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Assisting the global
COVID-19 response

#init4thecure

Bio-Rad is dedicated to advancing SARS-CoV-2 clinical testing with our molecular diagnostic and serology solutions that are optimized to provide accurate, sensitive, and timely results.


Diagnosis


Diagnostic testing to identify people infected with severe acute respiratory syndrome–related coronavirus-2 (SARS–CoV-2) is central in controlling the COVID-19 global pandemic. Bio-Rad offers both Real-Time PCR and Droplet Digital PCR solutions for COVID-19 molecular diagnostic testing. When either used alone or paired together these two technologies help identify infected individuals in a timely manner.

Real-Time PCR (RT-PCR)

In order to meet the high testing demands, labs are searching for reliable, accurate, and flexible instrumentation. The CFX Real-Time PCR Detection Systems offer user-friendly software, automated data quality control, and built-in LIMS file management that have been utilized by numerous testing laboratories for the detection of SARS-CoV-2 in patient samples.

Test kit manufacturers and commercial labs throughout the United States have validated the CFX instruments for use with their COVID-19 Emergency Use Authorizations (EUAs) highlighting the utility of Bio-Rad’s Real-Time PCR instrumentation for molecular diagnostics. Both Research Use Only and In Vitro Diagnostic versions are available.

Reliance One-Step RT-PCR Supermix

Reliance One-Step Multiplex Supermix has 24-hour room temperature stability for assembled reactions and was designed for high-throughput pathogen detection. It offers compatability with all major RT-PCR platforms and has superior performance for multiplexing up to 5 targets.

Learn More

Droplet Digital PCR (ddPCR)

SARS-CoV-2 viral levels vary significantly depending upon the number of days post-infection and appear to peak 5-7 days after symptoms present. This variability may demand precise and sensitive molecular assays.

Droplet Digital PCR technology has been shown to have increased precision beyond that of traditional RT-PCR assays and is able to reliably produce consistent results at low target concentrations. Based upon Bio-Rad’s sensitive Droplet Digital PCR (ddPCR) technology the SARS-CoV-2 ddPCR test is a powerful diagnostic tool that can aid in screening patients with a low viral load, including individuals in the early stages of infection with reproducible results. This test is now available for Emergency Use Authorization in the United States.

The test is a partition-based endpoint PCR assay intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal anterior nasal and mid-turbinate nasal swab specimens, as well as nasopharyngeal wash/aspirate and nasal aspirate specimens from patients suspected of having COVID-19 by their healthcare provider.

Flexible
Optimized for use on the Bio-Rad QX200 or QXDx Droplet Digital PCR Systems
Sensitive
Analytical sensitivity of 625 copies/ml of swab matrix
Convenient
Single-well test - 3 sequences aligned to CDC markers: SARS-CoV-2 N1 and N2 genes, human RPP30 gene.

Antibody Testing


As SARS-CoV-2 continues to quickly spread globally, accurate testing is needed to establish the 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 and IgG) in human serum or plasma to help provide a more complete understanding of infection rates and immunity to SARS-CoV-2.

The assay has been granted Emergency Use Authorization in the US and is validated on the automated Bio-Rad microplate systems (EVOLIS) and stand-alone systems (IPS, PR4100, PW40) and is suitable for processing on open microplate systems (upon internal lab validation). The Platelia SARS-CoV-2 Total Ab assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV2, indicating recent or prior infection.

Scalable
Open microplate assay platform meets a wide range if volume and throughput needs
Sensitive
92% ≤8 days after onset of symptoms

100% >8 days after onset of symptoms
Specific
>99% specificity without cross-reactivity

Workforce Testing


In response to the global COVID-19 pandemic, many industries adopted remote working strategies and social distancing in order to comply with shelter-in-place directives and aiding in flattening the curve. As states begin to slowly re-open, businesses and universities are faced with tough decisions on how to support safe work environments. A comprehensive COVID-19 testing plan is becoming a key component of re-opening strategies and workforce protection.

Combining sensitive molecular diagnostics with early total antibody serology testing can help quickly and accurately identify individuals with SARS-CoV-2 RNA and those that have developed an adaptive immune response SARS-CoV-2. Whether you are setting up your own test facility or offering testing as a service provider, Bio-Rad’s COVID-19 EUA testing portfolio will enable you to provide a comprehensive back to work solution.

Comprehensive Workforce Testing
Molecular Diagnostics

Identify individuals with SARS-CoV-2 RNA


Bio-Rad SARS-CoV-2 ddPCR Test
Serology

Identify individuals with recent or prior SARS-CoV-2 infection


Platelia SARS-CoV-2 Total Ab

SARS-CoV-2 ddPCR Test

Viral levels vary depending on the number of days post SARS-CoV-2 infection, therefore a highly sensitive assay is needed in order to reduce the chance of an indeterminate result and confidently bring employees back into the workplace. The SARS-CoV-2 ddPCR test is based on Bio-Rad’s highly sensitive and precise Droplet Digital PCR technology and is optimized for use on Bio-Rad QX200 or QXDx AutoDG Droplet Digital PCR Systems. Analytic sensitivity is calculated as 625 copies/ml of swab matrix, using different extraction kits, without any significant loss in specificity.

  • High sensitivity and precision in low viral abundance samples
  • Resistant to inhibition often seen in RT-PCR testing
  • Single-well test — 3 sequences aligned to CDC markers: SARS-CoV-2 N1 and N2 genes, human RPP30 gene

The sensitivity of ddPCR makes it an ideal technology for detecting low viral levels. Learn more about our research use only assay for detecting SARS-CoV-2 on in wastewater and surfaces in your facility.

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Platelia SARS-CoV-2 Total Ab Assay

The Platelia SARS-CoV-2 Total Ab assay is a blood-based immunoassay designed for the early detection of total antibodies (IgM, IgA and IgG) to SARS-CoV-2. The assay will help clinicians diagnose recent or prior infection with SARS-CoV-2 by identifying individuals with an adaptive immune response to the virus.

  • 92% sensitivity when testing patients ≤8 days after symptom onset
  • 100% sensitivity when testing patients >8 days after symptom onset
  • Highly accurate with >99% specificity and no cross-reactivity
  • Scaleable, 1-step antigen-capture microplate format
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