Alere™ qA platform to answer global health needs:TB and beyond
Duncan BlairDirector, Public Health Initiatives
7th FIND Symposium, Barcelona, October 2014
• Portable, battery operated
• Data connectivity enabled
• Primary samples collected directly into the assay disposable
• User inserts cartridge into analyser, enters ID data for full walk-away operation
• 100% automated processing by the Alere q analyser. Sample extraction, target purification, amplification and microarray-based detection
• Results are stored on the device and can be printed, exported via ethernet, USB or GPRS mobile modem
Alere q platform overview
Comprising the Alere q analyser & the Alere q cartridges the system provides molecular diagnostics capability in a true point-of-care package
Workflow
• 100% sample collection, processing, amplification and detection integrated into a single disposable
• No complex procedures, minimal qualification and training requirements
• Walk away operation
• High sensitivity, high specificity
• Rapid case detection (<20 min) and reflex DST (<40 minutes) from single specimen
• Facilitate decentralisation and task shifting to enable far greater access to treatment initiation
TB assay design goals and philosophiesA molecular TB diagnosis and DST solution for true point of care use. Zero manual sample manipulation steps, zero additional consumables or reagents and unparalleled ease of use with walk away operation to facilitate task shifting and greatly expanded access
Fully-Automated Workflow for TB Diagnosis
Custom sputum cup Processing, amplification and detection
Fully-Automated Workflow for TB Diagnosis
Fully-Automated Workflow for TB Diagnosis
1. Sputum liquefaction and homogenization
Fully-Automated Workflow for TB Diagnosis
2. Nucleic acid purification and mycobacterial DNA enrichment
Fully-Automated Workflow for TB Diagnosis
3. Reagent reformulation and reaction setup
Fully-Automated Workflow for TB Diagnosis
4. Nucleic acid amplification and real-time detection
• No new specimen required
• PCR and array based detection with rapid results (<40 min)
• Rifampicin
• Isoniazid
• Fluoroquinolones
• Potentially pyrazinamide
Reflex DST testing
Intended use setting
Level 4
Level 3
Level 2
Level 1
Potential TB Patients Served
Infr
astr
uctu
re C
ompl
exity
National Reference Labs
Regional Reference Labs
District Labs and Hospitals
Microscopy Centers and Community Health Clinics
Intended use setting
Intended use setting
• Two basic cartridge designs, low volume and high volume
• Molecular assays based on multiple amplification chemistries
• Microarray based detection
A highly versatile, adaptable system
Actual images from Alere q analyser
Low density array assay High density array assay
High volume cartridge
Low volume cartridge
Alere q system assay development targets
• HIV1/2 Detect launched July 2014• HIV1/2 Viral Load launching late 2014, early 2015
• TB Detect and reflex TB DST in advanced development, going into extensive clinical trials 2015, CE IVD marking and commercial launch by Q4 2015
• HCV viral load
• Infectious disease panels
• Many additional possibilities
Alere Data Point Connectivity
CONFIDENTIAL | 16
Data Point Connectivity offering Data Point is the connectivity package that delivers
analyser results to a central server enabling customers to access data remotely via the Data Point portal.
Regardless of how many analysers are in the field the portal allows near real-time monitoring of data including usage patterns, device condition & stock management.
The portal is also enabled with a flexible reporting & alerting system allowing program administrators to be alerted to activity that is of interest to them on a near real-time or scheduled basis.
Alere Data Point PortalAlere SIMsUSB ModemsAnalyser
Implementation Capabilities: Our Global FootprintWith 40+ affiliate offices and representation in over 100 countries worldwide our commercial teams and distribution partners are key to delivering sustainable diagnostic solutions to the market
Total Employees18,000
Represented In>100 countries
Implementation: Public Private PartnershipsAlere partners with ministries of health to provide teams of Field Support Staff to facilitate high quality point of care diagnostic testing
• Alere pays for and trains ministry-seconded Field Support Staff
• FSS assist other MoH staff with trouble shooting, training, mentoring, quality management, policy/guideline updates, linkage to care and more
• Programs functional in Uganda, Zambia and South Africa
• MoUs in development with Zimbabwe, Côte d’Ivoire and Cameroon. Additional program expansion expected.
http://alerehiv.com/video/alere-field-support-staff-in-uganda/
Acknowledgements
Glenn Johns Ines Labugger Eugen Ermantraut
Alere Technologies
Free State ofThuringia
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