Based on the technology, the global market has been segmented into Chemiluminescence Immunoassay (CLIA), Enzyme Linked Fluorescent Immunoassay
(ELFA), Enzyme Linked Immunosorbent Assay (ELISA), Radioimmunoassay (RIA), and Others.
(NASDAQ: QDEL) has received CE Mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay
analyser for the quantitative determination of total 25-OH vitamin D from serum samples, the company said.
Quidel Corporation has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA) to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay
Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B.
The US Food and Drug Administration revealed on Tuesday that it has granted approval for to healthcare company Oxford Immunotec Inc's Imugen Babesia microti Arrayed Fluorescent Immunoassay
(AFIA) for the detection of antibodies to Babesia microti (B.
The set of tests, known as the Imugen Babesia microti Arrayed Fluorescent Immunoassay
, are not meant to diagnose the disease, the FDA warned.
Fu, "Label-free fluorescent immunoassay
for [Cu.sup.2+] ion detection based on UV degradation of immunocomplex and metal ion chelates," Nanoscale, vol.
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.
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).
Measles antibody was measured by plaque reduction neutralization assay; mumps and rubella immunoglobulin G (IgG) titers were measured by enzyme-linked fluorescent immunoassay
; and varicella IgG was measured using a glycoprotein enzyme-linked immunosorbent assay.
M2 PHARMA-September 4, 2018-Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia 2 Lyme Fluorescent Immunoassay
for Use with Sofia 2 Instrument from Finger-Stick Whole Blood Specimens
pneumoniae Fluorescent Immunoassay
for use with the Sofia Fluorescent Immunoassay
Simultaneous measurement of thyroxine (T4) and thyrotropin (TSH) from newborn dried blood spot specimens using a multiplexed fluorescent immunoassay
. Clin Chem 2000; 46:1422-4.