scholarly journals Evaluation of a Rapid Immunochromatographic Assay and Two Enzyme-Linked Immunosorbent Assays for Detection of IgM-Class Antibodies to Zika Virus

2018 ◽  
Vol 57 (3) ◽  
Author(s):  
Dane Granger ◽  
Elitza S. Theel
Keyword(s):  
West Nile Virus ◽  
Dengue Virus ◽  
Drug Administration ◽  
Immunosorbent Assay ◽  
Zika Virus ◽  
Neutralizing Antibodies ◽  
Food And Drug Administration ◽  
Immunochromatographic Assay ◽  
Enzyme Linked Immunosorbent Assay ◽  
Antibody Capture

ABSTRACT There are currently five serologic assays available for detection of anti-Zika virus (ZIKV) IgM-class antibodies with U.S. Food and Drug Administration emergency use authorization. Among these are the Chembio DPP Zika IgM system (DPP Zika ICA; Chembio, Medford, NY), a rapid immunochromatographic assay (ICA), and the InBios ZIKV Detect 2.0 IgM antibody capture enzyme-linked immunosorbent assay (ZIKV 2.0 MAC-ELISA; InBios international, Inc., Seattle, WA), which has replaced the original InBios ZIKV Detect MAC-ELISA. We evaluated performance of these three serologic assays using 72 specimens characterized by plaque reduction neutralization testing (PRNT) for the presence or absence of neutralizing antibodies (NAbs) to ZIKV, dengue virus (DENV), and West Nile virus (WNV). The InBios ZIKV 2.0 MAC-ELISA was “presumptive Zika positive” in all 15 PRNT-confirmed ZIKV samples, while the Chembio DPP Zika ICA was nonreactive in three (20%) and the InBios ZIKV MAC-ELISA was negative in four (27%). The Chembio DPP Zika ICA and InBios ZIKV 2.0 MAC-ELISA showed >95% specificity in 22 ZIKV/DENV-seronegative specimens and in 13 samples positive for NAbs to non-ZIKV flaviviruses. Comparatively, the InBios ZIKV MAC-ELISA was “presumptive” or “possible Zika positive” in 8 of 12 WNV or DENV PRNT-positive samples and in 12 of 22 PRNT-seronegative sera. Our findings suggest that replacement of the InBios ZIKV MAC-ELISA with the InBios ZIKV 2.0 MAC-ELISA will lead to fewer samples requiring PRNT, minimizing unnecessary anxiety among patients ultimately determined to be seronegative for ZIKV and DENV by PRNT and alleviating some of the testing burden on laboratories performing PRNT.

scholarly journals Evaluation of Euroimmun Anti-Zika Virus IgM and IgG Enzyme-Linked Immunosorbent Assays for Zika Virus Serologic Testing

2017 ◽  
Vol 55 (8) ◽  
pp. 2462-2471 ◽  
Author(s):  
Arnaud G. L'Huillier ◽  
Anne Hamid-Allie ◽  
Erik Kristjanson ◽  
Louis Papageorgiou ◽  
Sam Hung ◽  
...  
Keyword(s):  
Public Health ◽  
Immunosorbent Assay ◽  
Zika Virus ◽  
Neutralization Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Convenience Sample ◽  
Plaque Reduction Neutralization Test ◽  
Serologic Diagnosis ◽  
Serologic Testing ◽  
Antibody Capture

ABSTRACTWith the emerging Zika virus (ZIKV) epidemic, serologic diagnosis relies on a labor-intensive IgM antibody capture enzyme-linked immunosorbent assay (MAC-ELISA) and confirmation by a plaque reduction neutralization test (PRNT). To streamline serologic testing, several commercial assays have been developed. Our aim was to compare the commercial Euroimmun anti-ZIKV IgM and IgG assays to the reference MAC-ELISA and PRNT currently in use. Serum specimens submitted to Public Health Ontario Laboratory, Canada, were tested for IgM and IgG using the Euroimmun assays and the results were compared with those from MAC-ELISA. The PRNT was performed on positive or equivocal specimens using either MAC-ELISA or Euroimmun assays, MAC-ELISA-inconclusive specimens, and a convenience sample of specimens negative by both assays (cohort 1). Another set of specimens selected on the basis of PRNT results was subsequently tested by the Euroimmun assays (cohort 2). MAC-ELISA was positive, equivocal, negative, and inconclusive in 57/223, 15/223, 147/223, and 4/223 specimens, respectively. Among the 76 specimens that were MAC-ELISA positive, equivocal, or inconclusive, 30 (39.5%) were Euroimmun IgM and/or IgG positive or equivocal. Among the 147 MAC-ELISA-negative specimens, 136 (92.5%) were Euroimmun IgM and IgG negative. The sensitivity of the combined Euroimmun IgM/IgG against the PRNT was 83% (cohort 1) and 92% (cohort 2), whereas the specificity was 81% (cohort 1) and 65% (cohort 2). The combined Euroimmun IgM/IgG showed good specificity (92.5%) but suboptimal sensitivity (39.5%) compared with that of the MAC-ELISA. However, the sensitivity of the combined Euroimmun IgM/IgG against the PRNT was significantly higher (83 to 92%). More studies are needed before commercial assays are implemented for routine ZIKV serologic diagnosis.

