Development and stability evaluation of cerebrospinal fluid quality control products
脑脊液质控品研制及其稳定性评价

摘要

目的 研制脑脊液生化质控品，评价其稳定性。方法 自配制不同浓度脑脊液质控品，在4℃-20℃、25℃下储存28天，采用全自动生化分析仪测定氯离子（CL）、葡萄糖（GLU）、脑脊液蛋白质（CSFP）、乳酸脱氢酶（LDH）、腺苷脱氨酶（ADA）浓度，计算变异系数（CV%）评价其稳定性，以回收试验评价准确性。评价自制脑脊液、临床收集脑脊液和商品化脑脊液4℃保存60天的稳定性。结果 自制脑脊液4℃保存28天CL\GLU\LDH\ADA的CV最小；正常浓度与B浓度自制脑脊液各项目均有显著差异（P<0.05），正常浓度自制脑脊液质控品中各项指标的回收率分别为CL：88%、GLU：89%、CSFP：104%、LDH98%、ADA：107%；4℃保存60天，自制正常浓度脑脊液中CL\GLU\ADA的CV值明显小于临床收集脑脊液和商品化脑脊液，CSFP变化与临床收集脑脊液接近，明显小于商品化脑脊液，但LDH浓度明显高于临床收集脑脊液。结论 自制脑脊液4℃保存28天稳定性好，正常浓度与B浓度自制脑脊液可满足高值和低值质控品要求，正常浓度脑脊液质控品多数项目正确性好。正常浓度脑脊液质控品在60天内4℃下保存稳定性较好，自制脑脊液多数项目的稳定性均优于商品化脑脊液和临床脑脊液样本。本方法自制脑脊液质控品可满足临床实验室常规使用。

Abstract

Objective To develop biochemical quality control substance for cerebrospinal fluid and evaluate its stability.
Methods Different concentration cerebrospinal fluid(CSF) quality control materials(self-maded CSF) were prepared and stored at 4℃-20℃ and 25 ℃ for 28 days, then using automatic biochemical analyzer to determine the concentrations of chlorideion (CL), glucose (GLU), cerebrospinal fluid protein (CSFP), lactic acid Dehydrogenase (LDH) and adenosine deaminase (ADA) ,Coefficient of variation (CV%) was calculated to evaluate its stability and accuracy was evaluated by recovery test. The stability of self-maded CSF, clinical collected CSF and commercial CSF stored at 4℃ for 60 days was evaluated.
Results The CV% of CL\GLU\LDH\ADA was the smallest in self-maded CSF stored at 4°C for 28 days;There were significant differences between the normal and B concentrations in all items of self-maded CSF(P<0.05).The recovery rates of normal concentrations quality control products were CL: 88% , GLU: 89% , CSFP: 104% , LDH: 98% , ADA: 107%;after stored at 4°C for 60 days, the value of CV% of CL\GLU\ADA in the self-maded normal concentration CSF was significantly lower than that of clinical collection CSF and commercial CSF. The change of CSFP was similar to that of clinical collection CSF and significantly smaller than that of commercial CSF, but the concentration of LDH was significantly higher than that of clinical collection CSF.
Conclusion   The self-maded CSF has good stability when stored at 4℃ for 28 days. The normal concentration and B concentration of the self-maded CSF may meet requirements of high-value and low-value quality control products. Most of the items in normal concentration self-maded CSF have a good quality. The normal concentration of self-maded CSF has better stability at 4 ℃ for 60 days,the stability of all items in the self-maded CSF is better than that of commercial CSF and clinical CSF. The self-maded CSF can meet the routine use in clinical laboratories.