Validation & Qualification Materials
Specimens
SHOP PRODUCTSSpecimens
SeraCare’s portfolio of disease state specimens and high-titer viral isolates enables IVD manufacturers, clinical laboratories, and academic researchers with tools to help throughout the workflow, providing difficult-to-find, reliable materials for development, validation, and diagnostic controls.
Disease State Specimens
Disease state specimens are a critical component to the successful development and validation of diagnostic assays for IVD manufacturers, clinical reference laboratories, and academic researchers. Having direct access to an extensive library of naturally occurring, undiluted disease state specimens (infectious and non-infectious) is critical to assessing validation protocols or for use as diagnostic controls. SeraCare offers an expansive portfolio of disease state samples, characterized extensively on current FDA, CE-marked, and RUO methods and platforms to provide you with a detailed reactivity profile to advance your research or validation applications.
- Raw plasma, serum, and other matrices collected from donors worldwide provides you with a unique, diverse set of disease state materials and data sets
- A wide assortment of reactivity profiles from negative to low- and high-positive to allow you to measure, monitor, and troubleshoot assay performance
- Detailed certificate of analysis provided with each batch contains valuable information such as demographics, collection dates, and test results
- Pre-packaged aliquots and bulk units to support all phases of IVD development from R&D through validation
- Bulk processing and custom scale-up services available for pre- and post-commercialization strategies
Supporting IVD Diagnostics from R&D to Market Adoption
SeraCare’s vast inventory of disease state specimens supports you from the early stages of research and development to full-scale commercial kit production. From small specimen aliquots to bulk-processed material and custom prospective collection services, our disease state products and services will provide a consistent source of materials to support your entire project.
Viral Isolates
SeraCare’s high-titer cultured viral isolates and purified RNA are critical components in the development workflow for infectious disease assays - and especially for HIV assays, where diverse geographical genotypes are difficult to find. Our AccuType™ viral isolates collection offers IVD manufacturers and clinical laboratories a high-quality, high-titer source of material to assess HIV genotype and viral load assay performances.
With genotypes spanning both group M and group O, SeraCare's unique portfolio of HIV isolates offers a rare collection unlikely to be found anywhere else. Paired with our vast inventory of disease state specimens and validation and qualification panels, you will have an abundant selection of products to choose from that support your R&D or validation needs.
