In today's regulatory climate, laboratories are responsible for validating the performance of every analytical procedure before their routine use and to periodically reassess performance of each existing assay. SeraCare | BBI offers the widest variety of materials for validation, linearity, sensitivity and method comparison. These include:

Sensitivity & Linearity Panels

Panels of diluted specimens that, where possible, are calibrated against International Standards. These panels are ideal for use when you:

• Establish assay sensitivity during method validation
• Periodically confirm sensitivity and compare different test methods
• Establish method linearity

Available for the following analytes:

Performance Panels

Performance panels contain a thoroughly characterized series of serum and plasma samples collected from different individuals. Each panel includes comprehensive, comparative data from a variety of commercially available test kits, allowing you to independently challenge kit performance, sensitivity and specificity.

The perfect solution for:

• Evaluation and validation of test methods
• Side-by-side method comparison
• Documentation of laboratory proficiency

Performance panel products for serological and nucleic assays include mixed and low titer panels and genotype panels.

• Low Titer Performance Panels are targeted near the assay cut-off to evaluate performance near the assay limit.
• Mixed Titer Performance Panels cover a broader range including: high, low and mid reactive samples to compare and validate test methods.
• Genotype Panels and Worldwide Panels have a wide representation of the global variants of HIV-1 Genotypes A-H and O or HCV genotypes for nucleic acid or antibody assays to test specificity.

View our Performance Panels

Seroconversion Panels

A SeraCare | BBI specialty for over a decade, seroconversion panels consist of a set of samples collected from a single individual over time during development of infection and subsequent immune response. Each panel includes a comprehensive datasheet with comparative test data from commercially available antibody, nucleic acid and/or foreign assays.

Seroconversion panels are the gold standard for:

• Benchmarking of assays
• Validation of test methods
• Regulatory and scientific submissions
• Available for HIV-1, HBV, HCV, HAV, CMV and WNV

Typical HBV Seroconversion

In December of 2002, SeraCare | BBI was awarded ISO13485 certification by G-MED. The ISO13485 is an International Standard for Quality Systems more rigorous than ISO9001 and designed for medical device manufacturers.