Glycosylated fibronectin point‐of‐care test for diagnosis of pre‐eclampsia in a low‐resource setting: a prospective Southeast Asian population study

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 p...

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Vydané v:	BJOG : an international journal of obstetrics and gynaecology Ročník 127; číslo 13; s. 1687 - 1694
Hlavní autori:	Nagalla, SR, Janaki, V, Vijayalakshmi, AR, Chayadevi, K, Pratibha, D, Rao, PV, Sage, KM, Nair‐Schaef, D, Bean, E, Roberts, CT, Gravett, MG
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	England Wiley Subscription Services, Inc 01.12.2020 John Wiley and Sons Inc
Predmet:	Adult Biomarkers Case-Control Studies Cohort Studies Creatinine Diagnosis Eclampsia Female Fibronectin Fibronectins - blood Gestation Gestational hypertension Glycation End Products, Advanced glycosylated fibronectin Health Resources Humans Hypertension India Maternal Medicine Medical diagnosis Placenta Point of care testing Point-of-Care Systems point‐of‐care test Population studies Population-based studies Poverty Pre-Eclampsia - blood Pre-Eclampsia - diagnosis Preeclampsia Pregnancy pre‐eclampsia Prospective Studies Protein-tyrosine kinase Proteins Young Adult India pre-eclampsia Gestational hypertension point-of-care test glycosylated fibronectin
ISSN:	1470-0328, 1471-0528, 1471-0528
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Abstract	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 The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. Tweetable The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.
AbstractList	The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. 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.OBJECTIVETo 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.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).DESIGNA 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).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.METHODSGlyFn 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.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.RESULTSIncreased 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.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.CONCLUSIONSThe 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.The Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.TWEETABLE ABSTRACTThe Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. 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 The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. Tweetable The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. ObjectiveTo 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.DesignA 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).MethodsGlyFn 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.ResultsIncreased 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.ConclusionsThe 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 abstractThe Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. 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. 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). 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. 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. 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. The Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.
Author	Vijayalakshmi, AR Chayadevi, K Roberts, CT Nagalla, SR Sage, KM Gravett, MG Janaki, V Pratibha, D Nair‐Schaef, D Rao, PV Bean, E
AuthorAffiliation	1 DiabetOmics, Inc. Hillsboro OR USA 4 Ramdevrao Hospital Hyderabad India 3 Department of Obstetrics and Gynaecology Mallareddy Institute of Medical Sciences Hyderabad India 5 Department of Obstetrics and Gynecology University of Washington Seattle WA USA 2 Department of Obstetrics and Gynaecology Osmania Medical College Hyderabad India
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Keywords	pre-eclampsia Gestational hypertension point-of-care test glycosylated fibronectin
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Snippet	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... The Lumella™ point‐of‐care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. 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... ObjectiveTo determine the performance of a glycosylated fibronectin (GlyFn) point‐of‐care (POC) test for pre‐eclampsia (PE) in a large Southeast Asian cohort...
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SubjectTerms	Adult Biomarkers Case-Control Studies Cohort Studies Creatinine Diagnosis Eclampsia Female Fibronectin Fibronectins - blood Gestation Gestational hypertension Glycation End Products, Advanced glycosylated fibronectin Health Resources Humans Hypertension India Maternal Medicine Medical diagnosis Placenta Point of care testing Point-of-Care Systems point‐of‐care test Population studies Population-based studies Poverty Pre-Eclampsia - blood Pre-Eclampsia - diagnosis Preeclampsia Pregnancy pre‐eclampsia Prospective Studies Protein-tyrosine kinase Proteins Young Adult
Title	Glycosylated fibronectin point‐of‐care test for diagnosis of pre‐eclampsia in a low‐resource setting: a prospective Southeast Asian population study
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