Comparison of the Status of Internal Quality Control and Industry Standard of Different Platforms for Second Trimester Prenatal Screening in China / 现代检验医学杂志

ABSTRACT

Objective To analyzed the differences between the status of internal quality control and industry standard of different platforms in second trimester prenatal screening,so as to provide recommendations to improve prenatal screening quality control.Methods Collected the coefficient of variation in control and accumulated coefficient of variation in control of 468 prenatal screening laboratory in September 2016,and the proportion of the laboratory that meet the industry standard and analyze the proportion of different platforms that meet the manufacturers standards and industry standards.Results For AFP,34.9 ％ ～ 100 ％ of the laboratory meeted the manufacturers standards and 25 ％ ～ 78 ％ meet the industry standards;for total HCG,59.2％ ～81.6％ of the laboratory meeted the manufacturers standards and 24.5 ％ ～30.6％ meeted the industry standards,for free β-hCG,38.9 ％ ～ 100 ％ of the laboratory meeted the manufacturers standards and 27.3 ％ ～ 63.0 ％ meeted the industry standards,for β-hCG,14.3％～68.8％ of the laboratory meeted the manufacturers standards and 14.3％～61.3 ％ meeted the industry standards.For uE3,19.7 ％ ～ 100％ of the laboratory meeted the manufacturers standards and 11.1~54.8％ meeted the industry standards.Conclusion Failure to meet the industry standards happens to all platforms.Prenatal screening laboratories need to pay attention to internal quality control to ensure the performance of the platforms meet the quality requirements of prenatal screening.