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46 results for “Immunoassay”
Research data supporting "Platinum Nanocatalyst Amplification: Redefining the Gold Standard for Lateral Flow Immunoassays with Ultra-Broad Dynamic Range"
<p>Research data supporting the publication: Loynachan C. N., et al., 2017, ACS Nano, DOI: http://dx.doi.org/10.1021/acsnano.7b06229.</p>
Diagnostic accuracy of a novel enzyme‑linked immunoassay for the detection of IgG and IgG4 against Strongyloides stercoralis based on the recombinant antigens NIE/SsIR.
<p>Background: The diagnosis of strongyloidiasis is challenging. Serological tests are acknowledged to have high sensitivity, but issues due to cross-reactions with other parasites, native parasite antigen supply and intrinsic test variability do occur. Assays based on recombinant antigens could represent an improvement. The aim of this study was to assess the sensitivity and specificity of two novel immunoglobulin (Ig)G and IgG4 enzyme-linked immunosorbent assays (ELISAs) based on the recombinant antigens NIE/SsIR for the diagnosis of strongyloidiasis.</p> <p>Methods: This was a retrospective diagnostic accuracy study. We included serum samples collected from immigrants from strongyloidiasis endemic areas for whom there was a matched result for Strongyloides stercoralis on agar plate culture and/or PCR assay, or a positive microscopy for S. stercoralis larvae. For the included samples, results were also available from an in-house indirect fluorescent antibody test (IFAT) and a commercial (Bordier ELISA; Bordier Affinity Products SA) ELISA. We excluded: (i) samples with insufficient serum volume; (ii) samples from patients treated with ivermectin in the previous 6 months; and (iii) sera from patients for whom only routine coproparasitology was performed after formol–ether concentration, if negative for S. stercoralis larvae. The performance of the novel assays was assessed against: (i) a primary reference standard, with samples classified as negative/positive on the basis of the results of fecal tests; (ii) a composite reference standard (CRS), which also considered patients to be positive who had concordant positive results for the IFAT and Bordier ELISA or with a single “high titer” positive result for the IFAT or Bordier ELISA. Samples with a single positive test, either for the IFAT or Bordier ELISA, at low titer, were considered to be “indeterminate,” and analyses were carried out with and without their inclusion.</p> <p>Results: When assessed against the primary reference standard, the sensitivities of the IgG and IgG4 ELISAs were 92% (95% confidence interval [CI]: 88–97%) and 81% (95% CI: 74–87%), respectively, and the specificities were 91% (95% CI: 88–95%) and 94% (95% CI: 91–97%), respectively. When tested against the CRS, the IgG ELISA performed best, with 78% sensitivity (95% CI: 72–83%) and 98% specificity (95% CI: 96–100%), when a cut-off of 0.675 was applied and the indeterminate samples were excluded from the analysis.</p> <p>Conclusion: The NIE-SsIR IgG ELISA demonstrated better accuracy than the IgG4 assay and was deemed promising particularly for serosurveys in endemic areas.</p>
Kenyan reference values for chemistry and immunoassay tests
<p>This data set contains reference values for several chemistry and immunoassay tests. The samples tha were analysed were from healthy adults aged 18-65 years recruited from selected counties in Kenya as part of a reference interval study carried out by the International Federation of Clinical Chemistry committee on reference intervals and decision limits. </p>
Evaluation of Ortho VITROS and Roche Elecsys S and NC immunoassays for SARS-CoV-2 serosurveillance applications
<p>SARS-CoV-2 seroprevalence studies are instrumental in monitoring epidemic activity and require <span>well-characterized, high-throughput assays, and appropriate testing algorithms.</span> The U.S. Nationwide Blood Donor Seroprevalence Study performed monthly cross-sectional serological testing from July 2020 to December 2021, implementing evolving testing algorithms in response to changes in pandemic activity. With high vaccine uptake, anti-Spike (S) reactivity rates reached > 80% by May 2021, and the study pivoted from reflex Roche anti-nucleocapsid (NC) testing of Ortho S-reactive specimens to parallel Ortho S/NC testing. We evaluated the performance of the Ortho NC assay as a replacement for the Roche NC assay and compared performance of parallel S/NC testing on both platforms. Qualitative and quantitative agreement of Ortho NC with Roche NC assays was evaluated on pre-selected S/NC concordant and discordant specimens. All 190 Ortho S+/Roche NC+ specimens were reactive on the Ortho NC assay; 34% of 367 Ortho S+/Roche NC- specimens collected prior to vaccine availability and 43% of 37 Ortho S-/Roche NC+ specimens were reactive on the Ortho NC assay. Performance of parallel S/NC testing using Ortho and Roche platforms was evaluated on 200 specimens collected in 2019 and 3,903 study specimens collected in 2021. All 200 pre-COVID 2019 specimens tested negative on the four assays. Agreement of S and NC reactivity on specimens was 96.4% (3,769/3,903); most discordant results had reactivity close to the cutoffs on the alternate assays. These findings, and higher efficiency and throughput, support use of parallel S/NC testing on either Roche or Ortho platforms for large serosurveillance studies.</p>
Lateral flow immunoassay-based laboratory algorithm for rapid diagnosis of diphtheria
<p><strong>Results of the ‘DIFTERIA’ Lateral Flow Immunoassay (LFIA) validation</strong></p>
Immunoassay and proteomics dataset: Identification and validation of urine CXCL-9 as a biomarker for diagnosis of acute interstitial nephritis
