Is Quest Diagnostics Igg Antibody Test Fda Approved

DiscoveryProbe? FDA-approved Drug Library

L1021-0.05 50 uL/well(10 mM solution)
EUR 4514.4
Description: DiscoveryProbe? FDA-approved drug library includes 1496 FDA approved drugs for high throughput screening (HTS) and high content screening (HCS). It can be used to find new targets for old drugs. The bioactivity and safety of these drugs were confirmed by clinical trials.

Igg Antibody Laboratories manufactures the is quest diagnostics igg antibody test fda approved reagents distributed by Genprice. The Is Quest Diagnostics Igg Antibody Test Fda Approved reagent is RUO (Research Use Only) to test human serum or cell culture lab samples. To purchase these products, for the MSDS, Data Sheet, protocol, storage conditions/temperature or for the concentration, please contact igg antibody. Other Is products are available in stock. Specificity: Is Category: Quest Group: Diagnostics Igg

COX (Coxsackievirus Antibody IgG) ELISA test

96T/Box Ask for price
Description: ELISA based test for quantitative detection of COX (Coxsackievirus Antibody IgG)

Typhoid IgG and IgM (S. typhi IgG + IgM) Rapid Test Kit

100 µl
EUR 650

Typhoid IgG and IgM (S. typhi IgG + IgM) Rapid Test Kit

1 ml
EUR 7200

Typhoid IgG and IgM (S. typhi IgG + IgM) Rapid Test Kit

200 µl
EUR 2100

Dengue IgG ELISA Test

96
EUR 595

Chagas IgG ELISA Test

96 Ask for price

MV (Measles Virus Antibody IgG) ELISA test

96T/Box Ask for price
Description: ELISA based test for quantitative detection of MV (Measles Virus Antibody IgG)

Diagnostics Igg information

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SARS-CoV-2 Human IgG (4-Plex) Multiplex ELISA Kit (EUA Approved)

MEK2009-1 1 kit
EUR 1122
Description:

Product Overview

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The Q-Plex™ SARS-CoV-2 Human IgG (4-plex) Multiplex ELISA Kit is a qualitative chemiluminescent assay (ELISA) allowing concurrent measurement of human IgG antibodies to SARS-CoV-2 S1 and SARS-CoV-2 S2 proteins in serum and plasma samples. It has been authorized by FDA under a EUA for use by high complexity CLIA labs. Sensitive, reproducible, and convenient 96-well format requiring low sample volumes. Requires the Q-View™ Imaging System for analysis.

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Assay Principle

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The Q-Plex™ SARS-CoV-2 Human IgG (4-Plex) multiplex assay is a qualitative enzyme-linked immunosorbent assay that detects IgG antibodies to SARS-CoV-2 in human serum or plasma. SARS-CoV-2 is the novel coronavirus that causes COVID-19. The SARS-CoV-2 virus has several structural proteins including two spike proteins, S1 and S2. When an individual is infected with the SARS-CoV-2 virus, their immune system produces antibodies to these viral proteins. The typical immune response produces detectable antibody levels ~8-10 days following the onset of symptoms.

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The Q-Plex SARS-CoV-2 Human IgG Quantitative (4-Plex) Multiplex ELISA detects IgG antibodies to both the S1 and S2 spike proteins present in a blood sample. If antibodies are detected, the result will be considered positive. If antibodies are not detected, the result will be considered negative. The assay only detects IgG antibodies, not other classes of antibodies such as IgM or IgA.

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The multiplex assay allows for simultaneous indirect ELISA on the following four printed spots:;_x000D_

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  1. SARS-CoV-2 Spike Glycoprotein (S1), a recombinant antigen which contains amino acids 1-674 of subunit 1. Spike S1 is expressed in mammalian HEK293 cells with a Sheep Fc-Tag.
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  3. SARS-CoV-2 Spike Glycoprotein (S2) is a recombinant antigen which contains the Spike subunit 2 protein, amino acids 685-1211. Spike S2 is expressed in mammalian HEK293 cells with a Sheep Fc-Tag.
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  5. Sheep Fc is a negative control to ensure no cross-reactivity occurs between human IgGs in the sample and the Fc-Tag on the SARS-Cov-2 Spike proteins.
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  7. Anti-Human IgG is a positive control to ensure the kit performs and the IFU was followed correctly.
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Assay Validation

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The Q-Plex™ SARS-CoV-2 Human IgG (4-Plex) ELISA tests for IgG antibodies to either the SARS-CoV-2 S1 protein or the SARS-CoV-2 S2 protein. Our validation studies identified measurable improvement in clinical performance when results from the S1 and S2 assays are considered together rather than single assays (see assay validation data below). Quansys recommends that a sample should only be considered positive for the presence of SARS-CoV-2 reactive IgGs when antibodies reactive to both S1 and S2 are detected.

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Negative samples, collected prior to August 2019, and known positive samples collected from individuals who tested positive for COVID-19 on a molecular test at least 14 days prior to sample collection were used to determine clinical sensitivity and specificity.

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Evaluating the S1 and S2 simultaneously allows for greater clinical sensitivity and specificity.

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SARS-CoV-2 IgG Assay (Combined Result from S1 & S2) vs. Molecular COVID-19 Test
N = 576Confirmed PositiveConfirmed Negative
IgG Test Positive330
IgG Test Negative1542
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The combined S1 & S2 reactive antibody assay demonstrates:
Estimated Sensitivity (PPA)97%
Estimated Specificity (NPA)100%
PPV100%
NPV100%
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SARS-CoV-2 IgG Assay Characteristics
PrincipleIndirect ELISA
Sample TypeHuman Serum, Plasma, Whole Blood
Sample Volume2 µL
Assay Incubation2 hours, RT
Total Wash Steps3
Within Plate Reproducibility8% CV
Between Plate Reproducibility10% CV
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Kit Components

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Each kit contains a 96-well plate, featuring the relevant biomarker panel in each well, and all reagents required to perform testing.

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Reagents include:

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Wash Buffer Concentrate (20X): Liquid, 50 mL/vial of a concentrated solution of buffered surfactant;_x000D_Sample Diluent (2X): Liquid, 10 mL/vial of a concentrated buffered protein solution with preservatives;_x000D_Detection Mix: Liquid, 6 mL/vial of biotinylated antibodies in a buffered protein solution with preservatives;_x000D_Calibrators (High, Low, Negative): Lyophilized, human serum diluted in a buffered protein base;_x000D_Streptavidin-HRP (1X): Liquid, 6 mL/vial of streptavidin-conjugated horseradish peroxidase;_x000D_Substrate A: Liquid, 3 mL/vial of peroxide solution;_x000D_Substrate B+: Liquid, 3 mL/vial of luminol solution;_x000D_Plate Seals (3): Adhesive strips

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Kit Processing

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The Multiplex assays require the use of the Q-View™ software to read and interpret the test results. A fully-functional, free trial version of the software is available to download, install, and use to analyze your first kit (s). At the end of the trial period, a purchased license is required to continue the use of the Q-View software.

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Q-Plex arrays are developed and optimized to work with Q-View imagers. We do not guarantee the results obtained from other imagers because not all imagers are compatible with Q-Plex arrays.

Fetal Bovine Serum (Chile. USDA approved) - 100ml

FB-1365/100 100ml
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Fetal Bovine Serum (Chile. USDA approved) - 500ml

FB-1365/500 500ml
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Fetal Bovine Serum (Mexico. USDA approved) -100ml

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Fetal Bovine Serum (Mexico. USDA approved) - 500ml

FB-1360/500 500ml
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