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Article ; Online: Reply to Escandon et al.

Sims, Matthew / Podolsky, Robert H / Maine, Gabriel N / Kennedy, Richard H / Homayouni, Ramin

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2021 Volume 73, Issue 11, Page(s) 2149–2150

Language	English
Publishing date	2021-03-23
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciab258
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Zs.A 1505: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Predictors of hospitalization and severe disease due to breakthrough SARS-CoV-2 infection in fully vaccinated individuals.

Johnson, Steven / Mielke, Nicholas / Mathew, Trini / Maine, Gabriel N / Chen, Nai-Wei / Bahl, Amit

Journal of the American College of Emergency Physicians open

2022 Volume 3, Issue 4, Page(s) e12793

Abstract: Objective: We aimed to identify risk factors for hospital admission and severe disease among fully vaccinated (FV) individuals with COVID-19. Further, we investigated if risk factors for hospitalization and severe disease are similar between ... ...

Abstract	Objective: We aimed to identify risk factors for hospital admission and severe disease among fully vaccinated (FV) individuals with COVID-19. Further, we investigated if risk factors for hospitalization and severe disease are similar between unvaccinated (UV) and vaccinated individuals. Methods: This was a multicenter, observational cohort analysis from a large regional healthcare system in metro Detroit using electronic health record data to evaluate risk factors for hospitalization and severe COVID-19 disease. Vaccination data were retrieved using electronic medical records linked to our statewide immunization database. Consecutive adult FV and UV patients with a primary admission diagnosis of COVID-19 were included in the comparative analysis. Partially vaccinated patients and patients who had received a booster dose were excluded. The primary outcome of this study was hospital admission and severe disease inclusive of intensive care unit (ICU) admission, mechanical ventilation, or death. Results: Between December 15, 2020 and December 19, 2021, 20,584 emergency department visits met our inclusion criteria. Among these, 2005 (9.7%) visits consisted of FV individuals, 18,579 (90.3%) were UV, and 40.3% of UV and 52.7% of FV required hospitalization with similar (12.7% and 12.6%, respectively) rates of severe disease. Hospitalized UV patients with severe disease were younger than their FV counterparts (49.5% <65 years vs. 13.5% Conclusions: FV patients with breakthrough SARS-CoV-2 infection who require hospitalization and have severe disease are older and have more medical comorbidities compared to UV patients. When comparing risk factors for severe disease between UV and FV individuals, FV status is particularly associated with reduced risk among patients with a BMI ≥30 kg/m
Language	English
Publishing date	2022-07-29
Publishing country	United States
Document type	Journal Article
ISSN	2688-1152
ISSN (online)	2688-1152
DOI	10.1002/emp2.12793
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Article: Clinical and analytical evaluation of the Abbott AdviseDx quantitative SARS-CoV-2 IgG assay and comparison with two other serological tests

Maine, Gabriel N. / Krishnan, Subhashree Mallika / Walewski, Kelly / Trueman, Jillian / Sykes, Elizabeth / Sun, Qian

Journal of immunological methods. 2022 Apr., v. 503

2022

Abstract: Serological testing is an important tool to assist with assessing the immune response to SARS-CoV-2 infections, the causative agent of COVID-19. A quantitative assay was recently developed by Abbott Laboratories to measures antibodies against the ... ...

