Abstract:
:The Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide accurate, reliable detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated sensitivity, specificity, cross-reactivity, and agreement with a vesicular stomatitis virus-based pseudoneutralization assay for the Elecsys Anti-SARS-CoV-2 immunoassay. Sensitivity and agreement between Elecsys Anti-SARS-CoV-2 immunoassay and pseudoneutralization assay measurements were evaluated using samples from patients with PCR-confirmed SARS-CoV-2 infection, a majority of whom were hospitalized. Specificity was evaluated using samples from routine diagnostic testing/blood donors collected before December 2019 and thus deemed negative for SARS-CoV-2-specific antibodies. Cross-reactivity was evaluated using samples containing a wide range of potentially cross-reacting analytes, purchased from commercial vendors. For sensitivity and specificity, point estimates and 95% confidence intervals (CIs) were calculated. Agreement between the Elecsys Anti-SARS-CoV-2 immunoassay and the pseudoneutralization assay was calculated. The sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay in patients with prior PCR-confirmed SARS-CoV-2 infection was 99.5% (95% CI, 97.0 to 100.0%) at ≥14 days post-PCR confirmation. Overall specificity (n = 10,453) was 99.80% (95% CI, 99.69 to 99.88%). Only 4/792 samples containing potential cross-reacting analytes were reactive with the Elecsys Anti-SARS-CoV-2 immunoassay, resulting in an overall specificity in this cohort of 99.5% (95% CI, 98.6 to 99.9%). Positive, negative, and overall agreement (n = 46) between the Elecsys Anti-SARS-CoV-2 immunoassay and the pseudoneutralization assay were 86.4% (95% CI, 73.3 to 93.6%), 100% (95% CI, 34.2 to 100%), and 87.0% (95% CI, 74.3 to 93.9%), respectively. The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated high sensitivity (99.5% at ≥14 days post-PCR confirmation) and specificity (99.80%), supporting its use as a tool for identification of past SARS-CoV-2 infection, including use in populations with low disease prevalence.
journal_name
J Clin Microbioljournal_title
Journal of clinical microbiologyauthors
Muench P,Jochum S,Wenderoth V,Ofenloch-Haehnle B,Hombach M,Strobl M,Sadlowski H,Sachse C,Torriani G,Eckerle I,Riedel Adoi
10.1128/JCM.01694-20subject
Has Abstractpub_date
2020-09-22 00:00:00issue
10eissn
0095-1137issn
1098-660Xpii
JCM.01694-20journal_volume
58pub_type
杂志文章abstract::Sequence detection by the 5' nuclease TaqMan assay uses online detection of internal fluorogenic probes in closed PCR tubes. Primers and probe were chosen from a part of the omlA gene common to all serotypes of Actinobacillus pleuropneumoniae, which gave an amplicon of 92 bp. The test was evaluated with 73 lung isolat...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.39.1.260-265.2001
更新日期:2001-01-01 00:00:00
abstract::Monoclonal antibodies to Staphylococcus aureus capsular polysaccharide types 5 and 8 were used in an enzyme-linked immunosorbent assay to serotype 74 and 42 coagulase-negative isolates from cow and goat milk, respectively. Eighteen (15.5%) isolates were typable: 13 Staphylococcus haemolyticus, 1 S. hyicus, 1 S. simula...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.28.2.358-360.1990
更新日期:1990-02-01 00:00:00
abstract::Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of an ongoing pandemic that has infected over 36 million and killed over 1 million people. Informed implementation of government public health policies depends on accurate data on SARS-CoV-2 immunity at a population scale. We hypothesized that d...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.02204-20
更新日期:2020-12-17 00:00:00
abstract::Levels of hepatitis B virus (HBV) DNA in the blood serve as an important marker in monitoring the disease progression and treatment efficacy of chronic HBV infection. Several commercial assays are available for accurate measurement of HBV genomic DNA, but many of them are hampered by relatively low sensitivity and lim...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.42.8.3438-3440.2004
更新日期:2004-08-01 00:00:00
abstract::Four human coronaviruses (HCoV-229E, HCoV-HKU1, HCoV-NL63, and HCoV-OC43) are associated with a range of respiratory outcomes, including bronchiolitis and pneumonia. Their epidemiologies and clinical characteristics are poorly described and are often reliant on case reports. To address these problems, we conducted a l...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.00636-10
更新日期:2010-08-01 00:00:00
abstract::Coronavirus disease (COVID) serological tests are essential to determine the overall seroprevalence of a population and to facilitate exposure estimates within that population. We performed a head-to-head assessment of enzyme immunoassays (EIAs) and point-of-care lateral flow assays (POCTs) to detect severe acute resp...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.01361-20
更新日期:2020-09-22 00:00:00
