Clearance for point-of-care haemoglobin analyser
EKF Diagnostics has announced US Food and Drug Administration (FDA) clearance for its hand-held, reagent-free haemoglobin analyser, the DiaSpect Tm, for use in point-of-care (POC) testing.
The DiaSpect Tm provides users with accurate haemoglobin measurements (precision: CV ≤1%) within two seconds of its whole blood-filled cuvette being inserted for analysis. This ensures immediate and robust haemoglobin results for patient health checks and anaemia screening at the point of care.
Based on its FDA categorisation, DiaSpect Tm can be used in various settings, as well as by a wide range of healthcare personnel. It is user-friendly and requiries minimal training. The user simply collects a capillary or venous blood sample of 10 µL in the cuvette before inserting into the analyser. Also making it simple for POC testing use, DiaSpect Tm is factory calibrated against the HiCN reference method in accordance with the International Council for Standardization in Haematology (ICSH). It is ‘always on’ and ready to use, with no re-calibration or maintenance necessary.