Preparation and evaluation of in-house Factor Ⅷ inhibitor-positive quality-control samples
10.13602/j.cnki.jcls.2025.11.08
- VernacularTitle:自制凝血因子Ⅷ抑制物阳性质量控制样品及评价
- Author:
Tiantian WANG
1
;
Jie WANG
;
Jia DU
;
Xunbei HUANG
;
Hehe WANG
;
Cuicui QIAO
;
Wei LIU
;
Jing ZHOU
;
Jun YANG
;
Yunhai FAN
Author Information
1. 山东省血液中心血友病诊疗中心,济南 250014
- Publication Type:Journal Article
- Keywords:
FⅧ inhibitor;
quality control,application analysis
- From:
Chinese Journal of Clinical Laboratory Science
2025;43(11):842-844
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare in-house coagulation factor Ⅷ(F Ⅷ)inhibitor-positive control material and evaluate its perform-ance.Methods Frozen plasma samples from hemophilia A patients with positive factor Ⅷ inhibitors were pooled,and diluted with Owren's Veronal Buffer(OVB)to 1 BU/mL of the inhibitor concentration in the mixture,then aliquoted and freeze-stored.The homo-geneity and stability of the in-house quality control material were verified,and its suitability was further assessed through intra-laborato-ry reproducibility among different technologists and inter-laboratory comparisons.Results Twenty-one aliquots were randomly tested for homogeneity assessment,yielding an average of 1.05 BU/mL(range 0.9-1.15 BU/mL),with a standard deviation(SD)of 0.083 and coefficient of variation(CV)of 7.90％.The freshly prepared inhibitor-positive control samples contained a concentration of 1.03 BU/mL.After storage at-80℃ for 24 hours,1 week,1 month,2 months,3 months,4 months,5 months,6 months,7 months,8 months,and 9 months,thawed the samples showed relative deviations of 9％,0％,10％,9％,14％,15％,6％,0％,-10％,-5％,and 2％,respectively.The intra-laboratory CV value from different technologists at this center was 7.28％,and the inter-labora-tory CV across different centers was 18.75％.Conclusion The prepared in-house positive control material of Factor Ⅷ inhibitor ex-hibited adequate uniformity and stability.
