Clinical Evaluation of Direct Reverse Transcription PCR for Detection of SARS-CoV-2 Compared to Conventional RT-PCR in Patients with Positive Rapid Antigen Test Results during Circulation of Emerging Viral Variants
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Clinical Specimens
2.2. RT-PCR Testing for SARS-CoV-2 Detection
2.3. Direct RT-PCR Assay
2.4. RT-PCR Detection of SARS-CoV-2 VOC
2.5. Point-of-Care Nucleic Acid Testing for SARS-CoV-2
2.6. Statistical Analyses
3. Results
3.1. Confirmation of At-Home RAT Positive Results with RT-PCR Test Results
3.2. Variant of Concern Real-Time RT-PCR Typing
3.3. Clinical Performance of Direct RT-PCR Assay
3.4. Establishing a Flowchart for Diagnosis of RAT-Positive Patients
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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All Patients (n = 5652) | ||
---|---|---|
RT-PCR result | ||
Negative, no, (%) | 362 (6.4%) | |
Positive, no, (%) | 5290 (93.6%) | |
All positive patients (n = 5290) | Ct Value, Mean (SD) | |
Variant | ||
Omicron BA.2.3, no, (%) | 5290 (100%) | 16.78 ± 4.30 |
Sex | ||
Male, no, (%) | 2367 (44.7%) | 16.72 ± 4.09 |
Female, no, (%) | 129 (55.3%) | 16.84 ± 4.46 |
Age, median (SD), y | 66 ± 17.6 | |
<12, no, (%) | 301 (5.7%) | 17.64 ± 3.61 |
12–17, no, (%) | 44 (0.8%) | 17.75 ± 4.51 |
18–49, no, (%) | 3142 (59.4%) | 17.03 ± 4.41 |
50–70, no, (%) | 1544 (29.2%) | 16.23 ± 4.11 |
>70, no, (%) | 259 (4.9%) | 15.96 ± 4.19 |
Ct Value | Conventional RT-PCR (n = 5652) | Direct RT-PCR (n = 5652) | p Value |
---|---|---|---|
<11, no, (%) | 68 (1.2%) | 59 (1.1%) | 0.4462 |
11–20, no, (%) | 4277 (75.7%) | 4247 (75.1%) | |
21–30, no, (%) | 853 (15.1%) | 858 (15.2%) | |
>30, no, (%) | 92 (1.6%) | 19 (0.3%) | |
Negative, no, (%) | 362 (6.4%) | 469 (8.3%) |
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Jian, M.-J.; Chen, C.-S.; Chung, H.-Y.; Chang, C.-K.; Perng, C.-L.; Shang, H.-S. Clinical Evaluation of Direct Reverse Transcription PCR for Detection of SARS-CoV-2 Compared to Conventional RT-PCR in Patients with Positive Rapid Antigen Test Results during Circulation of Emerging Viral Variants. Diagnostics 2023, 13, 3668. https://doi.org/10.3390/diagnostics13243668
Jian M-J, Chen C-S, Chung H-Y, Chang C-K, Perng C-L, Shang H-S. Clinical Evaluation of Direct Reverse Transcription PCR for Detection of SARS-CoV-2 Compared to Conventional RT-PCR in Patients with Positive Rapid Antigen Test Results during Circulation of Emerging Viral Variants. Diagnostics. 2023; 13(24):3668. https://doi.org/10.3390/diagnostics13243668
Chicago/Turabian StyleJian, Ming-Jr, Chi-Sheng Chen, Hsing-Yi Chung, Chih-Kai Chang, Cherng-Lih Perng, and Hung-Sheng Shang. 2023. "Clinical Evaluation of Direct Reverse Transcription PCR for Detection of SARS-CoV-2 Compared to Conventional RT-PCR in Patients with Positive Rapid Antigen Test Results during Circulation of Emerging Viral Variants" Diagnostics 13, no. 24: 3668. https://doi.org/10.3390/diagnostics13243668