不同检测系统促甲状腺激素测定结果的偏倚评价

目的评价不同检测系统测定血清促甲状腺激素(TSH)结果是否存在偏倚。方法分别选用拜尔、德普和自制不同水平的质控物和不同浓度的患者新鲜血清,应用4个不同的化学发光免疫检测系统(拜尔ACS180、拜尔CENTAUR、强生VITROSECI、德普Immulite-1000化学发光免疫检测系统)检测TSH,并对数据进行相关统计学分析。结果经随机区组设计资料的方差分析,不同厂家、不同水平的质控物和不同浓度的患者新鲜血清的测定结果在各检测系统间差异均有统计学意义(P<0.01);各检测系统间的相关系数均大于0.975;可靠性分析信度系数α均接近1;以CEN-AUR作目标检测系统,对其他检测系统作临床可接受性能评价,ACS180检测系统临床可接受,但另2个检测系统临床均部分接受。结论4个检测系统测定TSH结果精密度符合临床要求,但临床可接受性能评价部分存在不可比性。

Comparability research on TSH results among different detection systems

Objective To discuss the comparability of TSH results among different detection systems.Methods 4 different kinds of chemiluminescence immune detection systems (Bayer ACS180, Bayer CENTAUR, VITROS ECI and DPC immulite-1000) were used to detect TSH concentration in 3 kinds of quality control specimens (Bayer,DPC and self-made) and clinical sera. The collected data were dealt with statistical analysis.Results Analysis of variance showed the TSH results from different control and patients sera had significant difference in different detection systems (P<0.01). The correlation coefficient of each detection system was above 0.975 and the reliability coefficient close to 1. CENTAUR was regarded as the standard detection system and used to evaluate the acceptability of other detection systems. As a result, ACS 180 was accepted and VITROS ECI and immulite-1000 were partly accepted by clinic assessment.Conclusion The precision of TSH results in the 4 kinds of detection systems accords to clinical requirement. However, incomparability exists in the evaluation of clinical acceptability.