雅培i2000SR全自动化学发光分析仪检测甲状腺功能五项的性能验证

Performance verification of Abbott i2000SR automatic chemiluminescence analyzer for detecting five items of thyroid function

目的评价和验证雅培i2000SR全自动化学发光分析仪检测甲状腺功能五项[促甲状腺激素(TSH)、游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、总三碘甲状腺原氨酸(TT3)、总甲状腺素(TT4)]的方法学性能,并探讨甲状腺功能五项检测对甲状腺疾病的临床应用价值。方法选取该院2018年接受治疗的180例甲状腺功能异常患者,包括90例甲状腺功能亢进患者(甲亢组)和90例甲状腺功能减退患者(甲减组),同时选取健康体检者90例(健康对照组),比较不同组之间各指标检测结果的差异。根据ISO15189《医学实验室质量和能力认可准则》的要求,参照美国临床实验室标准协会(CLSI)EP系列文件和相关标准对甲状腺功能五项的精密度、正确度、分析测量范围、参考区间、不确定度进行评价分析,将结果与公认的质量目标或厂家声明的性能指标进行比较。结果甲状腺功能五项的批内精密度和批间精密度分别为1.08%~4.55%和1.08%~5.11%;正确度符合实验室要求;TSH、FT3、FT4、TT3、TT4验证的线性范围均在厂家线性范围内,二者具有良好的线性关系(R 2≥0.9932);参考区间符合率达到100%;不确定度的评定结果符合要求。与甲减组比较,甲亢组TSH水平明显降低(P<0.05),FT3、FT4、TT3、TT4水平明显升高(P<0.05);与健康对照组比较,甲减组TSH水平明显升高(P<0.05),甲亢组FT3、FT4、TT3、TT4水平明显升高(P<0.05)。结论雅培i2000SR全自动化学发光分析仪检测甲状腺功能五项的性能验证结果符合临床要求,精密度高,准确度高,线性范围宽,测定结果准确可靠,可用于大批量临床标本的检测,且TSH、FT3、FT4、TT3、TT4对甲状腺疾病的诊断具有重要的价值。

Objective To evaluate and verify the methodological performance of Abbott i2000SR automatic chemiluminescence analyzer in the detection of five items of thyroid function[thyrotrophic hormone(TSH),free triiodothyronine(FT3),free thyroxin hormone(FT4),total triiodothyronine(TT3)and total thyroxin hormone(TT4)],and to explore the clinical application value of five indicators in thyroid diseases.Methods One hundred and eighty patients with abnormal thyroid function receiving the treatment in this hospital during 2018 were selected,including 90 cases of hyperthyroidism(hyperthyroidism group)and 90 cases of hypothyroidism(hypothyroidism group).Meanwhile 90 people undergoing health physical examination were selected as the healthy control group.The differences of various indexes detection results were compared between different groups.According to the requirements of the Accreditation Criteria for the Quality and Competence of Medical Laboratories(ISO15189),as well as referring to EP series documents of CLSI and related standards,the precision,accuracy,analysis and measure range,reference interval and uncertainty conducted the evaluation and analysis,then their results were compared with the recognized quality targets or manufacturer stated performance indicator.Results The within-run precision and between-run precision of the five thyroid function items were 1.08%-4.55%and 1.08%-5.11%,respectively;the accuracy met the laboratory requirements.The linear range of the validation of TSH,FT3,FT4,TT3 and TT4 is within the range of manufacturers,showing the good linearity relation(R 2≥0.9932);the coincidence rate of reference intervals reached 100%;the evaluation results of uncertainty met the requirements.Compared with the hypothyroidism group,the TSH level in the hyperthyroidism group was significantly decreased(P<0.05),while the FT3,FT4,TT3 and TT4 levels were significantly increased(P<0.05);compared with the health control group,the TSH level in the hypothyroidism group was significantly increased(P<0.05),and the FT3,FT4,TT3 and TT4 levels in the hyperthyroidism group were significantly increased(P<0.05).Conclusion The performance verification of Abbott i2000SR automatic chemiluminescence analyzer for the detection of TSH,FT3,FT4,TT3 and TT4 meets the clinical requirements with high precision,high accuracy,wide linear range,accurate and reliable detection results,and can be used in the detection of large scale of clinical samples.Moreover,TSH,FT3,FT4,TT3 and TT4 have the important value in the diagnosis of thyroid diseases.