PMID- 34048503
OWN - NLM
STAT- MEDLINE
DCOM- 20210607
LR  - 20240402
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 16
IP  - 5
DP  - 2021
TI  - Validation of a multiplex flow immunoassay for detection of IgG antibodies 
      against SARS-CoV-2 in dried blood spots.
PG  - e0252621
LID - 10.1371/journal.pone.0252621 [doi]
LID - e0252621
AB  - 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.
FAU - Turgeon, Coleman T
AU  - Turgeon CT
AD  - Divisions of Laboratory Genetics and Genomics and Department of Laboratory 
      Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, United States of 
      America.
FAU - Sanders, Karen A
AU  - Sanders KA
AD  - Divisions of Laboratory Genetics and Genomics and Department of Laboratory 
      Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, United States of 
      America.
FAU - Rinaldo, Piero
AU  - Rinaldo P
AD  - Divisions of Laboratory Genetics and Genomics and Department of Laboratory 
      Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, United States of 
      America.
FAU - Granger, Dane
AU  - Granger D
AD  - Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo 
      Clinic, Rochester, Minnesota, United States of America.
FAU - Hilgart, Heather
AU  - Hilgart H
AD  - Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo 
      Clinic, Rochester, Minnesota, United States of America.
FAU - Matern, Dietrich
AU  - Matern D
AUID- ORCID: 0000-0001-6298-4138
AD  - Divisions of Laboratory Genetics and Genomics and Department of Laboratory 
      Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, United States of 
      America.
FAU - Theel, Elitza S
AU  - Theel ES
AD  - Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo 
      Clinic, Rochester, Minnesota, United States of America.
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20210528
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antibodies, Viral)
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Viral/*blood
MH  - COVID-19/*blood
MH  - *COVID-19 Serological Testing
MH  - *Dried Blood Spot Testing
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/*blood
MH  - Male
MH  - Middle Aged
MH  - *SARS-CoV-2
PMC - PMC8162624
COIS- I have read the journal's policy and among the authors of this manuscript Dr. 
      Theel has the following broad interests that could be perceived as conflicts of 
      interest: - Consulting fees from Roche Diagnostics and Accelerate Diagnostics - 
      Member of the College of American Pathologists' Microbiology Resource Committee 
      (travel compensation) - Editor, Clinical Microbiology Newsletter This does not 
      alter our adherence to PLOS ONE policies on sharing data and materials.
EDAT- 2021/05/29 06:00
MHDA- 2021/06/08 06:00
PMCR- 2021/05/28
CRDT- 2021/05/28 17:25
PHST- 2021/02/18 00:00 [received]
PHST- 2021/05/18 00:00 [accepted]
PHST- 2021/05/28 17:25 [entrez]
PHST- 2021/05/29 06:00 [pubmed]
PHST- 2021/06/08 06:00 [medline]
PHST- 2021/05/28 00:00 [pmc-release]
AID - PONE-D-21-05527 [pii]
AID - 10.1371/journal.pone.0252621 [doi]
PST - epublish
SO  - PLoS One. 2021 May 28;16(5):e0252621. doi: 10.1371/journal.pone.0252621. 
      eCollection 2021.