Survey of Deoxynivalenol in U.S. 1993 Wheat and Barley Crops by Enzyme-Linked Immunosorbent Assay

1995 ◽  
Vol 78 (3) ◽  
pp. 631-636 ◽  
Author(s):  
Mary W Trucksess ◽  
Frederick Thomas ◽  
Kathryn Young ◽  
Michael E Stack ◽  
Wendy J Fulgueras ◽  
...  
Keyword(s):  
Drug Administration ◽  
Immunosorbent Assay ◽  
Food And Drug Administration ◽  
Enzyme Linked Immunosorbent Assay ◽  
Human Consumption ◽  
Limit Of Determination ◽  
Inspection Service ◽  
The U.S

Abstract Wheat and barley from the 1993 crop year were analyzed for deoxynivalenol (DON). A total of 630 samples were collected by the Federal Grain Inspection Service in 25 states and analyzed using a commercially available, direct competitive, enzyme-linked immunosorbent assay. The limit of determination was about 0.5 μg/g. DON contamination in the 483 wheat samples averaged 2.0 μg/g and ranged from <0.5 to 18 μg/g. DON contamination in the 147 barley samples averaged 4.2 μg/g and ranged from <0.5 to 26 μg/g. About 40% of the wheat samples and 57% of the barley samples contained DON levels that were greater than the U.S. Food and Drug Administration 1982 advisory level of 2 μg/g for DON in wheat designated for milling (human consumption).

scholarly journals Evaluation of an Epitope-Blocking Enzyme-Linked Immunosorbent Assay for the Diagnosis of West Nile Virus Infections in Humans

2009 ◽  
Vol 16 (5) ◽  
pp. 749-755 ◽  
Author(s):  
M. A. Loroño-Pino ◽  
J. A. Farfan-Ale ◽  
B. J. Blitvich ◽  
J. L. Beebe ◽  
R. G. Jarman ◽  
...  
Keyword(s):  
West Nile Virus ◽  
Dengue Virus ◽  
Immunosorbent Assay ◽  
False Positive ◽  
False Positive Rate ◽  
Enzyme Linked Immunosorbent Assay ◽  
Virus Infections ◽  
Characteristic Analysis ◽  
West Nile ◽  
Positive Rate

ABSTRACT An epitope-blocking enzyme-linked immunosorbent assay (b-ELISA) was evaluated for the diagnosis of West Nile virus (WNV) infections in humans. Sera from patients diagnosed with WNV infections from an outbreak in 2003 in Colorado and from patients diagnosed with dengue virus infections from Mexico and Thailand were tested with the b-ELISA. The b-ELISAs were performed using the WNV-specific monoclonal antibody (MAb) 3.1112G and the flavivirus-specific MAb 6B6C-1. Although the WNV-specific b-ELISA was effective in diagnosing WNV infections in humans from Colorado, it was not efficacious for diagnosing WNV infections in serum specimens from Mexico and Thailand. In serum specimens from patients from Colorado, the WNV b-ELISA and the WNV plaque reduction neutralization test showed an overall agreement of 91%. The sensitivity and specificity of the WNV b-ELISA were 89% and 92%, respectively, with a false-positive rate of 5%, based on receiver operating characteristic analysis. In contrast, false-positive rate results in specimens from the countries of Mexico and Thailand, where flaviviruses are endemic, were 79% and 80%, presumably due to the presence of antibodies resulting from previous dengue virus infections in Mexico and/or Japanese encephalitis virus infections or vaccination in Thailand. Thus, in regions where people have experienced previous or multiple flavivirus infections, the use of the b-ELISA for WNV diagnosis is contraindicated.

scholarly journals Monoclonal Antibody-Based Competitive Enzyme-Linked Immunosorbent Assay for Detecting and Quantifying West Nile Virus-Neutralizing Antibodies in Horse Sera

