tetano
Editor, Senior Moderator
J Clin Virol
. 2021 Apr 1;139:104818.
doi: 10.1016/j.jcv.2021.104818. Online ahead of print.
Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay
Mamdouh Sibai[SUP] 1 [/SUP], Daniel Solis[SUP] 1 [/SUP], Katharina R?ltgen[SUP] 1 [/SUP], Bryan A Stevens[SUP] 2 [/SUP], Kenji O Mfuh[SUP] 3 [/SUP], Malaya K Sahoo[SUP] 1 [/SUP], Run Z Shi[SUP] 1 [/SUP], James Zehnder[SUP] 1 [/SUP], Scott D Boyd[SUP] 4 [/SUP], Benjamin A Pinsky[SUP] 5 [/SUP]
Affiliations
Abstract
Background: The coronavirus disease 2019 (COVID-19) endgame may benefit from simple, accurate antibody testing to characterize seroprevalence and immunization coverage.
Objectives: To evaluate the performance of the lateral flow QIAreach anti-SARS-CoV-2 Total rapid nanoparticle fluorescence immunoassay compared to reference isotype-specific IgG, IgM, and IgA SARS-CoV-2 ELISA using S1 or receptor binding domain (RBD) as antigens.
Study design: A diagnostic comparison study was carried out using 154 well-characterized heparin plasma samples. Agreement between assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient.
Results: Overall agreement between the QIAreach anti-SARS-CoV-2 Total and any anti-spike domain (S1 or RBD) antibody isotype was 96.0 % (95 % CI 89.8-98.8), the positive percent agreement was 97.6 % (95 % CI 91.0-99.9), the negative percent agreement was 88.2 % (95 % CI 64.4-98.0). The kappa coefficient was 0.86 (95 % CI 0.72 to 0.99).
Conclusion: The QIAreach anti-SARS-CoV-2 Total rapid antibody test provides comparable performance to high-complexity, laboratory-based ELISA.
Keywords: Rapid lateral flow immunoassay; SARS-CoV-2; Serology.
. 2021 Apr 1;139:104818.
doi: 10.1016/j.jcv.2021.104818. Online ahead of print.
Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay
Mamdouh Sibai[SUP] 1 [/SUP], Daniel Solis[SUP] 1 [/SUP], Katharina R?ltgen[SUP] 1 [/SUP], Bryan A Stevens[SUP] 2 [/SUP], Kenji O Mfuh[SUP] 3 [/SUP], Malaya K Sahoo[SUP] 1 [/SUP], Run Z Shi[SUP] 1 [/SUP], James Zehnder[SUP] 1 [/SUP], Scott D Boyd[SUP] 4 [/SUP], Benjamin A Pinsky[SUP] 5 [/SUP]
Affiliations
- PMID: 33932848
- DOI: 10.1016/j.jcv.2021.104818
Abstract
Background: The coronavirus disease 2019 (COVID-19) endgame may benefit from simple, accurate antibody testing to characterize seroprevalence and immunization coverage.
Objectives: To evaluate the performance of the lateral flow QIAreach anti-SARS-CoV-2 Total rapid nanoparticle fluorescence immunoassay compared to reference isotype-specific IgG, IgM, and IgA SARS-CoV-2 ELISA using S1 or receptor binding domain (RBD) as antigens.
Study design: A diagnostic comparison study was carried out using 154 well-characterized heparin plasma samples. Agreement between assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient.
Results: Overall agreement between the QIAreach anti-SARS-CoV-2 Total and any anti-spike domain (S1 or RBD) antibody isotype was 96.0 % (95 % CI 89.8-98.8), the positive percent agreement was 97.6 % (95 % CI 91.0-99.9), the negative percent agreement was 88.2 % (95 % CI 64.4-98.0). The kappa coefficient was 0.86 (95 % CI 0.72 to 0.99).
Conclusion: The QIAreach anti-SARS-CoV-2 Total rapid antibody test provides comparable performance to high-complexity, laboratory-based ELISA.
Keywords: Rapid lateral flow immunoassay; SARS-CoV-2; Serology.