Abstract	Serological testing is an important tool to assist with assessing the immune response to SARS-CoV-2 infections, the causative agent of COVID-19. A quantitative assay was recently developed by Abbott Laboratories to measures antibodies against the receptor binding domain of the spike protein. In addition to assessing disease prevalence, this assay is useful towards determining the scale and duration of the humoral response to infection and vaccination. Here we evaluated the clinical and analytical performance of the quantitative Abbott AdviseDx SARS-CoV-2 IgG II assay and characterized the longitudinal dynamics of the IgG response against SARS-CoV-2 in 402 infected individuals up to 322 days post-symptom onset. To assess test sensitivity, 1257 serum specimens derived from 402 patients positive for SARS-CoV-2 by RT-PCR were analyzed on the Abbott Alinity platform. To evaluate test specificity, 394 specimens were tested from patients who were symptomatic but PCR negative for SARS-CoV-2, as well as 305 archived pre-pandemic samples. To further characterize test performance metrics, we evaluated assay precision and linearity. The Abbott AdviseDx SARS-CoV-2 IgG II assay exhibited diagnostic specificity of 99.02% using 305 pre − COVID-19 serum specimens and 98.73% using 394 PCR negative specimens. Using 1257 sequential serum samples collected from PCR-confirmed individuals, clinical test sensitivity of the assay was 39.7% at 3–7 days, 75.9% at 8–14 days, 95.6% at 15–21 days, and 98.7% at 4–5 weeks post-symptom onset. The assay is linear across the analytical measurement range claimed by the manufacturer (22–25,000 AU/mL) and exhibited good analytical precision. The median concentration of IgG increased steadily from <22 AU/mL at 3–7 days post-symptom onset, to a peak of 14,421 AU/mL at 6–7 weeks. Although antibody concentration started to decline at 8–9 weeks following symptom onset, all patients remained seropositive during the observation period. When the positivity rate of this assay was compared with the Abbott anti-NP IgG and EUROIMMUN anti-S1 IgG tests, clinical sensitivity of the Abbott AdviseDx SARS-CoV-2 IgG II assay was the highest at all time points with the exception of 4–5 weeks after symptom onset. The Abbott AdviseDx SARS-CoV-2 IgG II assay offers high test specificity and sensitivity across a broad reportable range. We anticipate this assay will be a useful towards quantitatively assessing the humoral immune response to COVID-19 infection and vaccination.
Keywords	COVID-19 infection ; Severe acute respiratory syndrome coronavirus 2 ; antibodies ; blood serum ; diagnostic specificity ; disease prevalence ; etiological agents ; humoral immunity ; immune response ; seroprevalence ; vaccination
Language	English
Dates of publication	2022-04
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	120142-6
ISSN	1872-7905 ; 0022-1759
ISSN (online)	1872-7905
ISSN	0022-1759
DOI	10.1016/j.jim.2022.113243
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Clinical and analytical evaluation of the Abbott AdviseDx quantitative SARS-CoV-2 IgG assay and comparison with two other serological tests.

Maine, Gabriel N / Krishnan, Subhashree Mallika / Walewski, Kelly / Trueman, Jillian / Sykes, Elizabeth / Sun, Qian

Journal of immunological methods

2022 Volume 503, Page(s) 113243

Abstract: Introduction: Serological testing is an important tool to assist with assessing the immune response to SARS-CoV-2 infections, the causative agent of COVID-19. A quantitative assay was recently developed by Abbott Laboratories to measures antibodies ... ...

