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Article ; Online: Clinical Performance of a Novel LIAISON Fecal Calprotectin Assay for Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome.

Campbell, James P / Zierold, Claudia / Rode, Ashli M / Blocki, Frank A / Vaughn, Byron P

2020 Volume 55, Issue 3, Page(s) 239–243

Abstract: Goal: The goal of this study was to assess the clinical performance of an investigational in vitro fecal calprotectin immunoassay for differentiating inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS).: Background: Fecal ... ...

Abstract	Goal: The goal of this study was to assess the clinical performance of an investigational in vitro fecal calprotectin immunoassay for differentiating inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS). Background: Fecal calprotectin is a stool biomarker that can assist in the detection of intestinal inflammation and is utilized to identify individuals who have a higher chance of having IBD and who require further invasive tests. Current assays exhibit variable performance. Materials and methods: This study was a multicenter, cross-sectional analysis of prospectively collected stool samples from patients 4 years of age or older who presented with gastrointestinal (GI) symptoms and underwent colonoscopy for diagnostic confirmation. IBD was diagnosed based on clinical, endoscopic, and histologic findings. IBS was diagnosed based on Rome III Criteria and negative colonoscopy. Stool samples were extracted and tested on the DiaSorin LIAISON XL using the LIAISON Calprotectin Assay. Results: A total of 240 patients (67% female) were included in the study. In total, 102 patients had IBD (54% ulcerative colitis), 67 had IBS, and 71 had other GI disorders. Median fecal calprotectin levels were significantly higher in patients with IBD [522 μg/g; 95% confidence interval (CI): 354-970 μg/g] compared with IBS (34.5 μg/g; 95% CI: 19.7-44.2 μg/g, P<0.001) and other GI disorders (28.6 μg/g; 95% CI: 18.7-40.3 μg/g, P<0.001). Receiver operating characteristic curve analysis indicated a fecal calprotectin cutoff of 94 μg/g for distinguishing IBD from other GI disorders with an area under the curve of 0.964 (sensitivity=92.2%, specificity=88.4%). Conclusion: The automated LIAISON Calprotectin assay brings efficient calprotectin testing to the laboratory with a time to the first result of 35 minutes and is a sensitive marker for distinguishing IBD from IBS with a cutoff of ∼100 μg/g.
MeSH term(s)	Biomarkers ; Colitis, Ulcerative/diagnosis ; Cross-Sectional Studies ; Feces ; Female ; Humans ; Inflammatory Bowel Diseases/diagnosis ; Irritable Bowel Syndrome/diagnosis ; Leukocyte L1 Antigen Complex ; Male
Chemical Substances	Biomarkers ; Leukocyte L1 Antigen Complex
Language	English
Publishing date	2020-04-06
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	448460-5
ISSN	1539-2031 ; 0192-0790
ISSN (online)	1539-2031
ISSN	0192-0790
DOI	10.1097/MCG.0000000000001359
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Article ; Online: GFR-Specific versus GFR-Agnostic Cutoffs for Parathyroid Hormone and Fibroblast Growth Factor-23 in Advanced Chronic Kidney Disease.

Canney, Mark / Djurdjev, Ognjenka / Tang, Mila / Zierold, Claudia / Blocki, Frank / Wolf, Myles / Levin, Adeera

American journal of nephrology

2019 Volume 50, Issue 2, Page(s) 105–114

Abstract: Background: In the majority of patients with advanced chronic kidney disease (CKD), values of parathyroid hormone (PTH1-84) and fibroblast growth factor 23 (FGF-23) exceed the normal reference range, potentially as an appropriate adaptation to reduced ... ...

