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Immunoassays for the in vitro quantitative determination of the soluble fms like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio in human serum. The sFlt-1/PlGF ratio is indicated as an aid in the risk assessment of pregnant women, with a singleton pregnancy (23+0 to 34+6/7 weeks' gestation) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension), to develop preeclampsia with severe features within two weeks from testing. The sFit-1/PlGF ratio should be used in conjunction with clinical assessment and routine laboratory testing. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The Elecsys sFlt-1 and Elecsys PlGF assays employ a sandwich principle using electrochemiluminescence immunoassay "ECLIA" technology. The total duration of each assay is 18 minutes. Samples are incubated with biotinylated and ruthenium-labeled monoclonal antibodies specific to sFlt-1 or PlGF, forming a sandwich complex. Streptavidin-coated microparticles are added, binding the complex to the solid phase. The microparticles are magnetically captured, unbound substances are removed, and a voltage is applied to induce chemiluminescent emission, which is measured by a photomultiplier. Results are determined via a calibration curve generated by 2-point calibration and a master curve provided via the reagent barcode. The reagents for each assay are combined in a "rackpack".

The B.R.A.H.M.STM sFlt-1/PIGF KRYPTORTM Test System is comprised of the B . R . H . M S PIGF plus KRYPTOR assay and the B . A . H . M . S sFit-1 KRYPTOR assay. The B R . A . H . M . S PIGF plus KRYPTOR is an automated immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE™) technology for the quantitative determination of the concentration of Placental Growth Factor (PIGF) in human serum and plasma (K2 EDTA) on the B.R.A.H.M.S KRYPTOR analyzer. The B · A · H · M · S s F t - 1 K R PTOR is an automated immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology for the quantitative determination of the concentration of soluble fms-like tyrosine kinase-1 (sFit-1), also known as VEGF receptor-1, in human serum and plasma (K2 EDTA) on the B.R.A.H:M:S KRYPTOR analyzer. The B · A · H · M · S PIGF plus KRYPTOR is to be used in conjunction with the B · A · M · S sFlt-1 KRYPTOR along with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women (singleton pregnancies between gestational age 23+0 to 34+6/7weeks) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension) for progression to preeclampsia with severe features (as defined by American College of Obstetricians and Gynecologists (ACOG) guidelines) within 2 weeks of presentation.

The B · A · H · M · S · F · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · PIGF plus KRYPTOR assay and the B.R.A.H.M.S sFlt-1 KRYPTOR assay. B R . A H M . S PIGF plus KRYPTOR and B . R . H . M . STM sFit-1 KRYPTOR assays are supplied as two reagent kits that are run on the B-R-A-H-M-S KRYPTOR compact PLUS. Each kit is sufficient for 75 determinations, and is comprised of two bottled reagents: PIGF Cryptate conjugate: Lumi4®-Tb labeled, anti-human PlGF antibody, buffer, bovine albumin, rat immunoglobulins, bovine immunoglobulins, goat immunoglobulins, trehalose, mannitol. XL conjugate: Cyanin 5.5 labeled, anti-human PlGF antibody, buffer, bovine albumin, rat immunoglobulins, bovine immunoglobulins, goat immunoglobulins. sFlt-1 Cryptate conjugate: Lumi48-Tb labeled, anti-human sFlt-1 antibody, buffer, bovine albumin, bovine immunoglobulins, mouse immunoglobulins, dextran, preservative. XL conjugate: Cyanin 5.5 labeled, anti-human sFlt-1 antibody, buffer, bovine albumin, bovine immunoglobulins, mouse immunoglobulins, dextran, preservative. The B · A · H · M · S KRYPTOR compact PLUS is an automated test platform. The analyzer consumables are: B · R · A · H · M · S KRYPTOR compact Solution 1: ProClinTM 150 Solution B · R · A · H · M · S KRYPTOR compact Solution 2: Potassium fluoride solution B · R · A · H · M · S KRYPTOR compact Solution 3: Active chlorine and sodium hydroxide solution B · R · A · H · M · S KRYPTOR compact Solution 4: Sodium hydroxide solution B · R · A · H · M · S KRYPTOR BUFFER: Phosphate Buffer Saline B · R · A · H · M · S KRYPTOR compact REACT: 60 plates Also supplied and required are calibrators - single level B.R.A.H.M.S PIGF plus KRYPTOR CAL and two levels B. R. A. H. M.S sFlt-1 KRYPTOR CAL. The instrument is calibrated on a 15 day cycle, and re-calibrated with each new lot of reagents. Also supplied and required are three levels of controls - B.R.A.H.M.S PIGF plus KRYPTOR OC Controls and B.R.A.H.M.S sFlt-1 KRYPTOR OC.