Glycosylated fibronectin point-of-care test for diagnosis of pre-eclampsia in a low-resource setting: a prospective Southeast Asian population study.
BJOG
; 127(13): 1687-1694, 2020 12.
Article
in En
| MEDLINE
| ID: mdl-32426899
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 ABSTRACT The Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pre-Eclampsia
/
Fibronectins
/
Point-of-Care Systems
Limits:
Adult
/
Female
/
Humans
/
Pregnancy
Country/Region as subject:
Asia
Language:
En
Journal:
BJOG
Journal subject:
GINECOLOGIA
/
OBSTETRICIA
Year:
2020
Document type:
Article
Affiliation country:
United States