EasyNAT 系统 Tt 值与 Cobas z480 Ct 值在检测 SARS-Cov-2 中的潜在关系

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2024-09-26 DOI:10.1016/j.plabm.2024.e00431

Lu-Qing Zheng, Qing-Yong Wang

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引用次数: 0

摘要

目的本研究旨在评估基于交叉引物扩增（CPA）技术的商用 EasyNAT 系统的时间阈值（Tt）与基于实时荧光聚合酶链反应（PCR）方法的 Cobas z480 分析仪的周期阈值（Ct）之间在检测口咽拭子中的严重急性呼吸系统综合征冠状病毒-2（SARS-CoV-2）方面的潜在关系。设计与方法：结果使用 Cobas z480 分析仪同时检测了 277 份 EasyNAT 阳性样本（Tt 值从 3.83 到 29.5 不等）（Ct 值从 10.74 到 38.78 不等）。两个系统的吻合率为 100%。在阳性样本中，O 和 N 基因的平均 PCR Ct 值和最大 PCR Ct 值随着 EasyNAT 系统左右扩增区 Tt 值的增加而增加。当 UC0116 分析仪左右扩增区的 Tt 值不超过 6 时，Cobas z480 分析仪测定的 O 或 N 基因的最大 Ct 值不超过 29.52。EasyNAT 系统的 Tt 值（≤6）可以作为估计 SARS-CoV-2 阳性样本中最大 Ct 值（29.52）的参考指标。

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The potential relationship between EasyNAT system Tt values and Cobas z480 Ct values in the detection of SARS-Cov-2

Objectives

This study aimed to evaluate the potential relationship between the time threshold (Tt) values of a commercial EasyNAT system, which is based on cross priming amplification (CPA) technology, and the cycle threshold (Ct) values of the Cobas z480 analyzer, which is based on a real-time fluorescence polymerase chain reaction (PCR) method, in the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) from oropharyngeal swabs. Design and Methods: Data were retrospectively collected from a clinical laboratory between December 4, 2022 and July 1, 2024.

Results

A total of 277 EasyNAT-positive samples (Tt values from 3.83 to 29.5) were simultaneously investigated using the Cobas z480 analyzer (Ct values from 10.74 to 38.78). The concordance rate between the two systems was 100 %. Among the positive samples, the mean and maximum PCR Ct values of O and N genes increased in line with increasing Tt values of the left and right amplification areas of the EasyNAT system. The maximum Ct values of the O or N gene determined by the Cobas z480 analyzer were no more than 29.52 when the Tt values of the left or right amplification areas of the UC0116 analyzer were no more than 6.

Conclusions

The safe, simple, fast, accurate, and automatic EasyNAT system used in conjunction with a PCR system might be a better choice for the detection of SARS-CoV-2 in hospitals, especially in settings without sophisticated PCR facilities. The Tt value (≤6) of the EasyNAT system can be a reference index for estimating the maximum Ct value (29.52) in SARS-CoV-2-positive samples.

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.