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A new instant A1c kit was approved by the FDA
Filed in archive Diagnostics by kevin on July 27, 2005
afinion.jpg


A new instant hemoglobin A1c test was approved by the FDA, giving results in 3 minutes (which is the fastest time on the market):
The company, which has headquarters in Dundee and Oslo, said the US Food and Drug Administration had granted marketing clearance for the multitest Afinion system and an HbA1c haemoglobin test, one of several tests Afinion is used for.
The devices itself allow doctors to carry out blood tests in surgeries to provide so-called point of care checks, without the need to send samples to a laboratory.
The HbA1c kit, axis's first to be tested in the US, helps to monitor the crucial long-term control of blood glucose levels in diabetes patients and takes roughly half the time of rival tests Ö although often blood samples are sent to laboratories and weeks can pass before the results are returned to patient.
I find these instant results helpful during an office visit, since we can talk about the results right away. More information can be found here. (Smith, "Axis shares soar on US approval for Afinion device", The Herald, Jul.28)

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