Using Real-Time PCR Fluorescence Reaction Values to Improve SARS-CoV-2 Virus Detection and Benefit Clinical Decision-Making

Wan-Wen Yang; Chin-Wen Hsu; Yu-Ju Chan; Shih-Bin Su; I-Jung Feng; Chia-Yi Hou; Chien-Yuan Huang

doi:10.3390/life13030683

Using Real-Time PCR Fluorescence Reaction Values to Improve SARS-CoV-2 Virus Detection and Benefit Clinical Decision-Making

Life (Basel). 2023 Mar 2;13(3):683. doi: 10.3390/life13030683.

Authors

Wan-Wen Yang¹, Chin-Wen Hsu², Yu-Ju Chan², Shih-Bin Su^{3

4}, I-Jung Feng⁵, Chia-Yi Hou¹, Chien-Yuan Huang^{3

4}

Affiliations

¹ Department of Clinical Pathology, Chi-Mei Medical Center, Liouying, Tainan 736402, Taiwan.
² Department of Family Medicine, Chi-Mei Medical Center, Liouying, Tainan 736402, Taiwan.
³ Division of Occupational Medicine, Chi-Mei Medical Center, Liouying, Tainan 736402, Taiwan.
⁴ Division of Occupational Medicine, Chi-Mei Medical Center, Tainan 710402, Taiwan.
⁵ Institute of Precision Medicine, National Sun Yat-sen University, Kaohsiung 804201, Taiwan.

Abstract

This study aimed to compare the SARS-CoV-2 nucleic acid detection results of the BD MAX™ System and other platforms to formulate an optimized laboratory verification process. The re-examination of 400 samples determined as positive by BD MAX™ indicated that the inconsistency rate between BD MAX™ and the other platforms was 65.8%; the inconsistency rate of single-gene-positive results was as high as 99.2%. A receiver operating characteristic curve was drawn for the relative light unit (RLU) values of samples positive for a single gene, and RLU 800 was used as the cutoff. After setting the retest standard as single-gene positive and RLU ≥ 800, the number of the 260 BD MAX™ single-gene positives that needed to be confirmed again was 36 (13.8%) and the number that could be directly reported as negative was 224 (86.2%). This verification process can shorten the reporting period and speed up the epidemic adjustment time and turnover rate of special wards, thereby improving SARS-CoV-2 detection efficiency and clinical decision-making.

Keywords: SARS-CoV-2; clinical decision-making; relative light unit.

Grants and funding

This study was supported by the Chi-Mei Medical Center, Liouying, Tainan, Taiwan (grant number CLFHR11215). The funders had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript.