Pai Nitika Pant, Dhurat Rachita, Potter Martin, Behlim Tarannum, Landry Geneviève, Vadnais Caroline, Rodrigues Camilla, Joseph Lawrence, Shetty Anjali
Department of Medicine, McGill University, Montreal, Quebec, Canada Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Quebec, Canada.
Department of Dermatology, LTM Medical College, Mumbai, Maharashtra, India.
BMJ Open. 2014 Dec 15;4(12):e005040. doi: 10.1136/bmjopen-2014-005040.
Multiplexed point-of-care (POC) devices can rapidly screen for HIV-related co-infections (eg, hepatitis C (HCV), hepatitis B (HBV), syphilis) in one patient visit, but global evidence for this approach remains limited. This study aimed to evaluate a multiplex POC testing strategy to expedite screening for HIV-related co-infections in at-risk populations.
A multiplex strategy was developed with two subsequent versions of an investigational device Miriad. It was evaluated in two non-comparable settings and populations in two countries for feasibility of conduct, detection of new infections, preference and accuracy. Version 1 was evaluated in 375 sexually transmitted disease clinic attendees in Mumbai, India; version 2 was evaluated in 119 injection drug users in Montreal, Canada.
Feasibility (completion rate) of the multiplex strategy was high (86.1% Mumbai; 92.4% Montreal). A total of 170 new infections were detected in Mumbai (56 HIV, 75 HBV, 37 syphilis, 2 HCV) versus 2 in Montreal. Preference was 60% in Mumbai and 97% in Montreal. Miriad version 1 specificities were high: HIV 99.7% (98.3% to 100%), HBV 99.3% (97.6% to 99.9%), HCV 99.7% (98.5% to 99.9%), syphilis 85.2% (80.9% to 88.8%); sensitivities were as follows: HIV 100% (94.8% to 100%), HBV 13.3% (6.6% to 23.2%), HCV 50% (1.3% to 98.7%), syphilis 86.1% (70.5% to 95.3%). With version 2, specificities improved: HIV 100% (97.2% to 100%), HBV 100% (97.3% to 100%), HCV 85.3% (73.8% to 93.0%), syphilis 98.1% (93.3% to 99.8%); sensitivities were: HIV 100% (47.3% to 100%), HCV 80.4% (66.1% to 90.6%), syphilis 100% (22.4% to 100%).
A quad multiplex POC strategy for HIV and co-infections was feasible to operationalise and preferred by patients in both settings. Many new infections were identified in Mumbai and accuracy improved with version 2 of the assay. Such a strategy will help expedite screening for co-infections, particularly where baseline screening is low. These findings are valuable to practitioners, researchers, policymakers and funders involved in initiatives for all four diseases with implications for scale-up.
多重即时检验（POC）设备可在一次就诊中快速筛查与HIV相关的合并感染（如丙型肝炎（HCV）、乙型肝炎（HBV）、梅毒），但全球范围内关于这种方法的证据仍然有限。本研究旨在评估一种多重POC检测策略，以加快对高危人群中与HIV相关合并感染的筛查。
采用一种针对研究设备Miriad的两个后续版本开发的多重策略。在两个国家的两个不可比的环境和人群中对其进行了可行性、新感染检测、偏好性和准确性评估。版本1在印度孟买的375名性传播疾病门诊患者中进行评估；版本2在加拿大蒙特利尔的119名注射吸毒者中进行评估。
多重策略的可行性（完成率）很高（孟买为86.1%；蒙特利尔为92.4%）。在孟买共检测到170例新感染（56例HIV、75例HBV、37例梅毒、2例HCV），而在蒙特利尔检测到2例。偏好性在孟买为60%，在蒙特利尔为97%。Miriad版本1的特异性较高：HIV为99.7%（98.3%至100%），HBV为99.3%（97.6%至99.9%），HCV为99.7%（98.5%至99.9%），梅毒为85.2%（80.9%至88.8%）；敏感性如下：HIV为100%（94.8%至100%），HBV为13.3%（6.6%至23.2%），HCV为50%（1.3%至98.7%），梅毒为86.1%（70.5%至95.3%）。使用版本2时，特异性有所提高：HIV为100%（97.2%至100%），HBV为100%（97.3%至100%），HCV为85.3%（73.8%至93.0%），梅毒为98.1%（93.3%至99.8%）；敏感性为：HIV为100%（47.3%至100%），HCV为80.4%（66.1%至90.6%），梅毒为100%（22.4%至100%）。
针对HIV及其合并感染的四重多重POC策略在两种环境下实施都是可行的，且受到患者的青睐。在孟买发现了许多新感染病例，并且该检测方法的版本2准确性有所提高。这样的策略将有助于加快合并感染的筛查，特别是在基线筛查率较低的地方。这些发现对于参与这四种疾病防治项目的从业者、研究人员、政策制定者和资助者具有重要价值，对扩大规模具有启示意义。
