Diagnostic testing for M. tuberculosis infection has advanced with QuantiFERON and GeneXpert, but simple cost-effective alternatives for widespread TB screening has remained elusive and purified protein derivative (PPD)-based tuberculin skin testing (TST) remains the most widely used method. PPD-based tests have reduced performance, however, in BCG vaccinees and in individuals with immune deficiencies. We compared the performance of skin testing with the recombinant DPPD protein against that of a standard PPD-based skin test. Our data indicates similar performance of DPPD and PPD (r² = 0.7689) among HIV-negative, active TB patients, all of whom presented greater than 10 mm induration following administration. In contrast to results demonstrating that PPD induced indurations greater than 5 mm (i.e., the recommended threshold for positive results in this population) in only half (19 of 38) of the HIV positive TB patients, 89.5% (34 of 38) of these participants developed indurations greater than 5 mm when challenged with DPPD. Importantly, none of the patients that were positive following PPD administration were negative following DPPD administration, indicating markedly improved sensitivity of DPPD among HIV-infected individuals. Our data indicate that DPPD has superior performance in skin testing than the current TST standard.

中文翻译：

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单个重组结核分枝杆菌蛋白DPPD在HIV感染的结核病患者中提供了增强的皮肤测试性能。

QuantiFERON和GeneXpert已对结核分枝杆菌感染进行了诊断测试，但用于广泛的TB筛查的简单，经济高效的替代方案仍然难以捉摸，基于纯化蛋白衍生物（PPD）的结核菌素皮肤测试（TST）仍然是使用最广泛的方法。但是，基于PPD的测试在BCG疫苗和免疫缺陷个体中的性能下降。我们将用重组DPPD蛋白进行的皮肤测试与基于PPD的标准皮肤测试的性能进行了比较。我们的数据表明DPPD和PPD的性能相似（r ² = 0.7689）在HIV阴性，活动性TB患者中，所有患者给药后的硬结均超过10毫米。与证明PPD在仅一半（38名中的19名）HIV阳性结核病患者中诱发硬结超过5毫米（即该人群中阳性结果的推荐阈值）的结果相反，其中89.5％（38名中的34名）参与者在受到DPPD挑战时形成了大于5毫米的硬结。重要的是，PPD给药后呈阳性的患者均未在DPPD给药后呈阴性，这表明HIV感染者对DPPD的敏感性显着提高。我们的数据表明，DPPD在皮肤测试中的性能优于当前的TST标准。