tetano
Editor, Senior Moderator
Clin Chem Lab Med
. 2023 Mar 22.
doi: 10.1515/cclm-2023-0087. Online ahead of print.
Efficiency evaluation of a SARS-CoV-2 diagnostic strategy combining high throughput quantitative antigen immunoassay and real time PCR
Luca Bernasconi[SUP] 1 [/SUP], Peter Neyer[SUP] 1 [/SUP], Michael Oberle[SUP] 1 [/SUP], Bettina Schmid[SUP] 1 [/SUP], Eileen Martin[SUP] 2 [/SUP], Hans Fankhauser[SUP] 1 [/SUP], Sebastian Haubitz[SUP] 2 [/SUP], Angelika Hammerer-Lercher[SUP] 1 [/SUP]
Affiliations
Abstract
Objectives: Laboratory testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has played an important role in the effort to prevent and contain local outbreaks. The aim of this study was to assess the diagnostic accuracy of a new fully automated SARS-CoV-2 laboratory-based antigen assay (CoV2Ag) and to explore the efficiency of a diagnostic algorithm combining antigen and conventional high-throughput molecular assays to address potential future challenges of the SARS-CoV-2 pandemic.
Methods: One thousand two hundred and twenty four consecutive nasopharyngeal swabs were tested using RT-PCR and CoV2Ag assay.
Results: The overall sensitivity and specificity of CoV2Ag were 79.1 and 97.8%, respectively. When the analysis was restricted to cases with Ct values ≤30, the sensitivity of the assay improved to 98.1%. Acceptable sensitivity was found when the analysis was limited to patients presenting within one or two to four days of symptom onset (80.5 and 84.8%, respectively). A retrospective analysis of the use of a two-step diagnostic approach combining the CoV2Ag assay and RT-PCR during an acute pandemic phase of 97 days showed a potential reduction in the number of RT-PCR tests by 36.1%, corresponding to savings in reagent costs and technician workload of approximately €8,000 and 10.5 h per day, respectively.
Conclusions: Our data show that the proposed algorithm represents a valid alternative diagnostic approach to increase testing efficiency during future pandemic phases with high positivity rates (>20%) and elevated numbers of RT-PCR test requests.
Keywords: COVID-19; RT-PCR; SARS-CoV-2; antigen; immunoassay; molecular.
. 2023 Mar 22.
doi: 10.1515/cclm-2023-0087. Online ahead of print.
Efficiency evaluation of a SARS-CoV-2 diagnostic strategy combining high throughput quantitative antigen immunoassay and real time PCR
Luca Bernasconi[SUP] 1 [/SUP], Peter Neyer[SUP] 1 [/SUP], Michael Oberle[SUP] 1 [/SUP], Bettina Schmid[SUP] 1 [/SUP], Eileen Martin[SUP] 2 [/SUP], Hans Fankhauser[SUP] 1 [/SUP], Sebastian Haubitz[SUP] 2 [/SUP], Angelika Hammerer-Lercher[SUP] 1 [/SUP]
Affiliations
- PMID: 36947812
- DOI: 10.1515/cclm-2023-0087
Abstract
Objectives: Laboratory testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has played an important role in the effort to prevent and contain local outbreaks. The aim of this study was to assess the diagnostic accuracy of a new fully automated SARS-CoV-2 laboratory-based antigen assay (CoV2Ag) and to explore the efficiency of a diagnostic algorithm combining antigen and conventional high-throughput molecular assays to address potential future challenges of the SARS-CoV-2 pandemic.
Methods: One thousand two hundred and twenty four consecutive nasopharyngeal swabs were tested using RT-PCR and CoV2Ag assay.
Results: The overall sensitivity and specificity of CoV2Ag were 79.1 and 97.8%, respectively. When the analysis was restricted to cases with Ct values ≤30, the sensitivity of the assay improved to 98.1%. Acceptable sensitivity was found when the analysis was limited to patients presenting within one or two to four days of symptom onset (80.5 and 84.8%, respectively). A retrospective analysis of the use of a two-step diagnostic approach combining the CoV2Ag assay and RT-PCR during an acute pandemic phase of 97 days showed a potential reduction in the number of RT-PCR tests by 36.1%, corresponding to savings in reagent costs and technician workload of approximately €8,000 and 10.5 h per day, respectively.
Conclusions: Our data show that the proposed algorithm represents a valid alternative diagnostic approach to increase testing efficiency during future pandemic phases with high positivity rates (>20%) and elevated numbers of RT-PCR test requests.
Keywords: COVID-19; RT-PCR; SARS-CoV-2; antigen; immunoassay; molecular.