tetano
Editor, Senior Moderator
J Clin Virol
. 2020 Sep 7;132:104632.
doi: 10.1016/j.jcv.2020.104632. Online ahead of print.
Comparison of the GeneFinder [SUP]TM[/SUP] COVID-19 Plus RealAmp Kit on the sample-to-result Platform ELITe InGenius to the national reference method: An added value of N gene target detection?
David S Y Ong[SUP] 1 [/SUP], Eric C J Claas[SUP] 2 [/SUP], Simone Breijer[SUP] 3 [/SUP], Norbert Vaessen[SUP] 3 [/SUP]
Affiliations
Abstract
Background: Due to the emergence of the coronavirus disease 2019 (COVID-19) pandemic there is an urgent need for rapid and accurate testing on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Objectives: The aim of this study was to assess the diagnostic performance of the GeneFinder[SUP]TM[/SUP]COVID-19 Plus RealAmp Kit on the ELITe InGenius sample-to-result platform, which is a commercial nucleic acid amplification test (NAT) targeting genes of SARS-CoV-2.
Study design: Patients were eligible between March 18 and May 27, 2020, when they had respiratory symptoms that were suspected for COVID-19. The InGenius platform was compared to routine in-house NAT that was validated according to the national reference.
Results: Of 128 randomly selected patients, 58 (45 %) tested positive and 55 (43 %) tested negative in both platforms. Sensitivity of the InGenius platform was 100 % (95 % confidence interval 94-100). In the remaining 15 (12 %) cases E and RdRp genes were not detected in both platforms but the nucleoprotein (N) gene was tested positive by the InGenius platform. All solitary N gene positive cases were confirmed by a N-gene specific in-house validated NAT, and most of these patients could also be considered positive based on other recently available COVID-19 positive respiratory samples or highly suspected radiological findings.
Conclusion: The InGenius platform for SARS-CoV-2 detection has excellent sensitivity, is easy to use and provides fast results. The inclusion of the N gene as a third gene target may further increase sensitivity for the diagnosis of COVID-19 in comparison to the national reference method.
Keywords: COVID-19; Diagnostics; Molecular; NAT; PCR; SARS-CoV-2.
. 2020 Sep 7;132:104632.
doi: 10.1016/j.jcv.2020.104632. Online ahead of print.
Comparison of the GeneFinder [SUP]TM[/SUP] COVID-19 Plus RealAmp Kit on the sample-to-result Platform ELITe InGenius to the national reference method: An added value of N gene target detection?
David S Y Ong[SUP] 1 [/SUP], Eric C J Claas[SUP] 2 [/SUP], Simone Breijer[SUP] 3 [/SUP], Norbert Vaessen[SUP] 3 [/SUP]
Affiliations
- PMID: 32932152
- DOI: 10.1016/j.jcv.2020.104632
Abstract
Background: Due to the emergence of the coronavirus disease 2019 (COVID-19) pandemic there is an urgent need for rapid and accurate testing on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Objectives: The aim of this study was to assess the diagnostic performance of the GeneFinder[SUP]TM[/SUP]COVID-19 Plus RealAmp Kit on the ELITe InGenius sample-to-result platform, which is a commercial nucleic acid amplification test (NAT) targeting genes of SARS-CoV-2.
Study design: Patients were eligible between March 18 and May 27, 2020, when they had respiratory symptoms that were suspected for COVID-19. The InGenius platform was compared to routine in-house NAT that was validated according to the national reference.
Results: Of 128 randomly selected patients, 58 (45 %) tested positive and 55 (43 %) tested negative in both platforms. Sensitivity of the InGenius platform was 100 % (95 % confidence interval 94-100). In the remaining 15 (12 %) cases E and RdRp genes were not detected in both platforms but the nucleoprotein (N) gene was tested positive by the InGenius platform. All solitary N gene positive cases were confirmed by a N-gene specific in-house validated NAT, and most of these patients could also be considered positive based on other recently available COVID-19 positive respiratory samples or highly suspected radiological findings.
Conclusion: The InGenius platform for SARS-CoV-2 detection has excellent sensitivity, is easy to use and provides fast results. The inclusion of the N gene as a third gene target may further increase sensitivity for the diagnosis of COVID-19 in comparison to the national reference method.
Keywords: COVID-19; Diagnostics; Molecular; NAT; PCR; SARS-CoV-2.