Analytical validation of soluble fms-like tyrosine and placental growth factor assays on B·R·A·H·M·S KRYPTOR Compact Plus automated immunoassay platform

•B·R·A·H·M·S KRYPTOR automated immunoassay platform is analytically precise and accurate for sFlt1 and PlGF assays.•The sFlt1 and PlGF assays showed a wide dynamic measuring ranges.•Both sFlt1 and PlGF assays are relatively unaffected by common interferents (lipemia, icterus and hemolysis).•Method c...

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Bibliographic Details
Published in:Pregnancy hypertension 2018-01, Vol.11, p.66-70
Main Authors: Chan, Siaw Li, Rana, Sarosh, Chinthala, Sireesha, Salahuddin, Saira, Yeo, Kiang-Teck J.
Format: Article
Language:English
Subjects:
Analytical validation
Automation, Laboratory
Biomarkers - blood
Equipment Design
Female
Humans
Immunoassay - instrumentation
Immunoassay - methods
Limit of Detection
Placenta Growth Factor - blood
PlGF
Pre-Eclampsia - blood
Pre-Eclampsia - diagnosis
Predictive Value of Tests
Preeclampsia
Pregnancy
Reproducibility of Results
sFlt1
Vascular Endothelial Growth Factor Receptor-1 - blood
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Summary:•B·R·A·H·M·S KRYPTOR automated immunoassay platform is analytically precise and accurate for sFlt1 and PlGF assays.•The sFlt1 and PlGF assays showed a wide dynamic measuring ranges.•Both sFlt1 and PlGF assays are relatively unaffected by common interferents (lipemia, icterus and hemolysis).•Method comparison of sFlt1/PlGF ratio ran on identical platform showed excellent correlation. Preeclampsia is one of the leading hypertensive disorders of pregnancy. Angiogenic biomarkers such as anti-angiogenic factor soluble fms-like tyrosine kinase 1 (sFlt1) and pro-angiogenic factor placental growth factor (PlGF) are involved in the pathophysiology of preeclampsia. The aim of this study is to validate the analytical performance of sFlt1 and PlGF on the B·R·A·H·M·S KRYPTOR Compact Plus (ThermoFisher Scientific). We examined K2-EDTA plasma samples from 50 patients on B·R·A·H·M·S KRYPTOR Compact Plus, an automated immunoassay platform. QC materials were used to assess intra- and inter-precision of the assay. Lower limit of quantitation and interference studies were determined using pooled patient plasma. The sFlt1 and PlGF assays demonstrated an analytical measuring range of 90–69,000 pg/mL and 11–7000 pg/mL, respectively (r2 > 0.99). Lower limit of quantitation (20% CV) was interpolated to be 35 pg/mL for sFlt1 and 10 pg/mL for PlGF. Total precision for both assay displayed CVs of
ISSN:2210-7789
2210-7797
DOI:10.1016/j.preghy.2017.12.009