Diagnostic performances and thresholds: The key to harmonization in serological SARS-CoV-2 assays?

•Serological assays for SARS-CoV-2 are widely available.•Data on diagnostic sensitivity, specificity and likelihood ratio are needed.•The identification of reliable thresholds improves diagnostic accuracy.•The negative predictive value is a valuable clinical information. The evaluation of severe acu...

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Veröffentlicht in:	Clinica chimica acta Jg. 509; S. 1 - 7
Hauptverfasser:	Plebani, Mario, Padoan, Andrea, Negrini, Davide, Carpinteri, Benedetta, Sciacovelli, Laura
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Netherlands Elsevier B.V 01.10.2020
Schlagworte:	Adolescent Adult Aged Aged, 80 and over Antibodies Betacoronavirus - isolation & purification Child Clinical performances Coronavirus Infections - blood Coronavirus Infections - diagnosis COVID-19 Enzyme-Linked Immunosorbent Assay - methods Enzyme-Linked Immunosorbent Assay - standards Female Humans Male Middle Aged Pandemics Pneumonia, Viral - blood Pneumonia, Viral - diagnosis Reproducibility of Results Reverse Transcriptase Polymerase Chain Reaction - methods Reverse Transcriptase Polymerase Chain Reaction - standards SARS-CoV-2 Serologic Tests - methods Serologic Tests - standards Young Adult COVID-19 Antibodies Clinical performances SARS-CoV-2
ISSN:	0009-8981, 1873-3492, 1873-3492
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Abstract	•Serological assays for SARS-CoV-2 are widely available.•Data on diagnostic sensitivity, specificity and likelihood ratio are needed.•The identification of reliable thresholds improves diagnostic accuracy.•The negative predictive value is a valuable clinical information. The evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibody (Ab) assay performances is of the utmost importance in establishing and monitoring virus spread in the community. In this study focusing on IgG antibodies, we compare reliability of three chemiluminescent (CLIA) and two enzyme linked immunosorbent (ELISA) assays. Sera from a total of 271 subjects, including 64 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 patients were tested for specific Ab using Maglumi (Snibe), Liaison (Diasorin), iFlash (Yhlo), Euroimmun (Medizinische Labordiagnostika AG) and Wantai (Wantai Biological Pharmacy) assays. Diagnostic sensitivity and specificity, positive and negative likelihood ratios were evaluated using manufacturers’ and optimized thresholds. Optimized thresholds (Maglumi 2 kAU/L, Liaison 6.2 kAU/L and iFlash 15.0 kAU/L) allowed us to achieve a negative likelihood ratio and an accuracy of: 0.06 and 93.5% for Maglumi; 0.03 and 93.1% for Liaison; 0.03 and 91% for iFlash. Diagnostic sensitivities and specificities were above 93.8% and 85.9%, respectively for all CLIA assays. Overall agreement was 90.3% (Cohen’s kappa = 0.805 and SE = 0.041) for CLIA, and 98.4% (Cohen’s kappa = 0.962 and SE = 0.126) for ELISA. The results obtained indicate that, for CLIA assays, it might be possible to define thresholds that improve the negative likelihood ratio. Thus, a negative test result enables the identification of subjects at risk of being infected, who should then be closely monitored over time with a view to preventing further viral spread. Redefined thresholds, in addition, improved the overall inter-assay agreement, paving the way to a better harmonization of serologic tests.
