Preeclampsia-associated morbidity and mortality is most often due to a delay or misdiagnosis Recent studies showed misfolded proteins can be detected in urine of preeclamptic women. The previous research assay has been transitioned to a manufacturable diagnostic device. Here we present the clinical accuracy of the in vitro diagnostic device (GV-CR) intended as an aid in the diagnosis of preeclampsia.
We evaluated 346 frozen urine samples from a prospective study of women referred to a L&D triage center for rule-out preeclampsia. 89 (26%) patients were diagnosed with preeclampsia by expert adjudication with reference to the ACOG 2013 Guidelines. Results were visually scored at 3 minutes after urine was applied to the test device. The user was blinded to case diagnoses. Test results were compared to the adjudicated diagnosis. IRB approval was obtained.
The cohort comprised 52% multiparous, 91% overweight/obese, 38% early preterm, 31% late preterm, and 31% at term women. Cases were particularly challenging and ambiguous to at least one physician who referred for rule-out preeclampsia. Results showed an 84.1% (95% CI: 75.1-90.3) sensitivity, 76.8% (95% CI: 71.0-81.7) specificity, and a negative predictive value of 93% for the device compared to the adjudicated diagnosis.
This 3-minute urine test demonstrated strong correlation with an adjudicated diagnosis of preeclampsia in this cohort of complex cases referred with an uncertain diagnosis and holds promise as an aid in the diagnosis of preeclampsia. Multicenter clinical studies are warranted.