Abstract	Background: In the majority of patients with advanced chronic kidney disease (CKD), values of parathyroid hormone (PTH1-84) and fibroblast growth factor 23 (FGF-23) exceed the normal reference range, potentially as an appropriate adaptation to reduced glomerular filtration rate (GFR). We tested whether GFR-specific cutoffs for PTH1-84 and FGF-23 could better identify patients with inappropriately high PTH1-84 and FGF-23 for their degree of CKD and thereby improve prognostication of clinical outcomes compared to a uniform threshold. Methods: Prospective pan-Canadian cohort of 1,812 patients with mean estimated GFR (eGFR) 28.9 mL/min/1.73 m2 followed for a median of 52 months. Repeated log-rank tests were used to identify optimal cutoffs for PTH1-84 and FGF-23 within eGFR strata (<20, 20-29 and ≥30 mL/min/1.73 m2) that maximally differentiated high- and low-risk populations for (1) cardiovascular (CV) events (fatal or nonfatal myocardial infarction, coronary revascularization, stroke, heart failure) and (2) renal events (initiation of chronic renal replacement therapy). In multivariable models, we examined the association between -GFR-specific cutoffs and outcomes and compared their added prognostic value to existing uniform thresholds. Results: Risk-based cutoffs for PTH1-84 and FGF-23 increased in a graded fashion with decreasing eGFR. Among patients with eGFR <20 mL/min/1.73 m2, CV risk-based cutoffs for PTH1-84 and FGF-23 were 3.4 and 5.5 times the upper limit of normal, respectively, and reclassified 31.9 and 35.1% of patients when added to a multivariable base model for CV events. In contrast, the addition of PTH1-84 and FGF-23 to the base model using uniform cutoffs failed to reclassify such patients. Similar findings were demonstrated for renal outcomes. Conclusion: GFR-specific risk-based cutoffs for PTH1-84 and FGF-23 may facilitate more meaningful risk stratification in advanced CKD than current GFR-agnostic reference ranges derived from healthy adults. This may be most applicable in those with severely reduced GFR.
MeSH term(s)	Aged ; Aged, 80 and over ; Canada ; Chronic Kidney Disease-Mineral and Bone Disorder/blood ; Chronic Kidney Disease-Mineral and Bone Disorder/diagnosis ; Chronic Kidney Disease-Mineral and Bone Disorder/etiology ; Chronic Kidney Disease-Mineral and Bone Disorder/physiopathology ; Disease Progression ; Female ; Fibroblast Growth Factors/blood ; Glomerular Filtration Rate/physiology ; Humans ; Male ; Middle Aged ; Parathyroid Hormone/blood ; Prognosis ; Prospective Studies ; Reference Values ; Renal Insufficiency, Chronic/blood ; Renal Insufficiency, Chronic/complications ; Renal Insufficiency, Chronic/diagnosis ; Renal Insufficiency, Chronic/physiopathology ; Risk Assessment/methods ; Severity of Illness Index
Chemical Substances	Parathyroid Hormone ; Fibroblast Growth Factors (62031-54-3) ; fibroblast growth factor 23 (7Q7P4S7RRE)
Language	English
Publishing date	2019-06-25
Publishing country	Switzerland
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	604540-6
ISSN	1421-9670 ; 0250-8095
ISSN (online)	1421-9670
ISSN	0250-8095
DOI	10.1159/000501189
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Article: 1,25-dihydroxyvitamin D as Predictor of Renal Worsening Function in Chronic Kidney Disease. Results From the PASCaL-1,25D Study.

Galassi, Andrea / Fasulo, Eliana Maria / Ciceri, Paola / Casazza, Roberta / Bonelli, Fabrizio / Zierold, Claudia / Calleri, Mariella / Blocki, Frank A / Palmieri, Maria Assunta / Mastronardo, Claudio / Cozzolino, Mario G

Frontiers in medicine

2022 Volume 9, Page(s) 840801

Abstract: Background: Heterogeneous progression of chronic kidney disease (CKD) toward dialysis advocates improving in renal care management. Diagnosis and staging of CKD relies on estimated glomerular filtration rate (eGFR) and albuminuria. Tubular biomarkers ... ...

Abstract	Background: Heterogeneous progression of chronic kidney disease (CKD) toward dialysis advocates improving in renal care management. Diagnosis and staging of CKD relies on estimated glomerular filtration rate (eGFR) and albuminuria. Tubular biomarkers emerged as new predictors of worsening renal function (WRF), due to partial inaccuracy of eGFR and existing WRF in non-proteinuric patients. Active vitamin D is synthesized in renal tubules and participates to mineral adaptation in CKD. Circulating 1,25-dihydroxyvitamin D [1,25(OH) Objective: Investigate capability of 1,25(OH) Methods: PASCaL-1,25D was an observational, prospective, monocentric study. Primary outcomes were absolute and 20% increase in PTH, and WRF defined as 20% reduction in eGFR or dialysis initiation at 6 months. Results: Seventy-one patients completed follow up. Absolute increase in PTH (1-84) was independently predicted by lower 1,25(OH) Conclusion: 1,25(OH)
Language	English
Publishing date	2022-03-02
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2022.840801
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Article ; Online: LIAISON<sup>®</sup> Calprotectin for the prediction of relapse in quiescent ulcerative colitis: The EuReCa study.

