Diagnostics: Bench To Bedside Pathway - WHO

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Diagnostics: Bench to Bedside PathwayRosanna W PeelingProfessor and Chair, Diagnostic ResearchDirector, International Diagnostics CentreLondon School of Hygiene & TropicalMedicinewww.idx-dx.org

The Ideal Diagnostic TestA AffordableS SensitiveS Specific Accurate Fast/SimpleU User-friendlyR Rapid and robust CheapE Equipment-freePick 2 of 3!D Deliverable

Diagnostics Methods:Ease of Detection vs Confidence in diagnosisConfidenceINDIRECT METHODS:Host BiomarkersDIRECT METHODS:Pathogen tectionSerologyIgMSerologyIgGEase of detectionTime toResult:Days/HoursMinutesAdapted with permissionfrom J. Cardosa

Diagnostics:Access vs Accuracy vs urbanRuralRuralRuralAccurate Accurate Accurate Cheap Cheap Cheap Fast/simple Fast/simple Fast/simple

FDA approves Oral HIV Testsfor home use, July, 2012Source: time.comOct 22, 2013: European Parliament votes favourably for home use of IVDs

Performance of the oral HIV TestPerformanceMeasure*Professional Use OraQuick TestPerformance (2-sided 95% CI**)Minimum -Counter OraQuick TestPerformance (2-sided 95% CI**)Minimum ity98% (lower boundof the 2-sided 95%CI)98% (lower boundof the 2-sided 95%CI)95% (lowerbound of the 2sided 95% CI)95% (lowerbound of the 2sided 95% CI)Specificity99.3%(98.4 - 99.7%)99. 8%(99.6 – 99.9%)* Compared to a blood based HIV test**95%CI 95% Confidence Interval92.98%(86.64 – 96.92%)99.98%(99.90 – 100%)

Connectivity Solutions forRapid Point-of-care Tests

4th Generation HIV TestsBio-Rad Ag/Ab ComboAbbott Architect Ag/Ab Combo2010ControlAntigen2011AntibodyDetect HIV-1 p24 antigen and IgM and IgGantibodies against either HIV-1 or HIV-2Insufficient data for rapid Ag/Ab test torecommend it as 1st test in algorithmDetermine Combo Ag/Ab Rapid Test2013

HIV Viral Load Product PipelineAlere QAlereEOSCAPE HIV RapidRNA Assay SystemRT CPA HIV-1Viral LoadUstarWave 80 BiosciencesSample in-answer outSAMBA VLTruelab PCRLiat AnalyserGene-RADARMolbio/bigTecNanobiosymGene XpertCavidi AMPCepheidIQuumDDU/CambridgeLYNX Viral LoadPlatformNWGHF20132014Viral LoadAssay ketdynamics/publications/UNITAID-HIV Diagnostic Landscape-3rd edition2016

Sample In, Answer Out: A Multi-diseaseRandom Access Real-time PCR PlatformMTB/RIFMRSACT/NgHIV Viral Load .52080Samples per shift500-1000

Roche: Liat Molecular PlatformRoche LIAT AnalyserIQuum (Boston) currently has FDA-approved Flu H1N1, A and B detection assays. The LiatAnalyser has an internal optical system that provides 6 independent optical detectionchannels for real-time detection and quantification of multiple targets in each test. It can bepowered by AC mains or by battery, allowing mobile use.

Molecular point-of-care testsfor InfluenzaAlere i Influenza A&B test: ONLY molecular platform that is FDA approved as a POCT Nucleic acid amplification system that uses a fluorescencebased molecular signal to detect influenza A and B. Time to result: 15min (only 2 min of “hands on” time) Adapted to be used by non-laboratory staff Results from a multicentre clinical evaluation (Bell et al2014) indicate:- 99.3% sensitivity and 98.1% specificity for Influenza A- 97.6 sensitivity and 100% specificity for Influenza B- Sensitivities of 73.2% and 82.3% have ben reported inother studiesAlere i Influenza A&B (Alere, SanDiego, CA, USA)

STI Multiplex Molecular BioChip Array Chlamydia trachomatisNeisseria gonorrhoeaHerpes simplex IHerpes simplex IITreponema pallidumTrichomonas vaginalisMycoplasma hominisMycoplasma genitaliumUreaplasma urealyticumHaemophilus ducreyi25 ul sample, 22 assays per biochip, 45 samples and 4 calibrators per run

NanotechnologiesNanowire technology:From a finger-pricked sample of blood,this device can detect in 20 min:- malaria parasites- distinguish malaria species- malaria drug resistanceNanodot technology:

Diagnostics: Bench to Bedside PathwayR & D: 2-10 years; 10-100 millionRegulatory Approval: 2-5 yearsDiagnosticTargetsProductPrototypeTarget ProductProfileTechnologyplatformValley of Death:Proof ofPrincipleLab & fieldevaluationPolicy andguidelines foruseTestadoptionPolicy & Uptake 5-7 years

Overcoming Challenges along theDiagnostics Bench to Bedside PathwayRegulatory science to keep up withtechnological innovation;Harmonized RegulationDiagnosticTargetsProductPrototypeTarget ProductProfileProof ofPrincipleLab & lsSet up networks ofevaluation sitespre-approved forstandardisedprotocolsPolicy andguidelines foruseTestadoptionAccelerate policydevelopmentthrough modellinghealth impact andcost-effectiveness

Product profile of HIV/Syphilis Dual TestsStandard Diagnostics, Inc.BIOLINE HIV/Syphilis DuoPurpose/usesettingScreen for HIV and Syphilis in clinicsSpecimenMedMiraChembioMultiplo TP/HIV Antibody TestDPP HIV-Syphilis AssayScreen for HIV and Syphilis in clinicsScreen for HIV and Syphilis in clinicsSerum/Plasma/Whole Blood(10-20uL)S/P/WB(1 drop, approx.30-40uL)S/P/WB(1 drop, approx.30-40uL)Test time15-20min. 20min sample preparation15-20min sample preparation#Operatorsteps334PerformanceHIV: 100%/100%SYP : 95.7-100%/98.2-100%Price( ) 1.50 3.50 2.50 - 3.00

Alere i Influenza A&B (Alere, San Diego, CA, USA) Alere i Infl

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