Establishment of methods to evaluate the quality of two different separate gel tubes during ISO15189 accreditation / 国际检验医学杂志

ABSTRACT

Objective To explore the establishment of methods to evaluate the quality of two different separate gel tubes .Meth-ods An evaluation comparing two separate gel tubes with silicate glass tubes ,which are the standard tubes ,was performed using data from 50 subjects .The serum samples were assayed for routine chemistry or immunology after centrifugation using the quantita-tive or qualitative detection methods such as ECL ,enzyme-linked immunosorbent assay (ELISA) ,reflection luminescence or immu-nofluorescence .The data were collect for further statistical analysis .Results For quantitative results of the items ,the two separate gel tubes ,compared with the standard glass tube ,there was no significant difference between the test results (P>0 .05);for quali-tative projects ,two separate plastic tube ,compared with the standard glass tube ,really the positive rate and the true negative rate was no significant difference (P>0 .05 ,K>0 .75) .Conclusion By using different detection methods and test items ,it is demon-strated that using two separate gel tube for items assay does not affect the accuracy and consistency of the test results .As a result , the method for external supplies quality assessment is established in the laboratory for ISO15189 quality control .