Fiorino, Gionata / Danese, Silvio / Peyrin-Biroulet, Laurent / Sans, Miquel / Bonelli, Fabrizio / Calleri, Mariella / Zierold, Claudia / Pollastro, Roberta / Moretti, Fabio / Malesci, Alberto

United European gastroenterology journal

2022 Volume 10, Issue 8, Page(s) 836–843

Abstract: Introduction: Fecal calprotectin (FC) is established as a diagnostic marker to differentiate between inflammatory bowel diseases and non-inflammatory conditions. Furthermore, it may be effective in monitoring response to treatment, and to predict ... ...

Abstract	Introduction: Fecal calprotectin (FC) is established as a diagnostic marker to differentiate between inflammatory bowel diseases and non-inflammatory conditions. Furthermore, it may be effective in monitoring response to treatment, and to predict relapse during maintenance therapy. Design: This was a prospective longitudinal study carried out in Italy, France and Spain. The primary objective was to correlate the LIAISON<sup>®</sup> Calprotectin assay measurements to quiescent ulcerative colitis (UC) or relapse as assessed by clinical data. Patients were assessed every 3 months for 12 months, and at 18 months. Results: The last FC measured prior to relapse was the variable that predicted relapse in a statistically significant manner. With a 62.3 μg/g cut-off the area under the curve was 0.619, and the sensitivity was 62.9% (95% Confidence Interval [CI] 44.9%-78.5%) and specificity 63.0% (95% CI 53.1%-72.1%). Using machine learning methods, the last FC measurement was shown to have the largest impact in predicting relapse. An algorithm was developed that included other variables available following a clinician's visit, which resulted in an area under the curve of 0.754 for predicting relapse. Conclusion: In the present study FC measured by the LIAISON<sup>®</sup> Calprotectin assay on the visit before relapse is predictive of relapse in patients with quiescent UC. In a proof of concept, the accuracy of prediction can further be improved including other variables in an algorithm developed by machine learning. Trial registration: The trial is registered at clinicaltrials.gov with reference number NCT05168917.
MeSH term(s)	Biomarkers ; Colitis, Ulcerative/diagnosis ; Colitis, Ulcerative/drug therapy ; Feces ; Humans ; Leukocyte L1 Antigen Complex ; Longitudinal Studies ; Prospective Studies ; Recurrence
Chemical Substances	Biomarkers ; Leukocyte L1 Antigen Complex
Language	English
Publishing date	2022-07-04
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2728585-6
ISSN	2050-6414 ; 2050-6406
ISSN (online)	2050-6414
ISSN	2050-6406
DOI	10.1002/ueg2.12268
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Article ; Online: Clinical Performance of the Automated LIAISON® Meridian

Opekun, Antone R / Zierold, Claudia / Rode, Ashli / Blocki, Frank A / Fiorini, Giulia / Saracino, Ilaria Maria / Vaira, Dino / Sutton, Fred M

BioMed research international

2020 Volume 2020, Page(s) 7189519

Abstract: Background: Antigens derived from : Methods: This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February ...

Abstract	Background: Antigens derived from Methods: This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. Results: 277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen's kappa = 0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV. Conclusion: The automated LIAISON® Meridian
MeSH term(s)	Adult ; Aged ; Antigens, Bacterial/analysis ; Biopsy ; Feces/microbiology ; Female ; Helicobacter Infections/diagnosis ; Helicobacter Infections/immunology ; Helicobacter pylori/immunology ; Humans ; Immunoenzyme Techniques/methods ; Male ; Middle Aged ; Prospective Studies ; Reproducibility of Results ; Sensitivity and Specificity ; Urease ; Young Adult
Chemical Substances	Antigens, Bacterial ; Urease (EC 3.5.1.5)
Language	English
Publishing date	2020-03-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	2698540-8
ISSN	2314-6141 ; 2314-6133
ISSN (online)	2314-6141
ISSN	2314-6133
DOI	10.1155/2020/7189519
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Article ; Online: In defense of aldosterone measurement by immunoassay: a broader perspective.

