Verifying performance characteristics of the SLCO1B1 & APOE gene polymorphism detection kit
10.13602/j.cnki.jcls.2017.11.17
- VernacularTitle:SLCO1B1&APOE基因多态性检测性能验证
- Author:
Yuan LV
1
;
Fan QIU
;
Xue XUE
;
Yang YU
;
xin Tong DU
;
zheng Zi WANG
;
Feng WANG
Author Information
1. 南京医科大学附属南京医院/南京市第一医院核医学科
- Keywords:
SLCO1B1;
APOE;
gene polymorphism detection;
performance verification
- From:
Chinese Journal of Clinical Laboratory Science
2017;35(11):868-871
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the performance characteristics of the human SLCO1B1 & APOE gene detection kit (PCR-fluorescent probe technique).Methods The verification protocol for the human SLCO1B1 & APOE gene detection kit manufactured by Wuhan YZY Medical Science and Technology Co.,Ltd.was designed by referring to the requirements of professional standard and pertinent literatures,and its accuracy,specificity,lowest detection limit and anti-interference ability were compared with those of sequencing technique (gold standard).Results The results coincidence of 20 clinical samples from fluorescence PCR and sequencing technique was 100％,which met the requirement of accuracy.Forty clinical samples with wild type loci determined by fluorescence PCR were verified by sequencing and no any mutation was detected,which met the requirement of specificity.The lowest detection limit of the kit was 10 ng/μL.Three interfering substances,including hemoglobin,bilirubin and triglyceride,were individually added into the blood samples with known genotype,and the results determined by the kit were coincident with that without interfering substances,which met the requirement of anti-interference ability.Conclusion The verification parameters of the human SLCO1B1 & APOE gene detection kit are basically consistent with the manufacturer's statement,indicating that the kit meets the requirements of the relevant quality management and may be applied to the detection of clinical samples.
