Lab-Developed Test (LDT); How to Keep Calibrator Traceability (Consistency) in Your Lab?

This webinar will explain how to verify manufacturer-based new lot of calibrators, establish an efficient calibration system and maintain lot-to-lot consistency of calibrators in lab-developed tests (LDT).

Why Should You Attend:

Proper calibration of an in-vitro diagnostic (IVD) test is essential to assure product control, comparable measurement results and, hence, correct patient diagnosis. Traceability of calibrators in approved manufacturer-based IVD tests is taken care of by kit manufacturers. Under regulated lab environment, e.g. CLIA- or SAMHSA-certified labs, the lab has the ultimate responsibility of maintaining good quality. This responsibility includes verification of calibration of approved IVD tests and establishing and maintaining calibrators for lab-developed tests (also known as home-brew assays). Any drift in a calibrator produces erroneous results with a magnitude of uncertainty determined by the degree of bias in the calibrator.

This webinar will demonstrate the significant impact of improper calibration on a clinical or a toxicology lab result and, hence, on a medical or legal decision. It will provide a robust protocol to enable your lab to verify manufacturer-based new lot of calibrators. Attendees will be able to establish and maintain lot-to-lot traceability of calibrators in lab-developed tests where no FDA-approved test kits and/or calibrators are available.

Areas Covered in the Webinar:

• Impact of improper calibration on uncertainty of a clinical/toxicology lab results and, hence, on medical/legal decisions with real examples.
• How trustable is an approved manufacturer-based calibrators.
• Verification of manufacturer-based calibrator traceability.
• Preparation of working calibrators from reference material for an LDT.
• Establishing of an efficient calibration system and maintaining lot-to-lot consistency.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Clinical, reference, local or hospital-based clinical laboratory providing tests for patient management.
• Pharmaceutical company-owned, CRO or reference lab providing safety of efficacy testing for clinical trials.
• Clinical or forensic toxicology labs.
• Startups IVD manufacturer seeking FDA approval for an IVD.

Instructor Profile:

Dr. Abdel Halim, PharmD, PhD, DABCC, FACB, VP of research and quality at DrugScan and is the founder and president of Biomarkers and Diagnostics Consultation. Dr. Halim has been promoting the proper utilization of biomarkers in drug development and patient management for decades. He is recognized world-class thought leader in biomarker, personalized medicine and diagnostics with a unique vision on the potential utilities and limitations of biomarkers in drug development and patient management. He has 25+ years of experience in different aspects of biomarkers; discovery, development, qualification and applications, and extensive expertise in different technologies and platforms; from point-of-care devices till next-generation sequencing. He led efforts to develop and qualify assays for more than 600 LDT and utilized them for patient management and close to 100 PI-PIV clinical trials, led efforts on numerous companion DX programs and has a track record of multiple FDA 510K approvals of IVD.