Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination

Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Deidre Wilkins [verfasserIn] Anastasia A Aksyuk [verfasserIn] Alexey Ruzin [verfasserIn] Kevin M Tuffy [verfasserIn] Tina Green [verfasserIn] Rebecca Greway [verfasserIn] Brittany Fikes [verfasserIn] Cyrille J Bonhomme [verfasserIn] Mark T Esser [verfasserIn] Elizabeth J Kelly [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology

Übergeordnetes Werk:	In: Clinical & Translational Immunology - Wiley, 2015, 11(2022), 4, Seite n/a-n/a
Übergeordnetes Werk:	volume:11 ; year:2022 ; number:4 ; pages:n/a-n/a

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1002/cti2.1385

Katalog-ID:	DOAJ031348335

Internformat


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520			\|a Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies.
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650		4	\|a COVID‐19
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650		4	\|a immunoassay
650		4	\|a SARS‐CoV‐2
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653		0	\|a Immunologic diseases. Allergy
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700	0		\|a Tina Green \|e verfasserin \|4 aut
700	0		\|a Rebecca Greway \|e verfasserin \|4 aut
700	0		\|a Brittany Fikes \|e verfasserin \|4 aut
700	0		\|a Cyrille J Bonhomme \|e verfasserin \|4 aut
700	0		\|a Mark T Esser \|e verfasserin \|4 aut
700	0		\|a Elizabeth J Kelly \|e verfasserin \|4 aut
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912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
912			\|a GBV_ILN_636
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912			\|a GBV_ILN_2088
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912			\|a GBV_ILN_2108
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912			\|a GBV_ILN_2111
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912			\|a GBV_ILN_4035
912			\|a GBV_ILN_4037
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author_variant	d w dw a a a aaa a r ar k m t kmt t g tg r g rg b f bf c j b cjb m t e mte e j k ejk
matchkey_str	article:20500068:2022----::aiainnpromnefmlilxeooysatqatfatbdrsossolwn
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allfields	10.1002/cti2.1385 doi (DE-627)DOAJ031348335 (DE-599)DOAJ185998943a9c4bd88730c7fd662763ef DE-627 ger DE-627 rakwb eng RC581-607 Deidre Wilkins verfasserin aut Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies. antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology Immunologic diseases. Allergy Anastasia A Aksyuk verfasserin aut Alexey Ruzin verfasserin aut Kevin M Tuffy verfasserin aut Tina Green verfasserin aut Rebecca Greway verfasserin aut Brittany Fikes verfasserin aut Cyrille J Bonhomme verfasserin aut Mark T Esser verfasserin aut Elizabeth J Kelly verfasserin aut In Clinical & Translational Immunology Wiley, 2015 11(2022), 4, Seite n/a-n/a (DE-627)731890310 (DE-600)2694482-0 20500068 nnns volume:11 year:2022 number:4 pages:n/a-n/a https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/article/185998943a9c4bd88730c7fd662763ef kostenfrei https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/toc/2050-0068 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 4 n/a-n/a
spelling	10.1002/cti2.1385 doi (DE-627)DOAJ031348335 (DE-599)DOAJ185998943a9c4bd88730c7fd662763ef DE-627 ger DE-627 rakwb eng RC581-607 Deidre Wilkins verfasserin aut Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies. antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology Immunologic diseases. Allergy Anastasia A Aksyuk verfasserin aut Alexey Ruzin verfasserin aut Kevin M Tuffy verfasserin aut Tina Green verfasserin aut Rebecca Greway verfasserin aut Brittany Fikes verfasserin aut Cyrille J Bonhomme verfasserin aut Mark T Esser verfasserin aut Elizabeth J Kelly verfasserin aut In Clinical & Translational Immunology Wiley, 2015 11(2022), 4, Seite n/a-n/a (DE-627)731890310 (DE-600)2694482-0 20500068 nnns volume:11 year:2022 number:4 pages:n/a-n/a https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/article/185998943a9c4bd88730c7fd662763ef kostenfrei https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/toc/2050-0068 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 4 n/a-n/a
allfields_unstemmed	10.1002/cti2.1385 doi (DE-627)DOAJ031348335 (DE-599)DOAJ185998943a9c4bd88730c7fd662763ef DE-627 ger DE-627 rakwb eng RC581-607 Deidre Wilkins verfasserin aut Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies. antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology Immunologic diseases. Allergy Anastasia A Aksyuk verfasserin aut Alexey Ruzin verfasserin aut Kevin M Tuffy verfasserin aut Tina Green verfasserin aut Rebecca Greway verfasserin aut Brittany Fikes verfasserin aut Cyrille J Bonhomme verfasserin aut Mark T Esser verfasserin aut Elizabeth J Kelly verfasserin aut In Clinical & Translational Immunology Wiley, 2015 11(2022), 4, Seite n/a-n/a (DE-627)731890310 (DE-600)2694482-0 20500068 nnns volume:11 year:2022 number:4 pages:n/a-n/a https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/article/185998943a9c4bd88730c7fd662763ef kostenfrei https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/toc/2050-0068 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 4 n/a-n/a
