tetano
Editor, Senior Moderator
Microorganisms
. 2020 Dec 28;9(1):E58.
doi: 10.3390/microorganisms9010058.
Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
Annabelle Str?mer[SUP] 1 [/SUP], Ruben Rose[SUP] 1 [/SUP], Miriam Sch?fer[SUP] 2 [/SUP], Frieda Sch?n[SUP] 2 [/SUP], Anna Vollersen[SUP] 2 [/SUP], Thomas Lorentz[SUP] 2 [/SUP], Helmut Fickenscher[SUP] 1 [/SUP], Andi Krumbholz[SUP] 1 2 [/SUP]
Affiliations
Abstract
The rapid detection of infections caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is necessary in the ongoing pandemic. Antigen-specific point-of-care tests (POCT) may be useful for this purpose. Here, such a POCT (SARS-CoV-2 NADAL[SUP]?[/SUP] COVID-19 Ag) was compared to a laboratory-developed triplex real-time polymerase chain reaction (RT-PCR) designed for the detection of viral nucleoprotein gene and two control targets. This RT-PCR served as a reference to investigate POCT sensitivity by re-testing upper respiratory tract (URT) samples (n = 124) exhibiting different SARS-CoV-2 loads in terms of RT-PCR threshold cycle (Ct) values. The optical intensities of the antigen bands were compared to the Ct values of the RT-PCR. The infectivity of various virus loads was estimated by inoculating Vero cells with URT samples (n = 64, Ct 17-34). POCT sensitivity varied from 100% (Ct < 25) to 73.1% (Ct ≤ 30); higher SARS-CoV-2 loads correlated with higher band intensities. All samples with a Ct > 30 were negative; among SARS-CoV-2 free samples (n = 10) no false-positives were detected. A head-to-head comparison with another POCT (Abbott, Panbio™ COVID-19 Ag Rapid Test) yielded similar results. Isolation of SARS-CoV-2 in cell-culture was successful up to a Ct value of 29. The POCT reliably detects high SARS-CoV-2 loads and rapidly identifies infectious individuals.
Keywords: COVID-19; PCR; POCT; antigen; comparison; diagnostic.
. 2020 Dec 28;9(1):E58.
doi: 10.3390/microorganisms9010058.
Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
Annabelle Str?mer[SUP] 1 [/SUP], Ruben Rose[SUP] 1 [/SUP], Miriam Sch?fer[SUP] 2 [/SUP], Frieda Sch?n[SUP] 2 [/SUP], Anna Vollersen[SUP] 2 [/SUP], Thomas Lorentz[SUP] 2 [/SUP], Helmut Fickenscher[SUP] 1 [/SUP], Andi Krumbholz[SUP] 1 2 [/SUP]
Affiliations
- PMID: 33379279
- DOI: 10.3390/microorganisms9010058
Abstract
The rapid detection of infections caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is necessary in the ongoing pandemic. Antigen-specific point-of-care tests (POCT) may be useful for this purpose. Here, such a POCT (SARS-CoV-2 NADAL[SUP]?[/SUP] COVID-19 Ag) was compared to a laboratory-developed triplex real-time polymerase chain reaction (RT-PCR) designed for the detection of viral nucleoprotein gene and two control targets. This RT-PCR served as a reference to investigate POCT sensitivity by re-testing upper respiratory tract (URT) samples (n = 124) exhibiting different SARS-CoV-2 loads in terms of RT-PCR threshold cycle (Ct) values. The optical intensities of the antigen bands were compared to the Ct values of the RT-PCR. The infectivity of various virus loads was estimated by inoculating Vero cells with URT samples (n = 64, Ct 17-34). POCT sensitivity varied from 100% (Ct < 25) to 73.1% (Ct ≤ 30); higher SARS-CoV-2 loads correlated with higher band intensities. All samples with a Ct > 30 were negative; among SARS-CoV-2 free samples (n = 10) no false-positives were detected. A head-to-head comparison with another POCT (Abbott, Panbio™ COVID-19 Ag Rapid Test) yielded similar results. Isolation of SARS-CoV-2 in cell-culture was successful up to a Ct value of 29. The POCT reliably detects high SARS-CoV-2 loads and rapidly identifies infectious individuals.
Keywords: COVID-19; PCR; POCT; antigen; comparison; diagnostic.