Access SARS-CoV-2 IgM Antibody Test

Driving the path forward to end the coronavirus pandemic

By integrating a high-quality set of SARS-CoV-2-specific antibody tests into their routine workflow, laboratories of all sizes can give physicians greater clarity on patient immune response to the virus that causes COVID-19.

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.

The Case for Separate Tests

When a total IgG and IgM assay is positive, it is unclear if the patient is currently infected or has an immune response to a prior infection.

This is because developed IgM is not sustained, while developed IgG can potentially be sustained longer, depending upon the infection and the individual.

In various studies, it has been seen that seroconversion for SARS-CoV-2 IgG and IgM may occur simultaneously or sequentially1. Thus, it’s important to identify both IgG and IgM individually. An IgM assay may provide information about current or recent infection; while IgG may signal a more sustained immune response.

A Menu that Matters

By integrating high-quality antibody tests into a routine workflow, laboratories of all sizes can offer physicians a set of tools to gain greater clarity on individuals who have antibodies to SARS-CoV-2 due to prior or recent viral infection.

High Sensitivity and Specificity

High sensitivity and specificity are key to providing physicians an accurate picture of patient immune response. Both the Access SARS-CoV-2 IgM and Access SARS-CoV-2 IgG tests have been validated against large, broad-based samples to ensure high quality.

Seamless Integration with Routine Lab Workflow

The Access SARS-CoV-2 IgM assay can be seamlessly integrated into current laboratory workflow without the need for batching or special maintenance. This can help your laboratory experience industry-leading system uptime.

How else can the Access SARS-CoV-2 IgM assay empower your laboratory to fight the coronavirus pandemic?
  • The Access SARS-CoV-2 IgM test throughput on Beckman Coulter immunoassay analyzers and integrated automation systems leads the industry at up to 200 tests per hour depending on the analyzer used (up to 4,800 tests/day)
  • QC procedures only need to be run once every 24 hours, or as required by individual laboratory procedure
  • Each kit provides 200 tests, which reduces ordering frequency
  • REMISOL Advance middleware provides patient results from both diagnostic and serology tests on one screen to help improve laboratory efficiency

Assay Format 2x100 determinations
Calibrator Format C0-C1, 2 levels, 1 vial/level, 2 mL/vial
QC Format QC1-QC2, 2 levels, 3 vials/level, 4 mL/vial
Sample volume 10uL
Open pack stability 28 days
Calibration stability 28 days
Time-to-first result (approx.) 37 minutes

Access SARS-CoV-2 IgM Information Package

To download all technical documents needed for assay implementation, please log in to access launch documents below:

Access SARS-CoV-2 IgM New Product Information Package - English

If you have any questions about the Access SARS-CoV-2 IgM Antibody Test or the supporting procedural and technical documents, please contact Beckman Coulter technical support.

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.

This test has not been reviewed by the FDA.

1 Li, L., & Chen, Y. (2020, March 23). SARS-CoV-2: Virus dynamics and host response. Retrieved from https://doi.org/10.1016/S1473-3099(20)30235-8


REMISOL Advance is a trademark or registered trademark of Normand-Info SAS in the United States and other countries. Used under license.