Quidel Gets FDA Approval for Sofia(R) hCG Fluorescent Immunoassay
He managed the development of the recently FDA-cleared and CLIA-waived Sofia[R] Fluorescent Immunoassay
system with the associated Influenza A+B assay and is currently managing the development of a series of follow-on assays for the Sofia system.
Simultaneous measurement of thyroxine (T4) and thyrotropin (TSH) from newborn dried blood spot specimens using a multiplexed fluorescent immunoassay
In addition, although almost all of the participants using immunoassays with a cutoff of 300 ng/mL detected the opiate hydromorphone at 1000 ng/mL, the many laboratories that used fluorescent immunoassay
(FIA) and microparticle immunoassay (kinetic interaction of microparticles in solution) did not (UDS-A 2003) (Table 2).
Smaller labs still opt for fluorescent immunoassay
(FIA) systems or semi-automated CLIA systems.
Work is underway on developing cardiac markers with preliminary data demonstrating that myoglobin at 100ng/ml can be detected by the system using a fluorescent immunoassay
Simultaneous measurement of thyroxine (T,) and thyrotropin (TSH) from newborn dried blood spot specimens using a multiplexed fluorescent immunoassay
Carter-Wallace also markets enzyme and fluorescent immunoassay
tests to detect a broad range of infectious and autoimmune diseases.
IMMUNOASSAYS 9ENZYME IMMUNOASSAYS 10TABLE 1 ADVANTAGES OF ENZYME IMMUNOASSAY 10TABLE 2 LIMITATIONS OF ENZYME IMMUNOASSAY 11FLUORESCENT IMMUNOASSAYS 11TABLE 3 ADVANTAGES OF FLUORESCENT IMMUNOASSAY
11TABLE 4 LIMITATIONS OF FLUORESCENT IMMUNOASSAY
12IMMUNOASSAY TECHNOLOGIES 12DISPOSABLE MATRIX DEVICES 13Handheld Immunochromatographic Assays (HHAs) 13BTA Test Strips 13Sensitive Membrane Antigen Rapid Test (SMART) 13REAGENT TAG BIOSENSOR APPROACHES 14NO-TAG REAGENT BIOSENSOR METHODS 14RADIOISOTOPES 15TABLE 5 ADVANTAGES OF RADIOISOTOPES 15TABLE 6 LIMITATIONS OF RADIOISOTOPES 15
157Quidel 159Recent Key Events 159Sofia Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay
The global Immunoassays Market, by technology, is further segmented into enzyme immunoassays, fluorescent immunoassays
, chemiluminescence immunoassays, radioimmunoassays, and others.
In 2001, Bio-Rad introduced the Bio-Plex Protein Array System for fluorescent immunoassays
based on Luminex technology.