Validation and Qualification Materials
SeraCare Panels
SHOP PRODUCTSSeraCare’s portfolio of validation and qualification panels allows clinicians and researchers to assess overall assay performance. Whether it’s evaluating analyte specificity and sensitivity, new reagent lot qualification, method-to-method comparison, or to assess consistency in test run repeatability and reproducibility studies, our comprehensive set of panel products serve nearly all applications of IVD validation protocols to enable confidence in your test results.
Remove Doubt. Add Confidence.
- For more than 30 years, AccuSpan™ linearity panels have been a trusted source of validation material to clinical laboratories worldwide that test for quantitative molecular analytes.
- As shown in the World Health Organization HIV test evaluation kit reports, SeraCare HIV seroconversion and performance panels have been used for comparative studies for HIV test kit evaluations and are frequently referenced in package inserts of leading IVD infectious disease platforms.
- AccuTrak™ qualification panels are utilized by clinical laboratories worldwide to help strengthen quality control protocols and procedures for infectious disease diagnostic assays including HIV, hepatitis, CMV, syphilis, HPV, and HTLV.
AccuSpan Linearity Panels
AccuSpan linearity panels are designed to span the dynamic range of quantitative infectious disease assays and evaluate the analytical sensitivity of instrumentation. Linearity panels effectively challenge assay performance at defined intervals to ensure consistency throughout the entire reportable range. In addition to linearity studies, these panels are useful in validation procedures for new assay implementation, operator training, and troubleshooting signs of assay deterioration.
- Formulated with high-titer, recombinant, cultured, or naturally occurring whole viruses, serially diluted in human plasma
- Panel members are calibrated against the latest WHO international standards for informational purposes and to ensure traceability
- Tested against leading assays to provide customers with a detailed data sheet for the marker of interest
- Manufactured, consistent, ready-to-use material saves your lab the time and resources otherwise spent developing homebrew linearity panels
AccuVert™ Seroconversion Panels
When your assay development requires natural patient specimens that represent the body’s true response to an infection, you can depend on AccuVert seroconversion panels as a gold standard with which to assess your assay development milestones. AccuVert seroconversion panels are developed using raw, undiluted plasma collected from a single individual during the development of an infection and subsequent immunological response. Spanning an array of infectious diseases from HIV to hepatitis and syphilis, SeraCare's portfolio of seroconversion panels provides you with a diverse selection of products with high-quality datasets to help evaluate your assay.
- Serially drawn, raw patient plasma specimens collected from a donor during the development of a natural infection and subsequent response
- Detailed analyte evaluation generates data-rich comparative test reports, enabling you to benchmark your assay against other industry-leading IVD kit developers
- Manufactured batches provide consistent, reliable material for multiple stages of assay development
- HIV, HBV, HCV, and vector-borne seroconversion panels available for assay development and validation assessment
AccuTrak™ Qualification Panels
AccuTrak qualification panels are designed as a cost-effective solution to deliver the consistent results you need to gain confidence in your assay’s performance and ensure reagents are operating effectively lot-to-lot.
- Challenges, verifies, and monitors new reagent lot performance
- Prevents failed runs by intercepting problem kits affected by shipping and storage
- Used to train and evaluate personnel performance on new and existing equipment
- Helps validate performance of new infectious disease diagnostic assays
- Serves as an excellent source of affordable rotating reference material
AccuSet™ Performance Panels
Available for use with serological and molecular assays, SeraCare’s portfolio of AccuSet performance panels contain highly characterized, raw, undiluted plasma specimens collected from unique individuals positive for your analytes of interest. Each panel contains a comprehensive comparative data sheet with test results from a wide variety of leading commercially available assays and platforms. The AccuSet line of performance panels can be used to evaluate assay specificity, sensitivity, repeatability, and reproducibility to assist you in validating new test methods and equipment, run head-to-head assay comparisons, demonstrate lab proficiency, and train laboratory personnel.
- Raw patient plasma specimens collected worldwide from unique individuals containing your analyte of interest with complementary sets of diverse demographic information
- Wide varieties of analytes evaluated on multiple test methods from leading IVD manufacturers including RUO, CE-marked, and FDA
- Data-rich comparative reports to assist in benchmarking your assay against other industry manufacturers
- Manufactured panel kits ensure reliable, consistent material for the evaluation and validation of new test methods and equipment
For research use only. Not for use in diagnostic procedures.
