Agreement on Nucleic Acid Manual versus Automated Extraction Methods and Commercial Available Polymerase Chain Reaction (PCR) Assays for SARS-CoV-2
Main Authors: | Su Kelvin Sieng-Bing, Lee Jeffrey Soon-Yit, Yong Sook-Min, Kamilah Binti Dahian, Wong Chew-Ee, Nur Alfreena Binti Alfie, Ting Siew-Ming, Toh Teck-Hock |
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Format: | Proceeding poster Journal |
Bahasa: | eng |
Terbitan: |
, 2021
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Subjects: | |
Online Access: |
https://zenodo.org/record/5461111 |
Daftar Isi:
- Introduction: The availability of multiple PCR assays and extraction methods for SARS-CoV-2 viral ribonucleic acid cause a concern on their agreement. Validation tests have been conducted when new assays or extraction methods are introduced to understand their performance. This study evaluates the agreement of the results between different extraction methods and PCR assays. Methods: We searched the laboratory data in Sibu Hospital Clinical Research Centre Laboratory for any PCR validation results from 1 January to 31 May 2021 using two or more assays or extraction methods. A pooled gold standard was created by defining any samples detected positive using any extraction methods or assays. Wecalculatedtheaccuracyparameters. We compared the cyclic threshold (Ct) value for positivegenesinbothPCRassays. Results: The agreements for samples extracted manually versus automated method and run on Seegene was 0.869; on BioSewoom was 0.899. When extracted manually or using automated, the agreements for two different assays were 0.911 and 1.000, respectively. Cyclic threshold (Ct) using automated extraction was significantly lower in both assays (p<0.001). Compared to the pooled gold standard, both assays performed well using automated extraction, but BioSewoom extracted manually had lower sensitivity (86.67%; 95% CI: 69.28, 96.24) and negative predictive value (96.49%; 95% CI: 91.70, 98.56). Conclusion: The assays and extraction methods were generally in good agreement and accurate, albeit some differences. It is important to understand their performance to guide the interpretation and assist in patients management and pandemic. [Disclaimer: Abstract text might vary slightly from what is displayed in the e-poster]