Institute for Global Health, University College London, London, UK
Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Eur Respir J. 2021 Nov 25;58(5). doi: 10.1183/13993003.00167-2021. Print 2021 Nov.
Only the tuberculin skin test (TST) and two interferon-γ release assays (IGRAs), QuantiFERON-TB Gold In-Tube and T-SPOT.TB, are currently endorsed by the World Health Organization as tests for tuberculosis (TB) infection. While IGRAs are more specific than the TST, they require sophisticated laboratory infrastructure and are costly to perform. However, both types of tests have limited performance to predict development of active TB. Tests with improved predictive performance and operational characteristics are needed.
We reviewed the current landscape of tests for TB infection identified through a web-based survey targeting diagnostic manufacturers globally.
We identified 20 tests for TB infection: 15 tests and five skin tests. 13 of the tests are whole-blood IGRAs and 14 use early secreted antigenic target 6 (ESAT-6) and culture filtrate protein 10 (CFP-10), with or without additional antigens. 10 of the tests are based on assays other than an ELISA, such as a fluorescent lateral flow assay that requires less manual operation and shorter assay time and hence is more suitable for decentralisation compared with the existing IGRAs. Four of the five skin tests use ESAT-6 and CFP-10 proteins, while the remaining test uses a new antigen that is specific to complex.
New tests have the potential to improve accuracy, operational characteristics and end-user access to tests for TB infection. However, published data in various populations and settings are limited for most new tests. Evaluation of these new tests in a standardised design would facilitate their endorsement and programmatic scale-up.
目前，世界卫生组织仅推荐结核菌素皮肤试验（TST）和两种干扰素-γ释放检测（IGRAs），即 QuantiFERON-TB Gold In-Tube 和 T-SPOT.TB，作为结核病（TB）感染的检测方法。虽然 IGRAs 比 TST 更具特异性，但它们需要复杂的实验室基础设施，且检测成本较高。然而，这两种检测方法都具有预测活动性结核病发展的局限性。因此，需要具有改进的预测性能和操作特性的检测方法。
我们通过针对全球诊断制造商的网络调查，回顾了当前结核病感染检测方法的现状。
我们确定了 20 种结核病感染检测方法：15 种检测方法和 5 种皮肤检测方法。其中 13 种检测方法为全血 IGRAs，14 种方法使用早期分泌抗原靶 6（ESAT-6）和培养滤液蛋白 10（CFP-10），或在此基础上增加其他抗原。其中 10 种检测方法基于酶联免疫吸附试验（ELISA）以外的检测方法，如荧光侧向流动检测方法，这种方法需要的人工操作更少，检测时间更短，因此与现有的 IGRAs 相比更适合进行分散化检测。5 种皮肤检测方法中的 4 种使用 ESAT-6 和 CFP-10 蛋白，而其余的检测方法则使用一种新的特定于 复合体的抗原。
新的检测方法具有提高准确性、操作特性和终端用户获得结核病感染检测的潜力。然而，大多数新检测方法在不同人群和环境中的已发表数据有限。在标准化设计中对这些新检测方法进行评估将有助于它们的认可和计划推广。
