clinical diagnostics • infectious disease
Platelia SARS-CoV-2
Total Ab Assay
Detection of IgM, IgA and IgG in One Test
COVID-19 Serology Testing for IVD
As COVID-19 continues to impact countries worldwide, accurate screening is needed to establish serological status of different populations. Bio-Rad now offers the Platelia SARS-CoV-2 Total Ab assay, for the detection of total anti-nucleocapsid antibodies (IgM, IgA, IgG) to SARS-CoV-2. In one test, the assay helps identify the immune response to coronavirus SARS-CoV-2, the virus associated with COVID-19.
The following includes product offerings in certain areas. Some products have limited regional availability. If you have a specific question about our COVID-19 solutions, please contact your local sales office or representative.
Start the conversation ▸Discover other COVID-19 assay and research solutions from Bio-Rad
- Real-Time PCR instruments and reagents
- SARS-CoV-2 standards
- ddPCR instruments and reagents
- SARS-CoV-2 ddPCR kit (CE-IVD)
The Platelia SARS-CoV-2 Total Ab assay detects total antibodies against SARS-CoV-2, the virus that causes COVID-19, to help aid in diagnosing new infections as well as provide a more complete understanding of infection rates.
On Demand Webinar
Understanding the Role of Serology Assays in COVID-19 Diagnostics and Surveillance
This webinar focuses on the role of serology tests in the pandemic response as well as the clinical value of a Total Antibody assay.
Jean-Fancois Mouscadet, Director of Research and Development
View on demand ▸Platelia SARS-CoV-2 Total Ab Assay — At a Glance
Antibodies Detected
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IgM
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IgA
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IgG
Performance*
High
Specificity
>99%
No
Cross-
Reactivity-
High
Sensitivity
≤8 days**: 92%
>8 days**: 100%
**Post onset of symptoms
Testing on Systems of Your Choice
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Bio-Rad Systems
Bio-Rad
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Other Systems
Automated
Manual
Multiple Test Uses
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Aid in Diagnosis
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Surveillance
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Epidemiology
Authorization
CE-IVD
Total Anti-Nucleocapsid Antibody Detection for SARS-CoV-2
The Total Antibody immunoassay format is based on the detection of total antibodies – IgM, IgA and IgG – against the nucleocapsid protein (N-protein) of SARS-CoV-2, all in just one test. The antibodies IgM and IgA are detectable in the case of acute SARS-CoV-2 infection while IgG is detectable in the recovery phase or post infection. Combining the results from these phases delivers a Total Antibody positive result.
Antibody Detection Over the Course of SARS-CoV-2 Infection
Disclaimer: This serological profile is based on projections from other well-known infections and may not fully reflect the course of SARS-CoV-2 infection.
Total Ab Detection vs. Single Ab Detection
Studies by Zhao et al., 2020 demonstrated that total antibody detection with antibodies like IgM, IgA and IgG is associated with better sensitivity, regardless of the time after symptom onset, by comparison to IgM or IgG detection only.
Why Target the Nucleocapsid Protein?
The Nucleocapsid protein (N-protein) is the most abundant SARS-CoV-2 protein and is a significant marker for diagnostic testing assays. Studies in 2020 show that anti-nucleocapsid antibodies (IgM and IgG) can be produced at higher levels and detected very early in the acute infection in comparison to anti-spike antibodies.3,4 ELISA detection of anti-nucleocapsid antibodies is associated with higher sensitivity by comparison to anti-spike antibody detection.1,2
Accurate Performance
High Specificity
The assay showed >99% specificity for specimens from 500 blood donors and 100 hospitalized patients negative for SARS-CoV-2. A total of 600 specimens were tested.
Distribution of Negative Test Ratios
500 negative blood donor specimens screened with the SARS-CoV-2 Total Ab assay (specificity: 99.6%)
When negative specimens are tested with the Platelia SARS-CoV-2 Total Ab assay, strongly negative values are obtained. The high discrimination between negative and positive values is associated with accuracy and reliability of the results.
No Cross-Reactivity
The assay showed no cross-reactivity to four of the most common coronaviruses, along with EBV, CMV, RSV, flu vaccine and upwards of 25 other medical conditions. A total of 168 specimens were tested.
High Sensitivity
92% sensitivity was achieved for patients tested ≤ 8 days after onset of symptoms and 100% sensitivity for patients tested > 8 days after onset of symptoms. A total of 50 patients were tested.
Comparison of Platelia SARS-CoV-2 Total Ab Assay and Concurrent Assays
Longitudinal case study of one positive patient
Thanks to Total Antibody detection, the Platelia SARS-CoV-2 Total Ab assay is associated with earlier detection of seroconversion and consistent detection of the patient’s adaptive immune response over time. With just one test, the Platelia SARS-CoV-2 Total Ab assay reliably detects patients that have been exposed to SARS-CoV-2.
