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| 咽拭子、鼻拭子、痰液中SARS-CoV-2核酸检测结果一致性及检出率分析 |
| Analysis of consistency and positive rate of SARS-CoV-2 nucleic acid test results in oropharyngeal swabs, nasal swabs and sputum |
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| DOI：10.3969/j.issn.1007-8134.2020.04.004 |
| 中文关键词: 核酸检测 痰液标本 咽拭子标本 鼻拭子标本 |
| 英文关键词: nucleic acid testing sputum oropharyngeal swab nasal swab |
| 基金项目: |
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| 摘要点击次数: 1740 |
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| 中文摘要: |
| 目的 通过对不同类型标本严重急性呼吸综合征冠状病毒2（severe acute respiratory syndrome coronavirus 2, SARS-CoV-2）核酸检测结果的一致性及检出率分析，明确检测结果较优的标本类型。方法 回顾分析郑州市疾病预防控制中心自开展SARS-CoV-2核酸检测以来所有同时采集自同一被检者的不同种类的标本核酸检测结果，利用McNemar χ2检验分析不同标本病毒核酸阳性检出率的统计学差异；用kappa检验分析不同标本核酸检测结果的一致性。结果 本研究共有 61例被检者同时进行2种及以上标本的核酸检测，其中检测咽拭子标本158人次，痰液标本144人次，鼻拭子标本35人次；ORF1a/b基因和N基因同时检出率最高的为痰液标本（71.5%），其次是鼻拭子标本（34.3%），咽拭子标本检出率最低（29.1%）。同时进行痰液标本和咽拭子标本检测的有144人次，2者ORF1a/b基因检出率分别为75.0%、33.3%， N基因检出率分别为89.6%、42.4%，差异均有统计学意义（P均＜0.05），ORF1a/b基因检出结果中2者间一致性差（k＜0.4），N基因检出结果中2者间不存在一致性（k＜0），痰液标本病毒核酸阳性检出率明显高于咽拭子标本；同时进行痰液标本和鼻拭子标本检测的有22人次，2者ORF1a/b基因检出率分别为63.6%、27.3%，N基因检出率分别为81.8%、40.9%，差异均有统计学差异（P均＜0.05），ORF1a/b基因检出结果中2者间一致性差（k＜0.4），N基因检出结果中2者间不存在一致性（k＜0），痰液标本病毒核酸阳性检出率亦高于鼻拭子标本；同时进行鼻拭子标本和咽拭子标本检测的有35人次，鼻拭子标本病毒核酸阳性检出率高于咽拭子标本，2者ORF1a/b基因检出率分别为40.0%、25.7%，N基因检出率分别为51.4%、34.3%，但差异均无统计学意义（P均＞0.05），一致性检验结果则表明2者一致性差（k均＜0.4），因此2者在病毒核酸阳性检出率方面差异无统计学意义，但在核酸检出与未检出的结果方面存在差异，即检测结果可相互补充以提高检出率。结论 痰液标本病毒核酸阳性检出率高于咽拭子标本和鼻拭子标本，在人群筛查中3种标本检测结果可互相补充验证以减少漏诊。 |
| 英文摘要: |
| Objective To determine the type of specimen with optimal test results by assessing the consistency and positive rate of different types of specimens for SARS-CoV-2 nucleic acid test. Methods SARS-CoV-2 nucleic acid test results of all specimens simultaneously were selected in Zhengzhou Center for Disease Control and Prevention when the execution of SARS-CoV-2 nucleic acid test were retrospectively analyzed. The statistical differences of nucleic acid positive rate in various specimens were analyzed using McNemar χ2 test. The consistency analysis of nucleic acid testing results were performed using kappa test. Results A total of 61 cases were enrolled in this study for nucleic acid testing simultaneously in 2 or more specimens, including 158 person-time of oropharyngeal swab specimens, 144 person-time of sputum specimens and 35 person-time of nasal swab specimens. The highest positive rate of both ORF1a/b gene and N gene tests was sputum (71.5%), followed by nasal swabs (34.3%), and the lowest positive rate was oropharyngeal swabs (29.1%). Sputum specimens and oropharyngeal swabs were simultaneously tested in 144 person-time, the ORF1a/b gene positive rate was 75.0% and 33.3% respectively, the N gene positive rate was 89.6% and 42.4% respectively, with statistical differences (P＜0.05). The ORF1a/b gene positive results had a low consistency (k＜0.4) and the N gene positive results had no consistency (k＜0), the positive rate of nucleic acid testing in sputum specimens was obviously higher than that in oropharyngeal swabs. Sputum specimens and nasal swabs were simultaneously tested in 22 person-time, the ORF1a/b gene positive rate was 63.6% and 27.3% respectively, the N gene positive rate was 81.8% and 40.9% respectively, with statistical differences (P＜0.05). The ORF1a/b gene positive results had a low consistency (k＜0.4) and the N gene positive results had no consistency (k＜0), the positive rate of nucleic acid testing in sputum specimens was also higher than that in nasal swabs. Nasal swabs and oropharyngeal swabs were simultaneously tested in 35 person-time. The positive rate of nucleic acid testing in nasal swabs was higher than that in oropharyngeal swabs. The ORF1a/b gene positive rate was 40.0% and 25.7% respectively. The N gene positive rate was 51.4% and 34.3% respectively, without statistical differences (P＞0.05), and there was a low consistency in testing results (k＜0.4), suggesting no statistical difference in positive rate of oropharyngeal swabs and nasal swabs. However, there were differences between positive results and negative results of nucleic acid testing, indicating that the testing results could be mutually complemented to increase positive rate. Conclusions The positive rate of nucleic acid testing of sputum specimens is higher than that of oropharyngeal swabs and nasal swabs. The test results of 3 types of specimens would be mutually complemented and verified to avoid misdiagnosis in population screening process. |
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