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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Twelve lateral flow immunoassays (LFAs) to detect SARS-CoV-2 antibodies
AU - Owen, Sophie I.
AU - Williams, Christopher T.
AU - Garrod, Gala
AU - Fraser, Alice J.
AU - Menzies, Stefanie
AU - Baldwin, Lisa
AU - Brown, Lottie
AU - Byrne, Rachel L.
AU - Collins, Andrea M.
AU - Cubas-Atienzar, Ana I.
AU - de Vos, Margaretha
AU - Edwards, Thomas
AU - Escadafal, Camille
AU - Ferreira, Daniela M.
AU - Fletcher, Tom
AU - Hyder-Wright, Angela
AU - Kay, Grant A.
AU - Kontogianni, Konstantina
AU - Mason, Jenifer
AU - Mitsi, Elena
AU - Planche, Tim
AU - Sacks, Jilian A.
AU - Taylor, Joseph
AU - Todd, Stacy
AU - Tully, Caroline
AU - Cuevas, Luis E.
AU - Adams, Emily R.
PY - 2022/3/31
Y1 - 2022/3/31
N2 - Background: There are an abundance of commercially available lateral flow assays (LFAs) that detect antibodies to SARS-CoV-2. Whilst these are usually evaluated by the manufacturer, externally performed diagnostic accuracy studies to assess performance are essential. Herein we present an evaluation of 12 LFAs. Methods: Sera from 100 SARS-CoV-2 reverse-transcriptase polymerase chain reaction (RT-PCR) positive participants were recruited through the FASTER study. A total of 105 pre-pandemic sera from participants with other infections were included as negative samples. Results: At presentation sensitivity against RT-PCR ranged from 37.4 to 79% for IgM/IgG, 30.3–74% for IgG, and 21.2–67% for IgM. Sensitivity for IgM/IgG improved ≥ 21 days post symptom onset for 10/12 tests. Specificity ranged from 74.3 to 99.1% for IgM/IgG, 82.9–100% for IgG, and 75.2–98% for IgM. Compared to the EuroImmun IgG enzyme-linked immunosorbent assay (ELISA), sensitivity and specificity ranged from 44.6 to 95.4% and 85.4–100%, respectively. Conclusion: There are many LFAs available with varied sensitivity and specificity. Understanding the diagnostic accuracy of these tests will be vital as we come to rely more on the antibody status of a person moving forward, and as such manufacturer-independent evaluations are crucial.
AB - Background: There are an abundance of commercially available lateral flow assays (LFAs) that detect antibodies to SARS-CoV-2. Whilst these are usually evaluated by the manufacturer, externally performed diagnostic accuracy studies to assess performance are essential. Herein we present an evaluation of 12 LFAs. Methods: Sera from 100 SARS-CoV-2 reverse-transcriptase polymerase chain reaction (RT-PCR) positive participants were recruited through the FASTER study. A total of 105 pre-pandemic sera from participants with other infections were included as negative samples. Results: At presentation sensitivity against RT-PCR ranged from 37.4 to 79% for IgM/IgG, 30.3–74% for IgG, and 21.2–67% for IgM. Sensitivity for IgM/IgG improved ≥ 21 days post symptom onset for 10/12 tests. Specificity ranged from 74.3 to 99.1% for IgM/IgG, 82.9–100% for IgG, and 75.2–98% for IgM. Compared to the EuroImmun IgG enzyme-linked immunosorbent assay (ELISA), sensitivity and specificity ranged from 44.6 to 95.4% and 85.4–100%, respectively. Conclusion: There are many LFAs available with varied sensitivity and specificity. Understanding the diagnostic accuracy of these tests will be vital as we come to rely more on the antibody status of a person moving forward, and as such manufacturer-independent evaluations are crucial.
KW - COVID-19
KW - IgG
KW - IgM
KW - Lateral flow immunoassays
KW - SARS-CoV-2
U2 - 10.1016/j.jinf.2021.12.007
DO - 10.1016/j.jinf.2021.12.007
M3 - Journal article
C2 - 34906597
AN - SCOPUS:85121915055
VL - 84
SP - 355
EP - 360
JO - Journal of Infection
JF - Journal of Infection
SN - 0163-4453
IS - 3
ER -