abstract::A noncompetitive enzyme-linked immunosorbent assay that enables the quantitation of toxic shock syndrome toxin 1 (TSST-1) to as little as 30 pg/ml and the detection of TSST-1 to 10 pg/ml in phosphate-buffered saline including 33% human serum or plasma was developed. It takes only 3 h to complete this assay after plate...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.32.2.539-542.1994
更新日期:1994-02-01 00:00:00
abstract::The rate of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) has been steadily increasing in countries of the former USSR. The availability of rapid and reliable methods for the detection of drug resistance to second-line drugs is vital for adequate patient management. We evaluated the ...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章,多中心研究
doi:10.1128/JCM.00039-12
更新日期:2012-05-01 00:00:00
abstract::Well-defined Legionella pneumophila strains were analyzed by amplification of variable genomic regions with arbitrary and repeat sequence primers. Clinical and environmental outbreak-related isolates showed closely related amplicon patterns. Eleven strains of unrelated origins displayed 10 distinct patterns. Fingerpri...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.31.8.2198-2200.1993
更新日期:1993-08-01 00:00:00
abstract::Beagle dogs inoculated intravenously with 1.75 x 10(9) viable Encephalitozoon cuniculi spores at 12.5 months of age were monitored for 18 months to assess infection in the adult dog. Parameters monitored included packed cell volume, total and differential leukocyte counts, and humoral and cellular responses to infecti...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.26.3.557-563.1988
更新日期:1988-03-01 00:00:00
abstract::A case of tick-borne encephalitis (TBE) has not been reported for many years in Japan, although a serological survey of sera from domestic animals suggested the presence of TBE foci in Hokkaido, the northern island of Japan. Studies were conducted to prove the presence of an endemic focus of TBE virus in Japan by mean...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.35.8.1943-1947.1997
更新日期:1997-08-01 00:00:00
abstract::A method is described for the routine preparation of sputum samples for detection of Mycobacterium tuberculosis by using polymerase chain reaction amplification. Liquefaction of sputum samples with NaOH and subsequent removal of inhibitors of the polymerase reaction with a 50% sucrose centrifugation step (5 min) in a ...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.30.6.1514-1517.1992
更新日期:1992-06-01 00:00:00
abstract::A fully automated microparticle enzyme immunoassay (EIA), IMx Core, was developed for the detection of antibody against hepatitis B core antigen (anti-HBc). IMx Core sensitivity was less than 0.5 Paul Ehrlich Institut units per ml and was greater than that of the commercial radioimmunoassay (RIA) or EIA, Corab and Cor...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.29.3.611-616.1991
更新日期:1991-03-01 00:00:00
abstract::Molecular methodologies were used to identify 28 Achromobacter spp. from patients with cystic fibrosis (CF). Multilocus sequence typing (MLST) identified 17 Achromobacter xylosoxidans isolates (all bla(OXA-114) positive), nine Achromobacter ruhlandii isolates (all bla(OXA-114) positive), one Achromobacter dolens isola...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.02197-15
更新日期:2015-12-01 00:00:00
abstract::Hepatitis C virus (HCV) infection typically leads to antibody response within weeks after primary infection. Here, we describe the case of a child infected with HCV by mother-to-child transmission who remained persistently seronegative despite the presence of high levels of circulating HCV RNA. ...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.00622-12
更新日期:2012-07-01 00:00:00
abstract::The Lyme disease-associated spirochete, Borrelia burgdorferi, is maintained in enzootic cycles involving Ixodes ticks and small mammals. Previous studies demonstrated that B. burgdorferi expresses outer surface protein A (OspA) but not OspC when residing in the midgut of unfed ticks. However, after ticks feed on blood...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:
更新日期:2000-01-01 00:00:00
abstract::The description and evaluation of a PCR-based assay for the detection and species identification of the eight known human herpesviruses are presented. Two primer pairs targeting well-conserved regions of the genome allowed the amplification of the DNAs of all known human herpesviruses at a high level of sensitivity (1...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.38.9.3274-3279.2000
更新日期:2000-09-01 00:00:00
abstract::Despite advances in the standardization of quantitative DNAemia tests and efforts to better understand and characterize the performance of reference materials in different assays, it remains unclear how the commutability performance of reference materials is related to intra- and interassay agreement. Building upon pr...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.00963-18
更新日期:2019-01-02 00:00:00
