PDF(Pubmed)
Abstract：
Background: We compared the performance of 21 different assays performed by the Wantai Wan200+ (Wantai BioPharm, Beijing, China) with respect to other methods in use at the University Hospital of Padova (AOPD), Italy. Methods: The plasma (P) or serum (S) of 5027 leftover samples, collected from May to Sept 2023, was either analyzed or frozen at -20 °C. Beckman DXI800 (DXI), Roche Cobas 8000 e801 (RC), Snibe Maglumi 4000 plus (SM), DiaSorin Liaison XL (DL) and Binding Site Optilite (BS) equipment were used at the AOPD. P-procalcitonin (PCT), DXI; P-Troponin I (TnI), DXI; S-CA125, DXI; S-free PSA (f-PSA), DXI; S-total PSA (t-PSA), DXI; S-IL6, SM; P-Troponin T (TnT), RC; P-NT-proBNP, RC; P-Neuron-Specific Enolase (NSE), RC; S-CA15-3, DL; S-CA19-9, DL; S-AFP, DL; and S-CEA, DL were tested in fresh samples. P-Myoglobin (Myo), DXI; P-Cyfra21-1, RC; S-β2 microglobulin (B2MIC), BS; S-HE4, SM; S-PGI, SM; S-PGII, SM; S-CA72-4, SM; and S-CA50, SM were analyzed in frozen and thawed samples. Bland-Altman (BA), Passing-Bablok (PB) and Cohen\'s Kappa (CKa) metrics were used as statistics. Results: An excellent comparability profile was found for 11 analytes. For example, the t-PSA CKa was 0.94 (95%CI: 0.90 to 0.98), and the PB slope and intercept were 1.02 (95%CI: 0.99 to 1.03) and 0.02 (95%CI: 0.01 to 0.03), respectively; the BA bias was 2.25 (95%CI: -0.43 to 4.93). Ten tested measurands demonstrated a suboptimal comparability profile. Biological variation in EFLM (EuBIVAS) performance specifications was evaluated to assess the clinical relevance of measured biases. Conclusions: Evaluation of the Wantai Wan200+\'s performance suggests that between-method differences did not exceed the calculated bias. Metrological traceability may influence the comparisons obtained for some measurands.
摘要：
背景：我们比较了WantaiWan200+(WantaiBioPharm，北京,中国)关于帕多瓦大学医院(AOPD)使用的其他方法，意大利。方法：5027份剩余样本的血浆（P）或血清（S），从2023年5月至9月收集，在-20℃下进行分析或冷冻。贝克曼DXI800(DXI),罗氏Cobas8000e801(RC)，SnibeMaglumi4000plus(SM)，在AOPD处使用DiaSorinLiaxXL(DL)和结合位点Optilite(BS)设备。P-降钙素原(PCT),DXI；P-肌钙蛋白I(TnI)，DXI;S-CA125,DXI;无SPSA(f-PSA),DXI；S-总PSA（t-PSA），DXI；S-IL6，SM；P-肌钙蛋白T（TnT），RC；P-NT-proBNP，RC；P-神经元特异性烯醇化酶（NSE），RC；S-CA15-3，DL；S-CA19-9，DL；S-AFP，DL；和S-CEA，在新鲜样品中测试DL。P-肌红蛋白(Myo),DXI;P-Cyfra21-1,RC;S-β2微球蛋白(B2MIC),BS;S-HE4,SM;S-PGI,SM；S-PGII，在冷冻和解冻样品中分析SM;S-CA72-4,SM;和S-CA50,SM。Bland-Altman(BA),Passing-Bablok(PB)和Cohen的Kappa(CKa)指标被用作统计数据。结果:发现11种分析物具有极好的可比性。例如,t-PSACKa为0.94（95CI：0.90至0.98），PB斜率和截距分别为1.02（95CI：0.99至1.03）和0.02（95CI：0.01至0.03），BA偏倚分别为2.25（95CI：-0.43至4.93）。十个测试的被测对象显示出次优的可比性。评估EFLM（EuBIVAS）性能规格的生物学差异，以评估所测量偏差的临床相关性。结论：对万泰万200+\性能的评估表明，方法之间的差异没有超过计算的偏差。计量可追溯性可能会影响某些被测对象的比较。
