Assessing the sensitivity and specificity of First Response HIV-1-2 test kit with whole blood and serum samples: a cross-sectional study.
Assessing the sensitivity and specificity of First Response HIV-1-2 test kit with whole blood and serum samples: a cross-sectional study.
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DOI：
10.1186/s12981-016-0092-0
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发表时间：
2016
影响因子：
2.2
通讯作者：
Sarfo B
中科院分区：
文献类型：
--
作者：
Boadu R;Darko G;Nortey P;Akweongo P;Sarfo B
人类免疫缺陷病毒（HIV）快速诊断检测（RDT）试剂盒是许多国家HIV检测的首选检测方法。预防母婴传播、了解你的状况运动、血液安全、自愿咨询和检测是控制病毒传播的主要战略，这些干预措施的核心是通过检测对个人进行筛查或诊断。有报告称，从同一个体采集的全血和血清样本的灵敏度和特异性不一致。人们对第一反应HIV-1-2 RDT试剂盒的诊断特性知之甚少，该试剂盒在国家艾滋病毒预防和控制方案中用作单一检测试剂盒。争论一直集中在全血和血清之间的选择，在这种情况下，一个单一的测试试剂盒，只运行血液标本将用于测试。全血和血清样本的特异性和敏感性的变化意味着一些可能是真阳性的个体将被遗漏并逃避治疗。本研究确定了提高First Response HIV RDT试剂盒检测HIV特异性抗体性能的最佳血液样本类型（全血或血清）。2015年5月至2015年6月，对280名HIV感染者和非感染者进行了一项基于医院的横断面研究。将来自每个参与者的血液样品分离成全血和血清，并在First Response HIV-1-2试剂盒（Premier Medical Corporation Ltd.，Kachigam，India），使用电化学发光测定法（ECLIA）作为参考测定法。首效HIV-1-2 RDT试剂盒检测全血标本的灵敏度为100%，特异性为100%;检测血清标本的灵敏度为100%，特异性为82.86%。全血和血清的阳性和阴性预测值分别为100、100和85.35、82.86%.来自个体的全血标本具有比血清更高的特异性、阳性和阴性预测值。当筛查外周血中的HIV-1特异性抗体时，全血是First Response HIV-1-2 RDT试剂盒使用的主要标本。
Human immunodeficiency virus (HIV) Rapid diagnostic Test (RDT) kits are the preferred assays for HIV testing in many countries. Prevention of Mother-to-Child Transmission, Know Your Status Campaigns, Blood-Safety, Voluntary Counseling and Testing are major strategies adapted to control transmission of the virus and the pivot of these interventions is either screening or diagnosing individuals through testing. There are reports of inconsistent sensitivity and specificity with whole blood and serum samples collected from the same individual. Little is known about the diagnostic characteristics of First Response HIV-1-2 RDT kit, used as a single test kit in national HIV prevention and control programmes. The debate has always centered on choosing between whole blood and serum in a case where a single test kit that runs on only blood specimen will be used for testing. The variations in specificities and sensitivities with whole blood and serum samples imply that some individuals who might be true positives will be missed and elude care. This study determined the best blood-based specimen type (whole blood or serum) that improves performance of First Response HIV RDT kit in detecting HIV-specific antibodies. A hospital-based cross-sectional study was conducted on 280 HIV infected and non-infected patients from May 2015 to June 2015. Blood samples from each participant were separated into whole blood and serum, and tested on First Response HIV-1-2 kits (Premier Medical Corporation Ltd., Kachigam, India) using Electro-chemi-luminescence assay (ECLIA) as reference assay. First Response HIV-1-2 RDT kit showed 100 % sensitivity and 100 % specificity with whole blood specimen and 100 % sensitivity and 82.86 % specificity with serum specimen for the detection of HIV-1. The positive and negative predictive values were 100, 100 and 85.35, 82.86 % for whole blood and serum respectively. Whole blood specimen(s) from an individual have higher specificity, positive and negative predictive values than serum. Whole blood is the primary specimen to use on First Response HIV-1-2 RDT kit when screening peripheral blood for HIV-1-specific antibodies.