Abstract

ROMERO MARTINEZ, Kenia; PEREZ GUEVARA, María T; GARCIA AGRAMONTE, Norma  and  SANCHEZ DIEGUEZ, Esperanza. Validation of UMELISA HBsAg PLUS system based on umbilical cord serum samples. Rev Cubana Med Trop [online]. 2013, vol.65, n.1, pp. 46-56. ISSN 0375-0760.

Introduction: the selection and the development of analytical methods have always been an important issue for testing laboratories. The adoption of a method requires validation because the objective is to prove the capability of a method as well as the competencies of the laboratory to make an specific assay. The range of applications of UMELISA HbsAg PLUS system does not include the use of serum samples taken from the umbilical cord blood; however the use of placenta as raw material is certified with this kind of sample. Objective: to validate this system for umbilical cord serum sample taking into account the need of proving that this change does not affect the performance parameters of the system. Methods: three panels of samples were used to study specificity, agreement with the reference system Hepanostika HbsAg Uni-Form II, robustness, precision at two levels of repeatibility (intrassay) and intermediate precision (interassay) and detection limit. Results: validation of the system showed the following indicators: specificity and agreement of 100 %, robust system against temperatures changes between 35 and 38 °C, high intraassay precision (4.65 %) and interassays (VC less than 20 %), detection limit corresponding to 1/10 000 dilution rate. Conclusions: obtained results showed that UMELISA HbsAg PLUS system may be used to detect HBsAg in umbilical cord serum samples.

Keywords : validation; HBsAg diagnosis; ELISA; methods.

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