Blocki, Frank / Zierold, Claudia / Olson, Greg / Seeman, Jeremy / Cummings, Steve / Bonelli, Fabrizio

Clinical chemistry and laboratory medicine

2017 Volume 55, Issue 4, Page(s) e87–e89

MeSH term(s)	Aldosterone ; Biological Assay ; Humans ; Immunoassay
Chemical Substances	Aldosterone (4964P6T9RB)
Language	English
Publishing date	2017--01
Publishing country	Germany
Document type	Letter ; Comment
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2016-0707
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Article: GFR-Specific versus GFR-Agnostic Cutoffs for Parathyroid Hormone and Fibroblast Growth Factor-23 in Advanced Chronic Kidney Disease

Canney, Mark / Djurdjev, Ognjenka / Tang, Mila / Zierold, Claudia / Blocki, Frank / Wolf, Myles / Levin, Adeera

American Journal of Nephrology

2019 Volume 50, Issue 2, Page(s) 105–114

Abstract: Background: In the majority of patients with advanced chronic kidney disease (CKD), values of parathyroid hormone (PTH1–84) and fibroblast growth factor 23 (FGF-23) exceed the normal reference range, potentially as an appropriate adaptation to reduced ... ...

Institution	Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada BC Renal Agency, Analytics, Vancouver, British Columbia, Canada Nephrology Research, St. Paul’s Hospital, Vancouver, British Columbia, Canada Diasorin Inc., Scientific Affairs, Stillwater, Minnesota, USA Division of Nephrology, Department of Medicine, Duke University School of Medicine, and Duke Clinical Research Institute, Durham, North Carolina, USA
Abstract	Background: In the majority of patients with advanced chronic kidney disease (CKD), values of parathyroid hormone (PTH1–84) and fibroblast growth factor 23 (FGF-23) exceed the normal reference range, potentially as an appropriate adaptation to reduced glomerular filtration rate (GFR). We tested whether GFR-specific cutoffs for PTH1–84 and FGF-23 could better identify patients with inappropriately high PTH1–84 and FGF-23 for their degree of CKD and thereby improve prognostication of clinical outcomes compared to a uniform threshold. Methods: Prospective pan-Canadian cohort of 1,812 patients with mean estimated GFR (eGFR) 28.9 mL/min/1.73 m<sup>2</sup> followed for a median of 52 months. Repeated log-rank tests were used to identify optimal cutoffs for PTH1–84 and FGF-23 within eGFR strata (<20, 20–29 and ≥30 mL/min/1.73 m<sup>2</sup>) that maximally differentiated high- and low-risk populations for (1) cardiovascular (CV) events (fatal or nonfatal myocardial infarction, coronary revascularization, stroke, heart failure) and (2) renal events (initiation of chronic renal replacement therapy). In multivariable models, we examined the association between GFR-specific cutoffs and outcomes and compared their added prognostic value to existing uniform thresholds. Results: Risk-based cutoffs for PTH1–84 and FGF-23 increased in a graded fashion with decreasing eGFR. Among patients with eGFR <20 mL/min/1.73 m<sup>2</sup>, CV risk-based cutoffs for PTH1–84 and FGF-23 were 3.4 and 5.5 times the upper limit of normal, respectively, and reclassified 31.9 and 35.1% of patients when added to a multivariable base model for CV events. In contrast, the addition of PTH1–84 and FGF-23 to the base model using uniform cutoffs failed to reclassify such patients. Similar findings were demonstrated for renal outcomes. Conclusion: GFR-specific risk-based cutoffs for PTH1–84 and FGF-23 may facilitate more meaningful risk stratification in advanced CKD than current GFR-agnostic reference ranges derived from healthy adults. This may be most applicable in those with severely reduced GFR.
Keywords	Chronic kidney disease ; Fibroblast growth factor 23 ; Glomerular filtration rate ; Outcomes ; Parathyroid hormone
Language	English
Publishing date	2019-06-25
Publisher	S. Karger AG
Publishing place	Basel, Switzerland
Document type	Article
Note	Patient-Oriented, Translational Research: Research Article
ZDB-ID	604540-6
ISSN	1421-9670 ; 0250-8095
ISSN (online)	1421-9670
ISSN	0250-8095
DOI	10.1159/000501189
Database	Karger publisher's database

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Article ; Online: Trueness, precision and stability of the LIAISON 1-84 parathyroid hormone (PTH) third-generation assay: comparison to existing intact PTH assays.

