Abstract:
OBJECTIVES:Humoral immune response to SARS-CoV-2 infection has been reported in several patient cohorts with results that vary by method and population studied due to the lack of reliable commercial assays available as the pandemic initially spread. We sought to clinically assess commercial prototype SARS-CoV-2 IgG and IgA assays for use in screening for prior infection and convalescent plasma donation. DESIGN AND METHODS:Prototype SARS-CoV-2 IgG and IgA assays from Euroimmun were assessed utilizing remnant specimens. Specificity testing used specimens in their convalescent window for the common coronaviruses and other infectious diseases known to be associated with increased non-specificity in serologic assays. Sensitivity testing utilized serial specimens from molecularly confirmed SARS-CoV-2 critically ill patients to assess seroconversion. Utilizing recombinant spike protein we also developed a competitive confirmation procedure to increase assay specificity. RESULTS:We determined specificity to be 97% and 81%, respectively, when indeterminate samples were considered positive and 99% and 86% when indeterminate samples were considered negative. We developed a new confirmation methodology to enhance the specificity of the assays with an anticipated specificity of 98% for IgA. Valuation of hospitalized COVID-19 patients determined median IgA seroconversion to be 8 days and IgG 10 days. Neither level nor timing of antibody response correlated with days on ventilation. End titer measurements indicate that validated improved assays may be capable of semi-quantitative measurement. CONCLUSIONS:We found these assays to be clinically acceptable for the high prevalence population tested, for instance, for convalescent plasma donation.
journal_name
Clin Biochemjournal_title
Clinical biochemistryauthors
Wheeler SE,Shurin GV,Keetch C,Mitchell G,Kattel G,McBreen J,Shurin MRdoi
10.1016/j.clinbiochem.2020.08.008subject
Has Abstractpub_date
2020-12-01 00:00:00pages
8-14eissn
0009-9120issn
1873-2933pii
S0009-9120(20)30816-Xjournal_volume
86pub_type
杂志文章abstract:OBJECTIVES:The relative proportion in percentage of the isoenzyme A of beta-hexosaminidase (Hex) is the single discriminatory function most frequently used for the biochemical screening of heterozygote Tay-Sachs disease carriers. It has been suggested that the assay of the Hex isoenzymes in homogeneous cell preparation...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2005.05.016
更新日期:2005-10-01 00:00:00
abstract:OBJECTIVES:Measurements of myoglobin and creatine kinase (CK)-MB isoforms have been suggested to be sensitive tests for the early diagnosis of myocardial infarction (MI). We have investigated the utility of myoglobin, creatine kinase (CK)-MB isoforms and creatine kinase MB mass (CK-MBm) in early diagnosis of MI using c...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(02)00385-5
更新日期:2002-11-01 00:00:00
abstract::Autosomal dominant olivopontocerebellar degeneration was evaluated in a family numbering 414 living members. Urine samples were obtained from 5 affected and 5 unaffected not at-risk family members after 4 days on a synthetic diet. 159 urine vapor constituents were measured by gas-liquid and ion-exchange chromatography...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(75)93752-2
更新日期:1975-12-01 00:00:00
abstract:BACKGROUND:The availability of reference intervals is essential for physicians to interpret laboratory results. Most of our laboratory reference intervals are derived from data on the foreign population. We have studied the reference intervals of 24 common laboratory biochemical tests in an apparently healthy adult Han...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2012.06.022
更新日期:2012-10-01 00:00:00
abstract:OBJECTIVES:This study was undertaken to evaluate the relationship between serum bilirubin concentrations and the degree of urinary albumin excretion in hypertensive patients. DESIGN AND METHODS:A total of 120 hypertensive subjects were enrolled, in which 80 (67%) with normoalbuminuria (albumin excretion rate [AER] of ...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2011.03.137
更新日期:2011-07-01 00:00:00
abstract:OBJECTIVES:The liver has tremendous regenerative capacity but can be damaged by toxins, such as ethanol (EtOH). It has long been known that EtOH inhibits liver regeneration. Recent work demonstrates that the proinflammatory cytokine, tumor necrosis factor ( (TNF), is required for normal liver regeneration, as well as f...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(99)00057-0
