Microtiter plate assays
IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests. Get in touch to order our products or request more information.
Sphingotest® penKid®and sphingotest® bio-ADM® are CE IVD marked and are intended for the in vitro quantitative determination of Proenkephalin A 119-159 (penKid) and bioactive Adrenomedullin 1-52 (bio-ADM) in human EDTA plasma. The assays are designed for professional use only and may be used in central hospital laboratories. The results of sphingotest® penKid® and sphingotest® bio-ADM® should be evaluated and interpreted in conjunction with the patient’s medical history, symptoms, and other clinical information. Sphingotest® penKid® and sphingotest® bio-ADM® are CE IVD-marked and hence certified and approved for use in the European Economic Area (EEA) only. Human diagnostic use of such products may be subject to local regulations. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product based on the SphingoTec microtiter plate (sphingotest®) as IVD product in the United States of America or Canada. No product based on the SphingoTec microtiter plate technology is currently available for sale as an IVD product in the United States of America or Canada. The analytical and clinical performance characteristics in compliance with U.S. FDA medical device regulations of any product that may be sold at some future point in time in the U.S. have not yet been established.