tetano
Editor, Senior Moderator
Sci Rep
. 2021 Sep 23;11(1):18984.
doi: 10.1038/s41598-021-98296-y.
Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
Rebeca Santano[SUP] 1 [/SUP], Diana Barrios[SUP] 2 [/SUP], Fàtima Crispi[SUP] 3 [/SUP], Francesca Crovetto[SUP] 3 [/SUP], Marta Vidal[SUP] 2 [/SUP], Jordi Chi[SUP] 2 [/SUP], Luis Izquierdo[SUP] 2 [/SUP], Eduard Gratacós[SUP] 3 [/SUP], Gemma Moncunill[SUP] 2 [/SUP], Carlota Dobaño[SUP] 4 [/SUP]
Affiliations
Abstract
Serological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.
. 2021 Sep 23;11(1):18984.
doi: 10.1038/s41598-021-98296-y.
Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
Rebeca Santano[SUP] 1 [/SUP], Diana Barrios[SUP] 2 [/SUP], Fàtima Crispi[SUP] 3 [/SUP], Francesca Crovetto[SUP] 3 [/SUP], Marta Vidal[SUP] 2 [/SUP], Jordi Chi[SUP] 2 [/SUP], Luis Izquierdo[SUP] 2 [/SUP], Eduard Gratacós[SUP] 3 [/SUP], Gemma Moncunill[SUP] 2 [/SUP], Carlota Dobaño[SUP] 4 [/SUP]
Affiliations
- PMID: 34556736
- DOI: 10.1038/s41598-021-98296-y
Abstract
Serological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.