Alpha Dx system

Alpha Dx™ system

A panel of rapid tests for quantifying markers of acute MI, which measured myoglobin, CK, CK-MB and troponin I.
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Specimens from 166 apparently healthy individuals (68 males and 98 females) were used to estimate the reference interval for all four markers evaluated on the FM Alpha Dx system, including myoglobin, CKMB mass, cTnI, and total CK mass.
Whole blood specimens were analyzed within 30 min of collection on the Alpha Dx system. Paired serum specimens (frozen at below -20[degrees]C) were analyzed for each cardiac marker for comparison in the central laboratory at each of the four participating institutions on the following analyzers (diagnostic decision cutoffs): Dade Stratus II myoglobin (110 [micro]g/L); Dade Stratus II CKMB (7.0 [micro]g/L); Dade Stratus II cTnI (1.5 [micro]g/L) or Beckman Access cTnI (0.15 [micro]g/L); Ortho Clinical Diagnostics Vitros total CK (men, 300 U/L; women, 200 U/L).
The Alpha Dx System, a fluorescence immunoassay platform that integrates automated solid-phase sandwich immunoassay capabilities with fluorescence detection, provides quantitative measurement of four cardiac markers: myoglobin, total CK mass, CKMB mass, and cTnI (11).