Laboratory of Biochemistry, Scientific Institute for Digestive Disease, IRCCS Saverio de Bellis Via Turi 27, 70013-Castellana Grotte, BA, Italy.
Anticancer Res. 2010 Dec;30(12):5251-6.
BACKGROUND/AIM: The crucial role of KRAS status in new colorectal cancer target therapy raises the issue regarding which testing method to use. This study analysed 112 formalin fixed, paraffin-embedded (FFPE) metastatic tissue samples using three different commercially available kits.
A group of 40 KRAS wild-type (wt), 40 codon 12-mutated and 32 codon-13 mutated samples, previously evaluated by real-time PCR (TheraScreen kit), used as reference method, were analysed by Ampli-set-K-RAS and K-RAS StripAssay kit (herein called kit A and B, respectively) based on two different technologies.
The sensitivity of both kits was 92.5% for wt samples, 100% and 95.0% for kit A and B, respectively for samples mutated in codon 12. The specificity was 100% for both kits for all groups of samples. After a minor modification of the kit A method, its specificity reached 100%.
of low cost and easy to use, kit A may be suitable for use in a routine diagnostic setting.
背景/目的：KRAS 状态在新型结直肠癌靶向治疗中的关键作用引发了关于应使用哪种检测方法的问题。本研究使用三种不同的市售试剂盒分析了 112 例福尔马林固定、石蜡包埋（FFPE）的转移性组织样本。
一组 40 例 KRAS 野生型（wt）、40 例密码子 12 突变和 32 例密码子 13 突变的样本，之前通过实时 PCR（TheraScreen 试剂盒）进行评估作为参考方法，分别使用基于两种不同技术的 Ampli-set-K-RAS 和 K-RAS StripAssay 试剂盒（分别称为试剂盒 A 和 B）进行分析。
两种试剂盒对 wt 样本的灵敏度均为 92.5%，试剂盒 A 和 B 对密码子 12 突变样本的灵敏度分别为 100%和 95.0%。两种试剂盒对所有样本组的特异性均为 100%。对试剂盒 A 方法进行微小修改后，其特异性达到 100%。
试剂盒 A 具有成本低、使用方便的特点，可能适用于常规诊断设置。