AbstractList	The evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibody (Ab) assay performances is of the utmost importance in establishing and monitoring virus spread in the community. In this study focusing on IgG antibodies, we compare reliability of three chemiluminescent (CLIA) and two enzyme linked immunosorbent (ELISA) assays. Sera from a total of 271 subjects, including 64 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 patients were tested for specific Ab using Maglumi (Snibe), Liaison (Diasorin), iFlash (Yhlo), Euroimmun (Medizinische Labordiagnostika AG) and Wantai (Wantai Biological Pharmacy) assays. Diagnostic sensitivity and specificity, positive and negative likelihood ratios were evaluated using manufacturers' and optimized thresholds. Optimized thresholds (Maglumi 2 kAU/L, Liaison 6.2 kAU/L and iFlash 15.0 kAU/L) allowed us to achieve a negative likelihood ratio and an accuracy of: 0.06 and 93.5% for Maglumi; 0.03 and 93.1% for Liaison; 0.03 and 91% for iFlash. Diagnostic sensitivities and specificities were above 93.8% and 85.9%, respectively for all CLIA assays. Overall agreement was 90.3% (Cohen's kappa = 0.805 and SE = 0.041) for CLIA, and 98.4% (Cohen's kappa = 0.962 and SE = 0.126) for ELISA. The results obtained indicate that, for CLIA assays, it might be possible to define thresholds that improve the negative likelihood ratio. Thus, a negative test result enables the identification of subjects at risk of being infected, who should then be closely monitored over time with a view to preventing further viral spread. Redefined thresholds, in addition, improved the overall inter-assay agreement, paving the way to a better harmonization of serologic tests. The evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibody (Ab) assay performances is of the utmost importance in establishing and monitoring virus spread in the community. In this study focusing on IgG antibodies, we compare reliability of three chemiluminescent (CLIA) and two enzyme linked immunosorbent (ELISA) assays.BACKGROUNDThe evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibody (Ab) assay performances is of the utmost importance in establishing and monitoring virus spread in the community. In this study focusing on IgG antibodies, we compare reliability of three chemiluminescent (CLIA) and two enzyme linked immunosorbent (ELISA) assays.Sera from a total of 271 subjects, including 64 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 patients were tested for specific Ab using Maglumi (Snibe), Liaison (Diasorin), iFlash (Yhlo), Euroimmun (Medizinische Labordiagnostika AG) and Wantai (Wantai Biological Pharmacy) assays. Diagnostic sensitivity and specificity, positive and negative likelihood ratios were evaluated using manufacturers' and optimized thresholds.METHODSSera from a total of 271 subjects, including 64 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 patients were tested for specific Ab using Maglumi (Snibe), Liaison (Diasorin), iFlash (Yhlo), Euroimmun (Medizinische Labordiagnostika AG) and Wantai (Wantai Biological Pharmacy) assays. Diagnostic sensitivity and specificity, positive and negative likelihood ratios were evaluated using manufacturers' and optimized thresholds.Optimized thresholds (Maglumi 2 kAU/L, Liaison 6.2 kAU/L and iFlash 15.0 kAU/L) allowed us to achieve a negative likelihood ratio and an accuracy of: 0.06 and 93.5% for Maglumi; 0.03 and 93.1% for Liaison; 0.03 and 91% for iFlash. Diagnostic sensitivities and specificities were above 93.8% and 85.9%, respectively for all CLIA assays. Overall agreement was 90.3% (Cohen's kappa = 0.805 and SE = 0.041) for CLIA, and 98.4% (Cohen's kappa = 0.962 and SE = 0.126) for ELISA.RESULTSOptimized thresholds (Maglumi 2 kAU/L, Liaison 6.2 kAU/L and iFlash 15.0 kAU/L) allowed us to achieve a negative likelihood ratio and an accuracy of: 0.06 and 93.5% for Maglumi; 0.03 and 93.1% for Liaison; 0.03 and 91% for iFlash. Diagnostic sensitivities and specificities were above 93.8% and 85.9%, respectively for all CLIA assays. Overall agreement was 90.3% (Cohen's kappa = 0.805 and SE = 0.041) for CLIA, and 98.4% (Cohen's kappa = 0.962 and SE = 0.126) for ELISA.The results obtained indicate that, for CLIA assays, it might be possible to define thresholds that improve the negative likelihood ratio. Thus, a negative test result enables the identification of subjects at risk of being infected, who should then be closely monitored over time with a view to preventing further viral spread. Redefined thresholds, in addition, improved the overall inter-assay agreement, paving the way to a better harmonization of serologic tests.CONCLUSIONSThe results obtained indicate that, for CLIA assays, it might be possible to define thresholds that improve the negative likelihood ratio. Thus, a negative test result enables the identification of subjects at risk of being infected, who should then be closely monitored over time with a view to preventing further viral spread. Redefined thresholds, in addition, improved the overall inter-assay agreement, paving the way to a better harmonization of serologic tests. •Serological assays for SARS-CoV-2 are widely available.