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Zhang P.,Shenzhen Weiwuguangming Biological Products Co. | Wu E.-Y.,Shenzhen Weiwuguangming Biological Products Co. | Chen Y.-Q.,Shenzhen Weiwuguangming Biological Products Co. | Huang Q.-Y.,Shenzhen Weiwuguangming Biological Products Co. | Guo C.-P.,Shenzhen Weiwuguangming Biological Products Co.
Chinese Journal of Biologicals | Year: 2012

Objective: To develop and preliminarily apply a quantitative ELISA method for cytomegalovirus (CMV) IgG. Methods: A quantitative ELISA method for CMV IgG was developed by using CMV IgG standard, of which the optimal linear range was determined. Internal quality control serum was prepared and calibrated, based on which the developed method was verified for reproducibility, intermediate precision, accuracy and specificity, and the results were compared with those of Dia. Pro CMV IgG ELISA kit. The CMV IgG titers in plasma samples from 689 donors were determined by the developed method. Results: The optimal linear range of developed ELISA method was 0.000 78 ∼ 0.05 U/ml, and the antibody titer of prepared internal quality control serum was (5.67 ± 0.55) U/ml. The coefficient of variation (CV) of result of reproducibility test was 4.6%-9.8%, while that of intermediate precision test was 9.7%-10.6%. The recovery rates of standard at three concentrations determined by the developed method were 107.01%-112.97%. The diluent of samples and other interfering factors in serum showed no significant influence on test result. The correlation coefficient (r) of test results by the developed method and by Dia. Pro CMV IgG ELISA kit was 0.81. The CMV IgG titers in 30.8% of 689 samples determined by the developed method were not less than 10 U/ml. Conclusion: The developed quantitative ELISA method was easy to handle, which showed high precision and specificity and might be used for determination of CMV IgG in human plasma.

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