强生VITROS 3600全自动免疫分析仪检测血清β-HCG的临床应用评价

To Evaluate the Clinical Application of Detection for Serum β-HCG with Johnson VITROS 3600 Chemiluminescent Immunoassay

对强生VITROS 3600全自动免疫分析仪检测血清β-HCG水平进行初步临床应用评价。收集门、急诊检测血清β-HCG的患者血清标本400例与健康体检者血清标本100例,分别应用强生VITROS 3600、贝克曼库尔特Unicel DxI 800两种全自动免疫分析仪进行血清β-HCG水平检测,比较检测结果。结果显示:(1)精密度试验表明,VITROS 3600检测血清β-HCG水平准确度高,重复性好(高、中、低值血清标本的批内和批间CV均小于5.0%)。(2)线性试验表明,VITROS3600测定血清β-HCG水平灵敏度高,实测结果与预期值比较,平均回收率达98%。(3)两种仪器的比较试验表明:虽然两种免疫分析仪的正常参考值与检测下限不同,但是两组定量检测结果间无显著性差异(P>0.05);两种仪器的定量检测值正相关(r=0.99,P<0.01),对于临床诊断有较高一致性(P>0.05)。结论:强生VITROS 3600全自动免疫分析仪检测血清β-HCG水平灵敏、准确,与贝克曼库尔特Unicel DxI 800的检测结果具有可比性,且VITROS 3600可能在急诊早孕诊断中更具应用价值。

To evaluate the clinical application of detection of serum β-HCG with Johnson VITROS 3600 chemiluminescent immunoassay,the serum β-HCG levels in 400 patients and 100 healthy controls were determined by Johnson VITROS 3600 and Beckman-Coulter Unicel DxI 800 respectively.The results showed that Johnson VITROS 3600 had qualified precision.The Intra-assay and inter-assay CV of low,middle and high test results were all less than 5.0%.The linearity of serum β-HCG standard was well and the average recovery rate was 98%.There were no significant difference on the serum β-HCG levels detected by Johnson VITROS 3600 and Beckman-Coulter Unicel DxI 800（P0.05）.There was a positive correlation between two methods（r=0.99,P0.01）.The detection of serum β-HCG levels by VITROS 3600 chemiluminescent immunoassay is accurate and sensitive.It could be used in the early pregnancy diagnosis.