Laboratory Diagnosis Department, Changsha Kingmed Center for Clinical Laboratory, Changsha, China.
Laboratory Diagnosis Department, Guangzhou Kingmed Center for Clinical Laboratory, Guangzhou, China.
J Clin Lab Anal. 2021 Apr;35(4):e23710. doi: 10.1002/jcla.23710. Epub 2021 Jan 23.
Reduce the effects in the storage-and-thawing process of commercial control materials based on their interchangeability evaluation.
Seven assays-anti-streptolysin O, complement 3, carcinoembryonic antigen, urea, ferritin, total bilirubin, and glucose-were selected. Commercial control materials and serum samples with similar concentrations were chosen as samples. The experiment was carried out in three stages. In the first stage, the assays with statistical differences in imprecision were screened. In the second stage, two specimens were sealed with parafilm and frozen at -80°C and thawed in the water bath, and the imprecision differences were compared again. Finally, the effective means to reduce the effects were included in the standard operating procedure to repeat confirmation.
In the first stage, there was only a statistical difference (p < 0.05) in the imprecision of glucose and total bilirubin between two specimens, and the imprecision of control materials was higher than the serum samples. In the second stage, glucose imprecision was not statistically different (p > 0.05) and lower than in the first stage. In the third stage, the methods from the second stage were confirmed to be effective at reducing control material effects.
Finding variation factors and confirming and standardizing the measures will help lessen commercial control material effects.
通过互用性评估来降低商业控制品在储存和解冻过程中的影响。
选择了 7 种检测方法——抗链球菌溶血素 O、补体 3、癌胚抗原、尿素、铁蛋白、总胆红素和葡萄糖。选择具有相似浓度的商业控制品和血清样本作为样品。实验分三个阶段进行。在第一阶段，筛选出精密度有统计学差异的检测方法。在第二阶段，将两个样本用 Parafilm 密封，在-80°C 下冷冻并在水浴中解冻，再次比较精密度差异。最后，将有效降低影响的方法纳入标准操作程序进行重复确认。
在第一阶段，只有葡萄糖和总胆红素两种样本的精密度存在统计学差异（p<0.05），且控制品的精密度高于血清样本。在第二阶段，葡萄糖的精密度无统计学差异（p>0.05）且低于第一阶段。在第三阶段，证实第二阶段的方法可有效降低控制品的影响。
发现变异因素并确认和规范措施有助于降低商业控制品的影响。