abstract::The genetic compositions of 71 isoniazid-resistant Mycobacterium tuberculosis strains from Poland were determined by spoligotyping. Nearly 80% of the isolates belonged to either the T or the Haarlem family. The genotypic diversity was largely due to variation within those families. The scarcity of imported genotypes s...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.01315-08
更新日期:2008-12-01 00:00:00
abstract::The emergence of ciprofloxacin-resistant Salmonella enterica serovar Choleraesuis in recent years has become an important public health issue in Taiwan. The resistant strains that cause human infections are considered to be from pigs. In this study, we characterized 157 swine and 42 human Salmonella serovar Choleraesu...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.43.6.2798-2804.2005
更新日期:2005-06-01 00:00:00
abstract::Viral load testing for cytomegalovirus (CMV) has become the standard for the diagnosis of infection and monitoring of therapy at many transplant centers. However, no viral load test has been approved by the FDA. Therefore, many laboratories rely on laboratory-developed assays. This study evaluated the performance char...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.02558-06
更新日期:2007-06-01 00:00:00
abstract::The performance of four media for the isolation of Aeromonas strains from stool specimens, the importance of ampicillin-susceptible Aeromonas strains in the selection of culture media, and the usefulness of beta-hemolysis in screening blood-containing media for Aeromonas strains were evaluated in two phases. In the fi...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.26.9.1738-1740.1988
更新日期:1988-09-01 00:00:00
abstract::Conserved primers were used to PCR amplify 95% of the Helicobacter hepaticus 16S rRNA gene. Its sequence was determined and aligned to those of related bacteria, enabling the selection of primers to highly diverged regions of the 16S rRNA gene and an oligonucleotide probe for the development of a PCR-liquid hybridizat...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.33.5.1344-1347.1995
更新日期:1995-05-01 00:00:00
abstract::VlsE, the variable surface antigen of Borrelia burgdorferi, contains an immunodominant conserved region named IR(6). In the present study, the diagnostic performance of a peptide enzyme-linked immunosorbent assay (ELISA) based on a 26-mer synthetic peptide (C(6)) with the IR(6) sequence was explored. Sensitivity was a...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.37.12.3990-3996.1999
更新日期:1999-12-01 00:00:00
abstract::Indirect hemagglutinating and immunofluorescent antibody responses to Herpesvirus hominis types 1 and 2 were compared to neutralizing antibody responses in infected humans from whom H. hominis type 1 or 2 was isolated. The indirect immunofluorescent antibody test was shown to be the most sensitive and specific for pri...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:
更新日期:1979-03-01 00:00:00
abstract::Iodophor and alcohol pledgets were compared with the Medi-Flex Prep Kit II for skin disinfection before venipuncture. Of 12,367 blood cultures collected, 6,362 were done with conventional pledgets and 6, 005 were done with Medi-Flex kits. Contamination occurred in 351 of 6,362 blood cultures (5.5%; range, 3.7 to 8.1%)...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.38.12.4665-4667.2000
更新日期:2000-12-01 00:00:00
abstract::Yersinia enterocolitica serovar O:3 bacteria with and without plasmid-encoded proteins were compared as antigens in an enzyme-linked immunosorbent assay. Good correlations between the two antigen preparations were obtained for immunoglobulin M (IgM), IgG, and IgA antibodies of patients with yersiniosis. For routine di...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.27.3.583-585.1989
更新日期:1989-03-01 00:00:00
abstract::A novel PCR detection assay that amplifies the Helicobacter pylori-specific vacuolating cytotoxin gene (vacA) and thus enables rapid diagnosis of infection is described. Additionally, a real-time probe hybridization melting point analysis assay to detect all three mutations in the 23S rRNA gene associated with clarith...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.39.4.1217-1220.2001
更新日期:2001-04-01 00:00:00
abstract::In this study, we compared a recently developed PCR-restriction fragment length polymorphism (PCR-RFLP) assay with pulsed-field gel electrophoresis (PFGE) using three different Shiga toxin-producing Escherichia coli (STEC) strains to understand whether repeated subculture in vitro and prolonged storage at room tempera...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.00717-06
更新日期:2006-11-01 00:00:00
abstract::Eight Staphylococcus aureus strains initially identified by Vitek GPS-BS or GPS-SA cards as resistant to oxacillin, but susceptible to most non-beta-lactam antibiotics, were found on further testing to be susceptible to oxacillin and ceftizoxime by disk diffusion tests. For all these strains, the MICs of oxacillin wer...
journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.37.5.1619-1620.1999
更新日期:1999-05-01 00:00:00