Related Experiment Video
Updated: May 30, 2026

Clinical-oriented Three-dimensional Gait Analysis Method for Evaluating Gait Disorder
Published on: March 4, 2018
Assessment of clinical performance without adequate analytical validation: A prescription for confusion
Lawrence K Oliver1, Nikolay Voskoboev, Don Heser
1Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Objectives:
Lp-PLA2 is a biomarker with promise for predicting cardiac risk. The lack of reproducible results has limited its use. In evaluating a new reagent kit, we investigated conditions for optimal reproducibility.
Methods:
The Auto-PLAC reagents were evaluated on the Cobas instrument. Performance characteristics, stability, and population ranges were determined.
Results:
Analytical performance characteristics replicated manufacturer's claims. The stability profile of the analyte was unusual, with increasing results observed with storage at 4°C or -20°C. Only storage at -70°C gave acceptable stability. Population median values with properly preserved samples were much lower than the cut off previously validated for increased risk.
Conclusions:
It is postulated that variability in specimen handling was a major contributor to the lack of traceability of the current reagents to the earlier clinical studies demonstrating its utility. We are now unsure how to identify reliable criteria for result interpretation.
Related Concept Videos
Data Validation
Nursing assessment guides are generally based on holistic models rather than medical...
Data Validation
Key parameters for method validation include:
Documentation of Nursing Diagnosis
In some settings, data-driven computerized decision support systems are in place, allowing for more accurate nursing diagnoses. The database within one of these systems includes diagnostic labels defining characteristics, activities, and indicators for nursing. A nurse enters assessment...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Errors occurring during blood pressure monitoring
Several factors...
Automated Microbial Diagnostics