Access SARS-CoV-2 IgG II Assay, a semi-quantitative COVID-19 serology tool
Driving the path forward to end the coronavirus pandemic
By integrating a semi-quantitative SARS-CoV-2 antibody assay into the routine workflow, clinicians can establish a baseline to evaluate an individual’s immune status based on the numerical value and assess relative changes in an individual’s response to the SARS-CoV-2 virus over time.
This product may not be available in your country or region at this time. Please contact your Beckman Coulter sales representative or distributor for more information.
A New Assay in the COVID-19 Toolbox
Access SARS-CoV-2 IgG II is a semi-quantitative assay that measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection, providing a numerical result in arbitrary units (AU) from 2.00-450 AU/mL1 and a qualitative result reported as non-reactive (<10AU/mL) or reactive (>/=10AU/mL) to SARS-CoV-2.
With a semi-quantitative COVID-19 IgG antibody assay, clinicians can:
- Establish a baseline to evaluate an individual’s immune status based on a numerical value
- Assess relative changes of an individual’s response to SARS-CoV-2 over time
- Study the relevance of different levels of IgG antibodies2
Always, Quality First
The positive percent agreement (PPA) of the Access SARS-CoV-2 IgG II assay is 98.9% ≥ 15 days post symptom onset
The overall negative percent agreement (NPA) of the Access SARS-CoV-2 IgG II assay is 100%
High Specificity of 100% Minimizes Inaccurate Results
The Center for Disease Control (CDC) Recommends three strategies to improve positive predictive value3:
"Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response.4"
STEPHEN M. HAHN, M.D.
COMMISSIONER OF FOOD AND DRUGS
U.S. FOOD AND DRUG ADMINISTRATION
Deliver Results with a High Medical Value
This new assay offers the same level of quality as our other SARS-CoV-2 IgG and IgM serology tests. All of the Beckman Coulter COVID-19 antibody assays target the receptor-binding domain (RBD) of the spike protein (S1), as it is critical for viral entry and has shown to be neutralizing in a surrogate model.
This selection is aligned with the multiple vaccines in development that target or include the SARS-CoV-2 RBD S1, with the goal of producing protective antibodies.
Seamless Integration for Improved Lab Efficiency
- Integrate the assay seamlessly into your routine laboratory workflow
- Run in random-access-mode (RAM) without the need for batching or special maintenance
- Run up to 200 tests per hour depending on the analyzer used (for example, with DxI 800, labs can run up to 4,800 tests/day)
| Assay Format |
2x100 determinations |
| Calibrator Format |
S0-S5, 1 vial/kit, 2mL/vial |
| QC Format |
QC1-QC2, 3 vials/kit, 4mL/vial |
| Sample volume |
20uL |
| Open pack stability |
28 days |
| Calibration stability |
28 days |
| Time-to-first result (approx.) |
32 minutes |
Access SARS-CoV-2 IgG II New Product Information Package
Access Family of Immunoassay Systems
Assay Protocol File (APF) Download
Please review the APF Web Download Installation Instructions prior to installing the APF on your system.
Note: The APF web download is not available for the UniCel DxC 600i system at this time.
Available on These Analyzers
1The result will be displayed as non-reactive (<10AU/mL) and reactive (>/=10AU/mL.)
2 At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
3Information for Laboratories about Coronavirus (COVID-19). (2020, February 11). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibodytests-guidelines.html
4https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests
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