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Point-‐Of-‐Care Diagnostics Point-of-care Diagnostics Rosanna W Peeling Professor and Chair, Diagnostic Research Director, International Diagnostics Centre www.idx-dx.org London School of Hygiene & Tropical Medicine Point-of-care Diagnostics • Need for more accessible tests to reach 90-90-90 targets for HIV • Innovations in diagnostic technologies for HIV and HIV co-infections • Connectivity for POC tests • Summary Point-of-care Diagnostics • I have no conflicts of Interest to declare • Mention of company products does not imply endorsement by the London School of Hygiene & Tropical Medicine Accessible Diagnostics is critical for countries to reach the UNAIDS/WHO 2020 Targets for HIV 50% HIV rapid tests for self-testing POC Early infant diagnosis 37% POC CD4 assays 25% POC Viral load Assays Early Infant Diagnosis • An estimated 1.8 million children <15 years of age living with HIV • Undiagnosed and without treatment, 50% of children will die before their 2nd birthday with the highest peak of mortality in the first few months of life (UNAIDS) • As maternal antibodies remain in the blood of infants for 12-18 months, HIV diagnosis in infant require virus detection using a molecular assay, which is neither affordable nor accessible in many developing countries • In 2015, UNAIDS estimated that only 51% of children received early infant diagnosis testing and only 50% of children tested, received their test results, resulting in further delays in treatment initiation of HIV-infected children Trade-off between Access vs Sensitivity Sensitivity Access 100 90 80 70 100 100 90 80 70 90 90 81 72 63 80 80 72 64 56 70 70 63 56 49 60 60 54 48 42 50 50 45 40 35 40 40 36 32 28 30 30 27 24 21 20 20 18 16 14 10 10 9 8 7 NAT: Nucleic acid tests: Lab-NAT: laboratory-based; POC-NAT: at point-of-care; CLIA: chemiluminescence immunoassay; ECL: electrochemiluminescence immunoassay; EIA: enzyme immunoassay; RDT: rapid diagnostic test WHO Pre-qualified HIV POC Tests WHO has pre-qualified: • > 15 RDTs for detecting antibodies to HIV • 1 oral HIV RDT for self-testing • 1 HIV-syphilis duplex RDT • 2 POC NAT for qualitative detection of virus • 1 POC NAT for quantitative viral load detection http://www.who.int/diagnostics_laboratory/evaluations/170928_prequalified_ product_list.pdf?ua=1 Hepatitis B and C Virus Infections as HIV co-infections • Epidemiology of HBV and HCV as co-infections with HIV: HIV-HBV HIV-HCV Prevalence in general 6.6% 2.4% population Prevalence in MSM 6.1% 6.4% Prevalence in PWID 7.0% 82.4% • The majority of HBV infection is acquired perinatally, or in early childhood, many years before HIV acquisition whereas HCV is acquired generally in adulthood • HBV-HIV co-infection is associated with less spontaneous clearance of HBsAg, higher rates of chronicity and occult HBV (HBV-DNA positivity in the absence of HBsAg), accelerated fibrosis progression with increased risk of cirrhosis and hepatocellular carcinoma, and higher liver-related mortality • Odds of HCV infection were six times higher in people living with HIV (5·8, 95% CI 4·5-7·4) than their HIV-negative counterparts • HIV infection doubles the risk of HCV perinatal transmission in HIV-infected mothers, and is associated with less spontaneous HCV clearance, higher HCV viral loads, and more rapid HCV disease progression • Despite the significant burden of disease and advances and opportunities for treatment, <5% of people co-infected with HBV or HCV remain undiagnosed and unaware of their infection, particularly in populations such as PWID, prisoners, sex workers, and MSM Ref: Platt et al. Lancet Infect Dis 2016; Easterbrook et al. Lancet Infect Dis 2017 Diagnostic Algorithm for HBV Testing Systematic Review of HBsAg RDT Accuracy Sub- Pooled Clinical Accuracy* analysis # Sensitivity Specificity studies (95% CI) (95% CI) Patient Blood 19 91.6 99.5 Population donors (90.1-92.9) (99.3-99.7) HIV + 6 72.3 99.8 (67.9–76.4) (99.5-99.9) HIV - 4 92.6 99.6 (89.8-94.8) (99.0-99.9) Specimen Whole 11 91.7 99.9 blood (89.1-93.9) (99.8-99.9) *Performance compared to a laboratory-based immunoassay WHO guidelines on Hepatitis B and C Testing (http://apps.who.int/iris/bitstream/10665/254621/1/9789241549981-eng.pdf?ua=1) Diagnostic Algorithm for HCV WHO guidelines on Hepatitis B and C Testing (http://apps.who.int/iris/bitstream/10665/254621/1/9789241549981-eng.pdf?ua=1) Performance of RDTs to detect HCV Antibodies Comparison Pooled Sensitivity (95%CI) Pooled Specificity (95%CI) (# studies) RDT versus EIA only (n=5) 99 (98-100) 1.00 (100-100) RDT versus NAT or Immunoblot 0.93 (91-95) 0.98 (97-99) HCV RDTs cost between (n=13) $0.50 – 2.00, and $10 for RDT versus EIA, NAT or 0.97 (96-98) 1.00 (100-100) Immunoblot (n=14) an oral fluid RDT. Specimens Blood samples (n=45) 0.98 (97-98) 0.98 (98-99) HCV EIAs