Nasrullah Muazzam, Wesolowski Laura G, Ethridge Steven F, Cranston Kevin, Pentella Michael, Myers Robert A, Rudrik James T, Hutchinson Angela B, Bennett Spencer B, Werner Barbara G
Division of HIV/AIDS Prevention, National Center for HIV, Hepatitis, STD & TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Division of HIV/AIDS Prevention, National Center for HIV, Hepatitis, STD & TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
J Infect. 2016 Aug;73(2):164-72. doi: 10.1016/j.jinf.2016.05.006. Epub 2016 May 26.
In three U.S. State Public Health Laboratories (PHLs) using a fourth-generation immunoassay (IA), an HIV-1/HIV-2 differentiation antibody IA and a nucleic acid test (NAT), we characterized the yield and time to reporting of acute infections, and cost per positive specimen.
Routine HIV testing data were collected from July 1, 2012-June 30, 2013 for Massachusetts and Maryland PHLs, and from November 27, 2012-June 30, 2013 for Michigan PHL. Massachusetts and Michigan used fourth-generation and differentiation IAs with NAT conducted by a referral laboratory. In Maryland, fourth-generation IA repeatedly reactive specimens were followed by a Western blot (WB), and those with negative or indeterminate results were tested with a differentiation IA and HIV-1 NAT, and if positive by NAT, confirmed by a different HIV-1 NAT. Specimens from WB-positive persons at risk for HIV-2 were tested with a differentiation IA and, if positive, with an HIV-2 WB and/or differential HIV-1/HIV-2 proviral DNA polymerase chain reaction.
Among 7914 specimens from Massachusetts PHL, 6069 from Michigan PHL, and 36,266 from Maryland PHL, 0.10%, 0.02% and 0.05% acute infections were identified, respectively. Massachusetts and Maryland PHLs each had 1 HIV-2 positive specimen. The median time from specimen receipt to laboratory reporting of results for acute infections at Massachusetts, Michigan and Maryland PHLs was 8, 11, and 7 days respectively. The laboratory cost per HIV positive specimen was $336 (Massachusetts), $263 (Michigan) and $210 (Maryland).
Acute and established infections were found by PHLs using fourth-generation IA in conjunction with antibody tests and NAT. Time to reporting of acute HIV test results to clients was suboptimal, and needs to be streamlined to expedite treatment and interrupt transmission.
在美国三个州公共卫生实验室(PHLs)中,使用第四代免疫测定法(IA)、HIV-1/HIV-2鉴别抗体免疫测定法和核酸检测(NAT),我们对急性感染的检出率、报告时间以及每个阳性样本的成本进行了特征分析。
收集了2012年7月1日至2013年6月30日期间马萨诸塞州和马里兰州公共卫生实验室以及2012年11月27日至2013年6月30日期间密歇根州公共卫生实验室的常规HIV检测数据。马萨诸塞州和密歇根州使用第四代和鉴别免疫测定法,并由转诊实验室进行核酸检测。在马里兰州,对第四代免疫测定法反复呈阳性反应的样本进行免疫印迹法(WB)检测,对结果为阴性或不确定的样本进行鉴别免疫测定法和HIV-1核酸检测,如果核酸检测呈阳性,则用另一种HIV-1核酸检测进行确认。对有感染HIV-2风险的免疫印迹法阳性者的样本进行鉴别免疫测定法检测,如果呈阳性,则进行HIV-2免疫印迹法和/或HIV-1/HIV-2前病毒DNA聚合酶链反应检测。
在马萨诸塞州公共卫生实验室的7914个样本、密歇根州公共卫生实验室的6069个样本和马里兰州公共卫生实验室的36266个样本中,分别检出了0.10%、0.02%和0.05%的急性感染。马萨诸塞州和马里兰州公共卫生实验室各有1个HIV-2阳性样本。马萨诸塞州、密歇根州和马里兰州公共卫生实验室从收到样本到报告急性感染结果的中位时间分别为8天、11天和7天。每个HIV阳性样本的实验室成本分别为336美元(马萨诸塞州)、263美元(密歇根州)和210美元(马里兰州)。
公共卫生实验室使用第四代免疫测定法结合抗体检测和核酸检测发现了急性感染和已确诊感染。向客户报告急性HIV检测结果的时间并不理想,需要进行简化以加快治疗并阻断传播。