更新日期:1999-10-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to determine the adult reference values for cystatin C (CysC) and to evaluate their consistence with those reported in the literature. DESIGN AND METHODS:CysC was analyzed in a consecutive series of subjects (100 males and 100 females) by a nephelometric immunoassay. Medline was sea...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2007.05.011
更新日期:2007-09-01 00:00:00
abstract:OBJECTIVE:To evaluate the potential diagnostic value of apolipoprotein E (ApoE) measurements in pediatric patients with invasive bacterial infections. DESIGN AND METHOD:A total of 185 pediatric patients were enrolled in this study, including 94 patients with confirmable infections and 91 patients without confirmable i...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2011.11.009
更新日期:2012-02-01 00:00:00
abstract:OBJECTIVES:In future pig-to-man xenotransplantation it is important to master tools that identify potentially xenogenic alphagalactose (Galalpha) antigens in the doner tissue. DESIGN AND METHODS:We have measured the binding potentials of Galalpha detecting lectins and antibodies, including a naturally occurring subfra...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(03)00120-6
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:Vitamin D-binding protein (DBP) is the main systemic transporter of 1.25(OH)2D3 and is essential for its cellular endocytosis. There are two known polymorphisms in exon 11 of the DBP gene resulting in amino acid variants: GAT-->GAG substitution replaces aspartic acid by glutamic acid in codon 416; and ACG-->...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2004.12.013
更新日期:2005-05-01 00:00:00
abstract::Epidemiological evidence suggests that the ratio HDL-cholesterol (HDL-C)/total cholesterol (TC) or apolipoprotein A1 (apo A1)/apolipoprotein B (apo B) are good indicators of coronary heart disease risk. In investigating the distribution of these ratios in the typical population served by our routine laboratory, we ana...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/0009-9120(92)80004-z
更新日期:1992-10-01 00:00:00
abstract:OBJECTIVES:Pediatric serum samples collected from healthy children in the CALIPER (Canadian Laboratory Initiative in Pediatric Reference Interval) project are stored at -80 °C for various periods of time. This study aimed to determine the stability of chemistry, protein, and hormone analytes under these conditions. DE...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2012.03.029
更新日期:2012-07-01 00:00:00
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journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2009.04.008
更新日期:2009-07-01 00:00:00
abstract:INTRODUCTION:The USA hCG Reference Service has been dealing with cases of persistent low levels of hCG and gestational trophoblastic diseases for 10years. Here we present the complete experience. METHODS:Total hCG in serum and urine was measured using the Siemen's Immulite 1000 assay. Hyperglycosylated hCG, nicked hCG...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2010.05.006
更新日期:2010-08-01 00:00:00
abstract::We describe a patient who received intravenous dimethyl sulphoxide (DMSO) (as part of an experimental protocol) to control increased intracranial pressure. The patient died of a brain abscess. She developed extreme serum hyperosmolality from the DMSO with the osmolality peaking at 717 mosmol/kg. DMSO may induce extrem...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(83)90168-6
更新日期:1983-08-01 00:00:00
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journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2007.12.009
更新日期:2008-04-01 00:00:00
abstract:OBJECTIVE:The purpose of our study was to investigate the serum levels of soluble a-proliferation-inducing ligand (sAPRIL) in patients with colorectal cancer (CRC), benign intestinal disease and healthy volunteers and explore the potential possibility of sAPRIL severing as a CRC biomarker. METHODS:Our investigation wa...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2013.06.008
更新日期:2013-10-01 00:00:00
abstract:BACKGROUND:There is little information on temperature and period of freezing for generating hemolysate and blood cell lysate. MATERIALS AND METHODS:Primary tubes containing whole blood were frozen at -20°C and -80°C and then serially thawed to assess cell lysis and clinical chemistry tests in centrifuged plasma. RESU...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2011.07.015
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVES:To investigate the association between oxidative stress and certain trace elements in the blood of breast cancer patients. DESIGN AND METHODS:Malondialdehyde (MDA) was measured in serum of patients with breast cancer (n = 35) and controls (n = 35) by high performance liquid chromatography. Trace elements we...
