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一项评估 cobas 即时检测 RT-PCR 检测法(检测严重急性呼吸综合征冠状病毒 2 型以及甲型/乙型流感)对加利福尼亚大学戴维斯分校医学中心急诊科患者临床管理影响的研究。

A study to assess the impact of the cobas point-of-care RT-PCR assay (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center.

作者信息

May Larissa, Robbins Elissa M, Canchola Jesse A, Chugh Kamal, Tran Nam K

机构信息

Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento, California, USA.

Roche Molecular Systems, Pleasanton, California, USA.

出版信息

J Clin Virol. 2023 Nov;168:105597. doi: 10.1016/j.jcv.2023.105597. Epub 2023 Sep 18.

Abstract

BACKGROUND

Rapid detection of SARS-CoV-2 is crucial for reduction of transmission and clinical decision-making. Several rapid (<30 min) molecular point-of-care (POC) tests based on nucleic acid amplification exist for diagnosis of SARS-CoV-2 & Influenza A/B infections.

METHODS

This unblinded, pre-post study enrolled consecutive patients with symptoms/signs consistent with SARS-CoV-2 infection presenting to the University of California, Davis emergency department (ED). Outcomes following implementation of the cobas® SARS-CoV-2 & Influenza A/B test for use on the cobas Liat System (intervention: December 2020-May 2021) were compared with previous standard-of-care using centralized laboratory reverse transcriptase polymerase chain reaction (RT-PCR) methods (control: April 2020-October 2020).

RESULTS

Electronic health records of 8879 symptomatic patient visits were analyzed, comprising 4339 and 4540 visits and 538 and 638 positive SARS-CoV-2 PCR test results in the control and intervention periods, respectively. Compared with the control period, turnaround time (TAT) was shorter in the intervention period (median 0.98 vs 12.30 h; p < 0.0001). ED length of stay (LOS) was generally longer in the intervention period compared with the control period, but for those SARS-CoV-2-negative who were admitted, ED LOS was shorter (median 12.53 vs 17.93 h; p < 0.0001). The rate of antibiotic prescribing was lower in the intervention than in the control period (42.86% vs 49.16%; p < 0.0001) and antiviral prescribing was higher (7.64% vs 5.49%; p < 0.0001).

CONCLUSION

This real-world study confirms faster TAT with a POC RT-PCR method in an emergency care setting and highlights the importance of rapid SARS-CoV-2 detection to aid patient management and inform treatment decisions.

摘要

背景

快速检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)对于减少传播和临床决策至关重要。目前存在几种基于核酸扩增的快速(<30分钟)分子即时检测(POC)方法,用于诊断SARS-CoV-2和甲型/乙型流感感染。

方法

这项非盲法的前后对照研究纳入了连续出现与SARS-CoV-2感染相符的症状/体征并前往加利福尼亚大学戴维斯分校急诊科(ED)就诊的患者。将在cobas Liat系统上使用cobas® SARS-CoV-2和甲型/乙型流感检测(干预时间:2020年12月至2021年5月)后的结果与之前使用集中实验室逆转录聚合酶链反应(RT-PCR)方法的标准治疗(对照时间:2020年4月至2020年10月)进行比较。

结果

分析了8879例有症状患者就诊的电子健康记录,在对照期和干预期分别有4339次和4540次就诊,以及538次和638次SARS-CoV-2 PCR检测阳性结果。与对照期相比,干预期的周转时间(TAT)更短(中位数0.98小时对12.30小时;p<0.0001)。干预期的急诊科住院时间(LOS)总体上比对照期更长,但对于那些被收治的SARS-CoV-2阴性患者,急诊科住院时间更短(中位数12.53小时对17.93小时;p<0.0001)。干预期的抗生素处方率低于对照期(42.86%对49.16%;p<0.0001),抗病毒药物处方率更高(7.64%对5.49%;p<0.0001)。

结论

这项真实世界研究证实了在急诊护理环境中使用即时检测RT-PCR方法可实现更快的周转时间,并突出了快速检测SARS-CoV-2对协助患者管理和指导治疗决策的重要性。

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