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

Autor:	Nagalla, SR, Janaki, V, Vijayalakshmi, AR, Chayadevi, K, Pratibha, D, Rao, PV, Sage, KM, Nair‐Schaef, D, Bean, E, Roberts, CT, Gravett, MG, Nagalla, S R, Vijayalakshmi, A R, Rao, P V, Sage, K M, Nair-Schaef, D, Roberts, C T Jr, Gravett, M G
Předmět:	ASIANS POINT-of-care testing PREGNANCY proteins PLACENTAL growth factor PREECLAMPSIA ASIAN studies PREECLAMPSIA diagnosis FIBRONECTINS RESEARCH MEDICAL information storage & retrieval systems RESEARCH methodology CASE-control method EVALUATION research SOUTHEAST Asians MEDICAL care use COMPARATIVE studies CLINICAL medicine RESEARCH funding POVERTY LONGITUDINAL method
Zdroj:	BJOG: An International Journal of Obstetrics & Gynaecology; Dec2020, Vol. 127 Issue 13, p1687-1694, 8p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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