Testing on Systems of Your Choice
The Platelia SARS-CoV-2 Total Ab assay is designed for convenient processing on your choice of automated microplate processors. While the assay is recommended for use on the Bio-Rad validated, fully-automated EVOLIS Systems or stand-alone systems (IPS/PR4100/PW40), it can also be run on other validated manual or automated platforms.
Bio-Rad EVOLIS Advantages
Validated for Platelia SARS-CoV-2 Total Ab assay testing, Bio-Rad instruments feature automated, scalable processing, full results traceability, and high safety standards.
Download brochure ▸
User-friendly
Intuitive software automates each assay step to reduce operator intervention
Short Time-to-Result
Results obtained in 2 hr 30 min
Optimal Workflow
- Screening of 360 patients in an 8-hour work shift
- Ability to directly load kit reagents
- Possibility to scale up productivity by combining multiple EVOLIS systems
Secure Processing
Outstanding security and traceability
Safety
- Positive identification of samples and reagents
- Triple-detection technology including barometric, capacitive, and colorimetric
Traceability
- Bidirectional interfacing with LIS
- Comprehensive event log from sample loading to result release
COVID-19
Platelia SARS-CoV-2 Total Ab Assay
Compliant with regulatory standards (CE-IVD validated)
Detection of IgM, IgA and IgG in One Test
The Platelia SARS-CoV-2 Total Ab assay is a high performance screening immunoassay for the detection of anti-nucleocapsid IgM, IgA and IgG antibodies to SARS-CoV-2.
Convenient & Fast
- 1-step antigen capture format (only 90-min incubation time required)
- 96-well microplate testing with breakable strips
- Ready to use with colored reagents
- Visual control of sample dilution and reagent addition
Choose Bio-Rad as your partner in fighting against COVID-19.
Contact a Bio-Rad representative today.
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Bio-Rad offers a range of other valuable SARS-CoV-2 testing solutions including Real-Time PCR instruments and reagents, SARS-CoV-2 standards, Droplet Digital PCR instruments and reagents, and an FDA EUA SARS-CoV-2 ddPCR kit.
Learn more ▸Other SARS-CoV-2 Testing Solutions
As a leader and contributor in the fight against COVID-19, Bio-Rad offers this Total Antibody assay to complement our other SARS-CoV-2 testing and research solutions which include:
- Real-Time PCR instruments and reagents
- SARS-CoV-2 standards
- Droplet Digital PCR instruments and reagents
- CE-IVD SARS-CoV-2 ddPCR kit
Infectious Disease Testing Solutions
AST Disks, Media and Testing System
Antimicrobial susceptibility testing reagents and Bio-Rad's ADAGIO system.
Learn more ▸
Invasive Mycology Testing
Mycology assays and Bio-Rad's EVOLIS systems.
Learn more ▸
Geenius Reader and Confirmatory Testing
Geenius System for HIV confirmation and HCV supplemental testing.
Learn more ▸
Blood Donor Screening
Blood donor screening assays for testing on the EVOLIS testing systems.
Learn more ▸
Quality Control
Bio-Rad quality control solutions feature QC products, data management tools and services covering hundreds of analytes and thousands of methods.
Learn more ▸
BRiCare Support and Monitoring
Bio-Rad's instrument monitoring application for remote service and support. BRiCare is available for all of Bio-Rad's diagnostic instruments for continuous monitoring and remote sessions with an instrument's computer.
Download brochure ▸References
1. Burbelo PD et al. (2020). Detection of Nucleocapsid Antibody to SARS-CoV-2 is More Sensitive than Antibody to Spike Protein in COVID-19 Patients. J Infect Dis., jiaa273. Advance online publication. https://doi.org/10.1093/infdis/jiaa273
2. Okba, NMA et al. (2020). Severe Acute Respiratory Syndrome Coronavirus 2−Specific Antibody Responses in Coronavirus Disease Patients. Emerging Infectious Diseases, 26(7), 1478-1488. https://dx.doi.org/10.3201/eid2607.200841
3. Sun B et al. (2020). Kinetics of SARS-CoV-2 specific IgM and IgG responses in COVID-19 patients. Emerg Microbes Infect. 2020;9(1):940-948. doi:10.1080/22221751.20 20.1762515
4. Xiang F et al. (2020). Antibody Detection and Dynamic Characteristics in Patients with COVID-19. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America, ciaa461. Advance online publication. https://doi.org/10.1093/cid/ciaa461
5. Zhao J et al. (2020). Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019 [published online ahead of print, 2020 Mar 28]. Clin Infect Dis. 2020;ciaa344. https://doi.org/10.1093/cid/ciaa344