•Data on diagnostic sensitivity, specificity and likelihood ratio are needed.•The identification of reliable thresholds improves diagnostic accuracy.•The negative predictive value is a valuable clinical information. The evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibody (Ab) assay performances is of the utmost importance in establishing and monitoring virus spread in the community. In this study focusing on IgG antibodies, we compare reliability of three chemiluminescent (CLIA) and two enzyme linked immunosorbent (ELISA) assays. Sera from a total of 271 subjects, including 64 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 patients were tested for specific Ab using Maglumi (Snibe), Liaison (Diasorin), iFlash (Yhlo), Euroimmun (Medizinische Labordiagnostika AG) and Wantai (Wantai Biological Pharmacy) assays. Diagnostic sensitivity and specificity, positive and negative likelihood ratios were evaluated using manufacturers’ and optimized thresholds. Optimized thresholds (Maglumi 2 kAU/L, Liaison 6.2 kAU/L and iFlash 15.0 kAU/L) allowed us to achieve a negative likelihood ratio and an accuracy of: 0.06 and 93.5% for Maglumi; 0.03 and 93.1% for Liaison; 0.03 and 91% for iFlash. Diagnostic sensitivities and specificities were above 93.8% and 85.9%, respectively for all CLIA assays. Overall agreement was 90.3% (Cohen’s kappa = 0.805 and SE = 0.041) for CLIA, and 98.4% (Cohen’s kappa = 0.962 and SE = 0.126) for ELISA. The results obtained indicate that, for CLIA assays, it might be possible to define thresholds that improve the negative likelihood ratio. Thus, a negative test result enables the identification of subjects at risk of being infected, who should then be closely monitored over time with a view to preventing further viral spread. Redefined thresholds, in addition, improved the overall inter-assay agreement, paving the way to a better harmonization of serologic tests. • Serological assays for SARS-CoV-2 are widely available. • Data on diagnostic sensitivity, specificity and likelihood ratio are needed. • The identification of reliable thresholds improves diagnostic accuracy. • The negative predictive value is a valuable clinical information.
Author	Carpinteri, Benedetta Negrini, Davide Plebani, Mario Sciacovelli, Laura Padoan, Andrea
Author_xml	– sequence: 1 givenname: Mario orcidid: 0000-0002-0270-1711 surname: Plebani fullname: Plebani, Mario email: www.mario.plebani@unipd.it organization: Department of Laboratory Medicine, University Hospital of Padova, Italy – sequence: 2 givenname: Andrea orcidid: 0000-0003-1284-7885 surname: Padoan fullname: Padoan, Andrea organization: Department of Laboratory Medicine, University Hospital of Padova, Italy – sequence: 3 givenname: Davide surname: Negrini fullname: Negrini, Davide organization: Department of Medicine-DIMED, University of Padova, Italy – sequence: 4 givenname: Benedetta surname: Carpinteri fullname: Carpinteri, Benedetta organization: Department of Medicine-DIMED, University of Padova, Italy – sequence: 5 givenname: Laura orcidid: 0000-0003-3156-1399 surname: Sciacovelli fullname: Sciacovelli, Laura organization: Department of Laboratory Medicine, University Hospital of Padova, Italy
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Keywords	COVID-19 Antibodies Clinical performances SARS-CoV-2
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Snippet	•Serological assays for SARS-CoV-2 are widely available.•Data on diagnostic sensitivity, specificity and likelihood ratio are needed.•The identification of... The evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibody (Ab) assay performances is of the utmost importance in... • Serological assays for SARS-CoV-2 are widely available. • Data on diagnostic sensitivity, specificity and likelihood ratio are needed. • The identification...
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SubjectTerms	Adolescent Adult Aged Aged, 80 and over Antibodies Betacoronavirus - isolation & purification Child Clinical performances Coronavirus Infections - blood Coronavirus Infections - diagnosis COVID-19 Enzyme-Linked Immunosorbent Assay - methods Enzyme-Linked Immunosorbent Assay - standards Female Humans Male Middle Aged Pandemics Pneumonia, Viral - blood Pneumonia, Viral - diagnosis Reproducibility of Results Reverse Transcriptase Polymerase Chain Reaction - methods Reverse Transcriptase Polymerase Chain Reaction - standards SARS-CoV-2 Serologic Tests - methods Serologic Tests - standards Young Adult
Title	Diagnostic performances and thresholds: The key to harmonization in serological SARS-CoV-2 assays?
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