A blood protein marker for the early detection of pre- eclampsia


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A blood protein marker for the early detection of pre- eclampsia

  1. 1. A BLOOD PROTEIN MARKER FOR THE EARLYDETECTION OF PRE- ECLAMPSIA A G7 DIAGNOSTICS PRESENTATION Helena Gwani Ayotunde Awosusi Daniel Igwe Priyesh Waghmare Srishti Jain Vinie Varkey T
  2. 2. OUTLINE Pre- eclempsia: What is it? Causes of maternal death Global maternity mortality Pre-eclempsia distribution Current diagnosis Market need Product specifications Conclusion
  3. 3. Pre- EclampsiaGlobally, Causes: Symptoms:•10% of all •Damage to the •Rising High bloodpregnancies blood vessels pressure •Insufficient blood •High protein levels•12% of maternal flow to the uterus in the urinedeaths •Severe headache•1/3rd of pre maturebirths •Visual Disturbances •Vomiting and abdominal pain
  4. 4. 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
  7. 7. PRE-ECLAMPSIA DISTRIBUTION (EXTRAPOLATEDFIGURES) Source: http://www.cureresearch.com/p/preeclampsia/stats-country.htm
  8. 8. CURRENT DIAGNOSISMethod Description LimitationsBlood pressure (>140/90) • Time consumingProtein concentration in urine (>300mg/dL) •Complex •Low reliabilityBlood tests: liver, kidneys, plateletsnumber. •Late diagnosis •Rate of falseUterine artery Doppler ultrasound positive result is high.
  9. 9. HOW CAN WE APPROACH THE PROBLEM? The ideal Screening test:  Simple  Noninvasive  Rapid  Inexpensive  Early detection  Highly sensitivity & predictive
  10. 10. MARKET NEED12% of maternal deaths Global prevalence of pre-eclampsiaOur market research reveals: There is no clinically useful screening test to predict the development of preeclampsia in either low-risk or high-risk populations.
  11. 11. 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
  12. 12.  Biomarker:  A biological indicator whose presence, absence or abnormal concentration reflects the severity or presence of a disease.S.No. Biochemical Marker Plasma Concentration Manifest Trimester 1 Trimester 2 Preeclampsia1. sflt-1 (Soluble fms- like -- high Early increase tyrosine kinase)2. Soluble Endoglin (sEng) -- high Early increase3. Placental Growth Factor low low further decrease (PlGF)
  13. 13. Sample Port Blood Filter Cells are separated from Reaction plasma Chamber A small fraction ofthe Plasma sample Timegate mixes with the dried reagents Hyrdrophobic surface – ensures Three Internal Controls reaction time Independent Positive High – and low – control Assay Zones zones and a nonspecific binding Fluoroscent control tagged antibodies on Waste nano particles Reservoir are captured Excess sample collected in the on separate periphery zones
  15. 15. 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
  16. 16. REPRODUCIBILITY Reading system Automated Reproducibility near 95% clinical thresholdTEST PROCEDURE Number of timed steps One step Time to result 15 minutes
  17. 17. SAMPLING Volume of sample 550µL required Throughput 90 testsADDITIONAL 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 Disposable strip reagents/device Training needs No training required
  18. 18. 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
  19. 19. SCIENTIFIC EVIDENCE Nanoparticle based protein estimation:  Jiang et al (2009)  He et al (2010)
  20. 20. 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
  21. 21. THANK YOU!
  22. 22. 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
  23. 23. MOST RECENT – ALERE This technique uses immuno fluorescence. It is based on the PlGF marker Launched in Europe in January 2011.