학술논문
Clinical comparison of three SARS-CoV-2 nucleic acid amplification tests for routine diagnostic testing.
Document Type
Academic Journal
Author
Garmatiuk T; Department of Laboratory Medicine, Hietzing Hospital, Wolkersbergenstraße 1, 1130, Wien, Austria.; Gränitz-Trisko C; Department of Laboratory Medicine, Hietzing Hospital, Wolkersbergenstraße 1, 1130, Wien, Austria.; Sochor-Geischläger C; Department of Laboratory Medicine, Hietzing Hospital, Wolkersbergenstraße 1, 1130, Wien, Austria.; Polsterer T; Department of Laboratory Medicine, Hietzing Hospital, Wolkersbergenstraße 1, 1130, Wien, Austria.; Caselotto F; Department of Laboratory Medicine, Hietzing Hospital, Wolkersbergenstraße 1, 1130, Wien, Austria.; Willitsch L; Department of Laboratory Medicine, Hietzing Hospital, Wolkersbergenstraße 1, 1130, Wien, Austria.; Reinhardt B; Abbott GmbH, Max-Planck-Ring 2, 65205, Wiesbaden, Germany.; Huf W; Karl Landsteiner Institute for Clinical Risk Management, Wolkersbergenstraße 1, 1130, Wien, Austria.
Source
Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101672560 Publication Model: eCollection Cited Medium: Print ISSN: 2405-8440 (Print) Linking ISSN: 24058440 NLM ISO Abbreviation: Heliyon Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
2405-8440
Abstract
Background: Cycle threshold (Ct) values from SARS-CoV-2 nucleic acid amplification tests have been used to estimate viral load for treatment decisions. Additionally, there is a need for high-throughput testing, consolidating a variety of assays on one random-access analyzer.
Objectives: In this study, the clinical performance of the Alinity m SARS-CoV-2, RealTi m e SARS-CoV-2, and GeneXpert Xpress SARS-CoV-2/Flu/RSV assays was assessed.
Methods: Alinity precision and detection rates were evaluated using a dilution series of the Alinity m SARS-CoV-2 positive control. In a retrospective study, 7 remnant external quality assessment (EQA) specimens and 200 remnant nasopharyngeal swab specimens (100 positive and 100 negative) were tested in the three assays.
Results: Alinity had 100 % detection rate at 50 copies/mL and high reproducibility (Ct value coefficient of variation ≤3.1 %). All three assays correctly detected positive and negative EQA samples with comparable Ct values (max difference 2.38) and high linearity. In patient samples, positive percent agreement was 95 % (95 % CI 89-98 %) and negative percent agreement was 100 % (95 % CI 96-100 %) for Alinity, compared to the other two assays. Four specimens detected on Alinity m but not RealTi m e or Xpert had Ct values above 40. Assay results were highly correlated (r ≥ 0.94). Ct values (after addition of 10 unread cycles to the reported Ct of RealTi m e) were comparable across the three assays.
Conclusions: Alinity m had high precision and accuracy and Ct values comparable to those of the RealTi m e and Xpert assays. The assays could be used interchangeably, with no need for adjustment of patient management decisions based on Ct values from each assay.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Tetiana Garmatiuk reports article publishing charges and writing assistance were provided by Abbott Laboratories.
(© 2023 The Authors. Published by Elsevier Ltd.)
Objectives: In this study, the clinical performance of the Alinity m SARS-CoV-2, RealTi m e SARS-CoV-2, and GeneXpert Xpress SARS-CoV-2/Flu/RSV assays was assessed.
Methods: Alinity precision and detection rates were evaluated using a dilution series of the Alinity m SARS-CoV-2 positive control. In a retrospective study, 7 remnant external quality assessment (EQA) specimens and 200 remnant nasopharyngeal swab specimens (100 positive and 100 negative) were tested in the three assays.
Results: Alinity had 100 % detection rate at 50 copies/mL and high reproducibility (Ct value coefficient of variation ≤3.1 %). All three assays correctly detected positive and negative EQA samples with comparable Ct values (max difference 2.38) and high linearity. In patient samples, positive percent agreement was 95 % (95 % CI 89-98 %) and negative percent agreement was 100 % (95 % CI 96-100 %) for Alinity, compared to the other two assays. Four specimens detected on Alinity m but not RealTi m e or Xpert had Ct values above 40. Assay results were highly correlated (r ≥ 0.94). Ct values (after addition of 10 unread cycles to the reported Ct of RealTi m e) were comparable across the three assays.
Conclusions: Alinity m had high precision and accuracy and Ct values comparable to those of the RealTi m e and Xpert assays. The assays could be used interchangeably, with no need for adjustment of patient management decisions based on Ct values from each assay.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Tetiana Garmatiuk reports article publishing charges and writing assistance were provided by Abbott Laboratories.
(© 2023 The Authors. Published by Elsevier Ltd.)