ABSTRACT
Objective To study suitability of a series of lyophilized serum with definitive HBV DNA value in fluorescence quantitative COBAS Amplicor HBM kit and a sample with 106 copies/ml HBV DNA was prepared, and sent to various manufactures which would be asked to detect the samples using their own kits. Then a calibration curves from CT values of the series to the corresponding concentrations was compared with that obtained from the external standard-calibration curve with the manufactures series. Results The standard-calibration curve with the series of lyophilized serum showed an excellent correlation (
ABSTRACT
Objective To establish a statistics internal quality control method for false-positive in clinical qualitative immunoassays.Methods When the positive rates are normal distribution, the half-Levey-Jennings chart can be used. Based on the positive rates of more than 20 runs routine tests, mean value and standard deviation (SD) were calculated and quality control chart was plotted.The control rules are 1_ +2S for out-of-control.For non-normal distribution data, elementary probability calculation could be used.ResultsThe half-Levey-Jennings chart and elementary probability calculation are suitable for statistics internal quality control method for false-positive in clinical qualitative immunoassays.Conclusion The proposed internal quality control statistics method for false-positive monitoring in clinical qualitative immunoassays is practical and useful.