科研之友
微信
新浪微博
Facebook
分享链接
摘要
Background: Serum S-100B has clinical value in monitoring malignant melanoma and in monitoring and predicting outcomes in patients with traumatic brain injury.
Methods: Analytical performance characteristic and split-sample method comparison studies for three commercial S-100B immunoassays (CanAg (R) S100, Sangtec (R) 100, YK150 Human S-100 beta) were performed. Reference intervals (97.5th percentile) for each assay were established by non-parametric analysis of results from healthy volunteers.
Results: Linearity results were slope = 1.014, intercept = 65.1, r(2) = 0.999 for the Sangtec assay; slope = 1.038, intercept = 31.1. r(2) = 0.999 for the CanAg assay; slope = 1.123, intercept = -105.4, r(2) = 0.997 for the YK150 assay. Within-run CVs were <= 5.7, <= 63 and <= 10.8 for the Sangtec. CanAg and YK150 ELISAs. respectively. Between-run CVs were <= 113, <= 5.9 and <= 9.5, respectively. Upper reference interval limits of 141,96 and 735 ng/I S-100B were established for the Sangtec, CanAg and YK150 ELISAs, respectively. Deming regression generated the following: CanAg vs. Sangtec, slope = 0.339, intercept =24.1, r(2) = 0.932; YK150 vs. Sangtec, slope = 0.266, intercept = -140.0, r(2) = 0.690; YK150 vs. CanAg, slope = 1.376, intercept= -13.1, r(2) = 0.860.
Conclusions: The configurations, procedures and performance characteristics of the Sangtec and CanAg S-100B ELISAs are comparable and better than those of the YK150 assay. Poor agreement and large biases prevent interchangeable use of results.
- 出版日期2011-11-20
