背景:评估ElecsysHIVDuo测定用于原发性人类免疫缺陷病毒(HIV)筛查和急性HIV感染检测的临床性能。
方法:这项研究于2022年4月至2023年4月进行,涉及两个不同的人群。对于艾滋病毒筛查人群,三个HIVDuo结果[HIVDuo,HIV抗原(Ag),获得初筛中的HIV抗体(Ab)](2021年1月至2021年6月)。在被诊断为艾滋病毒的人群中,我们测量了2016年11月至2023年3月的回顾性样本.
结果:HIV筛查人群包括来自真实世界筛查计划的111,383个样本。该测定法显示出99.91%的特异性(95%CI:99.89%,99.93%),PPV为0.8516(95%CI:0.8225,0.8776)。关于被诊断为艾滋病毒的人群,纳入836名HIV患者,包括14例仅HIVAg+和WesternBlot(WB)确诊率为0%的急性HIV感染患者。HIVDuoAb和Ag的数字截止指数(COI)比率的中位数(IQR)在AgAb-之间显着不同,Ag-Ab+,和Ag+Ab+亚组。
结论:ElecsysHIVDuo检测方法适用于初级HIV筛查,可以整合到一种新的实验室HIV检测算法中,以改善中国临床实践中的急性HIV检测。
背景:HIV,人类免疫缺陷病毒;艾滋病,获得性免疫缺陷综合征;Ag,抗原;Ab,抗体;WB,西方印迹;COI,数字截止指数;CI,置信区间;NAT,核酸测试;EDC,电子数据采集系统;CDC,中国疾病预防控制中心;IQR,四分位距;PPV,阳性预测值;HCV,丙型肝炎病毒;HBV,乙型肝炎病毒;CI,置信区间;ND,无法定义;F,女性;M,male.
BACKGROUND: Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection.
METHODS: This study was conducted from April 2022 to April 2023 and involved two distinct populations. For the HIV screening population, three HIV Duo results [HIV Duo, HIV antigen (Ag), and HIV antibody (Ab)] in primary screening were obtained (January 2021 to June 2021). In the diagnosed HIV population, retrospective samples from November 2016 to March 2023 were measured.
RESULTS: The HIV screening population included 111,383 samples from a real-world screening program. The assay demonstrated a specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a PPV of 0.8516 (95 % CI: 0.8225, 0.8776). Regarding the diagnosed HIV population, 836 HIV patients were enrolled, including 14 acute HIV infectious patients with only HIV Ag + and a Western Blot (WB) confirmation rate of 0 %. The median (IQR) of the numeric cut-off index (COI) ratios of HIV Duo Ab and Ag significantly differed among the Ag + Ab-, Ag-Ab+, and Ag + Ab + subgroups.
CONCLUSIONS: The Elecsys HIV Duo assay is suitable for primary HIV screening and can be integrated into a novel laboratory HIV testing algorithm to improve acute HIV detection in Chinese clinical practice.
BACKGROUND: HIV, Human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; Ag, antigen; Ab, antibody; WB, Western Blot; COI, numeric cut-off index; CI, confidence interval; NAT, nucleic acid tests; EDC, electronic data capture systems; CDC, Chinese Centers for Disease Control and Prevention; IQR, interquartile range; PPV, positive predictive value; HCV, hepatitis C virus; HBV, hepatitis B virus; CI, confidence interval; ND, not able to define; F, female; M, male.