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Revista Científica Ciencia Médica
Print version ISSN 1817-7433On-line version ISSN 2220-2234
Abstract
TORRES-GAMARRA, Giancarlo. EVALUATION OF ANALYTICAL PERFORMANCE OF DRY CHEMISTRY VERIFICATION PARAMETERS AT HIGH ALTITUDE. Rev Cient Cienc Méd [online]. 2022, vol.25, n.2, pp.150-156. Epub Dec 31, 2022. ISSN 1817-7433. https://doi.org/10.51581/rccm.v25i2.513.
Correct installation of a biochemical analyzer depends on compliance with the manufacturer's specifications. The manufacturer of the Vitros 4600 biochemical analyzer (Ortho Clinical Diagnostics), which quantifies analytes based on the dry chemistry method, guarantees its good analytical performance up to 2438 masl. If the installation is carried out at higher altitudes, the clinical laboratory must apply experimental protocols that demonstrate that the performance of the analyzer has clinical validity.
Objective:
To evaluate the analytical performance of dry chemistry in a clinical laboratory located at high altitude (Huancayo-Peru, 3259 masl).
Methodology:
Application and longitudinal study. The CLSI protocol EP15-A2 was applied as a reference of standardized procedures to calculate the SD and CV (random error) as well as the bias (systematic error) for two concentration levels of some routine analytes such as glucose, urea, creatinine, triglycerides and AST, using Bio Rad third part controls. From the data obtained, the sigma metric was calculated as an indicator of analytical performance for each analyte, using CLIA criteria of total acceptable error.
Results:
Sigma metrics were obtained, higher than 4 for all the analytes, finding performances: good for urea, very good for glucose and excellent for creatinine, AST and triglycerides. Conclusion: Dry chemistry was shown to have acceptable analytical performance, despite being used at an altitude higher than the manufacturer's specifications.
Keywords : quality control; clinical chemistry; altitude; clinical laboratory.
