四种艾滋病病毒抗体筛查试剂检测性能评价

Evaluation of four kits for screening HIV antibody

目的通过对比分析艾滋病病毒（HIV）抗体筛查阳性结果与免疫印迹试验（WB）结果，评价4种HIV抗体筛杏试剂榆测性能。方法2004年1月至2009年6月，分别用中山生物工程有限公司、荷兰生物梅里埃有限公司、珠海丽珠有限公司生产的3种酶联免疫吸附试验（enzyme linked immunosorbentassay，ELISA）试剂初筛血清HIV抗体，用美国雅培Determine HIV-1／2胶体硒标试剂、原试剂复检。筛查阳性样本用WB法进行确认。结果共检测206151例患者血清HIV抗体，确认HIV抗体阳性193例（0．094％）：3种ELISA试剂敏感度、阴性预期值均为100％；雅培试剂分别为93．93％、91．67％，其漏检的样小均为WB不确定：中山、梅里埃、丽珠、雅培试剂的特异度分别为99．88％、99．89％、99．96％、89．38％；阳性预期值（study predictive value of apositive test result，PVP）分别为35．58％、46．46％、76．61％、92．20％；功效分别为99．88％、99．89％、99．96％、91．98％；3种ELISA试剂ROC曲线下面积分别为0．93、0．99、0．95。丽珠的PVP明显高于中山（Х^2=45．804，P=0．000）、梅咀埃（Х^2=25．231，P=0．000）；梅里埃的PVP比中山高，但无统计学意义（Х^2=2．488，P=0．115）；雅培PVP最高（与丽珠相比，Х^2=18．633，P=0．000）。在WB确认阳性、小确定、阴性组，均存在S／CO值[样本（sample）吸光度值／临界值（cutoff）]〈6或≥6的样本。中山试剂确认阳性组S／CO值（14．29±2．63）明显高于阳性-阴性组（2．80±3．25）（t=17．652，P=0．000）。悔里埃试剂确认阳性组S／CO值（16．09±2．35）明显高于阳性-阴性组（2．14±1．91）（t=31．622，P=0．000）：丽珠试剂确认阳性组S／CO值（11．54±1．95）明显高于阳性-不确定组（5．54±3．57）（t=6．386，P=0．000）、阳性-阴性组（3．25±2．41）（t=21．772，P=0．000）；阳性-不确定组S／CO值则高于阳性-阴性组（t=2．301，P=0．033）。结论4种筛查试剂性能良好，根据S／CO值不能准确估计WB确认结果，筛查阳性后必须进行确认。

Objective To Evaluate four kits for screening HIV antibody by comparing and analyzing the HIV antibody screening positive results and Western Blot（WB） test results. Methods From January, 2004 to June 2009, three ELISA kits （ Zhongshan, Biomerieux and Livzon ） were used for initial screening HIV antibody. The reactive positive samples were reexamed by initial ELISA kit and a rapid kit （Abbot Determine HIV-1/2）. All repeatedly reactive positive screening results were followed by WB test. Results A total of 193 （0. 094% ） WB confirmed positive results were obtained from 206 151 specimens. The sensitivities and predictive values of negative test result （PVN） of three ELISA kits were all 100% and those of Abbot Determine HIV-1/2 were 93.93% , and 91.67% respectively. All false negative results from Abbot were WB indeterminate. The specificities of Zhongshan, Biomerieux, Livzon and Abbot were 99.88% ,99.89% ,99.96% and 89.38% ; the study predictive values of a positive test result （PVP） were 35.58%, 46.46%, 76. 61% and 92. 20% ; the efficiencies were 99.88%, 99. 89%, 99.96% and 91.98% ; the areas under ROC curve of the three ELISA kits were 0. 93,0. 99, and 0. 95 respectively. PVP of Livzon was obviously higher than those of Zhongshan （Х^2 = 45. 804, P = 0. 000） , Biomerieux （ Х^2 = 25.231, P = 0. 000） and Biom6rieux was higher than Zhongshan （ Х^2 = 2. 488,P = 0. 115 ）. PVP of Abbot was highest （Х^2 = 18. 633 ,P = 0. 000, vs Livzon）. There were some specimens with S/CO（ optical density of sample/cut off） ratio 〈 6 or≥6 in all lhree groups with positive,indeterminate and negative WB results. The S/CO ratio from Zhongshan in confirmed positive group （14.29 ± 2.63 ） was higher than in positive-negative group （2. 80 ±3.25）（t = 17. 652, P= 0. 000）. The S/CO ratio from Biomerieux in confirmed positive group （ 16. 09± 2. 35 ） was higher than in positive-negative group （ 2.14 ± 1.91 ） （ t = 31. 622, P = 0. 000 ）. The S/CO ratio from Livzon in confirmed positive group（ 11.54 ± 1.95 ） was higher than in positive-indeterminate group （ 5. 54 ± 3.57 ） （ t = 6. 386, P = 0. 000 ）, positive-negative group （ 3.25 ± 2. 41 ） （ t = 21. 772, P = 0. 000） and positive-indeterminate group was higher than positive-negative group （ t = 2. 301, P = 0. 033 ）. Conclusion The performances of four HIV antibody screening kits are good but estimating WB confirming result in line with S/CO ratio is not available. All repeated screening positive results should be followed by confirmatory tests.