Study on quality control of ELISA method for screening TORCH infection / 国际检验医学杂志

ABSTRACT

Objective Onto investigate the indoor quality control method for qualitatively detecting the laboratory indicators of TORCH infection (rubella virus IgG ,cytomegalovirus IgG and IgM ,toxoplasma IgG and IgM ) .Methods The statistical method , normal distribution data ,ratio and standard deviation of positive rate detected by the ELISA method were adopted ,1+2s was set as the out of control rules ,the semi Lerey‐Jennings quality control chart was drawn;the direct probability calculation method was a‐dopted for the non‐normal distribution data and small probability event .The testing data of 57 batches were retrospectively ana‐lyzed .Results The positive rate of rubella virus IgG was 86 .66% ,cytomegalovirus IgG/IgM positive rates were 98 .87% and 0 .13% ,toxoplasma gondii IgG/IgM positive rates were 2 .43% and 1 .71% ,the data of 151 ,3 ,5 ,176 ,27 samples had the critical value range of five indicators .The number of out of control was once for cytomegalovirus IgG ,once and 4 times for Toxoplasma gondii IgG/IgM .Conclusion The indoor quality control for the ELISA qualitative detection of TORCH infection can adopt the data of daily detection positive rate or negative rate for monitoring the false positive .The critical value range of specimens should be fur‐ther conducted the recheck or confirmation experiment .