scholarly journals Performance of a high-throughput, automated enzyme immunoassay for the detection of SARS-CoV-2 antigen, including in viral “variants of concern”: Implications for clinical use

2021 ◽  
pp. 105048
Author(s):  
Slim Fourati ◽  
Alexandre Soulier ◽  
Aurélie Gourgeon ◽  
Souraya Khouider ◽  
Camille Langlois ◽  
...  
Keyword(s):  
Enzyme Immunoassay ◽  
High Throughput ◽  
Clinical Use

scholarly journals High-throughput immunoassays for SARS-CoV-2, considerable differences in performance when comparing three methods

2020 ◽  
Author(s):  
Oskar Ekelund ◽  
Kim Ekblom ◽  
Sofia Somajo ◽  
Johanna Pattison-Granberg ◽  
Karl Olsson ◽  
...  
Keyword(s):  
High Throughput ◽  
Rapid Test ◽  
Performance Criteria ◽  
Clinical Use ◽  
Rt Pcr ◽  
Regulatory Authorities ◽  
Flow Test ◽  
Lateral Flow Test ◽  
High Level ◽  
Positive Results

Background: The recently launched high-throughput assays for the detection of antibodies against SARS-CoV-2 may change the managing strategies for the COVID-19 pandemic. This study aimed at investigating the performance of three high-throughput assays and one rapid lateral flow test relative to the recommended criteria defined by regulatory authorities. Methods: A total of 133 samples, including 100 pre-pandemic samples, 20 samples from SARS-CoV-2 RT-PCR positive individuals, and 13 potentially cross-reactive samples were analysed with SARS-CoV-2 IgG (Abbott), Elecsys Anti-SARS-CoV-2 (Roche), LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) and 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology Co). Results: All assays performed with a high level of specificity; however, only Abbott reached 100% (95% CI 96.3-100). The pre-pandemic samples analysed with Roche, DiaSorin and Dynamiker Biotechnology resulted in two to three false-positive results per method (specificity 96.9-98.0%). Sensitivity differed more between the assays, Roche exhibiting the highest sensitivity (100%, CI 83.9-100). The corresponding figures for Abbott, DiaSorin and Dynamiker Biotechnology were 85.0%, 77.8% and 75.0%, respectively. Conclusions: The results of the evaluated SARS-CoV-2 assays vary considerably as well as their ability to fulfil the performance criteria proposed by regulatory authorities. Introduction into clinical use in low-prevalent settings, should therefore, be made with caution.

scholarly journals Developing an Automated Enzyme Immunoassay for High-Throughput Screening of Bovine Serum Antibodies to Neospora Caninum

2003 ◽  
Vol 8 (1) ◽  
pp. 46-50
Author(s):  
John T. Y. Wu ◽  
Sally Dreger ◽  
Eva Y. W. Chow ◽  
Evelyn E. Bowlby ◽  
Lester S. Y. Wong
Keyword(s):  
Enzyme Immunoassay ◽  
High Throughput ◽  
Bovine Serum ◽  
High Throughput Screening ◽  
Neospora Caninum ◽  
Enzyme Linked Immunosorbent Assay ◽  
Predictive Values ◽  
Automated Assay ◽  
Robotic Workstation ◽  
Elisa Data

An enzyme-linked immunosorbent assay (ELISA) for Neospora caninum antibodies was automated with a robotic workstation, the Beckman Coulter Biomek 2000, to screen 200 bovine sera. Comparing these results with manually run ELISA data, a 95.92% agreement (K = 0.9592) between the two assays was obtained. The automated assay was specific and sensitive with excellent positive and negative predictive values. The results were repeatable and reproducible. The automation flexibility was high and the operation complexity was minimal. High-throughput screening (HTS) for bovine antibodies to Neospora caninum was achieved. The assay was developed according to the internationally recognized ISO17025 standard requirements.

High-throughput determination of free d-aspartic acid in mammals by enzyme immunoassay using specific monoclonal antibody

2006 ◽  
Vol 357 (1) ◽  
pp. 15-20 ◽  
Author(s):  
Tomohiro Ohgusu ◽  
Kenji Hamase ◽  
Hiroyuki Tanaka ◽  
Yukihiro Shoyama ◽  
Kiyoshi Zaitsu
Keyword(s):  
Monoclonal Antibody ◽  
Enzyme Immunoassay ◽  
Aspartic Acid ◽  
High Throughput ◽  
Specific Monoclonal Antibody

Parallelized High Throughput Emulsification and Emulsion PCR for Clinical Use of BEAMing Technology

2017 ◽  
Author(s):  
K. Cai ◽  
Y. Koya ◽  
K. Yasuko ◽  
N. Katsumi ◽  
T. Ayato
Keyword(s):  
High Throughput ◽  
Clinical Use ◽  
Emulsion Pcr

Is high-throughput measurement of 25-hydroxyvitamin D3 without 25-hydroxyvitamin D2 appropriate for routine clinical use?