journal_title:Clinical biochemistry
pub_type: 临床试验,杂志文章
doi:10.1016/s0009-9120(98)00096-4
更新日期:1999-03-01 00:00:00
abstract:OBJECTIVES:This study examines the redox status of drug-resistant epileptic patients and how it is modified after surgical treatment. DESIGN AND METHODS:The activity of antioxidant enzymes (superoxide dismutase, catalase and glutathione peroxidase), and markers of damage to biomolecules (malondialdehyde and advanced o...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2006.11.019
更新日期:2007-03-01 00:00:00
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journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(00)00162-4
更新日期:2000-10-01 00:00:00
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journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2013.07.014
更新日期:2013-11-01 00:00:00
abstract::Steroids play an important role in sperm production and quality. These hormones have been extensively studied in blood, but poorly investigated in semen. The purpose of our study was to evaluate the relationship between sperm quality and steroid profiles in blood and semen in a small cohort of young Swiss men. Another...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2018.03.008
更新日期:2018-12-01 00:00:00
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journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(79)80125-3
更新日期:1979-12-01 00:00:00
abstract:OBJECTIVES:The aim was to study the influence of sampling time, food intake and sleep on tests used to screen for and monitor conditions of iron deficiency and overload. DESIGN AND METHODS:The 24 h variations of iron, transferrin, transferrin saturation (TS) and ferritin were studied in seven healthy individuals durin...
journal_title:Clinical biochemistry
pub_type: 临床试验,杂志文章
doi:10.1016/j.clinbiochem.2010.08.023
更新日期:2010-11-01 00:00:00
abstract:OBJECTIVES:We previously described a panel of four cytokines biomarkers in knee synovial fluid for acute knee pain associated with meniscal pathology. The cytokine biomarkers included interferon gamma (IFN-gamma), interleukin 6 (IL-6), monocyte chemotactic protein 1 (MCP-1), and macrophage inflammatory protein-1 beta (...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2010.04.069
更新日期:2010-07-01 00:00:00
abstract:OBJECTIVES:To characterize a novel deletion of exon 3 of CFTR gene and to evaluate the implications in Cystic Fibrosis (CF) care and genetic counseling. DESIGN AND METHODS:We performed a wide mutational analysis of CFTR gene, using reverse dot blot, Multiplex Ligation-dependent Probe Amplification (MLPA) assay and Rea...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2011.03.140
更新日期:2011-07-01 00:00:00
abstract::This review discusses the question: which steps are essential or need to be optimized so that maternal plasma RNA sequencing for pre-eclampsia and related syndromes will become as specific and sensitive as maternal plasma DNA sequencing for trisomy? ...
journal_title:Clinical biochemistry
pub_type: 杂志文章,评审
doi:10.1016/j.clinbiochem.2015.03.004
更新日期:2015-10-01 00:00:00
abstract:OBJECTIVE:To develop a tool to assess the clinical accuracy of glucose meter performance using an insulin dosing protocol to assess the frequency and extent of error in insulin dose categories. METHODS:Retrospective comparison of 1815 glucose meter and central laboratory glucose results obtained from 1698 critically i...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2019.06.001
更新日期:2019-08-01 00:00:00
abstract:BACKGROUND:Increased levels of circulating endostatin predicts cardiovascular morbidity and impaired kidney function in the general population. The utility of endostatin as a risk marker for mortality in the emergency department (ED) has not been reported. AIM:Our main aim was to study the association between plasma e...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2019.10.004
更新日期:2020-01-01 00:00:00