Elecsys® and Kryptor immunoassays for the measurement of sFlt-1 and PlGF to aid preeclampsia diagnosis: are they comparable?
Adult
Algorithms
Biomarkers
/ blood
Case-Control Studies
Female
Gestational Age
HELLP Syndrome
/ diagnosis
Humans
Immunoassay
/ methods
Placenta Growth Factor
/ analysis
Pre-Eclampsia
/ diagnosis
Pregnancy
Research Design
Sensitivity and Specificity
Vascular Endothelial Growth Factor A
/ blood
Vascular Endothelial Growth Factor Receptor-1
/ analysis
immunoassay
preeclampsia
sFlt-1/PlGF
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
27 08 2019
27 08 2019
Historique:
received:
16
11
2018
accepted:
28
02
2019
pubmed:
20
7
2019
medline:
5
8
2020
entrez:
20
7
2019
Statut:
ppublish
Résumé
Background For pregnant women with suspected preeclampsia, the soluble fms-like tyrosine-kinase 1 (sFlt-1)/placental growth factor (PlGF) ratio is a biomarker to aid diagnosis. We performed method comparisons between Elecsys® and Kryptor sFlt-1 and PlGF immunoassays and assessed the diagnostic performance for preeclampsia. Methods Serum samples from a case-control study involving 113 pregnant women with preeclampsia/elevated liver enzymes and low platelet count (HELLP) and 270 controls were analyzed. sFlt-1 and PlGF were measured using Roche Elecsys® and BRAHMS Kryptor sFlt-1/PlGF immunoassays. The sFlt-1/PlGF ratios were calculated, and Passing-Bablok regression/Bland-Altman plots were performed. Gestation-specific cut-offs, ≤33 and ≥85/≥110, were assessed. Results Mean (±2 standard deviation [SD]) differences between the Elecsys® and Kryptor values were: sFlt-1, 173.13 pg/mL (6237.66, -5891.40); PlGF, -102.71 pg/mL (186.06, -391.48); and sFlt-1/PlGF, 151.74 (1085.11, -781.63). The Elecsys® and Kryptor immunoassays showed high correlation: Pearson's correlation coefficients were 0.913 (sFlt-1) and 0.945 (PlGF). Slopes were 1.06 (sFlt-1) and 0.79 (PlGF), resulting in ~20% lower values for Kryptor PlGF. Sensitivities and specificities using the sFlt-1/PlGF ≥85 cut-off for early-onset preeclampsia (20 + 0 to 33 + 6 weeks) were 88.1%/100.0% (Elecsys®) and 90.5%/96.2% (Kryptor), respectively, and using the ≥110 cut-off for late-onset preeclampsia (≥34 + 0 weeks) were 51.3%/96.5% (Elecsys®) and 78.9%/90.1% (Kryptor), respectively. Using Elecsys® and Kryptor sFlt-1/PlGF, 0% and 3.8% of women, respectively, were falsely ruled-in for early-onset, and 3.5% and 9.9%, respectively, for late-onset preeclampsia. Conclusions Despite high correlation between the Elecsys® and Kryptor immunoassays, we observed significant differences between sFlt-1/PlGF and PlGF results. Therefore, sFlt-1/PlGF cut-offs validated for Elecsys® immunoassays are not transferable to Kryptor immunoassays.
Identifiants
pubmed: 31323000
doi: 10.1515/cclm-2018-1228
pii: cclm-2018-1228
doi:
Substances chimiques
Biomarkers
0
PGF protein, human
0
Vascular Endothelial Growth Factor A
0
Placenta Growth Factor
144589-93-5
FLT1 protein, human
EC 2.7.10.1
Vascular Endothelial Growth Factor Receptor-1
EC 2.7.10.1
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1339-1348Commentaires et corrections
Type : CommentIn
Références
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