The results agreement between the CoviQuick v2.0 RTqPCR Kit and AllplexTM 2019-nCoV assay for the detection of SARS-CoV-2 infection
Abstract
The detection of SARS CoV-2 utilizing the AllplexTM 2019-nCoV assay includes RNA extraction steps. A standard RNA extraction is used in the AllplexTM 2019-nCoV assay. The results of the AllplexTM 2019-nCoV assay and the CoviQuick v2.0 RT-qPCR Kit, which use direct specimens in nasopharyngeal and throat swabs, were compared in this study. Seventy-three patient samples were collected, including 28 positive and 45 negative samples. The concordance rate between both tests was 90.4% (66/73) and the inconsistency rate was 9.6% (7/73). The positive correlation was 75.0%, while the negative correlation was 100%. Furthermore, the CoviQuick v2.0 RT-qPCR Kit's correlation in positive samples with cycle threshold (Ct) > 25 was reduced to 68.4%. The CoviQuick v2.0 RT-qPCR Kit showed significantly higher Ct values for the N gene than the AllplexTM 2019-nCoV assay (p = 0.012). These findings imply that the CoviQuick v2.0 RT-qPCR Kit could be used to replace the prior reagent kit in the case of positive samples with Ct < 25 since it is more convenient and reduces turnaround time. If the CoviQuick v2.0 RT-qPCR Kit shows negative results, the procedure must be redone.
Keywords: SARS-CoV-2, COVID-19, real-time RT-PCR, AllplexTM 2019-nCoV assay, CoviQuick v2.0 RT-qPCR Kit
References
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–33.
Merindol N, Pépin G, Marchand C, Rheault M, Peterson C, Poirier A, et al. SARS-CoV-2 detection by direct rRT-PCR without RNA extraction. J Clin Virol. 2020;128:1–4.
Yu L, Wu S, Hao X, Dong X, Mao L, Pelechano V, et al. Rapid Detection of COVID-19 Coronavirus Using a Reverse Transcriptional Loop-Mediated Isothermal Amplification (RT-LAMP) Diagnostic Platform. Clin Chem. 2020;66(7):975–7.
Barza R, Patel P, Sabatini L, Singh K. Use of a simplified sample processing step without RNA extraction for direct SARS-CoV-2 RT-PCR detection. J Clin Virol. 2020;132:1–3.
Tang YW, Schmitz JE, Persing DH, Stratton CW. Laboratory diagnosis of COVID-19: Current issues and challenges. J Clin Microbiol. 2020;58(6):1–9.
Rabi FA, Al Zoubi MS, Al-Nasser AD, Kasasbeh GA, Salameh DM. Sars-cov-2 and coronavirus disease 2019: What we know so far. Pathogens. 2020;9(3):1–14.
Yang HC, Liang YJ, Huang MC, Li LH, Lin CH, Wu JY, et al. A genome-wide study of preferential amplification/hybridization in microarray-based pooled DNA experiments. Nucleic Acids Res. 2006;34(15).
Binny RN, Priest P, French NP, Parry M, Lustig A, Hendy SC, et al. Sensitivity of Reverse Transcription Polymerase Chain Reaction Tests for Severe Acute Respiratory Syndrome Coronavirus 2 through Time. J Infect Dis [Internet]. 2023;227(1):9–17. Available from: https://doi.org/10.1093/infdis/jiac317
He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020;26(5):672–5.
Owusu D, Pomeroy MA, Lewis NM, Wadhwa A, Yousaf AR, Whitaker B, et al. Persistent SARS-CoV-2 RNA Shedding without Evidence of Infectiousness: A Cohort Study of Individuals with COVID-19. J Infect Dis. 2021;224(8):1362–71.
Bergmans BJM, Reusken CBEM, van Oudheusden AJG, Godeke GJ, Bonačić Marinović AA, de Vries E, et al. Test, trace, isolate: evidence for declining SARS-CoV-2 PCR sensitivity in a clinical cohort. Diagn Microbiol Infect Dis. 2021;101(2).
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2023 Sornsith Jirungda, Tunchanok Prachakul, Apisada Kitsanasuwan, Suparat Baisungnuen, Kreangkri Thaitrakull
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Journal of TCI is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence, unless otherwise stated. Please read our Policies page for more information.
