Lai Florence Y, Dover Douglas C, Charlton Carmen L
Surveillance and Assessment, Alberta Ministry of Health, Edmonton, Alberta, Canada.
Provincial Laboratory for Public Health (ProvLab), Edmonton, Alberta, Canada; Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada.
J Clin Virol. 2016 Oct;83:43-7. doi: 10.1016/j.jcv.2016.08.294. Epub 2016 Aug 13.
Despite widespread use of a universal rubella standard, variability in rubella antibody titre can be observed between assays, particularly at the low end of the linear range.
Here, we investigate the impact of a methodology change for rubella IgG from the Abbott AXSYM to the Abbott Architect in a comprehensive prenatal screening program in the Canadian province of Alberta.
51,815 specimens (21,399 tested by AxSYM and 30,416 tested by Architect) submitted for routine prenatal screening between January 2006 and December 2012 from women who lived in Alberta after the universal childhood immunization programme for rubella was implemented, and whose immunization records were available, were included in the study.
Prenatal samples tested by AxSYM for rubella IgG were approximately 30% higher than those reported by Architect. Among individuals who had tests across multiple pregnancies, the change in test platform led to an additional 7% of women who initially tested positive, becoming non-positive (i.e. negative or indeterminate) in their subsequent tests. The tendency of the Architect IgG assay to report lower quantitative values was demonstrated across all birth cohorts and vaccination status, and resulted in an additional 2800 women requiring vaccination between 2010 and 2012 with an estimated cost of $38,500.
The change in rubella IgG screening assay resulted in a significant increase in the number of women who required post partum vaccination and Public Health follow-up.
尽管普遍使用通用风疹标准,但不同检测方法之间风疹抗体滴度存在差异,尤其是在线性范围的低端。
在此,我们在加拿大艾伯塔省的一项全面产前筛查项目中,研究风疹IgG检测方法从雅培AXSYM改为雅培Architect的影响。
纳入2006年1月至2012年12月期间提交进行常规产前筛查的51815份标本(21399份由AxSYM检测,30416份由Architect检测),这些标本来自在实施风疹儿童普遍免疫计划后居住在艾伯塔省且有免疫记录的女性。
AxSYM检测的产前风疹IgG样本比Architect报告的样本高约30%。在多次妊娠接受检测的个体中,检测平台的改变导致另外7%最初检测呈阳性的女性在后续检测中变为非阳性(即阴性或不确定)。在所有出生队列和疫苗接种状态中,均显示出Architect IgG检测报告较低定量值的趋势,这导致2010年至2012年期间又有2800名女性需要接种疫苗,估计费用为38500美元。
风疹IgG筛查检测方法的改变导致产后需要接种疫苗和公共卫生随访的女性数量显著增加。