SARS-CoV-2 Variants Genotyping and Diagnostic Performance of a 2-Genes Detection Assay.
In: The journal of applied laboratory medicine, Jg. 9 (2024-03-01), Heft 2, S. 273
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Zugriff:
Background: The emergence of the COVID-19 pandemic resulted in the unprecedented expansion of molecular testing technologies. This study aimed at evaluating the performance of the FluoroType® SARS-CoV-2 plus assay for SARS-CoV-2 detection as well as describing the detection of SARS-CoV-2 variants using the FluoroType® SARS-CoV-2 varID Q kit.
Methods: The study utilized 679 archived nasopharyngeal samples. Analytical performance and the diagnostic performance of the FluoroType® SARS-CoV-2 plus assay were determined using 320 samples and reference material. Variants identification on the FluoroType® SARS-CoV-2 varID Q assay was performed on 359 samples. The study was approved by the Aga Khan University Hospital Institutional Review Board.
Results: The FluoroType® SARS-CoV-2 plus assay's limit of detection was verified as 1.2 copies/µL. The repeatability SD and %CV were 2.45 and 9.8% while reproducibility had an SD and %CV of 1.39 and 5.68%, respectively, for the RdRP gene. The positive and negative percent agreement were determined to be 99.4% (95% CI; 98.1%-100%) and 99.4% (95% CI; 98.2%-100%) respectively. In the variants identification, samples from the original wave had no mutations identified while 12.3%, 49%, and more than 90% of the samples during the Alpha, Delta, and Omicron waves, respectively, had detectable mutations.
Conclusions: The FluoroType® SARS-CoV-2 plus assay demonstrated analytical performance comparable to the reference method with a diagnostic sensitivity and specificity of >99%. The FluoroType® SARS-CoV-2 varID Q assay achieved rapid detection of circulating variants.
(© Association for Diagnostics & Laboratory Medicine 2024. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
Titel: |
SARS-CoV-2 Variants Genotyping and Diagnostic Performance of a 2-Genes Detection Assay.
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Autor/in / Beteiligte Person: | Matheka, C ; Kilonzo, J ; Mbugua, E ; Munshi, Z ; Nyasinga, J ; Gunturu, R ; Njau, A |
Zeitschrift: | The journal of applied laboratory medicine, Jg. 9 (2024-03-01), Heft 2, S. 273 |
Veröffentlichung: | 2020- : Oxford : Oxford University Press ; <i>Original Publication</i>: [Washington, DC] : American Association for Clinical Chemistry, [2016]-[2019], 2024 |
Medientyp: | academicJournal |
ISSN: | 2576-9456 (print) |
DOI: | 10.1093/jalm/jfad127 |
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