Application of chemiluminescence immunoassay method in HIV antibody/antigen detection and analysis of confirmation cases
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摘要: 目的 评估罗氏化学发光免疫试验(CLIA)检测人类免疫缺陷病毒(HIV)抗体/抗原的特异性，了解CLIA法检测HIV的初筛阳性反应与免疫印迹试验(WB)阳性结果的关系。方法 用CLIA法检测拟定输血患者血清中HIV抗体/抗原标本，保留CLIA法检测的阳性标本，再用WB法对初筛阳性标本进行确认，分析CLIA法在HIV抗体/抗原检测中的应用及HIV确证结果。结果 CLIA法检测552例阳性，WB法检测108例阳性(19.57%); WB法证实HIV阳性率在1 < S/CO≤10、10 < S/CO≤50、50 < S/CO≤150、150 < S/CO≤500、S/CO>500 5个区间中，其阳性率分别为0.28%、12.51%、66.70%、100.00%、91.89%，5组HIV确诊阳性率差异有统计学意义(χ2=247.81，P< 0.01)。WB法确诊感染者108例，其中男70例(65.0%)，女38例(35.0%)。根据受试者工作特征曲线(ROC)分析，55.37 S/CO作为罗氏CLIA法检测HIV初筛试验的分界值。该值对应的灵敏度、特异度和ROC曲线下面积分别为100%、94.57%和0.986。结论 CLIA法检测HIV高数值的患者，感染HIV的风险高，采用55.37 S/CO作为罗氏CLIA法截断值，其特异度和灵敏度较高，高于此数值的患者感染HIV的可能性非常大，对HIV的检测流程完善有一定的指导意义。Abstract: Objective To evaluate the specificity of Roche chemiluminescence immunoassay(CLIA) in detecting human immunodeficiency virus(HIV) antibodies/antigens, and understand the relationship between the positive results of CLIA detection of HIV and the positive results of western blotting(WB).Methods The CLIA method was used to detect HIV antibody/antigen samples in the serum of blood transfusion patients planned by the hospital, and the positive samples detected by the CLIA method were retained, and then the positive samples were confirmed by WB at the initial screening. HIV confirmatory results were analyzed.Results Among 552 positive cases detected by CLIA method, 108 positive cases(19.57%) were detected positive by WB method. In the five intervals of S/CO≤150, 150 <S/CO≤500, and S/CO>500, the positive rates were 0.28%, 12.51%, 66.70%, 100.00%, and 91.89%, respectively. There were differences in the positive rates of HIV among the five groups. There was statistical significance(χ2=247.81,P< 0.01); among the 108 cases of infection confirmed by WB method, 70 cases(65.0%) were male, and 38 cases(35.0%) were female.According to receiver operating characteristic curve(ROC curve) analysis, 55.37 S/CO was used as the cut-off value for the detection of HIV primary screening test by Roche CLIA method. This value corresponded to sensitivity, specificity and area under the ROC curve of 100%, 94.57% and 0.986, respectively.Conclusion Cases with a high value of HIV detected by CLIA method may have a high risk of HIV infection. Using 55.37 S/CO as the cutoff value of Roche CLIA method can have high specificity and sensitivity. Patients with higher values than this value would be very likely to be infected with HIV. It may have certain guiding significance for the improvement of HIV detection process.
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表 1 CLIA法与WB法确证结果的比较
S/CO 总例数 阴性/例(%) WB法/例(%) 阳性 不确定 1 < S/CO≤10 359 355(98.87) 1(0.28) 3(0.84) 10 < S/CO≤50 73 65(89.04) 1(1.37) 7(9.59) 50 < S/CO≤150 53 11(20.75) 42(79.25) 0 150 < S/CO≤500 30 0 30(100.00) 0 S/CO>500 37 2(5.41) 34(91.89) 1(2.70) 合计 552 433(78.44) 108(19.57) 11(1.99) 
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表 2 552例CLIA法阳性患者年龄与WB法确证结果
年龄/岁 CLIA法阳性例数 WB法 阳性数 不确定数 阴性数 < 20 男 10 5 0 5 女 5 0 1 4 20~50 男 202 40 0 162 女 122 16 2 104 >50 男 98 25 3 70 女 115 22 5 88 合计 男 310 70 3 237 女 242 38 8 196
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表 3 WB法HIV确证患者的特征及感染途径
特征 阳性例数 构成比/% 性别 男 70 64.81 女 38 35.19 文化程度 小学 35 32.41 初中 17 15.74 中专(高中) 15 13.89 大专 9 8.33 大学以上 18 16.67 文化程度不详 14 12.96 婚姻状况 未婚 42 38.89 已婚 62 57.41 离婚(失偶) 4 3.70 可能的感染途径 异性性接触感染(嫖客) 61 56.48 吸毒(毒品输注者) 5 4.63 同性恋者 13 12.04 母亲阳性史 1 0.93 不详者 28 25.93
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