High-Performance IVD Critical Materials and Custom Services

Leinco Technologies provides antibodies, proteins, and reagents for diagnostic applications. Our manufacturing facilities are ISO 9001:2015 and ISO 13485:2016 certified to ensure uniform batch quality and strict regulatory compliance. We offer dedicated pricing to support commercial assay developers with scalable, cost-effective bulk supply.

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IVD Antibodies & Matched Pairs

Finding reliable antibody pairs with high sensitivity and low cross-reactivity dictates the success of lateral flow and ELISA kits. We validate our matched pairs in-house to confirm their performance. This testing eliminates the guesswork of sourcing raw materials for diagnostic immunoassays. Our catalog includes confirmed pairs for infectious diseases, reproductive health hormones, drugs of abuse, and endocrine biomarkers.

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IVD Antibodies

Matched Pair Antibodies

Secondary Antibodies

Hormone Antibodies

IVD Antigens & Conjugates

Accurate diagnostic tests require high-purity antigens and hapten conjugates to serve as positive controls and generate standard curves. We manufacture recombinant antigens and blocking peptides with high reliable reproducibility. These components integrate directly into established workflows to confirm test validity and measure target analyte concentrations reliably.

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IVD Antigens & Conjugates

Assay Substrates & Reagents

Stabilizing antigens and minimizing background noise requires precise buffer formulations. We supply a full range of coating buffers, blocking buffers, wash solutions, and highly sensitive enzyme substrates like TMB and pNPP. For streamlined development, our Surf’s Up Surfactant Kit provides 24 distinct ready-to-use surfactant solutions to simplify the optimization process.

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Immunoassay Reagents & Substrates

TMB Substrates

Surf’s Up® Surfactants

Custom IVD Development & CDMO Services

Our contract development and manufacturing organization (CDMO) services support diagnostic developers from initial benchtop ideation through commercial scale-up. A finalized assay design is not required to initiate a project; our scientific team provides structural guidance through feasibility testing, process optimization, and large-scale manufacturing. We utilize Class 10,000 (ISO 7) cleanrooms and proprietary cell culture media for antibody and recombinant protein production. Custom capabilities include buffer formulation, antibody conjugation, master cell banking, and lateral flow or ELISA kit assembly.

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Custom IVD Antibodies & Protein Purification

Lateral Flow Assay Development

Application Data & Technical Resources

Review our technical documentation detailing matched pair identification, assay design, and reagent optimization.

Influenza Assay Development

A case study that explores how we identified the best Influenza A matched pairs for a rapid lateral flow device.

Emerging Infectious Diseases

A monograph that examines cutting-edge available reagents for emerging infectious diseases using Monkeypox as a case study.

Cytokine Storm

A brochure that explores Cytokine Release Syndrome in severe infections and highlights our relevant recombinant cytokines, antibodies, and ELISA kits.

Quality & Regulatory Standards

All Leinco IVD antibodies and raw materials are manufactured at our facility in St. Louis, Missouri, USA. Domestic production provides our bulk and commercial partners with a secure, scalable supply chain. We operate under ISO 9001:2015 and ISO 13485:2016 certifications and adhere to current Good Manufacturing Practices (cGMP). Our quality management systems dictate controlled manufacturing and inspection processes, ensuring all materials deliver lot-to-lot consistency, regulatory compliance, and reproducible performance in diagnostic applications.