2009 ◽  
Vol 46 (1) ◽  
pp. 86-87 ◽  
Author(s):  
S J Costelloe ◽  
E Woolman ◽  
S Rainbow ◽  
L Stratiotis ◽  
G O'Garro ◽  
...  
Keyword(s):  
High Throughput ◽  
Clinical Use

scholarly journals Multiplexed CRISPR-based microfluidic platform for clinical testing of respiratory viruses and SARS-CoV-2 variants

2021 ◽  
Author(s):  
Nicole L Welch ◽  
Meilin Zhu ◽  
Catherine Hau ◽  
Juliane Weller ◽  
Marzieh Ezzaty Mirhashemi ◽  
...  
Keyword(s):  
High Throughput ◽  
Quantitative Measurement ◽  
Respiratory Virus ◽  
Cost Effective ◽  
Respiratory Viruses ◽  
Variant Classification ◽  
Clinical Use ◽  
Clinical Testing ◽  
Variant Detection ◽  
Grade Performance

The COVID-19 pandemic has demonstrated a clear need for high-throughput, multiplexed, and sensitive assays for detecting SARS-CoV-2 and other respiratory viruses as well as their emerging variants. Here, we present microfluidic CARMEN (mCARMEN), a cost-effective virus and variant detection platform that combines CRISPR-based diagnostics and microfluidics with a streamlined workflow for clinical use. We developed the mCARMEN respiratory virus panel (RVP) and demonstrated its diagnostic-grade performance on 533 patient specimens in an academic setting and then 166 specimens in a clinical setting. We further developed a panel to distinguish 6 SARS-CoV-2 variant lineages, including Delta and Omicron, and evaluated it on 106 patient specimens, with near-perfect concordance to sequencing-based variant classification. Lastly, we implemented a combined Cas13 and Cas12 approach that enables quantitative measurement of viral copies in samples. mCARMEN enables high-throughput surveillance of multiple viruses and variants simultaneously.

Validation of the Nextseq 500 and Development of a High-Throughput NGS Pipeline for Identifying Clinically-Relevant Gene Variants in Multiple Myeloma Specimens

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5346-5346
Author(s):  
Agnieszka K. Zielinska ◽  
Kenton Leigh ◽  
Horacio Gomez ◽  
Ryan K Van Laar
Keyword(s):  
Gene Expression ◽  
Multiple Myeloma ◽  
Bone Marrow ◽  
High Throughput ◽  
Bone Marrow Aspirate ◽  
Relative Effectiveness ◽  
Gene Expression Signature ◽  
Molecular Profiling ◽  
Clinical Use ◽  
Dna And Rna

Abstract As molecular profiling technologies have evolved, our understanding of multiple myeloma heterogeneity and the relative effectiveness of treatment options have increased dramatically. Most recently, next generation sequencing (NGS) studies have provided a new degree of molecular resolution into this disease, however it remains a challenge to translate these methodologies and insights from research tools to widely-available clinical assays which can be performed as part of routine patient care. MyPRS® is a clinically and scientifically validated high-throughput gene-expression (Affymetrix) based assay available in all 50 US states. The CLIA and CAP-accredited laboratory workflow is able to isolate sufficient RNA from small amounts of fresh bone marrow aspirate, up to 72 hours post collection[1]. In order to expand the content of the MyPRS assay to include DNA-sequencing based variant, copy number and mutation detection, we have validated highly-scalable methods for isolating RNA and DNA separately and in parallel from individual patient specimens of varying quality and quantity. Yet another challenge of translational NGS profiling is performing complex laboratory procedures, developed primarily for research use only, with the requisite reproducibility and accuracy required for submission to regulatory agencies and ultimately for clinical use. Coupled with the protocols we developed for isolation of both DNA and RNA from small amounts of patient bone marrow aspirate, we performed an investigation of the Illumina NextSeq 500 and "on-site" BaseSpace data processing server. With the multiplexing and parallel processing capability of this platform we estimate being able to sequence, align and variant-call up to 150 myeloma-relevant genes at 1000x coverage per run. Results from our MM cell-line-, normal human- and NIST reference-DNA whole-exome-profiling studies show extremely high levels of technical reproducibility and agreement with results generated from 3rd party laboratories. In addition, we describe associations between the (RNA-expression based) prognostic, molecular subtyping and virtual karyotyping currently included in the MyPRS assay, with results from DNA-based exome profiling, performed on matched specimens. We believe findings underscore the need for comprehensive DNA and RNA based molecular profiling in order to make the most informed patient management decisions. 1. van Laar R, Flinchum R, Brown N, Ramsey J, Riccitelli S, Heuck C, Barlogie B, Shaughnessy Jr J: Translating a gene expression signature for multiple myeloma prognosis into a robust high-throughput assay for clinical use. BMC Medical Genomics 2014, 7 (1):25. Disclosures Zielinska: Signal Genetics: Employment. Leigh:Signal Genetics: Employment. Gomez:Signal Genetics: Employment. Van Laar:Signal Genetics: Employment.

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