2006 ◽  
Vol 14 (2) ◽  
pp. 134-138 ◽  
Author(s):  
Kang-Seuk Choi ◽  
Young-Joon Ko ◽  
Jin-Ju Nah ◽  
Yong-Joo Kim ◽  
Shien-Young Kang ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
West Nile Virus ◽  
Immunosorbent Assay ◽  
Neutralizing Antibodies ◽  
Large Scale ◽  
Good Alternative ◽  
Standard Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
West Nile

ABSTRACT A rapid immunoassay for detecting and quantifying West Nile virus (WNV)-neutralizing antibodies in sera was developed as an alternative to the plaque reduction neutralization test (PRNT), the gold standard test for WNV. The assay is a competitive, enzyme-linked immunosorbent assay using neutralizing monoclonal antibody 5E8 (NT-ELISA). A cutoff percent inhibition (PI) value of 35% (mean PI plus 3 standard deviations), with a specificity of 99%, was established based on analysis of 246 serum samples from horses free of WNV. The NT-ELISA detected neutralizing antibodies in all sera collected 7 or 14 days postinoculation from mice (n = 11) infected with lineage I (strain NY385-99) or II (strain B956) WNV. When sera from WNV-vaccinated horses (n = 212) were tested by NT-ELISA and PRNT, the NT-ELISA gave a positive result for 96.1% (173/180) of the PRNT-positive sera and 3.1% (1/32) of the PRNT-negative sera. Discrepancies between the two tests were observed mainly with sera with low PRNT90 titers (expressed as the reciprocal of the highest dilution yielding ≥90% reduction in the number of plaques) for WNV or low PIs by NT-ELISA. The overall agreement (k value) between the two tests was 0.86. A good correlation (r 2 = 0.77) was also observed between the tests for endpoint titration of sera (n = 116). In conclusion, the newly developed NT-ELISA may be a good alternative serologic assay for detecting WNV that can be used for large-scale testing of WNV-neutralizing antibodies in multiple species.

scholarly journals Accuracy of the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay from the Centers for Disease Control and Prevention (CDC Zika MAC-ELISA) for Diagnosis of Zika Virus Infection

Diagnostics ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. 835
Author(s):  
Moyra Machado Portilho ◽  
Laise de Moraes ◽  
Mariana Kikuti ◽  
Leile Camila Jacob Nascimento ◽  
Mitermayer Galvão Reis ◽  
...  
Keyword(s):  
Immunosorbent Assay ◽  
Zika Virus ◽  
Cross Reactivity ◽  
Serological Diagnosis ◽  
Enzyme Linked Immunosorbent Assay ◽  
Rt Pcr ◽  
Zikv Infection ◽  
Igm Antibody ◽  
Convalescent Phase ◽  
Antibody Capture

Serological diagnosis of Zika virus (ZIKV) infection is challenging because of antigenic cross-reactivity with dengue virus (DENV). This study evaluated the accuracy of the Zika IgM antibody capture enzyme-linked immunosorbent assay (CDC Zika IgM MAC-ELISA) in differentiating between ZIKV and DENV infections. To determine sensitivity, we used acute- and convalescent-phase sera from 21 patients with RT-PCR-confirmed ZIKV infection. To determine specificity, we used acute- and convalescent-phase sera from 60 RT-PCR-confirmed dengue cases and sera from 23 blood donors. During the acute-phase of the illness, the assay presented a sensitivity of 12.5% (2/16) for samples collected 0–4 days post symptoms onset (DPSO), and of 75.0% (3/4) for samples collected 5–9 DPSO. During the convalescent-phase of the illness, the test sensitivity was 90.9% (10/11), 100% (2/2), and 0% (0/2) for samples obtained 12–102, 258–260, and 722–727 DPSO, respectively. Specificity for acute- and convalescent-phase samples from RT-PCR-confirmed dengue cases was 100% and 93.2%, respectively. Specificity for blood donor samples was 100%. The assay is an accurate method for Zika serological diagnosis and proved to be reliable for use during surveillance and outbreak investigations in settings where ZIKV and DENV cocirculate.

scholarly journals SARS-CoV-2 IgG Antibodies Seroprevalence and Sera Neutralizing Activity in MEXICO: A National Cross-Sectional Study during 2020

2021 ◽  
Vol 9 (4) ◽  
pp. 850
Author(s):  
José Esteban Muñoz-Medina ◽  
Concepción Grajales-Muñiz ◽  
Angel Gustavo Salas-Lais ◽  
Larissa Fernandes-Matano ◽  
Constantino López-Macías ◽  
...  
Keyword(s):  
Immunosorbent Assay ◽  
Neutralizing Antibodies ◽  
Herd Immunity ◽  
Cross Sectional Study ◽  
Molecular Techniques ◽  
Diagnostic Methods ◽  
Molecular Diagnostic ◽  
Enzyme Linked Immunosorbent Assay ◽  
Cross Sectional ◽  
Neutralizing Activity

