Dataset Information

Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza A/B Assay in Nasal Samples.

ABSTRACT:

Background and objective

Point-of-care type molecular diagnostic tests have been used for detecting SARS-CoV-2, although their clinical utility with nasal samples has yet to be established. This study evaluated the clinical performance of the cobas Liat SARS-CoV-2 & Influenza A/B (Liat) assay in nasal samples.

Methods

Nasal and nasopharyngeal samples were collected and were tested using the Liat, the cobas 6800 system and the cobas SARS-CoV-2 & Influenza A/B (cobas), and a method developed by National Institute of Infectious Diseases, Japan (NIID).

Results

A total of 814 nasal samples were collected. The Liat assay was positive for SARS-CoV-2 in 113 (13.9%). The total, positive, and negative concordance rate between the Liat and cobas/NIID assays were 99.3%/98.4%, 99.1%/100%, and 99.3%/98.2%, respectively. Five samples were positive only using the Liat assay. Their Ct values ranged from 31.9 to 37.2. The Ct values of the Liat assay were significantly lower (p < 0.001) but were correlated (p < 0.001) with those of other molecular assays. In the participants who tested positive for SARS-CoV-2 on the Liat assay using nasopharyngeal samples, 88.2% of their nasal samples also tested positive using the Liat assay.

Conclusion

The Liat assay showed high concordance with other molecular assays in nasal samples. Some discordance occurred in samples with Ct values > 30 on the Liat assay.

SUBMITTER: Akashi Y

PROVIDER: S-EPMC8989107 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza A/B Assay in Nasal Samples.

Akashi Yusaku Y Horie Michiko M Kiyotaki Junichi J Takeuchi Yuto Y Togashi Kenichi K Adachi Yuki Y Ueda Atsuo A Notake Shigeyuki S Nakamura Koji K Terada Norihiko N Kurihara Yoko Y Kiyasu Yoshihiko Y Suzuki Hiromichi H

Molecular diagnosis & therapy 20220407 3

<h4>Background and objective</h4>Point-of-care type molecular diagnostic tests have been used for detecting SARS-CoV-2, although their clinical utility with nasal samples has yet to be established. This study evaluated the clinical performance of the cobas Liat SARS-CoV-2 & Influenza A/B (Liat) assay in nasal samples.<h4>Methods</h4>Nasal and nasopharyngeal samples were collected and were tested using the Liat, the cobas 6800 system and the cobas SARS-CoV-2 & Influenza A/B (cobas), and a method ...[more]

PMID: 35391608

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Project description:ObjectiveTo present the technical verification and clinical validation of the companion diagnostic assay, cobas® EZH2 Mutation Test (cobas EZH2 Test), targeting gain-of-function EZH2 mutations in follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). The focus is on patient clinical samples proving that the test met the performance criteria required for FDA approval of a companion diagnostic test.DesignEpizyme, Inc., Eisai Co., Ltd., and Roche Molecular Systems, Inc., collaborated to develop the cobas EZH2 Test on an RT-PCR platform. The assay design needed to detect the gain-of-function EZH2 mutations found in FL and DLBCL indications. Thus, the test was optimized for investigational purposes in a clinical trial setting. Part of its technical verification included testing of patient tumor samples with a documented diagnosis of FL and DLBCL procured from commercial vendors, and the clinical validation used patient samples from the Epizyme clinical study. Both the technical performance verification method correlation study (104 clinical commercially acquired samples) and the clinical validation accuracy study (341 patient samples from the therapeutic study) used next-generation sequencing as a reference method to establish true vs. false results by cobas EZH2 Test. The reproducibility study used a 15-member panel of DNA samples with varying EZH2 mutation status from procured clinical FL and DLBCL patient samples under multiple variables.ResultsSingle and rare, infrequent double EZH2 mutations were detected in FL and DLBCL samples. Agreements between results from cobas EZH2 and sequencing were >98% from commercial clinical samples and from the therapeutic study clinical samples. The reproducibility study obtained 178 to 180 valid results for each panel member, with an overall invalid rate of 0.37%. The agreement for each per panel member was 100%.Conclusioncobas EZH2 Test data demonstrated that the test is reliable and will perform well in a commercial customer environment.

Dataset Information

Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza A/B Assay in Nasal Samples.

Background and objective

Methods

Results

Conclusion

Publications

Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza A/B Assay in Nasal Samples.

Similar Datasets

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