间：2020-04-04修订日期：2020-05-06 |
| 基金项目:国家自然科学基金（82402428，81572869）. |
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| Analysis of false negative results in throat swab nucleic acid test of severe acute resporatory syndrome coronavirus 2 |
| CHANG Yan-xin1,2△,XU Ming-lin1,3△,FU Xiao-hui1,4,YIN Lei1,4,WAN Xu-ying1,5,ZHANG Qian1,6* |
(1. Department of Infectious Diseases (Ⅳ), Guanggu Branch of Maternity and Child Healthcare Hospital of Hubei Province, Wuhan 430073, Hubei, China;
2. Department of Hepatobiliary Surgery (Ⅳ), Eastern Hepatobiliary Surgery Hospital, Naval Medical University (Second Military Medical University), Shanghai 200438, China;
3. Department of Recuperation (Ⅰ), Guilin Rehabilitation and Recuperation Center, Joint Service Support Force, Guilin 541002, Guangxi Zhuang Autonomous Region, China;
4. Department of Hepatobiliary Surgery (Ⅱ), Eastern Hepatobiliary Surgery Hospital, Naval Medical University (Second Military Medical University), Shanghai 200438, China;
5. Department of Integrated Traditional and Western Medicine, Eastern Hepatobiliary Surgery Hospital, Naval Medical University (Second Military Medical University), Shanghai 200438, China;
6. Department of Biotherapy, Eastern Hepatobiliary Surgery Hospital, Naval Medical University (Second Military Medical University), Shanghai 200438, China
△Co-first authors.
* Corresponding author) |
| Abstract: |
| Objective To investigate the false negative rate of throat swab nucleic acid test of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to analyze the causes, so as to provide references for the prevention and control of coronavirus disease 2019 (COVID-19) in China. Methods A retrospective analysis was conducted on the throat swab nucleic acid test results of 1 452 COVID-19 patients admitted to Guanggu Branch of Maternity and Child Healthcare Hospital of Hubei Province from Feb. 19 to Mar. 20, 2020. The negative results before positive results at discharge were judged as false negative results, and the false negative rate was calculated. The discharged patients were followed up to screen for the patients who were positive for nucleic acid test again, and the relationship between the times of consecutive negative nucleic acid tests before discharge and the positive again results was analyzed. Results Among the 1 452 COVID-19 patients, 592 (40.77%) were males and 860 (59.23%) were females. A total of 212 cases (14.60%) had false negative results. Twenty-eight cases (1.93%) were discovered nucleic acid positive again after discharge. Among the 918 patients whose nucleic acid tests were negative for two consecutive times, 24 (2.61%) were positive again, which was significantly higher than that of the patients whose nucleic acid tests were negative for three consecutive times (0.75%, 4/534; χ2=6.21, P=0.012 7). Conclusion The throat swab nucleic acid test of SARS-CoV-2 has a certain proportion of false negative results, which is one of the reasons for COVID-19 patients are found nucleic acid positive again after discharge. Multiple and continuous tests by different testers are recommended before discharge, and negative nucleic acid test for three or more consecutive times can reduce the incidence of nucleic acid positive results again after discharge. |
| Key words: coronavirus disease 2019|severe acute respiratory syndrome coronavirus 2|throat swab nucleic acid test|false negative reactions|nucleic acid re-positive |