Until recently, the incidence of COVID-19 was primarily estimated using molecular diagnostic methods. However, the number of cases is vastly underreported using these methods. Seroprevalence studies estimate cumulative infection incidences and allow monitoring of transmission dynamics, and the presence of neutralizing antibodies in the population. In February 2020, the Mexican Social Security Institute began conducting anonymous unrelated sampling of residual sera from specimens across the country, excluding patients with fever within the previous two weeks and/or patients with an acute respiratory infection. Sampling was carried out weekly and began 17 days before Mexico’s first officially confirmed case. The 24,273 sera obtained were analyzed by chemiluminescent-linked immunosorbent assay (CLIA) IgG S1/S2 and, later, positive cases using this technique were also analyzed to determine the rate of neutralization using the enzyme-linked immunosorbent assay (ELISA). We identified 40 CLIA IgG positive cases before the first official report of SARS-CoV-2 infection in Mexico. The national seroprevalence was 3.5% in February and 33.5% in December. Neutralizing activity among IgG positives patients during overall study period was 86.1%. The extent of the SARS-CoV-2 infection in Mexico is 21 times higher than that reported by molecular techniques. Although the general population is still far from achieving herd immunity, epidemiological indicators should be re-estimated based on serological studies of this type.

scholarly journals Immunoglobulin A Antibody Responses in Dengue Patients: a Useful Marker for Serodiagnosis of Dengue Virus Infection

2005 ◽  
Vol 12 (10) ◽  
pp. 1235-1237 ◽  
Author(s):  
M. Nawa ◽  
T. Takasaki ◽  
M. Ito ◽  
S. Inoue ◽  
K. Morita ◽  
...  
Keyword(s):  
Virus Infection ◽  
Dengue Virus ◽  
Immunoglobulin A ◽  
Antibody Responses ◽  
Enzyme Linked Immunosorbent Assay ◽  
Virus Infections ◽  
Serum Samples ◽  
Dengue Virus Infection ◽  
Iga Antibody ◽  
Antibody Capture

ABSTRACT We determined the usefulness of an immunoglobulin A (IgA) antibody-capture enzyme-linked immunosorbent assay for serodiagnosis of dengue virus infections. The results indicate that the presence of IgA and IgM in serum samples assures recent primary dengue virus infection even with a single serum sample.

scholarly journals Development of an Enzyme-Linked Immunosorbent Assay for Immunoglobulin M Antibodies against Measles Virus

2003 ◽  
Vol 10 (3) ◽  
pp. 439-442 ◽  
Author(s):  
F. Roodbari ◽  
M. H. Roustai ◽  
A. Mostafaie ◽  
H. Soleimanjdahi ◽  
R. Sarrami Foroshani ◽  
...  
Keyword(s):  
Immunosorbent Assay ◽  
Neutralizing Antibodies ◽  
Measles Virus ◽  
Clinical Symptoms ◽  
Maculopapular Rash ◽  
Immunoglobulin M ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Vaccination Programs ◽  
Elisa System

ABSTRACT Measles is a highly contagious respiratory virus infection, with typical clinical symptoms including maculopapular rash, fever, cough, coryza, and conjunctivitis. Despite implementation of widespread vaccination programs throughout the world, the rates of global morbidity and mortality are still considerable. This study was performed to design a reliable indirect enzyme-linked immunosorbent assay (ELISA) to measure measles-specific immunoglobulin M (IgM). First, human IgM was purified, and then an anti-IgM antibody was produced in rabbits and purified in a multistep process. The rabbit IgG against human IgM was conjugated with peroxidase. Measles virus-infected Vero cells produced viral antigen. One hundred serum samples from infants of 9 to 18 months of age, mostly vaccinated, were evaluated for determining the presence of specific IgM antibodies against measles virus. The samples were also evaluated for neutralizing antibodies against measles virus by a microneutralization test (MNT). By comparing the results of the ELISA with those of MNT, it was demonstrated that ELISA had a sensitivity and specificity of 100 and 92%, respectively. On the other hand, when the results obtained by our ELISA system were compared with those of an imported measles virus IgM ELISA kit (EIAgen; Adaltis Italia SPa, Bologna, Italy), a high level of agreement was shown (k = 0.926).

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