基于尿液的侧向流动脂阿拉伯甘露聚糖检测在缅甸HIV感染成人中的临床应用：一项观察性研究。

The clinical utility of the urine-based lateral flow lipoarabinomannan assay in HIV-infected adults in Myanmar: an observational study.

作者信息

Thit Swe Swe, Aung Ne Myo, Htet Zaw Win, Boyd Mark A, Saw Htin Aung, Anstey Nicholas M, Kyi Tint Tint, Cooper David A, Kyi Mar Mar, Hanson Josh

机构信息

University of Medicine 2, Yangon, Myanmar.

Insein General Hospital, Yangon, Myanmar.

出版信息

BMC Med. 2017 Aug 4;15(1):145. doi: 10.1186/s12916-017-0888-3.

DOI:10.1186/s12916-017-0888-3

PMID:28774293

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5543584/

Abstract

BACKGROUND

The use of the point-of-care lateral flow lipoarabinomannan (LF-LAM) test may expedite tuberculosis (TB) diagnosis in HIV-positive patients. However, the test's clinical utility is poorly defined outside sub-Saharan Africa.

METHODS

The study enrolled consecutive HIV-positive adults at a tertiary referral hospital in Yangon, Myanmar. On enrolment, patients had a LF-LAM test performed according to the manufacturer's instructions. Clinicians managing the patients were unaware of the LF-LAM result, which was correlated with the patient's clinical course over the ensuing 6 months.

RESULTS

The study enrolled 54 inpatients and 463 outpatients between July 1 and December 31, 2015. On enrolment, the patients' median (interquartile range) CD4 T-cell count was 270 (128-443) cells/mm. The baseline LF-LAM test was positive in 201/517 (39%). TB was confirmed microbiologically during follow-up in 54/517 (10%), with rifampicin resistance present in 8/54 (15%). In the study's resource-limited setting, extrapulmonary testing for TB was not possible, but after 6 months, 97/201 (48%) with a positive LF-LAM test on enrolment had neither died, required hospitalisation, received a TB diagnosis or received empirical anti-TB therapy, suggesting a high rate of false-positive results. Of the 97 false-positive tests, 89 (92%) were grade 1 positive, suggesting poor test specificity using this cut-off. Only 21/517 (4%) patients were inpatients with TB symptoms and a CD4 T-cell count of < 100 cells/mm. Five (24%) of these 21 died, three of whom had a positive LF-LAM test on enrolment. However, all three received anti-TB therapy before death - two after diagnosis with Xpert MTB/RIF testing, while the other received empirical treatment. It is unlikely that knowledge of the baseline LF-LAM result would have averted any of the study's other 11 deaths; eight had a negative test, and of the three patients with a positive test, two received anti-TB therapy before death, while one died from laboratory-confirmed cryptococcal meningitis. The test was no better than a simple, clinical history excluding TB during follow-up (negative predictive value (95% confidence interval): 94% (91-97) vs. 94% (91-96)).

CONCLUSIONS

The LF-LAM test had limited clinical utility in the management of HIV-positive patients in this Asian referral hospital setting.

摘要

背景

即时检测侧向流动脂阿拉伯甘露聚糖（LF-LAM）试验可能会加快对HIV阳性患者的结核病（TB）诊断。然而，在撒哈拉以南非洲以外地区，该试验的临床实用性尚不明确。

方法

该研究在缅甸仰光的一家三级转诊医院连续纳入HIV阳性成年人。入组时，根据制造商的说明对患者进行LF-LAM检测。负责管理患者的临床医生不知道LF-LAM检测结果，该结果与患者在随后6个月内的临床病程相关。

结果

2015年7月1日至12月31日期间，该研究纳入了54名住院患者和463名门诊患者。入组时，患者的CD4 T细胞计数中位数（四分位间距）为270（128 - 443）个细胞/mm³。基线LF-LAM检测中201/517（39%）呈阳性。随访期间54/517（10%）经微生物学确诊为结核病，其中8/54（15%）存在利福平耐药。在该研究资源有限的环境中，无法进行肺外结核病检测，但6个月后，入组时LF-LAM检测呈阳性的患者中有97/201（48%）既未死亡、未住院、未被诊断为结核病，也未接受经验性抗结核治疗，提示假阳性率较高。在这97例假阳性检测中，89例（92%）为1级阳性，表明使用此临界值时检测特异性较差。仅21/517（4%）的患者为有结核病症状且CD4 T细胞计数<100个细胞/mm³的住院患者。这21例患者中有5例（24%）死亡，其中3例入组时LF-LAM检测呈阳性。然而，这3例患者在死亡前均接受了抗结核治疗——2例在经Xpert MTB/RIF检测确诊后接受治疗，另1例接受了经验性治疗。了解基线LF-LAM检测结果不太可能避免该研究中其他11例死亡中的任何一例；8例检测结果为阴性，在3例检测结果为阳性的患者中，2例在死亡前接受了抗结核治疗，1例死于实验室确诊的隐球菌性脑膜炎。该检测在随访期间并不比排除结核病的简单临床病史更好（阴性预测值（95%置信区间）：94%（91 - 97）对94%（91 - 96））。