Valcour, Andre / Zierold, Claudia / Blocki, Frank A / Hawkins, Douglas M / Martin, Kevin J / Rao, Sudhaker D / Bonelli, Fabrizio

Clinical chemistry and laboratory medicine

2018 Volume 56, Issue 9, Page(s) 1476–1482

Abstract: Background: Over the past few decades, parathyroid hormone (PTH) immunoassays have progressed through successive generations resulting in increased specificity and accuracy for detecting circulating PTH. With the introduction of third-generation assays, ...

Abstract	Background: Over the past few decades, parathyroid hormone (PTH) immunoassays have progressed through successive generations resulting in increased specificity and accuracy for detecting circulating PTH. With the introduction of third-generation assays, in which the biologically active PTH(1-84) is specifically targeted, the PTH(7-84) and other fragments are not detected. The specific recognition of only PTH(1-84) whole molecule allows for more reliable standardization and calibration than with the existing assays. Methods: Samples from patients on hemodialysis or with primary hyperparathyroidism and apparently healthy subjects were examined in different collection matrices (EDTA plasma, unspun EDTA plasma and SST) stored for 0, 24 or 72 h at room temperature to reflect the prevailing sample collection methods, shipping and processing conditions of centralized labs in the United States. Samples were analyzed by the LIAISON 1-84 PTH and N-TACT assays, and by three additional commercially available intact PTH assays. Results: Defined samples, prepared using two different standards (WHO 95/646 international standard and the synthetic Bachem PTH(1-84)), show little bias with the LIAISON 1-84 PTH assay, but not with the other intact PTH assays. Furthermore, PTH is stable for up to 72 h in plasma, but less stable in serum beyond 24 h. Conclusions: The FDA-approved LIAISON 1-84 PTH assay is accurate and reliably measures the biologically active PTH molecule in plasma or serum stored at room temperature for up 72 and 24 h, respectively.
MeSH term(s)	Humans ; Hyperparathyroidism, Primary/pathology ; Immunoassay/methods ; Immunoassay/standards ; Parathyroid Hormone/blood ; Parathyroid Hormone/standards ; Reagent Kits, Diagnostic ; Reference Standards ; Renal Insufficiency, Chronic/pathology ; Reproducibility of Results ; Temperature
Chemical Substances	Parathyroid Hormone ; Reagent Kits, Diagnostic
Language	English
Publishing date	2018-05-10
Publishing country	Germany
Document type	Comparative Study ; Journal Article
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2018-0217
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Article ; Online: Validation of a novel, rapid, high precision sclerostin assay not confounded by sclerostin fragments.

Drake, Matthew T / Fenske, Jennifer S / Blocki, Frank A / Zierold, Claudia / Appelman-Dijkstra, Natasha / Papapoulos, Socrates / Khosla, Sundeep

Bone

2018 Volume 111, Page(s) 36–43

Abstract: Sclerostin is a 190 amino acid protein secreted primarily by osteocytes. It was initially identified due to mutations in the SOST gene associated with high bone mass phenotypes. Much recent work has sought to determine the importance of sclerostin across ...

