Validation and Lot Qualification Materials

SeraCare’s validation and lot qualification materials are the ideal resource to develop, challenge, and confidently validate your assays, verify new lots of reagents, as well as train and evaluate your laboratory personnel. Our materials are thoroughly evaluated and highly characterized for the targeted use by IVD manufacturers, clinical laboratories, and academic researchers.

Validation and lot qualification materials from SeraCare include a variety of products to help you meet your unique development and validation requirements. Natural donor samples, disease state panels, and formulated biological materials are readily available with detailed analyte data to help you develop, challenge, troubleshoot, verify, and validate your assays. Enjoy the reliability and experience of a company with a history of providing trusted validation materials to the diagnostic testing industry for over 25 years.           

Disease state panels (sample sets)

SeraCare has been a trusted provider of disease state panels for over 25 years. Assay developers and clinical laboratories worldwide have used our panel products in the ongoing development and validation of their assays. Found in many diagnostic assay package inserts and comparative test kit studies, our panels are a hallmark of our long-standing line of products for serology and molecular applications. 

AccuVert Seroconversion Panels
AccuSet Performance Panels
AccuSpan Linearity Panels
AccuTrak Qualification Panels

Disease state specimens (individual samples) 

Collected through our worldwide network of sourcing partners, SeraCare offers a diverse, expansive inventory of characterized individual donor specimens. With small aliquots, full bulk units and custom development services, we have the materials you need to help accelerate your assay development and validation projects. 

Take advantage of our expansive disease state inventory online by searching for your materials interest by disease family, disease, and analyte type. Each batch and its relevant test data is listed with a detailed certificate of analysis to provide you with the information necessary to identify the specimens you are seeking. 

Cultured virus and purified RNA

High-titer viral isolates and purified RNA are critical components in the development workflow for infectious disease assays, and for HIV assays, diverse genotypes can be very difficult to find. AccuType™ viral isolates offer IVD manufacturers and clinical laboratories a high-quality, high-titer source of material to challenge HIV genotype and viral load assays.  

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 performance panels, you will have abundant options to select from for genotype materials.