Thanassi Wendy, Noda Art, Hernandez Beatriz, Newell Jeffery, Terpeluk Paul, Marder David, Yesavage Jerome A
Department of Medicine, Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue MC-, Palo Alto, CA 94304-1207, USA ; Occupational Health Strategic Health Care Group, Office of Public Health, Veterans Health Administration, Washington, DC 20006, USA ; Division of Emergency Medicine, Stanford University School of Medicine, Stanford, CA 94304, USA ; War Related Illness and Injury Study Center (WRIISC) and Mental Illness Research Education and Clinical Center (MIRECC), Department of Veterans Affairs, Palo Alto, CA 94304, USA.
Pulm Med. 2012;2012:291294. doi: 10.1155/2012/291294. Epub 2012 Dec 30.
Objective. To find a statistically significant separation point for the QuantiFERON Gold In-Tube (QFT) interferon gamma release assay that could define an optimal "retesting zone" for use in serially tested low-risk populations who have test "reversions" from initially positive to subsequently negative results. Method. Using receiver operating characteristic analysis (ROC) to analyze retrospective data collected from 3 major hospitals, we searched for predictors of reversion until statistically significant separation points were revealed. A confirmatory regression analysis was performed on an additional sample. Results. In 575 initially positive US healthcare workers (HCWs), 300 (52.2%) had reversions, while 275 (47.8%) had two sequential positive tests. The most statistically significant (Kappa = 0.48, chi-square = 131.0, P < 0.001) separation point identified by the ROC for predicting reversion was the tuberculosis antigen minus-nil (TBag-nil) value at 1.11 International Units per milliliter (IU/mL). The second separation point was found at TBag-nil at 0.72 IU/mL (Kappa = 0.16, chi-square = 8.2, P < 0.01). The model was validated by the regression analysis of 287 HCWs. Conclusion. Reversion likelihood increases as the TBag-nil approaches the manufacturer's cut-point of 0.35 IU/mL. The most statistically significant separation point between those who test repeatedly positive and those who revert is 1.11 IU/mL. Clinicians should retest low-risk individuals with initial QFT results < 1.11 IU/mL.
目的。为全血γ-干扰素释放检测(QFT)找到一个具有统计学意义的分界点,该分界点可用于定义一个最佳的“重新检测区”,适用于对最初检测结果为阳性但随后转为阴性的低风险人群进行连续检测。方法。使用受试者工作特征分析(ROC)对从3家大型医院收集的回顾性数据进行分析,我们寻找检测结果逆转的预测因素,直到发现具有统计学意义的分界点。对另外一个样本进行了验证性回归分析。结果。在575名最初检测结果为阳性的美国医护人员(HCW)中,300人(52.2%)检测结果逆转,而275人(47.8%)连续两次检测结果为阳性。ROC确定的预测检测结果逆转的最具统计学意义的分界点(Kappa = 0.48,卡方 = 131.0,P < 0.001)是结核抗原减去零值(TBag-nil)为每毫升1.11国际单位(IU/mL)。第二个分界点是TBag-nil为0.72 IU/mL(Kappa = 0.16,卡方 = 8.2,P < 0.01)。该模型通过对287名医护人员的回归分析得到验证。结论。随着TBag-nil接近制造商设定的0.35 IU/mL的临界值,检测结果逆转的可能性增加。反复检测为阳性者与检测结果逆转者之间最具统计学意义的分界点是1.11 IU/mL。临床医生应对初始QFT结果<1.11 IU/mL的低风险个体进行重新检测。