TY - JOUR
T1 - Glycosylated fibronectin point-of-care test for diagnosis of pre-eclampsia in a low-resource setting
T2 - a prospective Southeast Asian population study
AU - Nagalla, S. R.
AU - Janaki, V.
AU - Vijayalakshmi, A. R.
AU - Chayadevi, K.
AU - Pratibha, D.
AU - Rao, P. V.
AU - Sage, K. M.
AU - Nair-Schaef, D.
AU - Bean, E.
AU - Roberts, C. T.
AU - Gravett, M. G.
N1 - Funding Information:
This work was funded by DiabetOmics, Inc.
Publisher Copyright:
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists
PY - 2020/12
Y1 - 2020/12
N2 - Objective: To determine the performance of a glycosylated fibronectin (GlyFn) point-of-care (POC) test for pre-eclampsia (PE) in a large Southeast Asian cohort (India) in comparison to previously described biomarkers. Design: A total of 798 pregnant women at ≥20 weeks of gestation were enrolled in a prospective case-control study. Study participants included 469 normotensive women with urinary mg protein/mmol creatinine ratio <0.3, 135 with PE (hypertension with urinary mg protein/mmol creatinine ratio ≥0.3) and 194 with gestational hypertension (hypertension with urinary mg protein/mmol creatinine ratio <0.3). Methods: GlyFn levels were determined using a POC device and PIGF, sFlt-1 and PAPPA2 levels were determined by immunoassay. Performance was assessed using logistic regression modelling and receiver-operating characteristic (ROC) curves. Classification performance and positive and negative predictive values are reported at specific thresholds. Results: Increased levels of GlyFn, soluble fms-like tyrosine kinase-1 (sFlt-1) and pregnancy-associated placental protein A2 (PAPPA2), and decreased levels of placental growth factor (PlGF) were significantly associated (P < 0.01) with clinically defined PE. Area under the ROC (AUROC) values with 95% confidence intervals were: GlyFn, 0.99 (0.98–0.99); PlGF, 0.96 (0.94–0.98); sFlt-1, 0.86 (0.83–0.89); and PAPPA2, 0.96 (0.94–0.97). Of subjects with GH, 48% were positive for more than two PE biomarkers, and 70% of these delivered preterm. Conclusions: The Lumella™ GlyFn POC test has been validated in a low/middle-income country setting for PE diagnosis and may be a useful adjunctive tool for early identification, appropriate triage, and improved outcomes. Tweetable abstract: The Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.
AB - Objective: To determine the performance of a glycosylated fibronectin (GlyFn) point-of-care (POC) test for pre-eclampsia (PE) in a large Southeast Asian cohort (India) in comparison to previously described biomarkers. Design: A total of 798 pregnant women at ≥20 weeks of gestation were enrolled in a prospective case-control study. Study participants included 469 normotensive women with urinary mg protein/mmol creatinine ratio <0.3, 135 with PE (hypertension with urinary mg protein/mmol creatinine ratio ≥0.3) and 194 with gestational hypertension (hypertension with urinary mg protein/mmol creatinine ratio <0.3). Methods: GlyFn levels were determined using a POC device and PIGF, sFlt-1 and PAPPA2 levels were determined by immunoassay. Performance was assessed using logistic regression modelling and receiver-operating characteristic (ROC) curves. Classification performance and positive and negative predictive values are reported at specific thresholds. Results: Increased levels of GlyFn, soluble fms-like tyrosine kinase-1 (sFlt-1) and pregnancy-associated placental protein A2 (PAPPA2), and decreased levels of placental growth factor (PlGF) were significantly associated (P < 0.01) with clinically defined PE. Area under the ROC (AUROC) values with 95% confidence intervals were: GlyFn, 0.99 (0.98–0.99); PlGF, 0.96 (0.94–0.98); sFlt-1, 0.86 (0.83–0.89); and PAPPA2, 0.96 (0.94–0.97). Of subjects with GH, 48% were positive for more than two PE biomarkers, and 70% of these delivered preterm. Conclusions: The Lumella™ GlyFn POC test has been validated in a low/middle-income country setting for PE diagnosis and may be a useful adjunctive tool for early identification, appropriate triage, and improved outcomes. Tweetable abstract: The Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.
KW - Gestational hypertension
KW - glycosylated fibronectin
KW - point-of-care test
KW - pre-eclampsia
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U2 - 10.1111/1471-0528.16323
DO - 10.1111/1471-0528.16323
M3 - Article
C2 - 32426899
AN - SCOPUS:85095574069
SN - 1470-0328
VL - 127
SP - 1687
EP - 1694
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 13
ER -