IVD Clinical Performance

IVD Specimen Sourcing & Procurement

Bioexcel assesses feasibility for prospective and archived IVD specimens across all major sample types and clinically relevant categories.

Bioexcel can assess feasibility for:

Specimen Feasibility

Sample Types

  • Serum
  • Plasma
  • Whole blood
  • Capillary blood
  • Urine
  • Saliva
  • Nasal swabs
  • Nasopharyngeal swabs
  • Vaginal swabs
  • Stool
  • Other assay-specific specimens

Sample Categories

  • Positive specimens
  • Negative specimens
  • Weak positives
  • Near-cutoff samples
  • High positives
  • Disease controls
  • Cross-reactive conditions
  • Interference samples
  • Serotype/genotype-defined samples
  • Archived samples
  • Fresh samples

Can Bioexcel Source Positive and Negative IVD Samples?

Bioexcel can assess availability of prospective or archived positive and negative specimens based on sample type, target condition, characterization method, residual volume, storage history, study quotas and regulatory requirements.

HIPAA Compliant
ICH-GCP Compliant
FDA 21 CFR Part 11
ISO 9001
ISO 14155
ISO 27001 Certified
EU MDR 2017/745
EU IVDR 2017/746
US FDA Requirements
ISO 20916

Request Sample Feasibility