Covid-19 Solutions

Kit Introduction

  1. The PCR Test that Burning Rock uses for clinical patient testing is FDA EUA approved Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing). It is based on real-time PCR technology and intended for the qualitative detection of nucleic acid from SARS-CoV-2 in specimens collected from individuals suspected of COVID-19 by their healthcare provider. Detailed information can be found following the link.
  2. Kit Feature-CWBIO
    1. FDA approval letter: https://www.fda.gov/media/140426/download
    2. Instructions for Use: https://www.fda.gov/media/140425/download
    3. Fact Sheet for Healthcare providers: https://www.fda.gov/media/140424/download
    4. Fact Sheet for Patients: https://www.fda.gov/media/140427/download

The test is fully verified and validated in Burning Rock Dx, LLC based on CLIA/CAP regulation.

Instrument

The Applied Biosystems™ 7500 Real-Time PCR Instrument is a real-time nucleic acid amplification and fluorescence detection system. The 7500 Real-Time PCR Instrument delivers the performance required for high-quality results in a 96-well format.

  • 96-well format eases plate setup if automation is not available
  • Accommodates tube strips, which can be capped immediately after pipetting each sample
  • Fast mode completes runs in less than forty minutes
  • Optional standard mode facilitates use of standard length real-time PCR assays without changing thermal cycling parameters

COVID Clinical Testing

Burning Rock developed and implemented tools to deliver COVID-19 Molecular PCR test for the novel COVID-19 disease. Our CLIA-certified Irvine lab serves as a diagnostic/screening site to help our customers for highly specific detection of COVID-19 infection to help guide clinical and infection control decisions. The highly sensitive method with Emergency Use Authorization (EUA) by FDA qualitatively detects nucleic acid from the SARS-CoV-2 viral RNA to identify active or recent infections.

We work with hospitals, physicians, and organizations to provide laboratory-based PCR COVID-19 testing and communication of tests results.  All samples are processed with a quick turnaround time at our CLIA high complexity laboratory, and test reports conform with U.S. federal CLIA requirements. In addition, we provide clinical trial services for COVID manufactures who are interested in FDA registration and clearance.

Test Procedure

Easy Booking

For fee inquiries, contact us.

Get Your Results

Test results can be delivered in PDF patient report format or the format that an external system requires. Our in-house developed and maintained LIMS specifically for COVID-19 tests is HIPPA compliant and can deliver encrypted PDF reports directly to emails of patients or ordering physicians. Additional delivery methods via encrypted API or SFTP connection are also available upon request.

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