allfieldsGer	10.1002/cti2.1385 doi (DE-627)DOAJ031348335 (DE-599)DOAJ185998943a9c4bd88730c7fd662763ef DE-627 ger DE-627 rakwb eng RC581-607 Deidre Wilkins verfasserin aut Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies. antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology Immunologic diseases. Allergy Anastasia A Aksyuk verfasserin aut Alexey Ruzin verfasserin aut Kevin M Tuffy verfasserin aut Tina Green verfasserin aut Rebecca Greway verfasserin aut Brittany Fikes verfasserin aut Cyrille J Bonhomme verfasserin aut Mark T Esser verfasserin aut Elizabeth J Kelly verfasserin aut In Clinical & Translational Immunology Wiley, 2015 11(2022), 4, Seite n/a-n/a (DE-627)731890310 (DE-600)2694482-0 20500068 nnns volume:11 year:2022 number:4 pages:n/a-n/a https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/article/185998943a9c4bd88730c7fd662763ef kostenfrei https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/toc/2050-0068 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 4 n/a-n/a
allfieldsSound	10.1002/cti2.1385 doi (DE-627)DOAJ031348335 (DE-599)DOAJ185998943a9c4bd88730c7fd662763ef DE-627 ger DE-627 rakwb eng RC581-607 Deidre Wilkins verfasserin aut Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies. antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology Immunologic diseases. Allergy Anastasia A Aksyuk verfasserin aut Alexey Ruzin verfasserin aut Kevin M Tuffy verfasserin aut Tina Green verfasserin aut Rebecca Greway verfasserin aut Brittany Fikes verfasserin aut Cyrille J Bonhomme verfasserin aut Mark T Esser verfasserin aut Elizabeth J Kelly verfasserin aut In Clinical & Translational Immunology Wiley, 2015 11(2022), 4, Seite n/a-n/a (DE-627)731890310 (DE-600)2694482-0 20500068 nnns volume:11 year:2022 number:4 pages:n/a-n/a https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/article/185998943a9c4bd88730c7fd662763ef kostenfrei https://doi.org/10.1002/cti2.1385 kostenfrei https://doaj.org/toc/2050-0068 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 4 n/a-n/a
language	English
source	In Clinical & Translational Immunology 11(2022), 4, Seite n/a-n/a volume:11 year:2022 number:4 pages:n/a-n/a
sourceStr	In Clinical & Translational Immunology 11(2022), 4, Seite n/a-n/a volume:11 year:2022 number:4 pages:n/a-n/a
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology Immunologic diseases. Allergy
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container_title	Clinical & Translational Immunology
authorswithroles_txt_mv	Deidre Wilkins @@aut@@ Anastasia A Aksyuk @@aut@@ Alexey Ruzin @@aut@@ Kevin M Tuffy @@aut@@ Tina Green @@aut@@ Rebecca Greway @@aut@@ Brittany Fikes @@aut@@ Cyrille J Bonhomme @@aut@@ Mark T Esser @@aut@@ Elizabeth J Kelly @@aut@@
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We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. 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callnumber-first	R - Medicine
author	Deidre Wilkins
spellingShingle	Deidre Wilkins misc RC581-607 misc antibodies misc COVID‐19 misc electrochemiluminescence misc immunoassay misc SARS‐CoV‐2 misc serology misc Immunologic diseases. Allergy Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination
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topic_title	RC581-607 Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination antibodies COVID‐19 electrochemiluminescence immunoassay SARS‐CoV‐2 serology
topic	misc RC581-607 misc antibodies misc COVID‐19 misc electrochemiluminescence misc immunoassay misc SARS‐CoV‐2 misc serology misc Immunologic diseases. Allergy
topic_unstemmed	misc RC581-607 misc antibodies misc COVID‐19 misc electrochemiluminescence misc immunoassay misc SARS‐CoV‐2 misc serology misc Immunologic diseases. Allergy
topic_browse	misc RC581-607 misc antibodies misc COVID‐19 misc electrochemiluminescence misc immunoassay misc SARS‐CoV‐2 misc serology misc Immunologic diseases. Allergy
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title	Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination
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title_full	Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination
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author_browse	Deidre Wilkins Anastasia A Aksyuk Alexey Ruzin Kevin M Tuffy Tina Green Rebecca Greway Brittany Fikes Cyrille J Bonhomme Mark T Esser Elizabeth J Kelly
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title_sort	validation and performance of a multiplex serology assay to quantify antibody responses following sars‐cov‐2 infection or vaccination
callnumber	RC581-607
title_auth	Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination
abstract	Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies.
abstractGer	Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies.
abstract_unstemmed	Abstract Objectives Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. Conclusions The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies.
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container_issue	4
title_short	Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination
url	https://doi.org/10.1002/cti2.1385 https://doaj.org/article/185998943a9c4bd88730c7fd662763ef https://doaj.org/toc/2050-0068
remote_bool	true
author2	Anastasia A Aksyuk Alexey Ruzin Kevin M Tuffy Tina Green Rebecca Greway Brittany Fikes Cyrille J Bonhomme Mark T Esser Elizabeth J Kelly
author2Str	Anastasia A Aksyuk Alexey Ruzin Kevin M Tuffy Tina Green Rebecca Greway Brittany Fikes Cyrille J Bonhomme Mark T Esser Elizabeth J Kelly
ppnlink	731890310
callnumber-subject	RC - Internal Medicine
mediatype_str_mv	c
isOA_txt	true
hochschulschrift_bool	false
doi_str	10.1002/cti2.1385
callnumber-a	RC581-607
up_date	2024-07-03T20:07:37.989Z
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We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Methods Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Results Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was < 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. 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Validation and performance of a multiplex serology assay to quantify antibody responses following SARS‐CoV‐2 infection or vaccination

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