Abstract	Introduction: Serological testing is an important tool to assist with assessing the immune response to SARS-CoV-2 infections, the causative agent of COVID-19. A quantitative assay was recently developed by Abbott Laboratories to measures antibodies against the receptor binding domain of the spike protein. In addition to assessing disease prevalence, this assay is useful towards determining the scale and duration of the humoral response to infection and vaccination. Here we evaluated the clinical and analytical performance of the quantitative Abbott AdviseDx SARS-CoV-2 IgG II assay and characterized the longitudinal dynamics of the IgG response against SARS-CoV-2 in 402 infected individuals up to 322 days post-symptom onset. Methods: To assess test sensitivity, 1257 serum specimens derived from 402 patients positive for SARS-CoV-2 by RT-PCR were analyzed on the Abbott Alinity platform. To evaluate test specificity, 394 specimens were tested from patients who were symptomatic but PCR negative for SARS-CoV-2, as well as 305 archived pre-pandemic samples. To further characterize test performance metrics, we evaluated assay precision and linearity. Results: The Abbott AdviseDx SARS-CoV-2 IgG II assay exhibited diagnostic specificity of 99.02% using 305 pre - COVID-19 serum specimens and 98.73% using 394 PCR negative specimens. Using 1257 sequential serum samples collected from PCR-confirmed individuals, clinical test sensitivity of the assay was 39.7% at 3-7 days, 75.9% at 8-14 days, 95.6% at 15-21 days, and 98.7% at 4-5 weeks post-symptom onset. The assay is linear across the analytical measurement range claimed by the manufacturer (22-25,000 AU/mL) and exhibited good analytical precision. The median concentration of IgG increased steadily from <22 AU/mL at 3-7 days post-symptom onset, to a peak of 14,421 AU/mL at 6-7 weeks. Although antibody concentration started to decline at 8-9 weeks following symptom onset, all patients remained seropositive during the observation period. When the positivity rate of this assay was compared with the Abbott anti-NP IgG and EUROIMMUN anti-S1 IgG tests, clinical sensitivity of the Abbott AdviseDx SARS-CoV-2 IgG II assay was the highest at all time points with the exception of 4-5 weeks after symptom onset. Conclusion: The Abbott AdviseDx SARS-CoV-2 IgG II assay offers high test specificity and sensitivity across a broad reportable range. We anticipate this assay will be a useful towards quantitatively assessing the humoral immune response to COVID-19 infection and vaccination.
MeSH term(s)	Antibodies, Viral ; COVID-19/diagnosis ; Humans ; Immunoglobulin G ; SARS-CoV-2 ; Sensitivity and Specificity ; Serologic Tests
Chemical Substances	Antibodies, Viral ; Immunoglobulin G
Language	English
Publishing date	2022-02-16
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	120142-6
ISSN	1872-7905 ; 0022-1759
ISSN (online)	1872-7905
ISSN	0022-1759
DOI	10.1016/j.jim.2022.113243
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ab Jg. 2022: Lesesaal (EG)

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Article ; Online: Immune responses of lung transplant recipients against SARS-CoV-2 and common respiratory coronaviruses: Evidence for pre-existing cross-reactive immunity.

Bansal, Sandhya / Fleming, Timothy / Canez, Jesse / Maine, Gabriel N / Bharat, Ankit / Walia, Rajat / Tokman, Sofya / Smith, Michael A / Tiffany, Brian / Bremner, Ross M / Mohanakumar, T

Transplant immunology

2023 Volume 81, Page(s) 101940

Abstract: Humoral and cellular immune responses to SARS-CoV-2 and other coronaviruses in lung transplant recipients are unknown. We measured antibodies and T cell responses against the SARS-CoV-2 spike S2 and nucleocapsid antigens and spike antigens from common ... ...

Abstract	Humoral and cellular immune responses to SARS-CoV-2 and other coronaviruses in lung transplant recipients are unknown. We measured antibodies and T cell responses against the SARS-CoV-2 spike S2 and nucleocapsid antigens and spike antigens from common respiratory coronaviruses (229E, NL63, OC43, and HKU1) after vaccination or infection of LTxRs. 148 LTxRs from single center were included in this study: 98 after vaccination and 50 following SARS-CoV-2 infection. Antibodies were quantified by enzyme-linked immunosorbent assay. The frequency of T cells secreting IL2, IL4, IL10, IL17, TNFα, and IFNγ were enumerated by enzyme-linked immunospot assay. Our results have shown the development of antibodies to SARS-CoV-2 spike protein in infected LTxRs (39/50) and vaccinated LTxRs (52/98). Vaccinated LTxRs had higher number of T cells producing TNFα but less cells producing IFNγ than infected LTxRs in response to the nucleocapsid antigen and other coronavirus spike antigens. We didn't find correlation between the development of antibodies and cellular immune responses against the SARS-CoV-2 spike protein after vaccination. Instead, LTxRs have pre-existing cellular immunity to common respiratory coronaviruses, leading to cross-reactive immunity against SARS-CoV-2 which likely will provide protection against SARS-Cov-2 infection.
MeSH term(s)	Humans ; SARS-CoV-2 ; Transplant Recipients ; Tumor Necrosis Factor-alpha ; COVID-19 ; Antibodies ; Immunity, Cellular ; Enzyme-Linked Immunospot Assay ; Antibodies, Viral
Chemical Substances	spike protein, SARS-CoV-2 ; Tumor Necrosis Factor-alpha ; Antibodies ; Antibodies, Viral
Language	English
Publishing date	2023-10-20
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1160846-8
ISSN	1878-5492 ; 0966-3274
ISSN (online)	1878-5492
ISSN	0966-3274
DOI	10.1016/j.trim.2023.101940
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Zs.A 3784: Show issues

