A/Prof David AndersonDeputy Director (Partnerships), and Co-Head – Global Health Diagnostics Lab
Burnet Institute, [email protected]
Burnet Institute and capacity in development (and deployment) of POC tests
APPRISE annual meeting, August 2017
POC testing and lateral flow chromatography
TECHNICAL LIMITATIONS
Depends on antibody response or highly sensitive antigen detection
Suitable at all levels of health systems
Global deployment with commodity pricing, ease of use
LATERAL FLOW
DEPLOYMENT LIMITATIONS
Detected earlier than immune response
Sequence-specific rather than reagents
Gold standard for many diseases
NUCLEIC ACID TESTING
POC testing and lateral flow chromatography
TECHNICAL LIMITATIONS
Depends on antibody response or highly sensitive antigen detection
Suitable at all levels of health systems
Global deployment with commodity pricing, ease of use
LATERAL FLOW
DEPLOYMENT LIMITATIONS
Detected earlier than immune response
Sequence-specific rather than reagents
Gold standard for many diseases
NUCLEIC ACID TESTING
DDMTC grant application – integrating sample preparation and LAMP (Burnet) with existing field deployable isothermal instrument and new
cartridge design (Axxin), for Nucleic Acid (virus) detection in collaboration with Doherty Institute, UWA, 360biolabs
GOLD
Always see red colour on Control Line
MabHEVAg
HEVIgMRapidTest:ReverseFlowTechnology
---------------------NITROCELLULOSE MEMBRANE----------------------
Anti-Hu IgM
SAMPLE PAD:
•Trap blood
CONJUGATE PAD:•Gold conj. to anti-HEV MAb, bound to HEV antigen
•reverses flow
flow
conjugate buffer
Anti-mu IgG
Y
GOLD
Anti-HEV MabHEVAg
See red colour on Test Line
flow
IgM in bloodY
PATIENT BENEFITS
UNMET MEDICAL NEEDS•Access to treatment, control of disease spread, targeting of vaccines or drugs
Priority Diagnostics Roadmap
Burnet Hepatitis E test in field use.
Develop novel (point-of-care)
tests
Laboratory validation of
tests
Field validation of tests
Implementation studies
PATIENT BENEFITS
UNMET MEDICAL NEEDS• Access to treatment, control of disease spread, targeting of vaccines or drugs
Priority Diagnostics Roadmap
Outlicensing formanufacture and sale
Test commercialisation
Hepatitis E IgM
Visitect CD4 (HIV)
Visitect Syphilis IgA
Pushing the boundaries of lateral flow
- An alternative to Flow Cytometry- CD4 T-cells in HIV (Visitect CD4); neutrophil CD64/NE in sepsis
- An alternative to enzymatic tests- Alanine aminotransferase (ALT) in liver disease
- An alternative to centrifugation- Plasma separation for HIV viral load (and molecular tests)
- Novel biomarkers- Treponemal IgA for confirmation of active syphilis- Dimeric IgA as a marker of acute mucosal infections (incl. hepatitis)
Neutrophil CD64 in sepsis
- Sepsis kills around 8 million people each year, mostly neonates and young children plus the elderly
- Urgent need for rapid diagnosis to identify severe infections requiring antibiotic treatment, while reducing over-treatment of those with similar signs/symptoms (fever)
- Adaptation of the neutrophil CD64 index test (Leuko64) to point of care using the same approach as CD4- But surprising discovery along the way….
- Clinical study of novel biomarkers (lab-based ELISAs) in healthy controls and sepsis patients, Alfred Hospital ICU (ongoing)
Axxin - Instrumentation for POC quantitation
350referenceCD4Testline
Alanineaminotransferase(ALT)test
Reference(40U/L)
ALTtestline
A BProceduralcontrol
C INTERPRETATION:
Testline≥reference=liverdisease
Testline<reference=notliverdisease
Developnovel(point-of-care)
tests
Laboratoryvalidationof
tests
Fieldvalidationoftests
Implementationstudies
PATIENT BENEFITS
UNMET MEDICAL NEEDS• Access to treatment, control of disease spread, targeting of vaccines or drugs
Priority DiagnosticsRoadmap
Outlicensing formanufacture and sale
Commercialisation (2)
Hepatitis E IgM
Visitect CD4 (HIV)
Visitect Syphilis IgA
BioPoint Liver
BioPoint VL-Plasma
• NanjingBioPointDiagnosticTechnologyCo.Ltd.
• Whollyforeign-ownedentity(WFOE),establishedin2013with321grantinJiangsuLifeScienceTechnologyandInnovationPark– ≈$240,000fromNanjingGovernment,plusancillarysupport– 12.5millionRMB(≈2.5M$A)Chineseinvestment2014
• Developmentandcommercialisationofpoint-of-carediagnostictestsforChinaandglobalmarketsinareasofunmetmedicalneed,startingwithALTtest(liverdisease)andVL-Plasma(plasmaseparator)
BurnetinChina– Buildingon20years....
JiangsuLifeScienceTechnologyandInnovationPark,Nanjing
NanjingBioPoint– GMPfacility
