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...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值展开更多
Background Most indices for evaluating a diagnostic test can be expressed as functions of sensitivity （SEN） and specificity （SPE）. Practically, all existing methods suffer from the inability to weight sensitivity ...Background Most indices for evaluating a diagnostic test can be expressed as functions of sensitivity （SEN） and specificity （SPE）. Practically, all existing methods suffer from the inability to weight sensitivity and specificity relative to their importance. In this paper, we developed a novel index, the weighted Youden index, that allows Youden index to be a combination of sensitivity and specificity with user-defined weights. Methods The weighted Youden index Jw is defined as Jw=2（wxSEN＋（1-w）SPE）-I （0 〈w 〈1）. It has three properties： （1） the sum of the weights which are attached to sensitivity and specificity should be equal to 1; （2） the range of Jw should be within [-1, 1], which is the range of the Youden index J; （3） Jw should be equal to J when sensitivity and specificity have equal weights. According to the central limit theorem, we obtain the standard error of Jw, and propose a statistical inference method to compare two weighted Youden indices. The monotonicity of the test statistic was discussed. Results An example of comparing two diagnostic tests for pheochromocytoma was used to demonstrate the weighted Youden index method. Weighted Youden index, the confidence interval for each test and the hypothesis test of comparing two independent diagnostic tests were presented. Assigning the weights is essential to the weighted Youden index approach. Conclusion The weighted Youden index can broaden further research in weighting sensitivity and specificity exp ts applications in diagnostic test development and motivate icitly.展开更多
文摘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
基金This work was supported by the grants from the National Natural Science Foundation of China （No. 30972554） and the Natural Science Foundation of Guangdong Province （No. 9 ! 5180200400001）.
文摘Background Most indices for evaluating a diagnostic test can be expressed as functions of sensitivity （SEN） and specificity （SPE）. Practically, all existing methods suffer from the inability to weight sensitivity and specificity relative to their importance. In this paper, we developed a novel index, the weighted Youden index, that allows Youden index to be a combination of sensitivity and specificity with user-defined weights. Methods The weighted Youden index Jw is defined as Jw=2（wxSEN＋（1-w）SPE）-I （0 〈w 〈1）. It has three properties： （1） the sum of the weights which are attached to sensitivity and specificity should be equal to 1; （2） the range of Jw should be within [-1, 1], which is the range of the Youden index J; （3） Jw should be equal to J when sensitivity and specificity have equal weights. According to the central limit theorem, we obtain the standard error of Jw, and propose a statistical inference method to compare two weighted Youden indices. The monotonicity of the test statistic was discussed. Results An example of comparing two diagnostic tests for pheochromocytoma was used to demonstrate the weighted Youden index method. Weighted Youden index, the confidence interval for each test and the hypothesis test of comparing two independent diagnostic tests were presented. Assigning the weights is essential to the weighted Youden index approach. Conclusion The weighted Youden index can broaden further research in weighting sensitivity and specificity exp ts applications in diagnostic test development and motivate icitly.
