评价 QMS® 替考拉宁免疫分析法（赛默飞世尔科技）在 Cobas® 8000 系统（罗氏诊断）上的性能，并与荧光偏振免疫分析法比较，用于测定人血浆中的替考拉宁浓度。
Evaluation of the QMS® Teicoplanin Immunoassay (ThermoFisher Scientific) on Cobas® 8000 System (Roche Diagnostics) and comparison to fluorescence polarization immunoassay for the determination of teicoplanin concentrations in human plasma.
机构信息
Clinical Pharmacology Department, Hôtel Dieu, CHU de Nantes, France.
出版信息
J Clin Lab Anal. 2013 Mar;27(2):96-8. doi: 10.1002/jcla.21567. Epub 2013 Feb 1.
BACKGROUND
The performances of the QMS(®) Teicoplanin immunoassay recently developed on Cobas(®) 6000/8000 systems were evaluated and compared to a fluorescence polarization immunoassay (FPIA) [Teicoplanin Innofluor(®) Assay (Thermo Fisher Scientific, Indianapolis, IN)] on FLX analyzer (Abbott Laboratories, Abbott Park, IL)].
METHODS
The validation was performed according to the Cofrac (French Accreditation Committee) document SH GTA 04. For the comparison, 48 plasma samples were analyzed by FPIA and QMS assays.
RESULTS
The QMS assay is accurate (intra assay and inter assay inaccuracy ≤ 2.4%) and precise (intra assay and inter assay imprecision ≤ 10.2%). A linear relationship [QMS = 1.0319 × FPIA - 2.8518, r(2) = 0.9246 (P < 0.001)] between FPIA and QMS was found. In the Bland-Altman plots, no systematic bias was found even if QMS results trends to be lower (mean of the ratio QMS concentration/FPIA concentration = 0.91).
CONCLUSION
These results between QMS and FPIA are consistent, which indicates that QMS(®) Teicoplanin immunoassay on Cobas(®) 8000 System is an alternative to FPIA.
背景
最近在 Cobas(®) 6000/8000 系统上开发的 QMS(®) 替考拉宁免疫测定法的性能得到了评估，并与 FLX 分析仪上的荧光偏振免疫测定法（FPIA）[替考拉宁 Innofluor(®) 测定法（Thermo Fisher Scientific，印第安纳波利斯，IN）]进行了比较。
方法
验证按照 Cofrac（法国认可委员会）文件 SH GTA 04 进行。为了进行比较，对 48 个血浆样本进行了 FPIA 和 QMS 检测。
结果
QMS 测定法准确（内部和外部不准确性≤2.4%）和精确（内部和外部不精密度≤10.2%）。发现 FPIA 和 QMS 之间存在线性关系[QMS = 1.0319 × FPIA - 2.8518，r(2) = 0.9246（P < 0.001）]。在 Bland-Altman 图中，即使 QMS 结果趋势较低（QMS 浓度/FPIA 浓度比值的平均值=0.91），也没有发现系统偏差。
结论
QMS 和 FPIA 之间的这些结果是一致的，这表明 Cobas(®) 8000 系统上的 QMS(®) 替考拉宁免疫测定法是 FPIA 的替代方法。
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