SARS-CoV-2 Variants Genotyping and Diagnostic Performance of a 2-Genes Detection Assay.

Matheka, C ; Kilonzo, J ; et al.

In: The journal of applied laboratory medicine, Jg. 9 (2024-03-01), Heft 2, S. 273

academicJournal

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.

Titel:	SARS-CoV-2 Variants Genotyping and Diagnostic Performance of a 2-Genes Detection Assay.
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
Schlagwort:	Humans Genotype Pandemics Reproducibility of Results COVID-19 Testing SARS-CoV-2 genetics COVID-19 diagnosis
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Research Support, Non-U.S. Gov't Language: English [J Appl Lab Med] 2024 Mar 01; Vol. 9 (2), pp. 273-283. MeSH Terms: SARS-CoV-2* / genetics ; COVID-19* / diagnosis ; Humans ; Genotype ; Pandemics ; Reproducibility of Results ; COVID-19 Testing SCR Organism: SARS-CoV-2 variants Entry Date(s): Date Created: 20240206 Date Completed: 20240304 Latest Revision: 20240502 Update Code: 20240502

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