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Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

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Article: Prognostic Value of SARS-CoV-2 Anti-RBD IgG Antibody Quantitation on Clinical Outcomes in Hospitalized COVID-19 Patients.

Madanat, Luai / Sager, Melinda / O'Connor, Daniel / Thapa, Bijaya / Aggarwal, Nishant / Ghimire, Bipin / Lauter, Carl / Maine, Gabriel N / Sims, Matthew / Halalau, Alexandra

International journal of general medicine

2022 Volume 15, Page(s) 5693–5700

Abstract: ... of admission. Anti-nucleocapsid IgG (anti-N) and Anti-RBD levels were measured. Anti-RBD level of 500 AU/mL was ... with higher median titer level (623 vs 0, P = 0.011) compared to unvaccinated patients. Anti-N positivity was ...

Abstract	Background: Antibody levels against SARS-CoV-2 can be used as an indicator of recent or past vaccination or infection. However, the prognostic value of antibodies targeting the receptor binding protein (anti-RBD) in hospitalized patients is not widely reported. Purpose: Determine prognostic impact of SARS-CoV-2 antibody quantification at the time of admission on clinical outcomes in hospitalized COVID-19 patients. Methods: We conducted a pilot observational study on patients hospitalized with SARS-CoV-2 infection to determine the prognostic impact of antibody quantitation within the first two days of admission. Anti-nucleocapsid IgG (anti-N) and Anti-RBD levels were measured. Anti-RBD level of 500 AU/mL was used as a cutoff to stratify patients. Spearman's rank Coefficient (r Results: Of the 26 patients included, those who were vaccinated more frequently tested positive for Anti-RBD (100% vs 46.2%, P = 0.005) with higher median titer level (623 vs 0, P = 0.011) compared to unvaccinated patients. Anti-N positivity was more frequently seen in unvaccinated patients (53.9% vs 7.7%, P = 0.03). Anti-RBD levels >500 were associated with lower overall hospital length of stay (LOS)(5 vs 10 days, P = 0.046). The analysis employing a Spearman Rank coefficient demonstrated a strong negative correlation between anti-S titer and LOS (r Conclusion: Anti-RBD IgG levels were associated with lower LOS and oxygen needs during hospitalization. Further studies are needed to determine if levels on admission can be used as a prognostic indicator.
Language	English
Publishing date	2022-06-18
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2452220-X
ISSN	1178-7074
ISSN	1178-7074
DOI	10.2147/IJGM.S370080
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Article ; Online: Dried blood spots are a valid alternative to venipuncture for COVID-19 antibody testing.

Sims, Matthew D / Podolsky, Robert H / Childers, Karen L / Higgins, Barbara / Trueman, Jillian / Homayouni, Ramin / Voss, Daniel R / Berkiw-Scenna, Natalie / Keil, Hans / Kennedy, Richard H / Maine, Gabriel N

Journal of immunological methods

2022 Volume 513, Page(s) 113420

Abstract: Background: Serologic analysis is an important tool towards assessing the humoral response to COVID-19 infection and vaccination. Numerous serologic tests and platforms are currently available to support this line of testing. Two broad antibody testing ... ...

