背景:CD4检测在晚期HIV疾病的治疗中至关重要。VISITECT®CD4晚期疾病(AccuBioLimited,阿尔瓦,英国;VISITECT)是一种无仪器的,即时护理,半定量测试允许视觉识别CD4≤200细胞/μl,或>200细胞/μl从手指刺血或静脉血。
方法:作为FUJIFILMSILVAMPTBLAM的诊断准确性研究的一部分(clinicaltrials.gov:NCT04089423),如果出现结核病症状,则在七个国家/地区前瞻性地从门诊部招募≥18岁的HIV感染者,和住院部。参与者使用流式细胞术(参考标准)提供用于CD4测量的静脉血和用于VISITECT的手指刺血(索引文本),在护理点进行。灵敏度,特异性,评估了VISITECT确定CD4≤200个细胞/μl的阳性和阴性预测值。
结果:在1604名参与者中,流式细胞术的中位CD4为367个(IQR128-626)个细胞/μl,521个(32.5%)的CD4≤200个细胞/μl.VISITECT敏感性为92.7%(483/521,95%CI90.1-94.7%),特异性为61.4%(665/1083,95%CI58.4-64.3%)。对于CD4在0-100、101-200、201-300、301-500和>500个细胞/μl之间的参与者,VISITECT错误分类4.5%(95%CI2.5-7.2%),12.5(95%CI8.0-18.2%),74.1%(95%CI67.0-80.5%),48.0%(95%CI42.5-53.6%),和22.6%(95%CI19.3-26.3%),分别。
结论:VISITECT的敏感性,但不是特异性,达到世界卫生组织的最低敏感性和特异性阈值80%的即时CD4测试。需要评估VISITECT的质量并优化其准确性。应研究VISITECT作为CD4分诊测试的实用性。
BACKGROUND: CD4 measurement is pivotal in the management of advanced HIV disease. VISITECT® CD4 Advanced Disease (AccuBio Limited, Alva, UK; VISITECT) is an instrument-free, point-of-care, semi-quantitative test allowing visual identification of a CD4 ≤200 cells/µl, or >200 cells/µl from finger-prick or venous blood.
METHODS: As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM (clinicaltrials.gov: NCT04089423), people living with HIV of ≥18 years old were prospectively recruited in seven countries from outpatient departments if a tuberculosis symptom was present, and from inpatient departments. Participants provided venous blood for CD4 measurement using flow cytometry (reference standard) and finger-prick blood for VISITECT (index text), performed at point-of-care. Sensitivity, specificity, and positive and negative predictive values of VISITECT to determine a CD4 ≤200 cells/µl were evaluated.
RESULTS: Among 1604 participants, the median flow cytometry CD4 was 367 (IQR 128-626) cells/µl and 521 (32.5%) had a CD4 ≤200 cells/µl. VISITECT sensitivity was 92.7% (483/521, 95% CI 90.1-94.7%) and specificity was 61.4% (665/1083, 95% CI 58.4-64.3%). For participants with a CD4 between 0-100, 101-200, 201-300, 301-500, and >500 cells/µl, VISITECT misclassified 4.5% (95% CI 2.5-7.2%), 12.5 (95% CI 8.0-18.2%), 74.1% (95% CI 67.0-80.5%), 48.0% (95% CI 42.5-53.6%), and 22.6% (95% CI 19.3-26.3%), respectively.
CONCLUSIONS: VISITECT\'s sensitivity, but not specificity, met the World Health Organization\'s minimal sensitivity and specificity threshold of 80% for point-of-care CD4 tests. VISITECT\'s quality needs to be assessed and its accuracy optimized. VISITECT´s utility as CD4 triage test should be investigated.