Your trusted partner when
testing immunoreactivity
of the adaptive immune system

Capture high quality data during your clinical trials and use it to support your regulatory approval

We will help with your T and B cell immunoassay needs from start to finish of your clinical trials, including:

  • Assay design, development and validation
  • High-volume testing implementation and operations
  • Data interpretation and reporting
  • Regulatory responses and quality management
  • Global partner lab onboarding and monitoring
  • Sample cryopreservation and long-term storage

Use specialty testing services modified to fit the parameters your clinical teams require

We take a consultative approach to assay development to ensure we maximize the quality of data produced and our standardized in-house protocols means quick turnaround from concept to assay validation.

Grow with your clinical trials across multiple geographies and participant numbers

We have an established global network of laboratories who have worked with us to implement our IVD test kits into their own labs. We are now working with many of these same labs to provide testing services for our Certimmune customers.

Our technical services team is situated across the globe. If a lab partner is required, they can quickly train new labs in support of growing clinical trial needs.

Partner with an experienced global immunology services team

We have partnered with many companies, research institutes and governmental bodies in SARS-CoV-2 vaccine research.

  • Selected as sole provider of T cell testing for SARS-CoV-2 vaccine research with the UK Vaccine Task Force (VTF)
  • Supported more than 20 clinical studies sponsored by vaccine developers and institutions
  • Completed ELISPOT and flow cytometry work on over 26,000 clinical trial samples in 2021

Produce data that will be worthwhile for regulatory submissions

We have developed IVD test kits using the ELISPOT technique that have received regulatory approval in 50 countries, including US FDA and CE mark authorization, as well as approvals in Japan, and China.

We have built an accredited clinical laboratory, called Oxford Diagnostic Laboratories (ODL®), which has been in service for over 18 years providing both routine clinical testing services and custom services in support of clinical studies.

All our products and services adhere to rigorous laboratory standards and practices, guided by Quality Assurance and Clinical Affairs teams.

Collecting relevant and quality data about the immunogenicity of your vaccine is important to you

When collecting immunogenicity data, it is important to consider which cell types and biomarkers will give you the most pertinent information about the effectiveness of your vaccine or immunotherapy. The team here at Certimmune have been evaluating the adaptive immune system for nearly 20 years. Today, we are equipped to evaluate:

T cells

Memory/differentiation status
Treg differentiation
Cytokine profile
Effector function
Transcription factor profile

B cells

Memory/differentiation status
Plasma cell development
Isotype class switching
Cytokine production
Transcription factor profile

Dendritic cells

Subset analysis
T cell activation


Target protein binding
Isotype classification

Currently we offer the following assay types:

  • Enzyme-linked immunospot assays (ELISPOT)
  • Multi-parametric flow cytometry (up to 16 parameters)
  • 2- color ELISPOT
  • Enzyme-linked immunosorbent assay (ELISA)
  • Multiplex analysis (up to 50 analytes simultaneously)
  • T cell expansion protocols using in vitro culture

Our development team is constantly considering new testing methodologies to implement, including:

  • Multi-parameter cell sorting for downstream applications
  • Drop-Seq molecular platforms for DNA-Seq/RNA-Seq microarray analysis
  • 4-color Fluorospot

Gain valuable efficacy data, faster, for regulatory approval of your vaccine or immunotherapy


Experts in ELISPOT

Oxford Immunotec has taken the classic ELISPOT methodology and developed it into the T-SPOT® technology platform, which is used by Certimmune.

Unlike other technologies, the T-SPOT technology:

  1. Measures antigen-specific response at the single cell level

    Increases the lab’s ability to discern a measurable response

  2. Removes ‘noise’ of irrelevant background signals

    Allows for easier and more accurate result interpretation

  3. Enumerates the number of immune cells tested

    Ensure high-quality data for all individuals, including immunocompromised

  4. Processes blood up to 32 hours after collection

    Longer blood stability means improved trial logistics:

    • Longer windows for patient enrollment daily
    • Ability to centralize samples
    • Capacity to expand testing to remote enrollment sites

    If using frozen cells is necessary, our standardized protocols will ensure a high-quality response from the cells you are evaluating

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The T-SPOT technology has been used in over 25 million patient tests globally

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The T-SPOT technology has been validated in over 500 of peer-reviewed clinical studies

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The only ELISPOT kit approved for clinical use by regulatory bodies in 50 countries

Certimmune has the capability and the facility to perform multi-parametric flow cytometry at high volumes, without reducing data quality

  1. Clinical expertise

    Expert team who can work with your clinical teams to create the right flow cytometry panels and readouts for your clinical trial

  2. High-volume capabilities

    Standardized validation and protocol implementation process by a team with experience running high volume testing ensures that data quality is not compromised as the trial ramps up

  3. Well-equipped laboratory

    We use flow cytometry equipment that allows for up to 16 parameters to be run with each sample.  This allows you to maximize data readouts so you can learn as much as possible about how the adaptive immune system is responding to your vaccine or immunotherapy

Contact us today