Validation of a multiplex flow immunoassay for detection of IgG antibodies against SARS-CoV-2 in dried blood spots
BACKGROUND: Dried blood spots (DBS) are an established specimen type for clinical testing given their low cost, ease of collection and storage, and convenient shipping capabilities through the postal system. These attributes are complementary to the expansion of SARS-CoV-2 serologic testing, which may be used to inform community seroprevalence rates.
METHODS: The Luminex xMAP SARS-CoV-2 Multi-Antigen assay utilizes magnetic beads labeled with three viral antigens (nucleocapsid [NC], receptor binding domain [RBD], spike S1 subunit) to detect anti-viral IgG-class antibodies, and has Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in serum and plasma. This assay was modified for use with DBS and validated against paired sera tested by one of two reference assays: the Roche Diagnostics Elecsys anti-SARS-CoV-2 ECLIA or the Euroimmun anti-SARS-CoV-2 IgG ELISA.
RESULTS: 159 paired DBS and serum specimens analyzed using the modified Luminex xMAP assay on DBS and the reference methods on serum showed an overall concordance of 96.9% (154/159). Use of multivariate pattern recognition software (CLIR) for post-analytical interpretation of the Luminex xMAP DBS assay results, instead of manufacturer provided interpretive thresholds, increased overall qualitative result concordance to 99.4% (158/159) between the modified Luminex xMAP DBS and reference results.
CONCLUSIONS: Use of DBS for detection of antibodies against SARS-CoV-2 provides comparable results to those obtained using serum. DBS concordance was improved with multivariate pattern recognition software (CLIR). We demonstrate that DBS are a reliable specimen type for SARS-CoV-2 antibody detection using the modified Luminex xMAP assay.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
|---|---|
| Enthalten in: |
PloS one - 16(2021), 5 vom: 01., Seite e0252621 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Turgeon, Coleman T [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antibodies, Viral |
|---|
| Anmerkungen: |
Date Completed 07.06.2021 Date Revised 02.04.2024 published: Electronic-eCollection Citation Status MEDLINE |
|---|
| doi: |
10.1371/journal.pone.0252621 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM325972222 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM325972222 | ||
| 003 | DE-627 | ||
| 005 | 20240402233224.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1371/journal.pone.0252621 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1360.xml |
| 035 | |a (DE-627)NLM325972222 | ||
| 035 | |a (NLM)34048503 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Turgeon, Coleman T |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Validation of a multiplex flow immunoassay for detection of IgG antibodies against SARS-CoV-2 in dried blood spots |
| 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 07.06.2021 | ||
| 500 | |a Date Revised 02.04.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Dried blood spots (DBS) are an established specimen type for clinical testing given their low cost, ease of collection and storage, and convenient shipping capabilities through the postal system. These attributes are complementary to the expansion of SARS-CoV-2 serologic testing, which may be used to inform community seroprevalence rates | ||
| 520 | |a METHODS: The Luminex xMAP SARS-CoV-2 Multi-Antigen assay utilizes magnetic beads labeled with three viral antigens (nucleocapsid [NC], receptor binding domain [RBD], spike S1 subunit) to detect anti-viral IgG-class antibodies, and has Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in serum and plasma. This assay was modified for use with DBS and validated against paired sera tested by one of two reference assays: the Roche Diagnostics Elecsys anti-SARS-CoV-2 ECLIA or the Euroimmun anti-SARS-CoV-2 IgG ELISA | ||
| 520 | |a RESULTS: 159 paired DBS and serum specimens analyzed using the modified Luminex xMAP assay on DBS and the reference methods on serum showed an overall concordance of 96.9% (154/159). Use of multivariate pattern recognition software (CLIR) for post-analytical interpretation of the Luminex xMAP DBS assay results, instead of manufacturer provided interpretive thresholds, increased overall qualitative result concordance to 99.4% (158/159) between the modified Luminex xMAP DBS and reference results | ||
| 520 | |a CONCLUSIONS: Use of DBS for detection of antibodies against SARS-CoV-2 provides comparable results to those obtained using serum. DBS concordance was improved with multivariate pattern recognition software (CLIR). We demonstrate that DBS are a reliable specimen type for SARS-CoV-2 antibody detection using the modified Luminex xMAP assay | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Validation Study | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Immunoglobulin G |2 NLM | |
| 700 | 1 | |a Sanders, Karen A |e verfasserin |4 aut | |
| 700 | 1 | |a Rinaldo, Piero |e verfasserin |4 aut | |
| 700 | 1 | |a Granger, Dane |e verfasserin |4 aut | |
| 700 | 1 | |a Hilgart, Heather |e verfasserin |4 aut | |
| 700 | 1 | |a Matern, Dietrich |e verfasserin |4 aut | |
| 700 | 1 | |a Theel, Elitza S |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t PloS one |d 2006 |g 16(2021), 5 vom: 01., Seite e0252621 |w (DE-627)NLM167327399 |x 1932-6203 |7 nnns |
| 773 | 1 | 8 | |g volume:16 |g year:2021 |g number:5 |g day:01 |g pages:e0252621 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1371/journal.pone.0252621 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 16 |j 2021 |e 5 |b 01 |h e0252621 | ||