Assessment of clinical performance without adequate analytical validation: A prescription for confusion
| Autor: | Allan S. Jaffe, Don Heser, Heidi Callanan, Nikolay Voskoboev, Joseph P. McConnell, Lawrence K. Oliver, Shannon Hodel-Hanson |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Analyte Traceability Clinical Biochemistry Population Specimen Handling Predictive Value of Tests Reference Values Medicine Humans Medical prescription education Confusion Aged Aged 80 and over education.field_of_study Reproducibility business.industry Clinical performance Reproducibility of Results General Medicine Middle Aged Reliability engineering Cardiovascular Diseases 1-Alkyl-2-acetylglycerophosphocholine Esterase Female Reagent Kits Diagnostic medicine.symptom business |
| Zdroj: | Clinical biochemistry. 44(14-15) |
| ISSN: | 1873-2933 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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