Evaluation of GenomEra® SARS-CoV-2 Assay Kit for the Detection of SARS-CoV-2 Viral RNA from Respiratory Samples
Iranto, Irmeli (2021)
2021
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-202105148722
https://urn.fi/URN:NBN:fi:amk-202105148722
Tiivistelmä
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the seventh identified coronavirus that causes disease in humans. SARS-CoV-2 is the causative agent of the coronavirus disease (COVID-19) pandemic.
This thesis deals with the evaluation of the clinical performance of Abacus Diagnostica’s GenomEra® SARS-CoV-2 Assay Kit for the qualitative detection of SARS-CoV-2 viral RNA from respiratory tract samples. The thesis work was carried out in the virology laboratory of Finnish Institute for Health and Welfare’s (THL) Expert Microbiology Unit. The purpose of the clinical evaluation was to obtain data for assessing the conformity of the assay kit for CE-IVD marking. Other study sites also participated in the clinical evaluation. However, those results are not taken into account in this thesis.
The clinical performance of the GenomEra® SARS-CoV-2 assay was evaluated through clinical sensitivity and specificity, inclusivity and cross-reactivity. Also, the reproducibility of the assay was analyzed. The results obtained with the GenomEra® SARS-CoV-2 assay were compared to results obtained with THL’s validated in-house real-time RT-PCR test for SARS-CoV-2 E gene. The sample material consisted of diagnostic upper respiratory tract samples taken from suspected COVID-19 cases, as well as a panel of pathogens known to cause upper respiratory tract infections in humans. The panel included diagnostic upper respiratory tract samples and isolated RNA/DNA samples.
Due to the excellent epidemic situation in Finland in the summer of 2020, the number of COVID-19 samples analyzed fell short of what was planned. However, estimates of the clinical sensitivity and specificity of the assay were optimistic. No difference in the ability of the test to identify temporally and geographically differing SARS-CoV-2 strains was ob-served. Cross-reactivity was also not observed. The reproducibility testing yielded consistent results on all days.
The studies indicated GenomEra® SARS-CoV-2 assay to be a reliable test for the fast qualitative detection of SARS-CoV-2 RNA from upper respiratory tract samples. The assay was CE-IVD marked in July 2020.
This thesis deals with the evaluation of the clinical performance of Abacus Diagnostica’s GenomEra® SARS-CoV-2 Assay Kit for the qualitative detection of SARS-CoV-2 viral RNA from respiratory tract samples. The thesis work was carried out in the virology laboratory of Finnish Institute for Health and Welfare’s (THL) Expert Microbiology Unit. The purpose of the clinical evaluation was to obtain data for assessing the conformity of the assay kit for CE-IVD marking. Other study sites also participated in the clinical evaluation. However, those results are not taken into account in this thesis.
The clinical performance of the GenomEra® SARS-CoV-2 assay was evaluated through clinical sensitivity and specificity, inclusivity and cross-reactivity. Also, the reproducibility of the assay was analyzed. The results obtained with the GenomEra® SARS-CoV-2 assay were compared to results obtained with THL’s validated in-house real-time RT-PCR test for SARS-CoV-2 E gene. The sample material consisted of diagnostic upper respiratory tract samples taken from suspected COVID-19 cases, as well as a panel of pathogens known to cause upper respiratory tract infections in humans. The panel included diagnostic upper respiratory tract samples and isolated RNA/DNA samples.
Due to the excellent epidemic situation in Finland in the summer of 2020, the number of COVID-19 samples analyzed fell short of what was planned. However, estimates of the clinical sensitivity and specificity of the assay were optimistic. No difference in the ability of the test to identify temporally and geographically differing SARS-CoV-2 strains was ob-served. Cross-reactivity was also not observed. The reproducibility testing yielded consistent results on all days.
The studies indicated GenomEra® SARS-CoV-2 assay to be a reliable test for the fast qualitative detection of SARS-CoV-2 RNA from upper respiratory tract samples. The assay was CE-IVD marked in July 2020.