Clinical usefulness of fully automated chemiluminescent immunoassay for quantitative antibody measurements in COVID-19 patients
© 2020 Wiley Periodicals LLC..
Since December 2019, we have been in the battlefield with a new threat to the humanity, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), characterized by viral pneumonia. It may be asymptomatic or cause various symptoms, ranging from flu-like symptoms to acute respiratory distress syndrome and eventually death. At present, the only reliable test for COVID-19 diagnosis is quantitative reverse transcriptase-polymerase chain reaction. Assessing the immune response against SARS-CoV-2 could increase the detection sensitivity of infected population. Hereby, we report the performances of a fully automated chemiluminescent immunoassay (CLIA) on 276 serum samples. One hundred samples obtained from COVID-19 negative subjects (COVID-19 free) were analyzed to evaluate the diagnostic specificity of antibody (Ab) detection. Thereafter, 176 samples obtained from 125 patients with confirmed COVID-19 (COVID-19 patients) were selected to assess the diagnostic sensitivity of the CLIA. All samples were analyzed on MAGLUMI 800 platform. All COVID-19 free samples had Ab levels below the cutoff values. Hence, the diagnostic specificity was estimated at 100% (95% confidence interval [CI] = 96.3-100.0; positive predictive value = 100%). By the 18th day from the onset of symptoms, we reached an optimal diagnostic sensitivity (more than 95.0%) In fact, the diagnostic sensitivity increased over time and between 15 and 25 days after symptoms onset, reached 95.5% (95% CI = 84.9-99.2). The new automated CLIA analyzer appeared to be a robust and reliable method to measure specific Ab against COVID-19 at high throughput. Our data suggest that combining Ab and nucleic acid detection could increase diagnostic sensitivity.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:93 |
|---|---|
| Enthalten in: |
Journal of medical virology - 93(2021), 3 vom: 14. März, Seite 1465-1477 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Soleimani, Reza [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antibodies, Viral |
|---|
| Anmerkungen: |
Date Completed 10.03.2021 Date Revised 16.07.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1002/jmv.26430 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM313722706 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM313722706 | ||
| 003 | DE-627 | ||
| 005 | 20231225151200.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1002/jmv.26430 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1045.xml |
| 035 | |a (DE-627)NLM313722706 | ||
| 035 | |a (NLM)32797641 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Soleimani, Reza |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinical usefulness of fully automated chemiluminescent immunoassay for quantitative antibody measurements in COVID-19 patients |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 10.03.2021 | ||
| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 Wiley Periodicals LLC. | ||
| 520 | |a Since December 2019, we have been in the battlefield with a new threat to the humanity, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), characterized by viral pneumonia. It may be asymptomatic or cause various symptoms, ranging from flu-like symptoms to acute respiratory distress syndrome and eventually death. At present, the only reliable test for COVID-19 diagnosis is quantitative reverse transcriptase-polymerase chain reaction. Assessing the immune response against SARS-CoV-2 could increase the detection sensitivity of infected population. Hereby, we report the performances of a fully automated chemiluminescent immunoassay (CLIA) on 276 serum samples. One hundred samples obtained from COVID-19 negative subjects (COVID-19 free) were analyzed to evaluate the diagnostic specificity of antibody (Ab) detection. Thereafter, 176 samples obtained from 125 patients with confirmed COVID-19 (COVID-19 patients) were selected to assess the diagnostic sensitivity of the CLIA. All samples were analyzed on MAGLUMI 800 platform. All COVID-19 free samples had Ab levels below the cutoff values. Hence, the diagnostic specificity was estimated at 100% (95% confidence interval [CI] = 96.3-100.0; positive predictive value = 100%). By the 18th day from the onset of symptoms, we reached an optimal diagnostic sensitivity (more than 95.0%) In fact, the diagnostic sensitivity increased over time and between 15 and 25 days after symptoms onset, reached 95.5% (95% CI = 84.9-99.2). The new automated CLIA analyzer appeared to be a robust and reliable method to measure specific Ab against COVID-19 at high throughput. Our data suggest that combining Ab and nucleic acid detection could increase diagnostic sensitivity | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Euroimmun | |
| 650 | 4 | |a MAGLUMI | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a immunoassay | |
| 650 | 4 | |a serology | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Immunoglobulin G |2 NLM | |
| 650 | 7 | |a Immunoglobulin M |2 NLM | |
| 700 | 1 | |a Khourssaji, Mehdi |e verfasserin |4 aut | |
| 700 | 1 | |a Gruson, Damien |e verfasserin |4 aut | |
| 700 | 1 | |a Rodriguez-Villalobos, Hector |e verfasserin |4 aut | |
| 700 | 1 | |a Berghmans, Mathilde |e verfasserin |4 aut | |
| 700 | 1 | |a Belkhir, Leila |e verfasserin |4 aut | |
| 700 | 1 | |a Yombi, Jean-Cyr |e verfasserin |4 aut | |
| 700 | 1 | |a Kabamba-Mukadi, Benoît |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of medical virology |d 1990 |g 93(2021), 3 vom: 14. März, Seite 1465-1477 |w (DE-627)NLM000285676 |x 1096-9071 |7 nnns |
| 773 | 1 | 8 | |g volume:93 |g year:2021 |g number:3 |g day:14 |g month:03 |g pages:1465-1477 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1002/jmv.26430 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 93 |j 2021 |e 3 |b 14 |c 03 |h 1465-1477 | ||