Abstract
Objective
To test the hypothesis that the sensitivity of Glycosylated Fibronectin (GlyFn) as Point-of-Care (POC) test is non-inferior to sflt/PlGF ratio for prediction of delivery within 4 weeks in women at risk of developing preeclampsia.
Methods
Prospective multicentre study, in five NHS hospitals in Southwest London. Participant meeting the eligibility criteria were recruited between 24 and
36 weeks’ gestation. POC GlyFn test was performed, and a paired blood sample taken for sflt/PlGF assessment. Testing was repeated in two and
four weeks if the women remained undelivered. Primary outcome of delivery for preeclampsia within 28 days of testing was compared, with a pre- defined non-inferiority margin of 5%. We generated receiver operating characteristic (ROC) curves using test cut-offs (38 for sflt/PlGF and 350 for GlyFn). Areas under the curve (AUC) with corresponding confidence intervals (95% CI) were also compared.
Results
A total of 150 participants were included in the analysis. The median gestational age at recruitment was 32 (IQR: 29 -35 ) weeks, gestation at
birth was 37 (IQR: 36 -38 ) weeks, median test to delivery interval was 26 (IQR: 12-50) days, with a preeclampsia prevalence of 27%. The
sensitivity of POC GlyFn for elective birth for PE within 4 weeks was 62 (95%CI: 51-73)% compared to 39 (95%CI: 28-51)% for sFlt/PlGF ratio. The
corresponding sensitivity for PE within 2 weeks were 70 (95%CI: 55-83)% versus 53 (95%CI: 37-68)% and anytime were 73 (95%CI: 57-85)% versus 57 (95%CI: 42-73)%. The AUCs of the ROCs for prediction of elective birth within four, two weeks and anytime for pre-eclampsia development were
65 (95%CI: 56-74)%, 66 (95%CI: 56-76)% and 68% (95%CI: 58-78)% for GlyFn, versus 66 (95%CI: 57-75)%, 69 (95%CI: 59-80)%), and 73% (95%CI
62-83%) for sflt/PlGF ratio.
Conclusion
The sensitivity of GlyFn used as a POC test appears to be non-inferior to sflt/PlGF ratio in predicting elective birth for preeclampsia within four or two weeks of testing in women at risk of PE.
To test the hypothesis that the sensitivity of Glycosylated Fibronectin (GlyFn) as Point-of-Care (POC) test is non-inferior to sflt/PlGF ratio for prediction of delivery within 4 weeks in women at risk of developing preeclampsia.
Methods
Prospective multicentre study, in five NHS hospitals in Southwest London. Participant meeting the eligibility criteria were recruited between 24 and
36 weeks’ gestation. POC GlyFn test was performed, and a paired blood sample taken for sflt/PlGF assessment. Testing was repeated in two and
four weeks if the women remained undelivered. Primary outcome of delivery for preeclampsia within 28 days of testing was compared, with a pre- defined non-inferiority margin of 5%. We generated receiver operating characteristic (ROC) curves using test cut-offs (38 for sflt/PlGF and 350 for GlyFn). Areas under the curve (AUC) with corresponding confidence intervals (95% CI) were also compared.
Results
A total of 150 participants were included in the analysis. The median gestational age at recruitment was 32 (IQR: 29 -35 ) weeks, gestation at
birth was 37 (IQR: 36 -38 ) weeks, median test to delivery interval was 26 (IQR: 12-50) days, with a preeclampsia prevalence of 27%. The
sensitivity of POC GlyFn for elective birth for PE within 4 weeks was 62 (95%CI: 51-73)% compared to 39 (95%CI: 28-51)% for sFlt/PlGF ratio. The
corresponding sensitivity for PE within 2 weeks were 70 (95%CI: 55-83)% versus 53 (95%CI: 37-68)% and anytime were 73 (95%CI: 57-85)% versus 57 (95%CI: 42-73)%. The AUCs of the ROCs for prediction of elective birth within four, two weeks and anytime for pre-eclampsia development were
65 (95%CI: 56-74)%, 66 (95%CI: 56-76)% and 68% (95%CI: 58-78)% for GlyFn, versus 66 (95%CI: 57-75)%, 69 (95%CI: 59-80)%), and 73% (95%CI
62-83%) for sflt/PlGF ratio.
Conclusion
The sensitivity of GlyFn used as a POC test appears to be non-inferior to sflt/PlGF ratio in predicting elective birth for preeclampsia within four or two weeks of testing in women at risk of PE.
| Original language | English |
|---|---|
| Publication status | Published - 2 Jul 2025 |
| Externally published | Yes |
| Event | World Congress in Fetal Medicine - Prague Congress Centre, Prague, Czech Republic Duration: 29 Jun 2025 → 3 Jul 2025 Conference number: 22 https://www.fetalmedicine.org/courses-n-congress/fmf-world-congress |
Conference
| Conference | World Congress in Fetal Medicine |
|---|---|
| Country/Territory | Czech Republic |
| City | Prague |
| Period | 29/06/25 → 3/07/25 |
| Internet address |