免疫比浊法检测血清游离轻链的方法学评价

目的对Beckman Immage 800全自动特种蛋白分析仪检测血清游离κ、λ轻链(sFLC)进行方法学评价。方法通过Beckman Immage 800定量测定sFLC,探讨其精密度、正确度、分析测量范围、干扰和携带污染率,同时对其参考区间进行验证。结果κFLC低、高值批内精密度的变异系数(CV)分别为7.84%、2.95%,批间精密度的CV分别为7.38%、5.57%;λFLC低、高值批内精密度(CV)分别为4.59%、3.94%,批间精密度CV分别为3.97%、2.01%;测定κFLC、λFLC定值质控血清与靶值的偏倚小于5%;κFLC、λFLC分析测量范围分别为10.8~128.0 mg/L、10.1~121.0 mg/L时,a值在0.95~1.05,r2≥0.98;κFLC、λFLC携带污染率分别为0.411%、0.216%;干扰试验结果显示游离胆红素≤342.0μmol/L、结合胆红素≤342.0μmol/L、血红蛋白≤5g/L和乳糜≤2 400浊度时,对sFLC结果无明显影响;40例健康体检者中有1例κFLC测定结果超出厂家推荐的参考区间,40例λFLC检测值均在厂家推荐的参考区间内。结论 Beckman Immage 800全自动特种蛋白分析仪检测sFLC的主要分析性能符合质量目标的要求,能够为临床提供科学、准确的诊疗依据。

Methodological evaluation on serum free light chains detected by immunoturbidimetry

Objective To perform the methodological evaluation on Beckman Immage 800 automatic special protein analyzer for determining serum freeκ,λlight chains (sFLC) .Methods The Beckman Immage800 automatic special protein analyzer was used to quantitatively detect sFLC values for investigating its precision and accuracy ,analyzing its detecting range ,interference and residual contamination rate ,meanwhile verifying its reference intervals .Results The low and high values of within‐run precision coefficients of variation(CV) forκsFLC were 7 .84% and 2 .95% respectively ;which of between‐run precision CV were 7 .38% and 5 .57% re‐spectively .The within‐run precision CV for λFLC were 4 .59% and 3 .94% respectively ,which of between‐run precision CV were 3 .97% and 2 .01% respectively ;bias for detecting theκFLC andλFLC fixed quality serum and the target values was less than 5% , when the analytical detection ranges of κFLC andλFLC were 10 .8-128 .0 mg/L and 10 .1-121 .0 mg/L ,a value was 0 .95-1 .05 , r2 ≥0 .98;the carry‐over rates of κFLC andλFLC were 0 .411% and 0 .216% respectively .The interference test results showed that when free hemoglobin≤342 .0 μmol/L ,conjugated bilirubin ≤342 .0 μmol/L ,hemoglobin≤5 g/L and chyle ≤2 400 turbidness , which had no influence on sFLC results ;among 40 healthy subjects undergoing the physical examination ,1 case of κFLC detection results exceeded the reference interval recommended by the manufacturer ,while theλFLC detection values in these 40 cases were all within the reference interval recommended by the manufacturer .Conclusion The main analytical performance of the Beckman Im‐mage800 automatic special protein analyzer for detecting sFLC meets the requirements of quality objectives and can provides the sci‐entific and precise evidence of diagnosis and treatment for clinic .