Production and application of improvement of dyeing on syphilis quality control material / 国际检验医学杂志

ABSTRACT

Objective The color of the syphilis quality control material adopted by most detection institutes was the same with the detected serum sample and they were all colorless,transparent or light yellow.There were cases of wrong adding,missing adding or insufficient adding due to the color of quality control materials which was hard to distinguish with naked eyes.To avoid this phenomenon,a new method was established for the distinction of quality control materials.Methods A new method of syphilis quality control materials that had been improved three concentrations control materials0.125,0.250 and 0.500 NCU/mL.The syphilis diagnostic kit that was created by Shanghai Kehua and Xiamen Yingke was adopted to conduct detection and compare results.Results The difference between stained quality control material and unstained quality control materials had no statistical significance (P＞0.05).Two different reagents were used to detect quality control materials of different concentration for 20 times and the CV were 11.7 ％-13.4％ and 9.3 ％-12.9 ％ respectively.Two different reagents were used to detect quality control materials of different concentration for 30 days and the CV range were 10.1 ％-13.4 ％ and 8.08 ％-12.8 ％.Conclusion Citric yellow staining does not influence the properties of syphilis control materials and it can be used stably for a long time.It is suitable for clinical lab application and promotion.