Abstract	Background: Serologic analysis is an important tool towards assessing the humoral response to COVID-19 infection and vaccination. Numerous serologic tests and platforms are currently available to support this line of testing. Two broad antibody testing categories are point-of-care lateral flow immunoassays and semi-quantitative immunoassays performed in clinical laboratories, which typically require blood collected from a finger-stick and a standard venipuncture blood draw, respectively. This study evaluated the use of dried blood spot (DBS) collections as a sample source for COVID-19 antibody testing using an automated clinical laboratory test system. Methods: Two hundred and ninety-four participants in the BLAST COVID-19 seroprevalence study (NCT04349202) were recruited at the time of a scheduled blood draw to have an additional sample taken via finger stick as a DBS collection. Using the EUROIMMUN assay to assess SARS-CoV-2 anti-spike IgG status, DBS specimens were tested on 7, 14, 21, and 28 days post- collection and compared to the reference serum sample obtained from a blood draw for the BLAST COVID-19 study. Results: SARS-CoV-2 anti-spike IgG status from DBS collections demonstrated high concordance with serum across all time points (7-28 days). However, the semi-quantitative value from DBS collections was lower on average than that from serum, resulting in increased uncertainty around the equivocal-to-positive analytical decision point. Conclusions: DBS collections can be substituted for venipuncture when assaying for COVID-19 IgG antibody, with samples being stable for at least 28 days at room temperature. Finger-stick sampling can therefore be advantageous for testing large populations for SARS-CoV-2 antibodies without the need for phlebotomists or immediate processing of samples. We have high confidence in serostaus determination from DBS collections, although the reduced semi-quantitative value may cause some low-level positives to fall into the equivocal or even negative range.
MeSH term(s)	Humans ; Antibodies, Viral ; COVID-19/diagnosis ; COVID-19 Serological Testing ; COVID-19 Testing ; Dried Blood Spot Testing ; Immunoglobulin G ; Phlebotomy ; SARS-CoV-2 ; Sensitivity and Specificity ; Seroepidemiologic Studies
Chemical Substances	Antibodies, Viral ; Immunoglobulin G
Language	English
Publishing date	2022-12-31
Publishing country	Netherlands
Document type	Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	120142-6
ISSN	1872-7905 ; 0022-1759
ISSN (online)	1872-7905
ISSN	0022-1759
DOI	10.1016/j.jim.2022.113420
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ab Jg. 2022: Lesesaal (EG)

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Article ; Online: Dried blood spots are a valid alternative to venipuncture for COVID-19 antibody testing

Sims, Matthew D. / Podolsky, Robert H. / Childers, Karen L. / Higgins, Barbara / Trueman, Jillian / Homayouni, Ramin / Voss, Daniel R. / Berkiw-Scenna, Natalie / Keil, Hans / Kennedy, Richard H. / Maine, Gabriel N.

Journal of Immunological Methods. 2023 Feb., v. 513 p.113420-

2023

Abstract: Serologic analysis is an important tool towards assessing the humoral response to COVID-19 infection and vaccination. Numerous serologic tests and platforms are currently available to support this line of testing. Two broad antibody testing categories ... ...

