Linearity and Calibration Verification Kits for Human Diagnostic Analysers

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General Chemistry
Therapeutic Drug Monitoring
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Challenge your analyser is performing as intended

VALIDATE® ready-to-use kits, from LGC Maine standards, are designed to assist in the documentation of linearity, calibration verification, and verification of linear range required by many inspection agencies. VALIDATE® will also provide assistance when troubleshooting instrument systems, reagent problems, and calibration anomalies.

Multiple product configurations are available to meet the different needs of the many instrument systems available. Configurations are specifically formulated to maximise reportable ranges with minimum dilutions. Please review products individually as the analytes listed below may not reflect the configuration for your instrument.

  • Liquid, ready-to-use
  • Stable, for multiple-use
  • Instrument specific configurations to challenge your full reportable range
  • Satisfy NIST, UKAS, INAB, CAP and ISO 15189 requirements
Available VALIDATE® products are:

General Chemistry
ACTH
Anaemia
Body fluids
Bone
Cardiac
Diabetes
Fertility
Hemostasis
Immunosuppressants

Osmolality
Point of Care
SARS CoV-2 – NEWSepsis
Serum Proteins
Therapeutic Drug Monitoring
Thyroid
Tumour Markers
Urine Chemistry

Are you linear?

WHY SHOULD I PERFORM CALIBRATION VERIFICATION?

  • Ensure reliable and precise test results.
  • To achieve/fulfil accreditation and legislation requirements.
  • Good lab practice – Linearity testing is important to perform as it provides confidence in results outside of your quality controlled range.

WHEN SHOULD I PERFORM CALIBRATION VERIFICATION?

  • Verification after installation of a new or replacement analyser, test or method.
  • Troubleshooting of test or instrument when quality controls are unacceptable or insufficient.
  • After major analyser maintenance or repair.

WHAT ARE THE REQUIREMENTS TO ACHIEVE ISO 15189 ACCREDITATION?

  • Requires clinical laboratories to carry out an independent verification once a new instrument, assay or method has been installed. This is done by performing various confirmatory checks to ensure that the manufacturer’s performance claims are met.
  • Linearity testing will help complete this verification procedure.

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