野战环境对Roche Cobas E411电化学发光免疫分析仪性能的影响

摘要

目的：探讨野战环境对Roche CCobas E411电化学发光免疫分析仪性能的影响。方法对Roche Cobas E411系统的降钙素原（PCT）、N末端脑钠肽前体（NT⁃proBNP）、肌红蛋白（Mb）、高敏肌钙蛋白T（hsTNT）4个项目在野战环境下进行精密度、正确度、回收率、线性评价，并与Roche Cobas E601电化学发光分析仪测定进行比较。结果该仪器测定PCT的低、高水平批内变异系数（ CV）分别为1�70％、0�70％，批间CV为4�09％、3�35％；NT⁃proBNP的批内CV为2�46％、1�61％，批间CV为5�10％、2�59％；Mb的批内CV为2�42％、1�17％，批间CV为4�71％、2�51％；hsTNT的批内CV为2�83％、1�79％，批间CV为4�77％、3�14％。 Roche Cobas E411与Roche Cobas E601电化学发光分析仪测定PCT、NT⁃proBNP、Mb、hsTNT的结果均显著相关（ r＞0�975， P＞0�05），各项目回收率均在97％～103％。 Roche Cobas E411测定PCT、NT⁃proBNP、Mb、hsTNT的线性范围分别为（0�08～98�75） ng／mL、（7�95～33815�65） pg／mL、（26�94～2816�40） ng／mL、（5�23～9311�05） ng／L。结论 Roche Cobas E411检测PCT、NT⁃proBNP、Mb、hsTNT具有优异的准确性、良好的精密度和较宽的线性范围，可满足野战环境需求。%Objective To explore the influence of Roche Cobas E411 electrochemistry luminescence immunity analyzer (Roche Cobas E411) performance under field environment. Methods Procalcitonin ( PCT), N⁃terminal pro⁃B⁃type natriuretic peptide (NT⁃proBNP), myoglobin (Mb) and high sensitive cardiac troponin T (hsTNT) detected by Roche Cobas E411 system were evaluated in precision, accuracy, recovery and linearity under field environment. The data was compared with Roche Cobas E601. Results The within⁃run coefficient of variations ( CVs) of PCT with low and high level control using Roche Cobas E 411 analyzer were 1.70%, 0.70% respectively, whereas the between⁃day CVs of PCT were 4. 09%, 3. 35%; the within⁃run CVs of NT⁃proBNP were 2.46%, 1.61%, which showed the between⁃day CVs of NT⁃proBNP were 5. 10%, 2. 59%; the within⁃run CVs of Mb were 2. 42%, 1.17%, meanwhile the between⁃day CVs of Mb were 4.71%, 2.51%;and the within⁃run CVs of hsTNT were 2.83%, 1.79%, whereas the between⁃day CVs of hsTNT were 4.77%, 3.14%. The level of PCT, NT⁃proBNP, Mb and hsTNT with Roche Cobas E411 analyzer were well related to the results on Roche Cobas E601 ( r>0.975, P>0.05) , and the recovery of these four items were all between 97%and 103%. The linear range of PCT, NT⁃proBNP, Mb and hsTNT were (0.08-98.75) ng/mL, (7.95-33815.65) pg/mL, (26.94-2816.40) ng/mL and (5.23-9311.05) ng/L respectively. Conclusion Roche Cobas E411 analyzer presents good accuracy, out⁃standing precision and wide analytical measurement range, which can meet the requirement of field environment.