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MagPix unreliable, but regulatory approval for GPP - how?
editThose that have a Luminex machine, like the MagPix, are well aware of the unreliability of the Luminex machines. Very high maintenance and downtime. At same time, results can be very unreliable and unpredictably wrong. I estimate serious malfunctions at the rate of at least 2 per microtiter plate. The Luminex instruments are so far only used in basic research for screening large numbers of analytes for candidate marker screening because it is possible to get through 50 or so analytes in 60-70 ul of plasma, etc. Once analytes are identified, very common to switch to more reliable systems like ELISA. Luminex states that it seeks regulatory approval and CE mark for the GPP assay. I work in gastro research myself and see no chance anyone would use this for diagnosing an actual patient. Does anyone know how Luminex could manage to get a CE mark and regulatory approval? — Preceding unsigned comment added by 79.102.182.59 (talk) 08:39, 10 November 2013