Comparison Between the Analytical Sensitivity and Clinical Performance of Two Cobas SARS-CoV-2 Tests Based on High-throughput and Point-of-care Systems

Overview

Journal Biomedicine (Taipei)

Specialty Biomedical Engineering

Date 2022 Jul 15

PMID 35836977

Authors

Tsai-Hsiu Lin

Ngoc-Niem Bui

Yu-Chang Chang

Li-Yun Hsu

Yang-Di Su

Chieh-Min Chang

Wei-An Hong

Uyen Nguyen Phuong Le

Su-Hua Huang

Cheng-Wen Lin

Affiliations

Soon will be listed here.

Abstract

Objectives: This study examined analytical sensitivity, specificity, and the clinical performance in detecting SARS-CoV-2 of the Cobas SARS-CoV-2 Test based on the high-throughput Cobas 6800 system and the Cobas SARS-CoV-2 & Flu A/B Test based on the point-of-care cobas Liat system.

Methods: The commercial reagents containing SARS-CoV-2 RNA subgenomes were diluted for assessing the sensitivity of the RT-qPCR assay. 385 nasopharyngeal swab specimens taken from contacts of COVID-19 cases were tested for the SARS-CoV-2 detection with both Cobas SARS-CoV-2 Tests.

Results: In analytical sensitivity assays, the Cobas SARS-CoV-2 & Flu A/B Test on the Liat system had a lower limit of detection (12.5-25 copies/mL) than the cobas SARS-CoV-2 Test on the cobas 6800 system (25-50 copies/mL). In clinical performance assays, the cobas SARS-CoV-2 Test demonstrated 89.36% (42 out of 47) PPA (positive percent agreement) and 98.82% (334 out of 338) NPA (negative percent agreement) compared to the results of the Cobas SARS-CoV-2 & Flu A/B test. Among five discordant specimens, four had the positive result of the cobas SARS-CoV-2 test, but the negative result of the cobas SARS-CoV-2 & Flu A/B Test. Moreover, these discordant specimens had the Ct values of greater than 33 for the cobas SARS-CoV-2 Test, implying a very small number of virions in the samples. Remarkably, four specimens with a presumptive positive result of the cobas SARS-CoV-2 test had been confirmed by the Cobas SARS-CoV-2 & Flu A/B Test. Next, the scatter plots of the Ct values showed a highly positive correlation between cobas SARS-CoV-2 & Flu A/B Test and the cobas SARS-CoV-2 Test (R-squared value = 0.954-0.962).

Conclusions: Both SARS-CoV2 tests of the cobas 6800 and Liat systems produce reliable high throughput and point-of-care assays respectively for the early virus detection and the personal care decision-making during COVID-19 pandemic.

Citing Articles

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A Case Report of Intratesticular Hematoma in a Patient with Reiter's Syndrome.

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Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study.

Lin P, Chiu H, Cheng F, Chang C, Chu F Can J Infect Dis Med Microbiol. 2022; 2022:9447251.

PMID: 36249591 PMC: 9560843. DOI: 10.1155/2022/9447251.

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