Sirivichayakul Sunee, Pankam Tippawan, Pattanachaiwit Supanit, Phancharoen Kannapat, Barisri Napapat, Areeyolwattana Supphachoke, Phanuphak Nittaya, Phanuphak Praphan
Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Thai Red Cross Anonymous Clinic Laboratory, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Asian Pac J Allergy Immunol. 2021 Oct 31. doi: 10.12932/AP-290521-1144.
Alere™ HIV Combo is the only rapid and sensitive point-of-care 4th generation (antigen/antibody) HIV test newly available in Thailand which is advantageous of differentiating between positivity of antigen or antibody or both, especially in acute HIV infection (AHI). AHI in this study was defined by positive machine-based 4th generation test with measurable HIV-RNA but negative 3rd generation (IgM/IgG antibody only) tests.
To evaluate the performance characteristics of Alere™ HIV Combo.
Fifty stored plasma samples of subjects diagnosed with AHI were used to evaluate Alere™ HIV Combo.
Of the 50 AHI samples, Alere™ HIV Combo was positive in 37 (74%): 5 with antibody positive only (R1), 26 with p24 antigen positive only (R2), and 6 with both p24 antigen and antibody positive (R3). Mean sample/cut-off (S/ CO) ratios from machine-based 4th generation test of R1, R2 and R3 were 21.55, 148.38 and 72.97 respectively as compared to 7.57 for the 13 non-reactive (NR) samples. The corresponding median log10 HIV-RNA of NR, R1, R2 and R3 were 5.59, 5.86, 7.00 and 6.61 copies/mL respectively. R2 and R3 had significantly higher S/CO and HIV-RNA than NR and R1. Alere™ HIV Combo detected mainly p24 antigen in AHI as seen in 32/50 (64%) subjects and could detect 11/50 (22%) antibody in AHI samples which were missed by the two 3rd generation HIV tests used in our testing algorithm.
Alere™ HIV Combo is the ideal screening test in a setting with high AHI where machine-based 4th generation test is not available.
Alere™ HIV组合检测是泰国新推出的唯一一种快速且灵敏的即时检测第四代（抗原/抗体）HIV检测方法，其优势在于能够区分抗原阳性、抗体阳性或两者均阳性，特别是在急性HIV感染（AHI）中。本研究中的急性HIV感染定义为基于机器的第四代检测呈阳性且HIV-RNA可检测，但第三代检测（仅IgM/IgG抗体）呈阴性。
评估Alere™ HIV组合检测的性能特征。
使用50份被诊断为急性HIV感染的受试者的储存血浆样本评估Alere™ HIV组合检测。
在50份急性HIV感染样本中，Alere™ HIV组合检测有37份（74%）呈阳性：5份仅抗体阳性（R1），26份仅p24抗原阳性（R2），6份p24抗原和抗体均阳性（R3）。与13份无反应（NR）样本的7.57相比，R1、R2和R3基于机器的第四代检测的平均样本/临界值（S/CO）比值分别为21.55、148.38和72.97。NR、R1、R2和R3相应的HIV-RNA对数中位数分别为5.59、5.86、7.00和6.61拷贝/毫升。R2和R3的S/CO和HIV-RNA显著高于NR和R1。在急性HIV感染中，Alere™ HIV组合检测主要检测到p24抗原，在32/50（64%）的受试者中可见，并且可以在急性HIV感染样本中检测到11/50（22%）的抗体，而我们检测算法中使用的两种第三代HIV检测未能检测到这些抗体。
在急性HIV感染率高且无法进行基于机器的第四代检测的环境中，Alere™ HIV组合检测是理想的筛查检测方法。
