Bio-Rad Laboratories Logo

Bio-Rad Launches CE-IVD SARS-CoV-2 Run Controls for Coronavirus
(COVID-19) Testing

The SARS CoV-2 Positive and Negative Run Controls from the Exact Diagnostics product line contain genomic DNA and allow laboratories to monitor the performance of the assay and evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency. 


Validation


The EDX SARS-CoV-2 Standard is manufactured with synthetic RNA transcripts containing five gene targets (E, N, ORF1ab, RdRP and S Genes of SARS-CoV-2), provided at high enough concentration to allow effective dilutions for Limit of detection studies, to confirm that your test detects target genes with almost all the current molecular kits

Independent Quality Control


Daily Routine use of EDX SARS-CoV-2 Positive Run Control allows laboratories to evaluate day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency. Data can compared with peers through the Unity Interlaboratory programs.

Effective


Matrix includes Human Genomic DNA, which is especially useful for CDC assays.

Efficient


Designed to monitor both extraction and PCR processes.


Learn more about Exact Diagnostics, a Bio-Rad Company.



CoV-2 Positive and Negative Run Controls



SARS-CoV-2 Positive Run Control


SKU: COV019CE
5 Vials, 0.3mL Fill Volume, -20°C Storage

EDX SARS-CoV-2 Positive Run Control is an external quality control intended to be used with SARS-CoV-2 assays to monitor the performance of that given assay. Routine use of EDX SARS-CoV-2 Positive Run Control allows laboratories to evaluate day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.

EDX SARS-CoV-2 Positive Run Control is manufactured with synthetic RNA transcripts containing five gene targets (E, N, ORF1ab, RdRP, and S Genes of SARS-CoV-2) and Human Genomic DNA. The control is intended to test the entire process of a molecular assay including extraction, amplification, and detection.

EDX SARS-CoV-2 Positive Run Control is internally value assigned using Bio-Rad Digital Droplet PCR (ddPCR). EDX SARS-CoV-2 Positive Run Control is formulated in Synthetic Matrix, which contains preservatives


Download the flyer


SARS CoV-2 Negative Run Control


SKU: COV000CE
5 Vials, 0.3mL Fill Volume, -20°C Storage

EDX SARS-CoV-2 Negative Run Control is an external quality control intended to be used with SARS-CoV-2 assays to monitor the absence of SARS-CoV-2. Routine use of EDX SARS-CoV-2 Negative Run Control allows laboratories to evaluate day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.

EDX SARS-CoV-2 Negative Run Control contains Human Genomic DNA and is negative for SARS-CoV-2. The control is intended to test the entire process of a molecular assay including extraction, amplification, and detection.

EDX SARS-CoV-2 Negative Run Control is internally value assigned using Bio-Rad Digital Droplet PCR (ddPCR). EDX SARS-CoV-2 Negative Run Control is formulated in Synthetic Matrix, which contains preservatives.


Download the flyer



Contact us      Request a quote



SARS-CoV-2 Positive Run ControlSARS CoV-2 Negative Run Control
Product insert Product insert
Safety data sheet Safety data sheet
Certificates of analysis:

  • 20032103
  • Certificates of analysis:

  • 20032104


  • Bio-Rad's products are used in research and clinical laboratories around the world, contributing to the advancement of COVID-19 research, SARS-CoV-2 screening assays, and vaccine development. We are committed to providing reliable, sensitive solutions to help you combat this global pandemic.


    View other product offering.



    Exact Diagnostics, a Bio-Rad Company



    Bio-Rad Laboratories, a global provider of life science research and clinical diagnostic products, welcomes molecular diagnostic control manufacturer Exact Diagnostics.


    Based in Fort Worth, Texas, Exact Diagnostics is a leader in developing and manufacturing a broad range of innovative molecular diagnostic controls and verification panels designed to meet the quality control needs of clinical labs and assay manufacturers ensuring consistent results.


    “We are pleased to have Exact Diagnostics join Bio-Rad,” said Jim Barry, Vice President and General Manager, Quality Controls Division, Bio-Rad. “They have a reputation for providing quality products and services to labs and manufacturers and we believe Exact Diagnostics' portfolio of molecular quality controls will extend our reach into molecular diagnostics and strengthen our position in the area of lab quality,” he added.


    With the acquisition of Exact Diagnostics, Bio-Rad has access to a comprehensive catalog of molecular quality control products in the area of transplant, respiratory, virology, microbiology, sexually transmitted infections, and vector-borne diseases.


    Contact Us

    Copyright © Bio-Rad Laboratories, Inc. | 026-20 | All rights reserved. | Trademarks | Privacy Policy