Abstract	Sclerostin is a 190 amino acid protein secreted primarily by osteocytes. It was initially identified due to mutations in the SOST gene associated with high bone mass phenotypes. Much recent work has sought to determine the importance of sclerostin across an array of conditions which affect the human skeleton. However, accurate measurement of sclerostin from serum and plasma sources remains a significant impediment, with currently available commercial assays showing marked differences in measured sclerostin values. Accordingly, sclerostin assay standardization remains an important but unmet need before sclerostin measurements can be used for the clinical management of bone disease. Here we characterize a novel automated chemiluminescent sclerostin assay (LIAISON®, DiaSorin) which overcomes many of these limitations. Important assay characteristics include: a wide dynamic range (50-6500pg/mL); high intra- (<2.5%) and inter- (<5%) assay precision; matched serum and plasma equivalence (<10% difference); specificity for the intact sclerostin molecule; and rapid assay results. Serum sclerostin levels measured with the LIAISON® assay in a population-based sample of adult men (n=278) and women (n=348) demonstrated that sclerostin levels were significantly higher in men as compared to women and were positively associated with age in both sexes, consistent with previously published work. In postmenopausal women, serum sclerostin levels measured with the LIAISON® assay were reduced in response to treatment with either estrogen or teriparatide, again consistent with previous findings. Collectively, the above data demonstrate that the LIAISON® sclerostin assay provides a reliable tool for more confident assessment of emergent mechanisms wherein sclerostin may impact a number of bone related pathologies.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Bone Density ; Bone Morphogenetic Proteins/analysis ; Bone Morphogenetic Proteins/blood ; Female ; Genetic Markers ; Humans ; Luminescent Measurements/methods ; Luminescent Measurements/standards ; Male ; Middle Aged ; Osteocytes/cytology ; Osteocytes/metabolism ; Osteoporosis, Postmenopausal/blood
Chemical Substances	Bone Morphogenetic Proteins ; Genetic Markers ; SOST protein, human
Language	English
Publishing date	2018-03-14
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Validation Studies
ZDB-ID	632515-4
ISSN	1873-2763 ; 8756-3282
ISSN (online)	1873-2763
ISSN	8756-3282
DOI	10.1016/j.bone.2018.03.013
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Article ; Online: Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively.

Bonelli, Fabrizio / Sarasini, Antonella / Zierold, Claudia / Calleri, Mariella / Bonetti, Alice / Vismara, Chiara / Blocki, Frank A / Pallavicini, Luca / Chinali, Alberto / Campisi, Daniela / Percivalle, Elena / DiNapoli, Anna Pia / Perno, Carlo Federico / Baldanti, Fausto

Journal of clinical microbiology

2020 Volume 58, Issue 9

Abstract: In the coronavirus (CoV) disease 2019 (COVID-19) pandemic, highly selective serological testing is essential to define exposure to severe acute respiratory syndrome CoV 2 (SARS-CoV-2). Many tests have been developed, yet with variable speeds to first ... ...

Abstract	In the coronavirus (CoV) disease 2019 (COVID-19) pandemic, highly selective serological testing is essential to define exposure to severe acute respiratory syndrome CoV 2 (SARS-CoV-2). Many tests have been developed, yet with variable speeds to first results, and are of unknown quality, particularly when considering the prediction of neutralizing capacity. The LIAISON SARS-CoV-2 S1/S2 IgG assay was designed to measure antibodies against the SARS-CoV-2 native S1/S2 proteins in a standardized automated chemiluminescence assay. The clinical and analytical performances of the test were validated in an observational study using residual samples (>1,500) with a positive or negative COVID-19 diagnosis. The LIAISON SARS-CoV-2 S1/S2 IgG assay proved to be highly selective and specific and offered semiquantitative measures of serum or plasma levels of anti-S1/S2 IgG with neutralizing activity. The assay's diagnostic sensitivities were 91.3% and 95.7% at >5 or ≥15 days from diagnosis, respectively, and 100% when assessed against a neutralizing assay. The assay's specificity ranged between 97% and 98.5%. The average imprecision of the assay was a <5% coefficient of variation. Assay performance at 2 different cutoffs was evaluated to optimize predictive values. The automated LIAISON SARS-CoV-2 S1/S2 IgG assay brings efficient, sensitive, specific, and precise serological testing to the laboratory, with the capacity to test large amounts of samples per day; first results are available within 35 min, with a throughput of 170 tests/hour. The semiquantitative results provided by the test also associate with the presence of neutralizing antibodies and may provide a useful tool for the large-scale screening of convalescent-phase plasma for safe therapeutic use.
MeSH term(s)	Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Automation, Laboratory ; Betacoronavirus/immunology ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques/methods ; Clinical Laboratory Techniques/standards ; Clinical Laboratory Techniques/statistics & numerical data ; Coronavirus Infections/diagnosis ; Coronavirus Infections/immunology ; Humans ; Immunoglobulin G/blood ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/immunology ; Reproducibility of Results ; SARS-CoV-2 ; Sensitivity and Specificity ; Serologic Tests/methods ; Serologic Tests/standards ; Serologic Tests/statistics & numerical data ; Spike Glycoprotein, Coronavirus/immunology
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Immunoglobulin G ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-08-24
Publishing country	United States
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01224-20
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