Have confidence in your COVID-19 antibody test.
In these uncertain times, laboratories need to have confidence in their COVID-19 antibody test results—which is why Luminex has developed a comprehensive xMAP® SARS-CoV-2 Multi-Antigen IgG Assay. Using a combination of robust internal controls and highly-specific antigens, the xMAP SARS-CoV-2 antibody assay enables the rapid and reliable detection of SARS-CoV-2 antibodies in human serum and plasma samples.
xMAP® SARS-CoV-2 Multi-Antigen IgG Assay
The xMAP® SARS-CoV-2 Multi-Antigen IgG Assay is a multiplex, microsphere-based, highly sensitive and specific assay that detects the presence or absence of antibodies against three different SARS-CoV-2 antigens. By using multiple antigens, this assay may provide earlier, more sensitive results.
The xMAP SARS-CoV-2 Multi-Antigen IgG Assay features:
- Broad Coverage: Detects IgG antibodies against 3 SARS-CoV-2 antigens, providing comprehensive results:
- S1 subunit of the spike protein
- Receptor Binding Domain (RBD) of the spike protein
- Nucleocapsid protein
- Flexible Throughput: Test up to 96 samples per run in less than 3 hours to meet your throughput needs.
- Versatile System Options: Validated on MAGPIX®, Luminex® 200™, and FLEXMAP 3D® Systems, so you can use the platform that best fits your lab.
- Common Sample Types: Designed for use with human serum and plasma samples, eliminating the need to implement additional collection protocols.
xMAP® SARS-CoV-2 Multi-Antigen IgG Assay Workflow
Add sample and bead mix to the well and incubate for 60 min at room temperature.
Add detection antibody mix to the well and incubate for 60 min at room temperature.
Resuspend sample and transfer plate to instrument.
Read on Luminex Instrument.
xMAP SARS-CoV-2 Multi-Antigen IgG Assay (EUA) Performance
|TP||FN||PPA||95% Cl||TN||FP||NPA||95% Cl||Total|
|*or days from molecular positive
The performance was determined separately for each instrument (Luminex® 200™, MAGPIX® NxTAG®-enabled, MAGPIX®, and FLEXMAP 3D® Systems) and each matrix (serum and plasma).
Serum and plasma specimens collected from patients with known molecular positive results from an EUA PCR method were tested with the xMAP® SARS-CoV-2 Multi-Antigen IgG Assay.
Negative percent agreement in serum and plasma was determined by using presumed SARS-CoV-2 IgG antibody negative specimens collected in the US prior to December 2019.
Resources / Documentation
- xMAP® SARS-CoV-2 Multi-Antigen IgG Assay (EUA) – Sales Sheet
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- Luminex Receives FDA Emergency Use Authorization for COVID-19 Antibody Test – Press Release
- Planning SARS-CoV-2 Serological Assay Development – White Paper
- xMAP® Technology: A Benchmark for Serological Testing – White Paper
- Highly Sensitive and Specific Multiplex Antibody Assays to Quantify Immunoglobulins M, A and G Against SARS-CoV-2 Antigens
- Validation of FlexImmArray™ SARS-CoV-2 Human IgG Antibody Test, a High-Performance & Multiplex Serology Assay
- Enabling COVID-19 Research with Simplified T/B Cell and PBMC Characterization
- Development of Luminex Based Serological Test for COVID-19 Diagnosis and Monitoring
- High-throughput Assay for Monitoring COVID-19 Antibodies and Their Isotypes
- Rapid Development of Multiplex Serological Assays for COVID-19 and Beyonds
- Planning SARS-CoV-2 Serological Assay Development
- Rush University Medical Center: Novel Serological Test for Immune Response to SARS-CoV-2 Virus
- xMAP® Technology: A Benchmark for Serological Testing
- METHODS Special Issue: New Assays to Characterize Vaccination and Infection History
- Five Things We Learned from an xMAP Power User
- Webinar: Multiplex Serological Assay Developed to Identify Avian Influenza Subtypes
- METHODS Special Issue: New Multiplex Assay for Vaccine Immunogenicity Testing
- METHODS Special Issue: Multiplexing Enables More Robust Surveillance for Avian Influenza
- Bitten by the Tropical Medicine Bug
About xMAP® Technology
Luminex’s xMAP® Technology combines advanced fluidics, optics, and digital signal processing with proprietary microsphere technology to deliver powerful multiplex assay capabilities. Featuring a flexible, open-architecture design, xMAP Technology can be configured to perform a wide variety of protein and nucleic acid assays accurately, affordably, and quickly.
xMAP Technology enables multiplexing of biological assays—reducing time, labor, and costs compared to traditional methods such as ELISA, Western blot, PCR, and microarrays. Systems using xMAP Technology offer robust detection due to the surface chemistry of Luminex’s color-coded beads, or microspheres. Using multiple lasers or LEDs for detection and high-speed digital-signal processors, the analyzer reads multiplex assay results by reporting the reactions occurring on each individual microsphere—enabling you to get more data with less sample.
Luminex offers three different xMAP-based instruments—MAGPIX®, Luminex® 200™, and FLEXMAP 3D®—covering a broad range of laboratory and budgetary needs. The xMAP® SARS-CoV-2 antibody assay is validated for all three of these platforms.
Whether you are looking for an instrument that is easy to learn and use, or a system for high-throughput applications that offers fast read times and integration with front-end automation systems—we have a Luminex multiplexing platform to support your research needs.
xMAP® SARS-CoV-2 Multi-Antigen IgG Assay
|Product Name||Description||Registration Status||Part Number|
|xMAP® SARS-CoV-2 Multi-Antigen IgG Assay||96 Tests|
|xMAP® SARS-CoV-2 Multi-Antigen IgG Assay Accessory Kit*||Data Analysis Software and Package Inserts|
|xMAP® SARS-CoV-2 IgG Control Kit||50 µL|
|* One-time order only|
The xMAP® SARS-CoV-2 Multi-Antigen IgG Assay is a multiplex, microsphere-based assay intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA).
The xMAP SARS-CoV-2 Multi-Antigen IgG Assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets requirements to perform high complexity tests.
Results are for the detection of SARS-CoV-2 IgG antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
The sensitivity of xMAP SARS-CoV-2 Multi-Antigen IgG Assay early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for xMAP SARS-CoV-2 Multi-Antigen IgG Assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
The xMAP SARS-CoV-2 Multi-Antigen IgG Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
(EUA) – In Vitro Diagnostic Use Under Emergency Use Authorization. This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories.