基于HIV检测结果对反应性献血者分类管理的探讨

Classification management of HIV reactive blood donors based on test results

目的利用血站实验室HIV检测结果探讨对反应性献血者分类管理的可行性。方法按照献血者HIV检测结果(包括2遍ELISA、1遍NAT),将检测结果为HIV反应性的献血者分为3组。组1为HIV全项反应性(ELISA和NAT均为反应性)、组2为HIV血清学单反应性(仅ELISA为反应性)、组3为HIV核酸单反应性(仅NAT为反应性)。分析2017年5-12月191628名献血者HIV检测结果,并通过RIBA明确标本真实血清学状态。RIBA结果阳性和(或)核酸重复试验反应性则判定为HIV真阳性,比较3组献血者HIV真阳性检出率。通过绘制ROC曲线,以99%特异性对应S/CO低值作为相应ELISA方法的献血者屏蔽界限值,评估其在献血者分类中的功效。结果191628名献血者共检出HIV反应性标本180份,包括组1标本77份(42.78%)、组2标本100份(55.56%)、组3标本3份(1.67%)。(1)HIV反应性结果呈现多样性:82名真阳性献血者中发现4名HIV早期感染者(3名HIV ELISA抗原抗体窗口期,1名HIV ELISA抗体窗口期)、2名疑似HIV精英控制者、76名血清学和核酸均为反应性HIV感染者。(2)总体HIV真阳性检出率为47.67%,组1(100%)=组3(100%)>组2(2.17%)(P<0.01)。(3)ELISA1、ELISA2屏蔽界限值分别为5.40、9.69(S/CO值),相应阳性预期值分别为98.73%、91.14%(P>0.05)。同时使用2种ELISA屏蔽界限值可精准屏蔽组1和组2所有真阳性献血者(79/79,100%)。结论献血人群HIV结果分布呈现多样性和复杂性,需持续提高HIV防控意识。对反应性献血者进行分类有助于精细化和科学管理。组1和组3献血者可实施永久屏蔽,组2中疑似HIV精英控制者应引起实验室关注并永久屏蔽。

Objective To explore the viability of classification management of HIV reactive blood donors based on test results in blood screening laboratory.Methods According to the HIV test results of blood donors(including twice ELISA and once NAT),the HIV reactive blood donors were divided into three groups.Group 1 was all-test reactive(both ELISA and NAT were reactive),group 2 serological reactive(only ELISA was reactive),and group 3 NAT reactive(only NAT was reactive).The HIV test results of 191628 blood donors from May to December 2017 were analyzed.Samples with positive RIBA results and/or the repeated reactive NAT results were determined as HIV true positive.The yielding rates of HIV true positivity in each group were analyzed.Receiver operating characteristic curve(ROC curve)was used to elevate the S/CO limit under 99%specificity as the blood donor deferral limit for ELISA.Results A total of 180 HIV reactive samples were detected out of 191628 blood donors,including 77 positive cases in group 1,100 in group 2 and 3 in group 3.(1)The HIV reactive results were diverse.Among the 82 true positive blood donors,4 were early HIV infection(3 HIV antibody+antigen window period yield,1 HIV antibody window period yield),2 were suspected elite controllers,and 76 cases were both serology and NAT reactive.(2)The overall yielding rate of HIV was 47.67%,with group 1(100%)=group 3(100%)>group2(2.17%),showing statistically significant(P<0.01).(3)The blood donor deferral limit for ELISA1,ELISA2 was 5.40and 9.69(S/CO value),respectively,with the corresponding positive expective values of 98.73%and 91.14%(P>0.05).All true positive blood donors in group 1 and group 2 could be accurately screened by using the blood donor deferral limit for ELISA1 and ELISA2 simultaneously.Conclusion The composition of HIV results among blood donors is diverse and complex.It is necessary to continuously improve the awareness of HIV prevention and control.The classification of HIV reactive blood donors is conducive to conduct fine and scientific manage-ment.The blood donors in group 1 and group 3 should be permanently deferral,and the suspected HIV elite controllers in group 2 should be paid attention to and permanently deferral.