a blood protein marker for the early detection of pre- eclampsia
DESCRIPTION
TRANSCRIPT
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
OUTLINE Pre- eclempsia: What is it?
Causes of maternal death
Global maternity mortality
Pre-eclempsia distribution
Current diagnosis
Market need
Product specifications
Conclusion
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
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
CAUSES OF MATERNAL DEATH
GLOBAL MATERNAL MORTALITY
PRE-ECLAMPSIA DISTRIBUTION (EXTRAPOLATED FIGURES)
Source: http://www.cureresearch.com/p/preeclampsia/stats-country.htm
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
The ideal Screening test: Simple
Noninvasive
Rapid
Inexpensive
Early detection
Highly sensitivity & predictive
HOW CAN WE APPROACH THE PROBLEM?
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
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
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
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
G7 PRE-ECLAMPSIA DIAGNOSTIC DEVICE
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
REPRODUCIBILITY
Reading system Automated
Reproducibility near clinical threshold
95%
TEST PROCEDURE
Number of timed steps
One step
Time to result 15 minutes
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
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
SCIENTIFIC EVIDENCE
Nanoparticle based protein estimation:
Jiang et al (2009) He et al (2010)
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
THANK YOU!
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
MOST RECENT – ALERE This technique uses immuno fluorescence.
It is based on the PlGF marker
Launched in Europe in January 2011.
PRODUCT SPECIFICATION