title: Will a quadruple multiplexed point-of-care screening strategy for HIV-related co-infections be feasible and impact detection of new co-infections in at-risk populations? Results from cross-sectional studies.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, McGill University, Montreal, Quebec, Canada Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Quebec, Canada.
authors.forename: Nitika Pant
authors.initials: NP
authors.lastname: Pai
authors.affiliation: Department of Dermatology, LTM Medical College, Mumbai, Maharashtra, India.
authors.forename: Rachita
authors.initials: R
authors.lastname: Dhurat
authors.affiliation: Chronic Viral Illness Service, Division of Infectious Disease, McGill University Health Centre, Montreal, Quebec, Canada Centre de recherche et d'aide pour narcomanes (CRAN), Montreal, Quebec, Canada.
authors.forename: Martin
authors.initials: M
authors.lastname: Potter
authors.affiliation: Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Quebec, Canada.
authors.forename: Tarannum
authors.initials: T
authors.lastname: Behlim
authors.affiliation: Centre de recherche et d'aide pour narcomanes (CRAN), Montreal, Quebec, Canada.
authors.forename: Geneviève
authors.initials: G
authors.lastname: Landry
authors.affiliation: Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Quebec, Canada.
authors.forename: Caroline
authors.initials: C
authors.lastname: Vadnais
authors.affiliation: Division of Microbiology, P.D. Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, India.
authors.forename: Camilla
authors.initials: C
authors.lastname: Rodrigues
authors.affiliation: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Joseph
authors.affiliation: Division of Microbiology, P.D. Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, India.
authors.forename: Anjali
authors.initials: A
authors.lastname: Shetty
mesh_terms: D000328:Adult; D002170:Canada / Q000453:epidemiology; D060085:Coinfection / Q000175:diagnosis* / Q000453:epidemiology; D003430:Cross-Sectional Studies; D005260:Female; D006678:HIV; D015658:HIV Infections / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D006509:Hepatitis B / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D006526:Hepatitis C / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D012680:Sensitivity and Specificity; D015819:Substance Abuse, Intravenous / Q000150:complications; D013587:Syphilis / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D055815:Young Adult
keywords: PUBLIC HEALTH