Clinical Specimens for Diagnostic Manufacturers


The Global Repository

A unique and unparalled collection of pedigreed specimens available for research or validation needs. All specimens were collected under strict adherence to relevant HIPAA, IRB, and informed consent procedures, and material includes:

  • Disease-state plasma and tissues
  • Blood-based specimens
  • DNA and RNA
  • Frozen tissue
  • Isolated Peripheral Blood Mononuclear Cells
  • Paraffin-embedded, formalin-fixed blocks

Custom Prospective Collections

The SeraCare network of disciplined sites delivers reliable and efficient custom collections from concept through study design to ultimate delivery of clinical specimens and data. We pay careful attention to ethical guidelines, HIPAA, and informed consent, and our experienced MD, PhD and nursing staff will provide guidance to achieve your objectives in the most efficient manner. Successful results require even more, which we provide:

High-value multigenic disease states; client-directed disease-based collections

  • CRF design and management
  • Sample integrity and quality-control
  • Objective inclusion criteria and independent pathologist confirmation of diagnosis
  • Custom specimen collection kits

Collections of : Whole Blood, Serum, Plasma, Tissue, DNA & RNA



Click here to view:

Patient Conditions Represented by Specimens in the Global Repository - BLOOD BASED

Patient Conditions Represented by Specimens in the Global Repository - TISSUE





Unique HIV Specimens

SeraCare has assembled a library from unique populations of HIV patients:

  • ACCUTYPE HIV : 40 standardized viral isolates from various parts of the world
  • Blood specimens from 60+ HIV-positive individuals receiving atazanvir, idinavir, lopinavir, or nelfinavir, accompanied by CRF information for each
  • Isolates of drug-resistant HIV mutations and non-infective HIV




Validation Products:

Our validation panels have comprehensive data sets including all major infectious disease assays.

  • HBV, HCV, HIV, West Nile Virus, ToRCH, Chagas and other analytes are available
  • Highly characterized individual samples in each panel are not linked to demographic information

Validation Panels are prepackaged sets of specimens from individual donors. The panels are useful for assay improvement, side-by-side method comparison, evaluation and validation of test methods.

  • Low Titer Performance Panels are targeted near the assay cut-off for antibody or antigen tests in order to evaluate performance near the assay sensitivity limit.
  • Mixed Titer Performance Panels cover a broader reactivity range including high, low, and mid reactive samples, to compare and validate test methods.
  • Seroconversion Panels are set of specimens collected from a single individual during the course of infection.
  • Worldwide Panels contain a wide representation of global variants for HIV and HCV for testing antibody method specificity.
  • Genotype Panels for nucleic acid tests include: HIV (Group M Type A-H and Group O), HCV (Type 1-6) and HBV (Type A-F) to test specificity.
  • Sensitivity and Linearity Panels are sets of diluted specimens calibrated for end-point sensitivity or linearity over a broad dynamic range. IU standardization is provided if available.