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厄瓜多尔有症状和无症状 COVID-19 患者的痰液中 SARS-CoV-2 的 RT-qPCR 与扩大分诊的比较。

Comparison between RT-qPCR for SARS-CoV-2 and expanded triage in sputum of symptomatic and asymptomatic COVID-19 subjects in Ecuador.

机构信息

Medicina General Integral, Máster en Enfermedades Infecciosas, Hospital Gineco-obstétrico Nueva Aurora Luz Elena Arismendi, Quito, Ecuador.

Escuela de Medicina, Facultad de Ciencias de la Salud, Redondel del Ciclista, Antigua Via a Nayón, Universidad de las Américas, 170125, Quito, Ecuador.

出版信息

BMC Infect Dis. 2021 Jun 12;21(1):558. doi: 10.1186/s12879-021-06272-8.

Abstract

BACKGROUND

The quantitative reverse transcriptase-polymerase chain reaction (RT-qPCR) effectively detects the SARS-COV-2 virus. SARS-CoV-2 Nevertheless, some critical gaps remain in the identification and monitoring of asymptomatic people.

METHODS

This retrospective study included 733 asymptomatic and symptomatic COVID-19 subjects, who were submitted to the RT-qPCR test. The objective was to assess the efficacy of an expanded triage of subjects undergoing the RT-qPCR test for SARS-COV-2 to identify the largest possible number of COVID-19 cases in a hospital setting in Ecuador. SARS-CoV-2 Firstly, the sensitivity and specificity as well as the predictive values of an expanded triage method were calculated. In addition, the Kappa coefficient was also determined to assess the concordance between laboratory test results and the expanded triage.

RESULTS

Of a total of 733 sputum samples; 229 were RT-qPCR-positive (31.2%) and mortality rate reached 1.2%. Overall sensitivity and specificity were 86.0% (95% confidence interval: 81.0-90.0%) and 37.0% (95% confidence interval: 32.0-41.0%) respectively, with a diagnostic accuracy of 52.0% and a Kappa coefficient of 0.73. An association between the positivity of the test and its performance before 10 days was found.

CONCLUSIONS

The clinical sensitivity for COVID-19 detection was within acceptable standards, but the specificity still fell below the values of reference. The lack of symptoms did not always mean to have a negative SARS-COV-2 RT-qPCR test. The expanded triage identified a still unnoticed percentage of asymptomatic subjects showing positive results for the SARS-COV-2 RT-qPCR test. The study also revealed a significant relationship between the number of RT-qPCR-positive cases and the performance of the molecular diagnosis within the first 10 days of COVID-19 in the symptomatic group.

摘要

背景

实时荧光定量逆转录聚合酶链反应(RT-qPCR)可有效检测 SARS-CoV-2 病毒。然而,在无症状人群的识别和监测方面仍存在一些关键空白。

方法

本回顾性研究纳入了 733 例无症状和有症状的 COVID-19 患者,他们均接受了 RT-qPCR 检测。目的是评估在厄瓜多尔医院环境中对接受 SARS-CoV-2 RT-qPCR 检测的患者进行扩大分诊的效果,以尽可能多地发现 COVID-19 病例。首先,计算了扩大分诊方法的灵敏度、特异性和预测值。此外,还确定了 Kappa 系数以评估实验室检测结果与扩大分诊的一致性。

结果

总共 733 例痰样本中,229 例 RT-qPCR 阳性(31.2%),死亡率达到 1.2%。总体灵敏度和特异性分别为 86.0%(95%置信区间:81.0-90.0%)和 37.0%(95%置信区间:32.0-41.0%),诊断准确率为 52.0%,Kappa 系数为 0.73。检测阳性与检测前 10 天的性能之间存在关联。

结论

COVID-19 检测的临床灵敏度符合可接受标准,但特异性仍低于参考值。无症状并不一定意味着 SARS-CoV-2 RT-qPCR 检测结果为阴性。扩大分诊发现了一定比例的无症状患者,他们的 SARS-CoV-2 RT-qPCR 检测结果呈阳性,而这些患者之前并未被发现。研究还揭示了在有症状组中,COVID-19 发病的前 10 天内,RT-qPCR 阳性病例数量与分子诊断性能之间存在显著关系。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f272/8196537/ae2f9a296912/12879_2021_6272_Fig1_HTML.jpg

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