TY - JOUR
T1 - Analytical performance of lateral flow immunoassay for SARS-CoV-2 exposure screening on venous and capillary blood samples
AU - Black, Margaret A.
AU - Shen, Guomiao
AU - Feng, Xiaojun
AU - Garcia Beltran, Wilfredo F.
AU - Feng, Yang
AU - Vasudevaraja, Varshini
AU - Allison, Douglas
AU - Lin, Lawrence H.
AU - Gindin, Tatyana
AU - Astudillo, Michael
AU - Yang, Diane
AU - Murali, Mandakolathur
AU - Iafrate, A. John
AU - Jour, George
AU - Cotzia, Paolo
AU - Snuderl, Matija
N1 - Publisher Copyright:
© 2020 Elsevier B.V.
PY - 2021/2
Y1 - 2021/2
N2 - Objectives: We validate the use of a lateral flow immunoassay (LFI) intended for rapid screening and qualitative detection of anti-SARS-CoV-2 IgM and IgG in serum, plasma, and whole blood, and compare results with ELISA. We also seek to establish the value of LFI testing on blood obtained from a capillary blood sample. Methods: Samples collected by venous blood draw and finger stick were obtained from patients with SARS-CoV-2 detected by RT-qPCR and control patients. Samples were tested with Biolidics 2019-nCoV IgG/IgM Detection Kit lateral flow immunoassay, and antibody calls were compared with ELISA. Results: Biolidics LFI showed clinical sensitivity of 92% with venous blood at 7 days after PCR diagnosis of SARS-CoV-2. Test specificity was 92% for IgM and 100% for IgG. There was no significant difference in detecting IgM and IgG with Biolidics LFI and ELISA at D0 and D7 (p = 1.00), except for detection of IgM at D7 (p = 0.04). Capillary blood of SARS-CoV-2 patients showed 93% sensitivity for antibody detection. Conclusions: Clinical performance of Biolidics 2019-nCoV IgG/IgM Detection Kit is comparable to ELISA and was consistent across sample types. This provides an opportunity for decentralized rapid testing and may allow point-of-care and longitudinal self-testing for the presence of anti-SARS-CoV-2 antibodies.
AB - Objectives: We validate the use of a lateral flow immunoassay (LFI) intended for rapid screening and qualitative detection of anti-SARS-CoV-2 IgM and IgG in serum, plasma, and whole blood, and compare results with ELISA. We also seek to establish the value of LFI testing on blood obtained from a capillary blood sample. Methods: Samples collected by venous blood draw and finger stick were obtained from patients with SARS-CoV-2 detected by RT-qPCR and control patients. Samples were tested with Biolidics 2019-nCoV IgG/IgM Detection Kit lateral flow immunoassay, and antibody calls were compared with ELISA. Results: Biolidics LFI showed clinical sensitivity of 92% with venous blood at 7 days after PCR diagnosis of SARS-CoV-2. Test specificity was 92% for IgM and 100% for IgG. There was no significant difference in detecting IgM and IgG with Biolidics LFI and ELISA at D0 and D7 (p = 1.00), except for detection of IgM at D7 (p = 0.04). Capillary blood of SARS-CoV-2 patients showed 93% sensitivity for antibody detection. Conclusions: Clinical performance of Biolidics 2019-nCoV IgG/IgM Detection Kit is comparable to ELISA and was consistent across sample types. This provides an opportunity for decentralized rapid testing and may allow point-of-care and longitudinal self-testing for the presence of anti-SARS-CoV-2 antibodies.
KW - COVID-19
KW - Lateral flow immunoassay
KW - SARS-CoV-2
KW - Serology
KW - Validation
UR - http://www.scopus.com/inward/record.url?scp=85098875897&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85098875897&partnerID=8YFLogxK
U2 - 10.1016/j.jim.2020.112909
DO - 10.1016/j.jim.2020.112909
M3 - Article
C2 - 33166549
AN - SCOPUS:85098875897
SN - 0022-1759
VL - 489
JO - Journal of Immunological Methods
JF - Journal of Immunological Methods
M1 - 112909
ER -