<p>Background: Acute tubulointerstitial nephritis (AIN) is one of the few causes of acute kidney injury with diagnosis-specific treatment options. However, due to the need to obtain a kidney biopsy for histological confirmation, AIN diagnosis can be delayed, missed, or incorrectly assumed. Here we identify and validate urine CXCL-9, an interferon-γ-induced chemokine involved in lymphocyte chemotaxis, as a diagnostic biomarker for AIN.</p> <p>Methods: In a prospectively-enrolled cohort with pathologist-adjudicated histological diagnoses (<em>discovery cohort</em>), we tested the association of 180 immune proteins measured by an aptamer-based assay with AIN and validated the top protein, CXCL-9, using sandwich immunoassay. We externally validated these findings in 2 cohorts with biopsy-confirmed diagnoses (<em>validation cohorts</em>) and examined mRNA expression differences in kidney tissue from patients with AIN and controls.</p> <p>Results: In aptamer-based assay, urine CXCL-9 was 7.6-fold higher in AIN than controls (<em>P</em>=1.23·10<sup>-5</sup>). Urine CXCL-9 measured by sandwich immunoassay was associated with AIN in the discovery cohort (n=204; 15% AIN) independently of currently available clinical tests for AIN (adjusted odds ratio for highest vs lowest quartile: 6.0; 95% CI: 1.8-20). Similar findings were noted in external validation cohorts, where CXCL-9 had an AUC of 0.94 (0.86-1.00) for AIN diagnosis. <em>CXCL9</em> mRNA expression was 3.9-fold higher in kidney tissue from patients with AIN (n=19) as compared with controls (n=52; P=5.8·10<sup>-6</sup>).</p> <p>Conclusion: We identified CXCL-9 as a biomarker for AIN diagnosis using aptamer-based urine proteomics, confirmed this association using sandwich immunoassays in discovery and validation cohorts, and observed higher expression of this protein in kidney biopsies with AIN. </p>
DNA origami signal amplification in lateral flow immunoassays
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Immunoassay and proteomics dataset: Identification and validation of urine CXCL-9 as a biomarker for diagnosis of acute interstitial nephritis
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Kenyan reference values for chemistry and immunoassay tests
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Evaluation of Ortho VITROS and Roche Elecsys S and NC immunoassays for SARS-CoV-2 serosurveillance applications
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Comparative evaluation of ten lateral flow immunoassays to detect SARS-CoV-2 antibodies
<p><b>Background: </b>Rapid mobilisation from industry and academia following the outbreak of the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), led to the development and availability of SARS-CoV-2 lateral flow immunoassays (LFAs). High-quality LFAs are urgently needed at the point of care to add to currently available diagnostic tools. In this study, we provide evaluation data for ten LFAs suitable for use at the point of care.</p> <p><b>Methods:</b> COVID-19 positive patients (N=45), confirmed by reverse transcription – quantitative polymerase chain reaction (RT-qPCR), were recruited through the International Severe Acute Respiratory and Emerging Infection Consortium - Coronavirus Clinical Characterisation Consortium (ISARIC4C) study. Sera collected from patients with influenza A (N=20), tuberculosis (N=5), individuals with previous flavivirus exposure (N=21), and healthy sera (N=4), collected pre-pandemic, were used as negative controls. Ten LFAs manufactured or distributed by ASBT Holdings Ltd, Cellex, Fortress Diagnostics, Nantong Egens Biotechnology, Mologic, NG Biotech, Nal von Minden, and Suzhou Herui BioMed Co. were evaluated.</p> <p><b>Results: </b>Compared to RT-qPCR, sensitivity of LFAs ranged from 87.0-95.7%. Specificity against pre-pandemic controls ranged between 92.0-100%. Compared to IgG ELISA, sensitivity and specificity ranged between 90.5-100% and 93.2-100%, respectively. Percentage agreement between LFAs and IgG ELISA ranged from 89.6-92.7%. Inter-test agreement between LFAs and IgG ELISA ranged between kappa=0.792-0.854.</p> <p><b>Conclusions: </b>LFAs may serve as a useful tool for rapid confirmation of ongoing or previous infection in conjunction with clinical suspicion of COVID-19 in patients attending hospital. Impartial validation prior to commercial sale provides users with data that can inform best use settings.</p>
Complement (C1q) Binding to HLA Antibodies in a Solid-phase Immunoassay and Clinical Effect on Platelet Transfusion
ClinicalTrials.gov study NCT02858323. IPD Sharing: Not stated. Countries: 1. Publications: 3.
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
ClinicalTrials.gov study NCT02208011. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay
ClinicalTrials.gov study NCT01637610. IPD Sharing: Not stated. Countries: 1. Publications: 4.
Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis
ClinicalTrials.gov study NCT04105699. IPD Sharing: UNDECIDED. Countries: 1. Publications: 0.
Circulating-free DNA Assessment as a Tool to Predict Colorectal Cancer in Subjects With a Positive Fecal Immunoassay.
ClinicalTrials.gov study NCT03981679. IPD Sharing: NO. Countries: 1. Publications: 5.
Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in Children
ClinicalTrials.gov study NCT06852846. IPD Sharing: NO. Countries: 1. Publications: 1.
Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
ClinicalTrials.gov study NCT03075111. IPD Sharing: NO. Countries: 1. Publications: 1.
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
ClinicalTrials.gov study NCT04688996. IPD Sharing: NO. Countries: 2. Publications: 6.
Comparative evaluation of ten lateral flow immunoassays to detect SARS-CoV-2 antibodies
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International Brain Laboratory public data
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OpenNeuro
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