血液安全筛查联合检测系统的研制

Development of An Associated Detection System for Safe Blood Screening

目的研制一种应用于应急采供血的血液安全筛查联合检测系统(联合系统)。方法将ABO/RhD血型、血红蛋白(Hb)、丙氨酸转氨酶(ALT)、乙型肝炎表面抗原(HBsAg)、丙型肝炎(HCV)抗体、艾滋病病毒(HIV)抗体和梅毒(TP)抗体筛查等整合在一张血液安全筛查联合检测卡上,利用相应的血液安全筛查联合检测仪检测和判读结果。随机选择47例住院患者血液样本,应用联合系统检测,并分别与酶联免疫吸附测定法(ELISA法)、微柱凝胶法、血细胞分析仪和全自动生化分析仪测定结果进行比较。结果传染病四项检测以ELISA检测结果为标准,联合系统检测HBsAg、TP抗体符合率100%,HIV抗体和HCV抗体存在一定假阳性。ABO/RhD血型鉴定结果与微柱凝胶法完全一致。联合系统检测ALT(17.7±11.3)U/L,Hb(137.1±20.8)g/L,与血细胞分析仪和全自动生化分析仪测定结果比较差异无统计学意义(P>0.05)。结论联合系统操作简单快捷,准确性较高,可满足突发事件时血液应急保障的需求。

Objective To develop an associated detection system for safe blood screening （association system） for emer- gency blood collection. Methods Screening tests for ABO/RhD grouping, haemoglobin （ Hb）, alanine transarninase （ALT）, hep- atitis B surface antigen （HBsAg）, hepatitis C virus （HCV） antibody, human immunoddficiency virus （HIV） antibody and trepone- ma pallidum （TP） antibody were integrated into an associated detection card. The test results were assessed by related safe blood screening and automatic detector. Forty-seven blood samples were randomly collected and detected by association system. The re- suits by association system were compared with those by enzyme-linked immunosorbent assay （ELISA）, microcolumn gel test, he- matology analyzer, and automatic biochemical analyzer. Results Results by ELISA were regarded as standards of 4 items of infec- tious diseases detection, the coincidence rates of HBsAg and TP were 100%, while a certain of false positive of HIV and HCV anti- bodies were exited by association system. The results of ABO/RhD grouping by association system were identical to those by micro- column gel test. The concentrations of ALT and Hb were （ 17.7± 11.3 ） U/L and （ 137.1 ± 20.8） g/L respectively by association system, and the differences in results between association detection system and hematology analyzer or automatic biochemical analy- zer showed no statistical significance （P 〉 0. 05）. Conclusion The association system for safe blood screening is easy to operate with high accuracy, and can be used for emergency security under emergent or special circumstances.