关键词: 室内质控, 聚合酶链反应, 乙型肝炎

Abstract: Objective To investigate the internal quality control of hepatitis B virus (HBV) DNA determination by real time fluorescence quantitation polymerase chain reaction (PCR). Methods The coefficients of variation (CV) of previous 20 internal quality control data of HBV DNA determination under routine condition from PCR laboratories in Shanghai region were analyzed, and the control chart was drawn by the mean(±s).1_3s/2_2s multi-rule quality control method and Levey-Jennings single-rule quality control method were used to determine internal quality control data from laboratory A,B and C whose CV were ≥10%,5%-<10% and 1%-<5%, respectively. Results When the concentrations of the internal quality control materials were 5×10⁴ and 5×10⁶ IU/mL, there were no error data detected in laboratory A whose CV were 14.96% and 12.15% by 1_3s/2_2s multi-rule quality control method and Levey-Jennings single-rule quality control method, respectively. There were both 2 random error data detected in laboratory B whose CV were 6.49% and 5.00% by1_3s/2_2s multi-rule quality control method and Levey-Jennings single-rule quality control method, respectively. The CV of laboratory C were 4.36% and 2.43%. There were 3 systematic error data detected by 13s/2_2s multi-rule quality control method, and there were no error data detected by Levey-Jennings single-rule quality control method. Conclusions When the CV of the previous 20 internal quality control data were ≥ 10%, the error detections are all low both by the multi-rule quality control method and single-rule quality control method. The laboratory should set the suitable CV and use the multi-rule quality control method to improve the systematic error detection.

Key words: Internal quality control, Polymerase chain reaction, Hepatitis B virus