a blood protein marker for the early detection of pre- eclampsia
DESCRIPTION
TRANSCRIPT
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A BLOOD PROTEIN MARKER FOR THE EARLY DETECTION OF PRE- ECLAMPSIA
Helena Gwani
Ayotunde Awosusi
Daniel Igwe
Priyesh Waghmare
Srishti Jain
Vinie Varkey T
A G7 DIAGNOSTICS PRESENTATION
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OUTLINE Pre- eclempsia: What is it?
Causes of maternal death
Global maternity mortality
Pre-eclempsia distribution
Current diagnosis
Market need
Product specifications
Conclusion
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Pre- Eclampsia
Globally,
•10% of all pregnancies
•12% of maternal deaths
•1/3rd of pre mature births
Causes:
•Damage to the blood vessels
•Insufficient blood flow to the uterus
Symptoms:
•Rising High blood pressure
•High protein levels in the urine
•Severe headache
•Visual Disturbances
•Vomiting and abdominal pain
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RISK FACTORS
Medical problems
First time pregnancy
Family history
Previous case of pre-eclampsia
40 years or older
Obesity
Multiple birth
Source: http://jalesknowsbabiesrock.blogspot.com/2010/10/annotated-webliography-of-preeclampsia.html
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CAUSES OF MATERNAL DEATH
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GLOBAL MATERNAL MORTALITY
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PRE-ECLAMPSIA DISTRIBUTION (EXTRAPOLATED FIGURES)
Source: http://www.cureresearch.com/p/preeclampsia/stats-country.htm
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CURRENT DIAGNOSISMethod Description Limitations
Blood pressure (>140/90) • Time consuming
•Complex
•Low reliability
•Late diagnosis
•Rate of false positive result is high.
Protein concentration in urine (>300mg/dL)
Blood tests: liver, kidneys, platelets number.
Uterine artery Doppler ultrasound
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The ideal Screening test: Simple
Noninvasive
Rapid
Inexpensive
Early detection
Highly sensitivity & predictive
HOW CAN WE APPROACH THE PROBLEM?
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MARKET NEED
12% of maternal deaths
Our market research reveals:
There is no clinically useful screening test to predict the development of preeclampsia in either low-risk or high-risk populations.
Global prevalence of pre-eclampsia
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PRODUCT SPECIFICATIONS
Intended uses of the test: early detection pre-eclempsia
Target population/patient: Pregnant women (first trimester)
Health facility where the test will be used: clinics, health centers and hospitals
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Biomarker:
A biological indicator whose presence, absence or abnormal concentration reflects the severity or presence of a disease.
S.No. Biochemical Marker Plasma ConcentrationTrimester 1 Trimester 2
Manifest Preeclampsia
1. sflt-1 (Soluble fms- like tyrosine kinase)
-- high Early increase
2. Soluble Endoglin (sEng)
-- high Early increase
3. Placental Growth Factor (PlGF)
low low further decrease
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Sample Port
Reaction Chamber
A small fraction of the Plasma sample mixes
withthe dried reagents
Three Internal Controls
Independent Positive High –
and low – control zones and a nonspecific
binding control
Waste Reservoir
Excess sample collected in the
periphery
Blood FilterCells are
separated from plasma
TimegateHyrdrophobic surface –
ensures reaction time
Assay Zones
Fluoroscent tagged
antibodies on nano
particles are captured on
separate zones
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G7 PRE-ECLAMPSIA DIAGNOSTIC DEVICE
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PRIORITY FEATURES
Target molecule •Placental Growth Factor(PlGF), •Soluble Isoforms of flt-1 (sflt-1), •Soluble Endoglin (sEng)
Sensitivity 94.5%
Specificity 95%
Type of analysis Nano particles based Fluoro-Immuno Assay(FIA)
Reading system Automated
Sample type Blood
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REPRODUCIBILITY
Reading system Automated
Reproducibility near clinical threshold
95%
TEST PROCEDURE
Number of timed steps
One step
Time to result 15 minutes
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SAMPLINGVolume of sample required
550µL
Throughput 90 tests
ADDITIONAL CHARACTERISTICS
Heat stability 15°C- 30°C
Storage conditions 20°C
End user profile Can be guided by the manual
Bio-safety requirement
Low
Shelf-life of reagents/device
Disposable strip
Training needs No training required
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CONCLUSIONS
The product is superior compared to the existing technologies for the detection of pre- eclempsia: Three independent biomarkers increase
reliability of result Automated
A Point of Care approach
Huge market demand
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SCIENTIFIC EVIDENCE
Nanoparticle based protein estimation:
Jiang et al (2009) He et al (2010)
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REFERENCES:
Jiang, X., Weise, S., Hafner, M., Röcker, C., Zhang, F., Parak, W.J. and Nienhaus, G. U. (2009) Quantitative analysis of the protein corona on FePt nanoparticles formed by transferrin binding J R Soc Interface 7, S5-S13
He, Y., Li, Y. and Hun, X. (2010) Polymer nanoparticles as fluorescent labels in a fluoroimmunoassay for human chorionic gonadotropin Microchimica Acta 171:393–398
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THANK YOU!
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SCREENING TESTS AND THEIR LIMITATIONS Current Diagnosis
Measuring blood pressure (>140/90) protein concentration in urine (>300mg/dL)
Blood tests: liver, kidneys, platelets number.
Uterine artery Doppler ultrasound
Non stress test or biophysical profile: Check if baby is getting sufficient O2 and nutrients Response of baby’s heart rate relative to baby’s movement
Limitations : Time Consuming
Tendency of false positive result is high
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MOST RECENT – ALERE This technique uses immuno fluorescence.
It is based on the PlGF marker
Launched in Europe in January 2011.
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PRODUCT SPECIFICATION