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Analytical Validation of Relative Average Telomere Length Measurement in a Clinical Laboratory Environment
Marsha N Blauwkamp1, Clare L Fasching1, Jue Lin1
1Telomere Diagnostics, Inc., Menlo Park, CA.
The Journal of Applied Laboratory Medicine
|February 27, 2021
Summary
This study validated a quantitative PCR (qPCR) method for measuring relative average telomere length (rATL) in whole blood, achieving high reproducibility for clinical use in aging and disease risk assessment.
Area of Science:
- Biomarker Discovery
- Molecular Diagnostics
- Aging Research
Background:
- Average telomere length in whole blood is a key biomarker for aging, disease, and mortality risk.
- Quantitative PCR (qPCR) is the standard method for telomere length measurement in large patient cohorts.
- Clinical laboratory tests require rigorous analytical validation under CLIA regulations.
Purpose of the Study:
- To analytically validate a qPCR-based method for relative average telomere length (rATL) measurement.
- To establish a reproducible assay suitable for CLIA laboratory environments.
- To define reference intervals for rATL in diverse populations.
Main Methods:
- Analytical validation using whole blood samples from 40 donors.
- Inclusion of technical replicates and multiple assays per sample.
- Study conducted over 20 days with multiple operators to assess reproducibility.
Main Results:
- Achieved high repeatability and reproducibility with coefficients of variation (CV) <5%.
- Demonstrated amplification efficiencies near 100%.
- Established rATL reference intervals from two cohorts (n=504 and n=357).
Conclusions:
- Presents an analytically validated, highly reproducible process for rATL determination.
- Enables reliable rATL measurement in a CLIA laboratory setting.
- Advances the use of telomere length as a clinical biomarker.