Abstract	Serologic analysis is an important tool towards assessing the humoral response to COVID-19 infection and vaccination. Numerous serologic tests and platforms are currently available to support this line of testing. Two broad antibody testing categories are point-of-care lateral flow immunoassays and semi-quantitative immunoassays performed in clinical laboratories, which typically require blood collected from a finger-stick and a standard venipuncture blood draw, respectively. This study evaluated the use of dried blood spot (DBS) collections as a sample source for COVID-19 antibody testing using an automated clinical laboratory test system. Two hundred and ninety-four participants in the BLAST COVID-19 seroprevalence study (NCT04349202) were recruited at the time of a scheduled blood draw to have an additional sample taken via finger stick as a DBS collection. Using the EUROIMMUN assay to assess SARS-CoV-2 anti-spike IgG status, DBS specimens were tested on 7, 14, 21, and 28 days post- collection and compared to the reference serum sample obtained from a blood draw for the BLAST COVID-19 study. SARS-CoV-2 anti-spike IgG status from DBS collections demonstrated high concordance with serum across all time points (7–28 days). However, the semi-quantitative value from DBS collections was lower on average than that from serum, resulting in increased uncertainty around the equivocal-to-positive analytical decision point. DBS collections can be substituted for venipuncture when assaying for COVID-19 IgG antibody, with samples being stable for at least 28 days at room temperature. Finger-stick sampling can therefore be advantageous for testing large populations for SARS-CoV-2 antibodies without the need for phlebotomists or immediate processing of samples. We have high confidence in serostaus determination from DBS collections, although the reduced semi-quantitative value may cause some low-level positives to fall into the equivocal or even negative range.
Keywords	COVID-19 infection ; Severe acute respiratory syndrome coronavirus 2 ; ambient temperature ; antibodies ; automation ; blood serum ; humoral immunity ; laboratory experimentation ; point-of-care systems ; seroprevalence ; uncertainty ; vaccination ; Dried blood spot ; COVID-19 ; COVID-19 antibody ; SARS-CoV-2 IgG ; DBS ; PA
Language	English
Dates of publication	2023-02
Publishing place	Elsevier B.V.
Document type	Article ; Online
Note	Use and reproduction
ZDB-ID	120142-6
ISSN	1872-7905 ; 0022-1759
ISSN (online)	1872-7905
ISSN	0022-1759
DOI	10.1016/j.jim.2022.113420
Database	NAL-Catalogue (AGRICOLA)

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ab Jg. 2022: Lesesaal (EG)

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Article ; Online: SARS-CoV-2 infection in lung transplant recipients induces circulating exosomes with SARS-CoV-2 spike protein S2.

Bansal, Sandhya / Tokman, Sofya / Fleming, Timothy / Maine, Gabriel N / Sanborn, Kristina / Hachem, Ramsey / Bharat, Ankit / Smith, Michael A / Bremner, Ross M / Mohanakumar, T

Clinical and translational medicine

2021 Volume 11, Issue 11, Page(s) e576

MeSH term(s)	Asymptomatic Diseases ; Blotting, Western ; COVID-19/pathology ; COVID-19/virology ; Exosomes/metabolism ; Humans ; Lung Transplantation ; Mass Spectrometry ; Microscopy, Electron, Transmission ; Nucleocapsid Proteins/chemistry ; Nucleocapsid Proteins/immunology ; Nucleocapsid Proteins/metabolism ; Protein Subunits/chemistry ; Protein Subunits/immunology ; Protein Subunits/metabolism ; SARS-CoV-2/isolation & purification ; SARS-CoV-2/metabolism ; Spike Glycoprotein, Coronavirus/chemistry ; Spike Glycoprotein, Coronavirus/immunology ; Spike Glycoprotein, Coronavirus/metabolism
Chemical Substances	Nucleocapsid Proteins ; Protein Subunits ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
Language	English
Publishing date	2021-11-28
Publishing country	United States
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2697013-2
ISSN	2001-1326 ; 2001-1326
ISSN (online)	2001-1326
ISSN	2001-1326
DOI	10.1002/ctm2.576
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Article ; Online: SARS‐CoV‐2 infection in lung transplant recipients induces circulating exosomes with SARS‐CoV‐2 spike protein S2

Sandhya Bansal / Sofya Tokman / Timothy Fleming / Gabriel N. Maine / Kristina Sanborn / Ramsey Hachem / Ankit Bharat / Michael A. Smith / Ross M. Bremner / T. Mohanakumar

Clinical and Translational Medicine, Vol 11, Iss 11, Pp n/a-n/a (2021)

2021

Keywords	Medicine (General) ; R5-920
Language	English
Publishing date	2021-11-01T00:00:00Z
Publisher	Wiley
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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