cost between Oral samples (n=12) 0.94 (93-96) 100 (100-100) $0.50 – 1.70, but high- Population throughput EIAs require General screening (n=17) 0.95 (94-96) 1.00 (100-100) additional laboratory infrastructure and Key population (n=19) 0.97 (96-98) 0.99 (98-99) equipment Hospital patients (n=16) 0.97 (96-98) 1.00 (100-100) HIV and Syphilis • There has been alarming increase in incidence of syphilis, compared to other STIs, in HIV-infected MSM cannot be explained by behavioural factors alone • Frequent co-infection of HIV and syphilis in MSM in many countries have led researchers and policy makers to consider the hypothesis that treatment for HIV may be a double-edged sword that contributed to increased susceptibility to syphilis through impairment of the innate or acquired immunity to T. pallidum • Rekart, M. L. et al. A double-edged sword: does highly active antiretroviral therapy contribute to syphilis incidence by impairing immunity to Treponema pallidum? Sex. Transm. Infect. 93, 374–378 (2017). • Tuddenham, S., Shah, M. & Ghanem, K. g. Syphilis and HIV: Is HAART at the heart of this epidemic? Sex. Transm. Infect. 93, 311–312 (2017). Diagnostics is a Key Component of Disease Elimination: Mother-to-Child Transmission of HIV & Syphilis WHO/UNAIDS Process Targets: 95% Access ANC 95% Tested for HIV & Syphilis 95% Treated HIV/Syphilis Product Pipeline July 2015 Biolytical MedMira Junco Labs Standard INSTI Combined mChip Assay Diagnostics Chembio Multiplo Rapid HIV/Syphilis Test DPP® HIV- TP/HIV HIV/Syphilis Duo AntibodyTest Rapid Test Syphilis Assay CTK Biotech OnSite™ HIV/Syphilis 2013 2014 2015 2016 2017 Disposable Device http://www.unitaid.org/images/marketdynamics/publications/UNITAID-HIV_ Congenital_Syphilis_Diagnostic_Landscape.pdf. Performance of dual HIV/syphilis tests in laboratory evaluation in China and Nigeria Comparison with Comparison with TPPA/TPHA HIV ELISA Sensitivity (%) Specificity (%) Sensitivity (%) Specificity (%) SD Bioline 99.0 99.0 96.6 99.1 (98.0-99.5) (98.0-99.5) (95.0-97.7) (98.2-99.6) Chembio 99.6 97.9 97.0 99.6 (98.8-99.9) (96.7-98.7) (95.5-98.0) (98.9-99.9) MedMira 99.5 98.3 94.2 97.2 (99.4-99.8) (97.2-99.0) (92.3-95.7) (95.8-98.1) N=1,514 specimenss Performance of Multiplex Tests *compared to laboratory based tests **reader available Fisher Dg, et al. Open Forum Infect Dis. 2015 Jul 7;2(3):ofv101. doi: 10.1093/ofid/ofv101. POC Tests for Advanced HIV Disease POC Tests for ART initiation and prophylaxis: • POC CD4 • LAM RDT for TB diagnosis • Cryptococcal antigen RDT • Fo rd N, et al. The evolving role of CD4 cell counts in HIV care. Curr Op in HIV AIDS. 2017;12:123–8. • WHO gUIDELINES FOR MANAgINg ADVANCED HIV DISEASE AND RAPID INITIATION OF ANTIRETROVIRAL THERAPY JULY 2017 (http://apps.who.int/iris/bitstream/10665/255884/1/9789241550062 -en g.p d f ) Innovations in HIV VL POC Platforms http://www.unitaid.eu/images/marketdynamics/publications/UNITAID_HIV_Nov_2015_Dx_Landscape.PDF Cepheid: A Multi-disease Random Access Real-time PCR Platform HIV early infant diagnosis, Viral Load, HCV MTB/RIF, Flu A, B/RSV, MRSA, C. difficile, Norovirus, CT/Ng, HPV, Group B Strep Omni: - 9 in. tall (23 cm) - 1 kg - AC or battery operated - controlled via dedicated mobile device - wireless, web enabled - USD 2,895 5 20 80 500-1000 Samples per shift Roche: Cobas Liat RT-PCR System • Principle: RT-PCR with an internal optical analyser that provides 6 independent optical detection channels for real-time detection and quantification of multiple targets • Applications: • FDA and CE approved: Influenza virus A and B and Strep A • In development: HIV viral load, HCV • Operation: • time to result: 15-20 min • AC or battery powered • Self checks and calibrations with Internal and volume controls • Connectivity: to be confirmed Smart Phone based Diagnostics Convergence of Technologies: an opportunity to strengthen health systems Quality Assurance, especially for 1 POCTs 2 Patient treatment Connectivity 3 Public health monitoring 4 Outbreak response 5 LI(M)S interfacing With connectivity we can turn data into 6 Stock management intelligence to strengthen health systems Operator performance; and improve the quality of patient care 7 Instrument performance Connectivity Dashboards Monitoring Error Rates: Monitoring stock/supplies: purchase purchase Laboratories or POC Testing sites Months With permission from SystemOne Impact of Digital Technology & Connectivity on health outcomes and health systems Parameters Local Impact Health system impact Rapid return of diagnostic results Reducing time for management of patients Increasing health systems efficiency Improving data quality/reliability Reducing transcription errors Monitoring POC instrument placement and Reduce stock outs by optimizing instrument utilization placement and supply
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