Akbas Neval, Gonzalez Graciela, Edwards Rachel, Devaraj Sridevi
Department of Pathology & Immunology, Baylor College of Medicine, 6621 Fannin Street, Houston, Tx 77030, USA.
Texas Children's Hospital, 6621 Fannin Street, Houston, Tx 77030, USA.
Pract Lab Med. 2015 Oct 3;3:1-7. doi: 10.1016/j.plabm.2015.09.002. eCollection 2015 Dec 1.
Point of care testing (POCT) contributes to diagnosis and monitoring with fast testing time and easily performed assays. We evaluated the Abaxis Piccolo Xpress point of care chemistry analyzer using the Liver Panel Plus discs for our pediatric patient population at Texas Children's Hospital.
Analytical performance was evaluated for precision and linearity using quality control materials and commercially available verification samples. Comparison studies were performed between Piccolo Xpress analyzer and Vitros 5600 analyzer using patient samples. Interference studies were carried out using nine different patient pool sera. Lipemia interference was removed using LipoClear for severely lipemic sample pools.
Precision of all tests was excellent (CVs<5% for all measured analytes except TBIL). All assays were linear and accurate within the allowable total error. Comparison studies showed that three analytes (amylase, GGT and TBIL) had statistically significant bias. Interference study results did not exceed the total allowable error for hemoglobin (<150 mg/dL), bilirubin (<15 mg/dL) and lipemia (<400 mg/dL except ALT, GGT and TP). LipoClear treatment removed lipemia interference for all analytes except total protein.
The Piccolo Xpress chemistry analyzer showed an acceptable analytical performance for precision, linearity and interference from common substances. Increased bias for three analytes in comparison studies could be due to different methodologies.
即时检验(POCT)凭借快速的检测时间和易于操作的检测方法,有助于疾病的诊断和监测。我们在德克萨斯儿童医院,针对儿科患者群体,使用肝脏检测组合 Plus 试剂盘,对 Abaxis Piccolo Xpress 即时化学分析仪进行了评估。
使用质量控制材料和市售验证样本,对分析性能的精密度和线性进行评估。使用患者样本,在 Piccolo Xpress 分析仪和 Vitros 5600 分析仪之间进行比较研究。使用九种不同的患者混合血清进行干扰研究。对于严重脂血样本池,使用 LipoClear 去除脂血干扰。
所有检测的精密度都非常出色(除总胆红素外,所有被测分析物的变异系数<5%)。所有检测方法在允许的总误差范围内呈线性且准确。比较研究表明,三种分析物(淀粉酶、γ-谷氨酰转移酶和总胆红素)存在统计学上的显著偏差。干扰研究结果未超过血红蛋白(<150mg/dL)、胆红素(<15mg/dL)和脂血(除谷丙转氨酶、γ-谷氨酰转移酶和总蛋白外<400mg/dL)的总允许误差。LipoClear 处理消除了除总蛋白外所有分析物的脂血干扰。
Piccolo Xpress 化学分析仪在精密度、线性以及常见物质干扰方面表现出可接受的分析性能。比较研究中三种分析物偏差增加可能是由于方法不同所致。