Marson Kara G, Marlin Robert, Pham Phong, Cohen Stephanie E, Jones Diane, Roemer Marguerite, Peters Philip J, Haller Barbara, Pilcher Christopher D
Division of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, United States.
Department of Medicine, University of California, San Diego, United States.
J Clin Virol. 2017 Jun;91:73-78. doi: 10.1016/j.jcv.2017.04.003. Epub 2017 Apr 7.
Our medical center laboratory recently adapted its 24/7, two-hourly testing program to use an ARCHITECT-Multispot-viral load (AR-MS-VL) algorithm in place of a previous rapid test-immunofluorescence (RT-IF) algorithm.
We evaluated screening test performance, acute case detection, turnaround time and ability to resolve HIV status under the new algorithm.
We considered consecutive HIV tests from January to November 2015. AR-MS-VL results at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) were compared with RT-IF results at ZSFG and also with AR-MS-VL results in the recently completed CDC Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) Study for targeted testing of MSM at publicly funded testing sites in San Francisco.
Among 21,985 HIV tests performed at ZSFG, 16,467 were tested by RT-IF and 5518 by AR-MS-VL. There were 321 HIV infections detected, of which 274 (84%) were known HIV+ cases, and 47 were newly identified HIV infections. Considering only patients of HIV-negative or -unknown status, prevalence was 0.22%. Under the AR-MS-VL algorithm, turnaround times for screening results and full algorithm results were 3 and 21h; status-unresolved cases were reduced (from 47% to 22%) compared with the RT-IF algorithm. The positive predictive value (PPV) of a new-positive AR screening test was low (0.44) at ZSFG, where no acute infections were detected. At STOP Study sites where HIV prevalence was higher and acute infection was more common, the AR PPV was higher (0.93). All 24 false-positive AR screening tests at ZSFG had a signal/cutoff (S/CO) ratio of <15 and all 88 true-positive tests had S/CO ratio >15. Of 62 acute infections in the STOP Study, 23 (37%) had an S/CO<15.
An AR-MS-VL algorithm is feasible and can return rapid results in a large medical center. In this setting, reactive 4th generation assay tests that are negative for HIV antibodies are typically false-positive with low S/CO ratios.
我们医学中心实验室最近调整了其全天候每两小时一次的检测程序，采用ARCHITECT-多斑点-病毒载量（AR-MS-VL）算法取代先前的快速检测-免疫荧光（RT-IF）算法。
我们评估了新算法下筛查检测性能、急性病例检测、周转时间以及确定HIV状态的能力。
我们纳入了2015年1月至11月的连续HIV检测。将扎克伯格旧金山总医院和创伤中心（ZSFG）的AR-MS-VL结果与ZSFG的RT-IF结果进行比较，并与最近完成的美国疾病控制与预防中心筛查目标人群以通过加强性伴侣通知中断HIV传播链（STOP）研究中旧金山公共资助检测点对男男性行为者进行针对性检测的AR-MS-VL结果进行比较。
在ZSFG进行的21985次HIV检测中，16467次通过RT-IF检测，5518次通过AR-MS-VL检测。共检测到321例HIV感染，其中274例（84%）为已知HIV阳性病例，47例为新发现的HIV感染。仅考虑HIV阴性或状态不明的患者，患病率为0.22%。在AR-MS-VL算法下，筛查结果和完整算法结果的周转时间分别为3小时和21小时；与RT-IF算法相比，状态未解决的病例减少（从47%降至22%）。在ZSFG，新阳性AR筛查检测的阳性预测值（PPV）较低（0.44），未检测到急性感染。在HIV患病率较高且急性感染更常见的STOP研究地点，AR PPV较高（0.93）。ZSFG的所有24例假阳性AR筛查检测的信号/临界值（S/CO）比值均<15，所有88例真阳性检测的S/CO比值均>15。在STOP研究的62例急性感染中，23例（37%）的S/CO<15。
AR-MS-VL算法是可行的，并且可以在大型医学中心快速得出结果。在这种情况下，HIV抗体检测为阴性的反应性第四代检测通常为假阳性，S/CO比值较低。
