Current status and problems of coagulation factor Ⅷ and Ⅸ assay / 中华检验医学杂志

ABSTRACT

Objective To investigate current status and problems of coagulation factor Ⅷ and Ⅸ assay in domestic laboratories so as to provide the reference for implementing the standardization and quality improvement.Methods A questionnaire survey was carried out in 76 laboratories,and quality control materials were distributed to 54 laboratories for activity assay.The questionnaire information was analyzed statistically.Test results of quality control materials were classified into three groups according to the reagents and the ranked grading analysis were used to evaluate the performance.Results This research was investigative study.The amount of sample was less than 30 per month in 72％ (52/72)of laboratories.The frequencies of calibration were different,and 33％ (24/72) of laboratories did not perform calibration in a different assay batch.39％ (28/72)of laboratories did not run internal quality control,and about 21％ (15/ 72) of laboratories just performed the normal level quality control.Individual laboratories showed a high cumulative CV (＞ 30％) of intemal quality control.For normal FⅧ and FⅨ control materials,the CV of results were 11.3％-18.2％ and 11.3％-17.9％ respectively as well as 15.3％-20.3％ and 19.5％-21％ for abnormal.Of the three groups,the proportions of laboratories which the FⅧ test results out with consensus were18％,24％ and 22％ as well as 20％,24％ and 28％ for FⅨ.Conclusions The key requirements for quality control of coagulation factors active assay remain to be addressed and implemented.The repeatability and comparability in some laboratories are not satisfactory to meet the clinical needs.With the purpose of promoting quality improvement,we need to develop guidelines,organize related training and establish a national external quality assessment scheme.