Abstract:

Objective To investigate the internal quality control（IQC） of hepatitis B virus（HBV） DNA determination in blood center nucleic acid laboratory. Methods The experiment was effective when quality control（QC） and positive control（PC） were positive,and negative control（NC） was negative. The average value,standard deviation and coefficient of variation of QC cycle threshold（Ct）,PC Ct,VIC Ct and VIC Ct SD were calculated. Draw Levey-Jenning QC chart was drawed. Westgard multi-rules were used. The total number of samples,mixed reactivity and split reactivity were evaluated. The general monitoring was performed（minipool nucleic acid test positive ratio,positive split ratio and effective split ratio）. Results Every experiment was effective in 3 months. QC Ct in day 32,VIC Ct in day 30 and 58 was out of control by rule 1_3s. VIC Ct SD was out of control in day 27 by 2_2s and day 58 by R_4s. Total number of samples,mixed reactivity and split reactivity were 14 172,13 and 8,respectively. Minipool nucleic acid test positive ratio,positive split ratio and effective split ratio were 0.092%,0.056% and 61.54%,respectively. Conclusions It could be applied effectively for blood center to use QC as IQC and Levey-Jenning QC chart of QC Ct,PC Ct,VIC Ct and VIC Ct SD combined with general monitoring indicators.

Key words: Internal quality control, Levey-Jenning quality control chart, Retrospective analysis