摘要
目的对迈瑞全自动化学发光免疫分析仪CL600-i检测梅毒螺旋体抗体性能进行验证,并对23298例标本的梅毒检测数据进行分析。方法选择两个水平的迈瑞CL6000-i配套梅赤螺旋体抗体质控品进行重复实验,评价迈瑞CL6000-i检测梅毒螺旋体抗体的批内和批间CV。梅毒螺旋体抗体血清盘用来对试剂进行评价。对迈瑞CL6000-i检测的23298例标本的梅毒螺旋体结果进行数据分析。结果通过对迈瑞CL6000-i低值质控品和高值质控品重复检测,计算得其批间CV分别为1.47%和1.20%,批内CV分别是1.31%和0.61%。血清盘中阴性企业参考品检出率19/20,阳性企业参考品检出率9/10,最低检出限的4个参考品L1和12均检出阳性,13和L4均检出阴性。对迈瑙CL6000-i检测的23298例样本梅毒螺旋体抗体数据进行分析,结果显示初筛阳性样本286例。286例样本进行TPPA确证,检出真阳性样本176例,假阳性样本110例。随着检测结果的S/C0值增加,真阳性率增加,当S/C0>10时,真阳性率达到100%。将286例初筛阳性样本按照科室和年龄分类,结果显示与其他科室患者比较,产科门诊和体检组患者的真阳性率低,与其他年龄段比较,年龄≥60岁患者真阳性率低。结论迈瑞CL6000-i检测梅毒螺旋体抗体重复性较好,随着S/C0值增加.检测真阳性率增加,当S/C0>10时,真阳性率达到100%。体检人群和产科患者及年龄≥60岁的患者真阳性率低,这部分患者报告在审核时应格外注意。
Objective To test and verify the performance of Mindray C1.6000-i for detection of treponema pallidum antibody by c-16000-i and analyze the results of 23298 samples.Methods Two levels of quality control materials were selected for calculation of coefficient of variation of Mindray CL6000-i.Serum plate was used to evaluate the quality of reagent kit.23298 serum samples was screened for TP with Mindray CL6000-i.Results The CV between groups of two levels of quality control materials were 1.47%and 1.20%,respectively,and CV of groups were 1.31%and 0.61%.Detection rate of negative control in serum plate was 19/20,and that of positive control was 9/10.LI and L2 of the four reference samples with the lowest detection limit were all positive,while L3 and L4 were all negative.23298 serums were collected and TP was tested with M indray CL6000-i,286 serums were positive.TPPA used as confirmation method,176 serums were true positive and 110 serums were false positive.True positive rate was 100%for patients whose S/CO value was more than 10.Compared with patients from other departments,patients of Obstetrics Department and Medical Examination had lower true positive rate.Patients over 60 years old had lower true positive rate.Conclusion The repeatability for detection of treponema pallidum antibody by Mindray CL6000-i is good.True positive rate increases in patients with higher S/CO and reaches 100%when S/CO>10.False positive rate in patients from Obstetrics Department and Medical Examination and patients over 60 years old is higher than others,so more attention was necessary.
作者
宋燕
刘金玲
王兵
Song Yan;Liu Jinling;Wang Bing(Department of Clinical Laboratory,Aerospace Center Hospital,Beijing 100049,China)
出处
《医学研究杂志》
2020年第8期171-173,82,共4页
Journal of Medical Research
