广州地区献血者HBV核酸检测非重复反应性样本确认及追踪研究

The study on the confirmation and tracking of unrepeatable reactive samples in HBV NAT blood screening in Guangzhou

目的研究无偿献血乙型肝炎病毒(HBV)核酸检测中非重复反应性样本确认方法,探讨此类献血者血液安全性及归队屏蔽策略。方法对391例HBV单项NAT(Grifols Proleix Elite Assay)反应性样本使用原NAT检测系统进行重复检测,非反应性样本使用罗氏MPX 2.0核酸检测试剂进行确认,并补充乙肝"两对半"试验,对部分HBV单项NAT反应性献血者进行回访追踪。结果 391例单项HBV NAT反应性样本原系统重测,90例样本仍为反应性(占23.01%),301例样本为非反应性(占76.99%)。296例非重复反应性样本在罗氏MPX 2.0试剂复核阴性,5例样本呈反应性,推断为低水平HBV隐匿性感染。HBV NAT重复检测非反应性样本组在抗-HBs项的阳性率高于重复检测反应性样本组(x^2=7.629,P<0.05),在抗-HBc项则反之(x^2=15.303,P<0.05)。8例HBV NAT非重复反应性献血者随访复检NAT合格,18例献血者复检呈单项NAT反应性,后用双NAT系统重测,6例献血者单或双NAT系统为反应性(抗-HBc均为阳性),12例献血者为阴性(抗-HBc阳性9例)。结论在鉴定HBV NAT非重复反应性样本及献血者复查时,在原有检测基础上补充另外一种灵敏度相当的核酸检测系统进行复试,并增加抗-HBs和抗-HBc检测能进一步甄别假反应性样本和隐匿性乙肝病毒感染样本,建议采供血机构以3-6个月为间隔对核酸检测中HBV NAT非重复反应性的献血者进行一次以上复检。

Objective To investigate the non-repetitive reactive sample confirmation method for hepatitis B virus(HBV)nucleic acid detection of unpaid blood donation,explore the blood safety of such blood donors and the screening strategy.Methods Same NAT system was used to retest 391 samples reactive in HBV NAT(Grifols Proleix Elite Assay),and Roche MPX 2.0 was used to confirm the unrepeatable reactive samples;the HBV serological test was completed,and a return visit was paid to track some single HBV NAT reactive donors. Results The HBV NAT retest had been preformed to391 samples negative in ELISA test while reactive in NAT;90 samples were still reactive(23.01%);301 samples were unreactive(76.99%). Among 301 cases of HBV NAT unrepeatable reactive samples,there were 296 cases negative and 5 cases reactive in Roche MPX 2.0 NAT. The positive rate of anti-HBs in the group of unrepeatable reactive samples in HBV NAT was higher than that of the group of unrepeatable reactive samples,on the contrary in anti-HBc. Follow-up tracking had been done to 26 HBV NAT unrepeatable reactive blood donors;8 cases of blood donors were NAT unqualified in second time screening;18 cases of blood donors were single NAT reactive;6 cases were still reactive after double NAT system testing(all cases were reactive in anti-HBc),and 12 cases were negative(9 cases were positive in anti-HBc).Conclusion In identification of HBV NAT unrepeatable positive samples and blood donors review,on the basis of original test,retesting by another NAT system with same sensitivity,and completing the HBV serological test could identify false reactive samples and samples of occult hepatitis B virus infection. We suggested that blood services should preform more than one review on donors unrepeatable reactive in HBV NAT for 3-6 months intervals.