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Urine from pregnant women with pre-eclampsia typically contains aggregates of misfolded proteins, which can be selectively bound by Congo red dye (congophilia). When a mixture of Congo red dye and urine from a pregnant woman is loaded onto the separation matrix in a detection cuvette, the presence (positive) or absence (negative) of misfolded proteins can be determined based on the colour of eluate collected in the cuvette. A red eluate colour indicates a positive pre-eclampsia diagnosis, whereas a colourless eluate indicates a negative diagnosis.

Cerca Biotech is currently enrolling centres across Europe to carry out clinical evaluations of the CercaTest™ Pre-eclampsia Vue™ assay. If you or your centre would like to get involved please contact us to discuss further.

  • Sensitivity: 74.3%
  • Specificity: 98.4%
  • NPV: 95.5%
  • Accuracy: 94.7%

The CercaTest™ Pre-eclampsia Vue™ assay was tested in a prospective cohort of nearly 1000 patients across several centres in China. When compared to a diagnosis of Pre-Eclampsia using standard diagnostic confirmation, the above results were observed, paper pending.