Background: The ratio of the antiangiogenic factor, soluble fms-like tyrosine kinase 1 (sFlt-1), to the proangiogenic factor, placental growth factor (PlGF), is associated with increased risk of preeclampsia. Here, we describe an analytical evaluation of the Elecsys sFlt-1 and PlGF assays at the first North American site in which they were clinically implemented.
Methods: The analytical evaluation included short- and long-term imprecision, method comparison, accuracy, linearity, sample stability, limit of quantification verification, and measurement uncertainty. Quality indicators were also evaluated, including turnaround time and repeat test frequency.
Results: Short-term (13-day) and long-term (12-month) imprecision for sFlt-1 and PlGF were <4% CV. Method comparison (n = 40) between Roche cobas e602 and e411 exhibited r > 0.99 and bias <10%. sFlt-1/PlGF ratio rule-out cutoffs (≤33 and ≤38) and rule-in cutoffs (>38, >85, and >110) exhibited negative percent agreement and positive percent agreement of 100%, respectively (n = 40). During the first 12 months, 257 orders were placed, repeat test frequency was 17.5%, mean time between repeat orders was 23 days, and 72.0% of results were reported within 2 h from sample receipt when quality control was run continuously.
Conclusions: We describe analytical performance parameters and quality indicators of the Elecsys sFlt-1 and PlGF assays, which was the first North American clinical laboratory site to implement these assays in support of the institution's high-risk obstetrical unit.
Keywords: PlGF; preeclampsia; pregnancy; sFlt-1.
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