用于诊断HIV感染者结核感染的VIDAS®结核感染γ-干扰素释放试验：一项初步研究。

VIDAS® TB-IGRA assay for diagnosing tuberculosis infection in people living with HIV: A preliminary study.

作者信息

Esmail Aliasgar, Swanepoel Jeremi, Oelofse Suzette, Reyneke Brandon, Pooran Anil, Jaumdally Shameem, Wiese Lara, Dheda Keertan

机构信息

Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute & South African MRC/UCT Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa; Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, UK.

出版信息

Int J Infect Dis. 2025 Sep;158:107955. doi: 10.1016/j.ijid.2025.107955. Epub 2025 Jun 15.

DOI:10.1016/j.ijid.2025.107955

PMID:40527449

Abstract

BACKGROUND

The diagnosis of presumed latent tuberculosis (TB) infection (LTBI) is problematic in people living with HIV (PLWH) because of sub-optimal sensitivity and high indeterminate rates, especially in those with advanced immunosuppression. Better diagnostic tools for LTBI are needed in this sub-population.

METHODS

We compared the sensitivity of VIDAS TB-IGRA, a fully automated RD1-specific new interferon-ϒ-release assay (IGRA), to QFT-Plus in 77 PLWH with active pulmonary TB who had varying CD4 counts. Sputum culture positivity served as the reference standard for active TB.

RESULTS

The sensitivity of VIDAS TB-IGRA was similar to QFT-Plus overall [90.9% (70/77) vs 92.0% (69/75)], in those with CD4 <200 cells/mm, [88.9% (40/45) vs 88.6% (39/44)], and in those with CD4 <100 [85.7% (18/21) vs 80.0% (16/20)]. However, VIDAS TB-IGRA had a higher sensitivity in those with CD4 <50 [92.3% (12/13) vs 75% (9/12)] and fewer indeterminate results overall [0 vs 2]. When the indeterminate results in this subgroup were regarded as negative, the comparative sensitivity was [92.3% (12/13) vs 69.2% (9/13)].

CONCLUSION

VIDAS TB-IGRA had a similar sensitivity to QFT-Plus in PLWH. Whether VIDAS TB-IGRA sensitivity is significantly better at lower CD4 counts remains to be confirmed in a larger study. These data have implications for the diagnosis of LTBI in those with advanced immunosuppression.

摘要

背景

由于敏感性欠佳和不确定率高，对于人类免疫缺陷病毒（HIV）感染者（PLWH），潜伏性结核感染（LTBI）的诊断存在问题，尤其是在免疫抑制严重的患者中。这一亚群需要更好的LTBI诊断工具。

方法

我们比较了VIDAS TB-IGRA（一种全自动的RD1特异性新型干扰素-γ释放试验（IGRA））与QFT-Plus在77例患有活动性肺结核且CD4细胞计数各异的PLWH中的敏感性。痰培养阳性作为活动性肺结核的参考标准。

结果

总体而言，VIDAS TB-IGRA的敏感性与QFT-Plus相似[90.9%（70/77）对92.0%（69/75）]，CD4<200个细胞/mm的患者中[88.9%（40/45）对88.6%（39/44）]，以及CD4<100的患者中[85.7%（18/21）对80.0%（16/20）]。然而，VIDAS TB-IGRA在CD4<50的患者中敏感性更高[92.3%（12/13）对75%（9/12）]，总体不确定结果更少[0对2]。当将该亚组中的不确定结果视为阴性时，比较敏感性为[92.3%（12/13）对69.2%（9/13）]。