Performance of the Innova SARS-CoV-2 antigen rapid lateral flow test in the Liverpool asymptomatic testing pilot: population based cohort study.
Performance of the Innova SARS-CoV-2 antigen rapid lateral flow test in the Liverpool asymptomatic testing pilot: population based cohort study.
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利物浦无症状测试试验中的Innova SARS-COV-2抗原快速横向流程测试：基于人群的同类研究。
DOI：
10.1136/bmj.n1637
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发表时间：
2021-07-06
期刊：
影响因子：
--
通讯作者：
Buchan I
中科院分区：
文献类型：
--
作者：
García-Fiñana M;Hughes DM;Cheyne CP;Burnside G;Stockbridge M;Fowler TA;Fowler VL;Wilcox MH;Semple MG;Buchan I
目的：评估SARS-CoV-2抗原快速侧向流动试验(LFT)与聚合酶链式反应试验在无症状普通人群参加检测中心的性能。观察性队列研究。在英国利物浦的新冠肺炎测试点进行社区LFT试点。5,869名无症状成年人(≥18岁)在2020年11月6日至29日期间自愿参加48个考点中的一个。参与者接受了Innova LFT和定量逆转录聚合酶链式反应(RT-qPCR)测试，该测试基于测试地点的监督自我擦拭。在没有典型疾病症状的成年人中，在新冠肺炎流行稳定状态下，LFT与RT-qPCR比较的敏感性、特异性和预测值。在5869个检测结果中，22个(0.4%)LFT结果和343个(5.8%)RT-qPCR结果无效(即当控制线在30分钟内未出现时)。排除VOID结果，LFT与RT-qPCR的敏感性为40.0%(95%可信区间为28.5%~52.4%；28/70)，特异性为99.9%(99.8%~99.99%；5431/5434)，阳性预测值为90.3%(74.2%~98.0%；28/31)，阴性预测值为99.2%(99.0%~99.4%；5431/5473)。当空洞样本为阴性时，LFT的灵敏度为37.8%(26.8%~49.9%；28/74)，特异度为99.6%(99.4%~99.8%；5431/5452)，阳性预测值为84.8%(68.1%~94.9%；28/33)，阴性预测值为93.4%(92.7%~94.0%；5431/5814)。RT-qPCR循环阈值(Ct)为18.3(近似病毒载量106RNA拷贝/毫升)的受试者的敏感度为90.9%(58.7%至99.8%；10/11)，CT为24.4(104RNA拷贝/毫升)的受试者为69.4%(51.9%至83.7%；25/36)，Ct为24.4(<；104RNA拷贝数/毫升)为9.7%(1.9%~23.7%；3/34)。LFT很可能在每1000人中检测到至少五分之三，最多998人，RT-qPCR检测结果为阳性，病毒载量高。INNOVA LFT可用于识别报告没有新冠肺炎症状的成年人中的感染情况，特别是那些病毒载量高的人，他们更有可能感染其他人。LFT漏诊的无症状成人的Ct较低(表明病毒载量较高)的数量虽然很少，但在高后果情况下使用单一LFT时应考虑在内。就如何解释检测结果与公众进行明确和准确的沟通是重要的，因为即使在高病毒载量的情况下，也有可能漏掉一些病例。还需要进一步的研究，以了解LFT检测到的病毒抗原脱落与RT-qPCR近似的病毒载量之间是如何反映传染性的。
To assess the performance of the SARS-CoV-2 antigen rapid lateral flow test (LFT) versus polymerase chain reaction testing in the asymptomatic general population attending testing centres. Observational cohort study. Community LFT pilot at covid-19 testing sites in Liverpool, UK. 5869 asymptomatic adults (≥18 years) voluntarily attending one of 48 testing sites during 6-29 November 2020. Participants were tested using both an Innova LFT and a quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) test based on supervised self-administered swabbing at testing sites. Sensitivity, specificity, and predictive values of LFT compared with RT-qPCR in an epidemic steady state of covid-19 among adults with no classic symptoms of the disease. Of 5869 test results, 22 (0.4%) LFT results and 343 (5.8%) RT-qPCR results were void (that is, when the control line fails to appear within 30 minutes). Excluding the void results, the LFT versus RT-qPCR showed a sensitivity of 40.0% (95% confidence interval 28.5% to 52.4%; 28/70), specificity of 99.9% (99.8% to 99.99%; 5431/5434), positive predictive value of 90.3% (74.2% to 98.0%; 28/31), and negative predictive value of 99.2% (99.0% to 99.4%; 5431/5473). When the void samples were assumed to be negative, a sensitivity was observed for LFT of 37.8% (26.8% to 49.9%; 28/74), specificity of 99.6% (99.4% to 99.8%; 5431/5452), positive predictive value of 84.8% (68.1% to 94.9%; 28/33), and negative predictive value of 93.4% (92.7% to 94.0%; 5431/5814). The sensitivity in participants with an RT-qPCR cycle threshold (Ct) of <18.3 (approximate viral loads >106 RNA copies/mL) was 90.9% (58.7% to 99.8%; 10/11), a Ct of <24.4 (>104 RNA copies/mL) was 69.4% (51.9% to 83.7%; 25/36), and a Ct of >24.4 (<104 RNA copies/mL) was 9.7% (1.9% to 23.7%; 3/34). LFT is likely to detect at least three fifths and at most 998 in every 1000 people with a positive RT-qPCR test result with high viral load. The Innova LFT can be useful for identifying infections among adults who report no symptoms of covid-19, particularly those with high viral load who are more likely to infect others. The number of asymptomatic adults with lower Ct (indicating higher viral load) missed by LFT, although small, should be considered when using single LFT in high consequence settings. Clear and accurate communication with the public about how to interpret test results is important, given the chance of missing some cases, even at high viral loads. Further research is needed to understand how infectiousness is reflected in the viral antigen shedding detected by LFT versus the viral loads approximated by RT-qPCR.
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DOI：
10.15585/mmwr.mm695152a3
发表时间：
2021-01-01
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
通讯作者：
--
DOI：
10.1016/s0140-6736(21)00425-6
发表时间：
2021-04-17
期刊：
Lancet (London, England)
影响因子：
--
作者：
Mina MJ;Peto TE;García-Fiñana M;Semple MG;Buchan IE
通讯作者：
Buchan IE
DOI：
10.1016/s1473-3099(20)30985-3
发表时间：
2021-05
期刊：
The Lancet. Infectious diseases
影响因子：
--
作者：
Marks M;Millat-Martinez P;Ouchi D;Roberts CH;Alemany A;Corbacho-Monné M;Ubals M;Tobias A;Tebé C;Ballana E;Bassat Q;Baro B;Vall-Mayans M;G-Beiras C;Prat N;Ara J;Clotet B;Mitjà O
通讯作者：
Mitjà O
影响因子：
15.1
作者：
Peto T;UK COVID-19 Lateral Flow Oversight Team
通讯作者：
UK COVID-19 Lateral Flow Oversight Team
影响因子：
16.6
作者：
Alexandersen S;Chamings A;Bhatta TR
通讯作者：
Bhatta TR