Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Department of Convergence Medicine, Asan Medical Institute of Convergence Science and Technology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
J Clin Microbiol. 2019 Apr 26;57(5). doi: 10.1128/JCM.01975-18. Print 2019 May.
We evaluated the diagnostic performance of a imple and abel-free pathogen enrichment method using homobifunctional midoesters (HI) and a icrofluidic system, called the SLIM assay, followed by real-time PCR from cerebrospinal fluid (CSF) in human immunodeficiency virus (HIV)-uninfected patients with suspected tuberculous meningitis (TBM). Patients with suspected TBM were prospectively enrolled in a tertiary hospital in an intermediate tuberculosis (TB)-burden country during a 30-month period. TBM was classified according to the uniform case definition. Definite and probable TBM were regarded as the reference standards for TBM, and possible TBM and not-TBM as the reference standards for not-TBM. Of 72 HIV-uninfected patients with suspected TBM, 10 were diagnosed with definite ( = 2) and probable ( = 8) TBM by the uniform case definition. The sensitivity of the SLIM assay was 100% (95% confidence interval [CI], 69 to 100%) compared with definite or probable TBM, and it was superior to those of mycobacterial culture (20% [95% CI, 3 to 56%]) and the Xpert MTB/RIF assay (0% [95% CI, 0 to 31%]). Of 21 possible TBM and 41 not-TBM patients by the uniform case definition, 5 possible TBM and no not-TBM patients gave positive results in the SLIM assay. The specificity of the SLIM assay was 92% (95% CI, 82 to 97%; 5/62). We demonstrated that the SLIM assay had a very high sensitivity and specificity with small samples of 10 cases of definite or probable TBM. Further studies are needed to confirm this finding and to compare the SLIM assay with mycobacterial culture, Xpert MTB/RIF, and Xpert MTB/RIF Ultra assays in a larger prospective cohort of patients with suspected TBM, including both HIV-infected and HIV-uninfected cases.
我们评估了一种简单且无标签的病原体富集方法的诊断性能，该方法使用同双功能亚氨基二酯（HI）和一种微流控系统，称为 SLIM 检测，随后对疑似结核性脑膜炎（TBM）的人类免疫缺陷病毒（HIV）未感染患者的脑脊液（CSF）进行实时 PCR。在 30 个月的时间里，前瞻性地招募了来自一个中结核负担国家的三级医院的疑似 TBM 患者。根据统一的病例定义对 TBM 进行分类。明确和可能的 TBM 被视为 TBM 的参考标准，而可能的 TBM 和非-TBM 被视为非-TBM 的参考标准。在 72 名疑似 TBM 的 HIV 未感染患者中，根据统一的病例定义，有 10 名被诊断为明确（ = 2）和可能（ = 8）TBM。与明确或可能的 TBM 相比，SLIM 检测的敏感性为 100%（95%置信区间 [CI]，69 至 100%），优于分枝杆菌培养（20%[95%CI，3 至 56%]）和 Xpert MTB/RIF 检测（0%[95%CI，0 至 31%]）。根据统一的病例定义，21 例可能的 TBM 和 41 例非 TBM 患者中，5 例可能的 TBM 和 0 例非 TBM 患者的 SLIM 检测结果呈阳性。SLIM 检测的特异性为 92%（95%CI，82 至 97%；5/62）。我们证明，SLIM 检测在 10 例明确或可能的 TBM 病例的小样本中具有很高的灵敏度和特异性。需要进一步的研究来证实这一发现，并在更大的疑似 TBM 患者前瞻性队列中比较 SLIM 检测与分枝杆菌培养、Xpert MTB/RIF 和 Xpert MTB/RIF Ultra 检测，包括 HIV 感染和未感染的病例。
