目的 通过同一实验室两台化学发光仪器间测定血清β-hCG的方法比对和预期偏倚评估,探讨两台化学发光仪器之间测定数据是否具有可比性,或检测结果的偏倚是否在允许范围内,以确保测定结果具有可比性和一致性,为实验室不同仪器测定结果互认提供依据。 方法 2009年11月2日-6日,参考美国CLSI EP9-A2文件,以Roche cobas e 601为参比方法,Roche cobas e 411为待评方法,用40份患者新鲜血清标本,测定血清β-HCG,对两台仪器之间的预期偏倚进行评估。 结果 相关系数 r =0.9988,截距a =3.48,斜率b =1.03,以20%为允许限,两仪器测定的结果在允许范围内。 结论 两仪器测定血清β-HCG的偏倚在实验室允许范围内,测定具有很好的相关性,结果具有可比性。
ObjectiveTo verify the consistency between artificial interpretation and automatic interpretation by HELIOS automatic immunofluorescence system by comparing their results on the same antinuclear antibodies (ANA) fluorescent slides, and analyze the application of automatic interpretation clinically. MethodA total of 281 ANA fluorescent slides of 281 impatients or outpatients in February 2015 were analyzed by HELIOS automatic immunofluorescence system and artificial interpretation respectively. As HELIOS could only determine the titer not the fluorescence type, only the negative or positive results qualitatively and the titer of ANA positive slides were analyzed. ResultsThere was no statistically significant difference between HELIOS automatic immunofluorescence system and artificial interpretation in negative or positive rate qualitatively (P>0.05) . The total coincidence rate was 98.9%, the positive coincidence rate was 99.5%, and the negative coincidence rate was 97.4%, and the kappa coefficient was 0.973. The difference of titer between the two groups had no statistical significance (P>0.05) . ConclusionsThe results of HELIOS automatic Immunofluorescence system and artificial interpretation are in good consistency. HELIOS automatic immunofluorescence system is suitable for clinical use as its high degree of automation, simple operation and result reliability.