Verification and Validation Kits

Lakeside Life Science now offers Verification and Validation Kits for:

  • ŸProduct Developers Ÿ
  • Clinical Laboratories

Don’t reinvent the wheel.  Lakeside’s complete solution for verification and validation leads to shorter timelines and higher quality validation allowing significantly faster time to market.

Let Lakeside Life Science guide your company in the development of novel in vitro diagnostic assays. Together we can lower costs and shorten time to market of high impact laboratory tests.

Our verification and validation kits include:

Standard Components

Verification and Validation Kit Graphic

  • Naturally occurring HAMA samples and RF serum samples: Testing done in house
  • Normal samples to establish Reference Ranges: Individual or matched serum/ plasma samples that are analyte specific for age/gender/race
  • Interference Panel from patients with autoimmune, liver and renal diseases
  • Endogenous Interferents: human lipoproteins, hemolysate, protein, bilirubin
  • Exogenous Interferents: Drug Panels

Custom Compenents

  • Infectious Disease Panels
  • Cancer Panels
  • Linearity Panels
  • Assay Range Panels
  • Complete CLSI and FDA compliant verification protocols, backed by IVD experienced Ph.D. Scientists.
  • Programmed data capture Spreadsheets that provide complete study results automatically

We are reaching out to the in-vitro diagnostic community, to make your work easier. We understand the difficulty in obtaining samples necessary for validation and verification studies. We also realize that with FDA guidance on Laboratory Developed Tests on the horizon, a need for validation studies for each LDT may be necessary.

Don’t spend MONTHS searching for specimens when we can supply them in a matter of DAYS!

Contact Lakeside Life Science, LLC for easy implementation of your verification and validation studies.