Resumen

MOLERO PAREDES, Tania et al. Quality parameters in control sera used in clinical laboratories of Zulia state, Venezuela. Saber [online]. 2013, vol.25, n.4, pp.390-398. ISSN 1315-0162.

The quality assurance is an essential aspect that ensures reliable results in the clinical analysis. For this reason, this study, descriptive and transverse, is aimed at evaluating the quality parameters in control materials employed in clinical laboratories of Zulia State, Venezuela. Control sera of five commercial houses were evaluated, through physico chemical variables and bacteriological and immunological quality. The latter involved the determination of antibodies for HIV, Hepatitis B and C. Finally, an association was established between the biochemical data obtained with those provided by the manufacturer. Following the guidelines of the Latin American Confederation of Clinical Biochemistry; when considering physical and chemical aspects, all the results were satisfactory for reconstitution time. With regard to turbidity, one level of control sera (7,14%) reflected high values and three (21,4%) presented a pH lower than the set range. All control materials were negative from bacteriological and immunological point of view By associating the means provided by the manufacturer and those obtained in this research, we use the percentage of deviation or Percentage Relative Deviation, resulting that 35.7% of the lots exceed the limit of acceptability of 10%, which suggests that the manufacturer should study the reallocation of the permissible limits of error. These results are a starting point for future research that enable the verification that the control materials in clinical laboratories comply with quality standards to ensure the reliability of the clinical analysis.

Palabras clave : Química clínica; Clinical chemistry.

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