Waters H M, Thornton J A, Stevens R F, Gowenlock A H, Maciver J E, Delamore I W
J Clin Pathol. 1981 Sep;34(9):972-8. doi: 10.1136/jcp.34.9.972.
A commercial kit method (Technia Diagnostics) for the estimation of serum vitamin B12 claiming certain practical advantages was examined. Analytical and clinical performance were compared with a non-commercial radioisotope B12 method, previously compared to other commercial radioisotope B12 methods. The kit's analytical performance in our hands was satisfactory, although the within-batch precision and recovery of added cyanocobalamin were disappointing. Clinical performance was comparable with the non-commercial B12 method. Establishment of suitable reference ranges as a prerequisite to diagnostic use is apparent.
对一种声称具有某些实际优势的用于估算血清维生素B12的商业试剂盒方法(Technia诊断法)进行了检测。将其分析性能和临床性能与一种非商业放射性同位素B12方法进行了比较,该非商业方法之前已与其他商业放射性同位素B12方法进行过比较。尽管该试剂盒批内精密度和添加氰钴胺素的回收率不尽人意,但在我们手中其分析性能令人满意。临床性能与非商业B12方法相当。显然,确定合适的参考范围是诊断应用的前提条件。