Services-Assay-Services

Custom Immunoassay Development Services and Reagents Deliver Quality Results

Leinco offers a full range of immunoassay development services that can accelerate timelines along the path from biotherapeutic discovery to diagnostic tests. When an off-the-shelf ELISA option is not available, our team of scientific experts can design and create custom assay solutions to your specifications and  deliver the quality results you expect. We take a  collaborative approach with your organization to enable transparent communication and share our scientific expertise in biomarker immunoassay development and manufacturing for drug discovery and diagnostic applications.

Expertise in Assay Sensitivity & Specificity

With over 30 years of knowhow, proprietary methods and project management competencies, Leinco Technologies is your partner to bring assays and diagnostic tests to market more quickly. We are certified to ISO 9001 and ISO 13485.

Collaborative Approach

  • Highly experienced scientific and project management staff
  • Stringent quality and cGMP standards
  • Focused on transparent communication at every project stage and on recommending data-driven decisions
  • Achieve your goals more quickly using our biomarker immunoassay development and manufacturing experience for drug discovery and diagnostic applications
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Assay Services

Delivering reproducibility and accuracy when an off-the-shelf assay option is not available.

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Step 1: Planning

  • Collaboration
  • Antibody selection & pairing (if relevant)
  • Proof of concept
  • Design inputs
  • Report: Standard curve
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Step 2: Development

  • Assay optimization
  • Integration of cassettes, sample handler and reader systems
  • Performance verification
  • Report: sensitivity, cross-reactivity, shelf life (stability)
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Step 3: Validation

  • Sample testing
  • QC assay performance qualification
  • Validate that product meets customer’s requirement specifications
  • Report: sensitivity, precision, longer range stability testing
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Step 4: cGMP Manufacturing

  • Scale-up manufacturing
  • Bulk lot production
  • Lot release testing
  • Delivery of final kits
  • Report: SOPs and batch records

Immunoassay Substrates & Reagents

Reagents for immunoassay development include substrates, secondary antibody conjugates, blocking buffers, coating buffers, washing buffers and stabilization diluents. Choosing quality reagents provides the necessary tools to develop and manufacture assays for in vitro diagnostics, development of new therapeutics, and basic life science research. In addition, high quality reagents are essential to develop assays with lot-to-lot consistency, higher signal-to-noise ratios, increased sensitivity, and longer shelf life. 

Shop full list of reagents for immunoassay development.

Primary Substrates Available for Incorporation into Custom ELISA Kits

  • TMB Substrate used with HRPO Enzyme –  TMB forms a water-soluble blue reaction product that can be measured spectrophotometrically at 605nm. Upon acidification, the reaction product becomes yellow with an absorbance peak at 450nm.
  • ABTS used with HRPO Enzyme – The green product has two major absorbance peaks, 410nm and 650nm. ABTS is less sensitive than OPD and TMB in ELISA applications. It is less readily oxidized, and its color development is slower (approximately 20 minutes). This may be advantageous if unacceptable background results from the use of the OPD or TMB substrates due to higher sensitivities
  • PnPP substrate used with Alkaline Phosphatase –  When alkaline phosphatase and PNPP are reacted, a yellow water-soluble reaction product is formed. This reaction product absorbs light at 405nm.

ELISA or Lateral Flow Tests

Looking at producing a lateral flow assay for qualitative and quantitative analysis? Trying to develop a new assay? Our collaborative and flexible approach provides you with a dedicated team of experienced scientists who are equally adept at development and troubleshooting.

Learn more about lateral flow development.

Qualifying Matched Antibody Pairs in Lateral Flow Tests

Qualifying Matched Antibody Pairs in Lateral Flow Tests

All the data that are part of the verification and validation phases are provided. The design history file includes all the necessary details (SOPs, batch records, etc.) covering all the regulatory requirements.

 

“With a proof of concept for a novel cancer diagnostic assay in-hand, a biotech company approached Leinco interested in verifying and  validating this assay. It quickly became apparent that an alternative assay platform would be needed in order to make the assay more  patient-friendly. Collaboration and transparency, two things Leinco prides itself on, were critical to this customer. They wanted to be able to work alongside the scientists at Leinco, review the data as soon as it was generated, and understand the next steps to progressing the project. This continuous dialogue and detailed documentation enabled us to combine our technical expertise and knowhow with their understanding of the disease state and unmet market needs. We welcomed this hands-on collaboration and will continue to encourage both new and long-standing customers to take this approach with us on future projects.”

– Patrick Leinert Sr. Founder, President, and CSO

Read full interview