COVID-19 Clinical Testing & Labs

Access significant technical and cross-functional experience for your COVID-19 testing needs. As the world’s leading network of clinical research central labs, Covance Central Laboratories delivers globally consistent, actionable data to drive your COVID-19 studies forward – faster.

Supporting Your Assay or Biomarker Needs for COVID-19 at Covance

Extract the most value out of our globally integrated central laboratory network with the help of our scientific and operational experts. With deep experience gained from more than 4,400 clinical trials during the past five years across all therapeutic areas, we know how to optimize your studies and mitigate potential issues to meet the fast-pace associated with coronavirus (COVID-19) studies. 

Molecular Assays  

  • RT-qPCR assays
  • Sequencing assays
  • Specialty assays

Immunochemistry

  • Serology testing for COVID-19 infection
  • Immunoassays – inflammatory and immunologic response

Cell-Based and Micro Assays 

  • Viral culture
  • Neutralizing antibody assays
  • BSL3 capabilities

COVID-19 Assay Availability

Several assays for COVID-19 are undergoing expedited validation to meet trial testing standards. 

Viral Load by qPCR

  • Built on the LabCorp Emergency Use Authorization Diagnostic, which was made available in early March
  • Now available for clinical trials

Viral Neutralization Assay

  • Expected availability for clinical trials in early Q3 of 2020

COVID-19 Screening/Rapid Detection by PCR

  • Validation will begin immediately following FDA approval of the GeneXpert® assay from Cepheid
  • Expected availability for clinical trials 3 weeks following reagent kit availability

Antibody Detection by ELISA

  • Validation has been initiated for IgG and IgA; expected availability for clinical trials in June 2020
  • Additional evaluations of IgM and quantitative serology tests will begin immediately upon availability of kits and reagents and be completed within 6-8 weeks
image of COVID-19 virus

Exclusion Assays

Assay panels that can be used to exclude other respiratory illnesses are already validated to meet clinical trial testing standards. 

  • BioFire® FilmArray® Respiratory Panel rules out 21 different respiratory illnesses. BioFire Diagnostics is adding COVID-19 to the panel; expanded panel expected to be available for clinical trials 3-4 weeks following reagent kit availability.

Infectious Disease & Vaccine Lab Testing Experience

Each year, we generate over 55 million reported results. (source: Covance CLA Internal Metrics 2018) 

Infectious Disease

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Vaccines

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Accelerated Study Setup

To speed up study startups, we've created a the Streamlined Study Start-Up (SSSU) team to help liaise with key departments to shorten timelines. We've seen unprecented speeds, including a 5-business-day turnaround. 

Discover how technology innovation expedites your study startup.


Bioanalytical Assays

  • Abacavir/Darunavir/Etravirine
    /Lamivudine/Nevirapine/
    Saquinavir/Stavudine/Zidovudine
    – combo method
  • Amprenavir
  • Amprenavir/Ritonavir – combo method
  • Atazanavir/Ritonavir – combo method
  • Azithromycin
  • Emtricitabine
  • Emtricitabine/Tenofovir – combo method
  • Lopinavir/Ritonavir – combo method
  • Maraviroc
  • Raltegravir
  • Ribavirin
  • Rilpivirine
  • Ritonavir
  • Tenofovir

Proprietary method approved for use in COVID-19 trials:
Hydroxychloroquine

CMC Analytical

  • Analytical control strategy and plan to align with product CQAs
  • Method development, phase appropriate qualifications and validation (GMP/ICH)
  • Potency assays and formulation development
  • Analytical testing (including in-process): safety, identity, strength, quality and purity
  • Routine global lot release and stability testing under commercial GMP conditions 

Available for clinical trials

  • Viral Load by qPCR

    Built on the LabCorp Emergency Use Authorization Diagnostics, which was made available in early March 2020

    Expected availability for clinical trials in April 2020

Vaccine Types

  • Live-attenuated
  • Inactivated
  • Viral vector
  • Virus-like particles
  • Protein subunit
  • Loaded nanoparticles
  • Polysaccharide subunit
  • DNA
  • mRNA
  • Polyvalent
  • Synthetic
  • Liposomes 

2x1-aland-center
Aland Center (Shanghai)

Related Laboratory Content  

GeneXpert® is a trademark of Cepheid

BioFire® FilmArray® is a trademark of BioFire Diagnostics LLC