French diagnostics firm Sebia said Thursday that it has received US Food and Drug Administration 510(k) clearance for its FLC Kappa and Lambda assays.
If Chinese chemiluminescence would eventually replace imported products completely, it must ensure the accuracy and reliability of the test results. In addition to the improvement of equipment system and methodology, the accuracy of results will involve two very core competitions in the future.
The analyzer will develop in two directions as per different customer needs and application scenarios.
Immunoassay is the largest subdivision in in vitro diagnosis and is in rapid develop-ment, in which chemiluminescence has gradually replaced enzyme-linked immuno-sorbent assay as the mainstream immune diagnosis in China.
DiaSorin on Thursday said it has submitted for US Food and Drug Administration approval an immunoassay for the early identification of Lyme disease.
Roche announced on Tuesday that it has received CE marking for a claim extension on its Elecsys Anti-Müllerian Hormone (AMH) Plus test.
The immunoassay method involves the widest range of items among all fields of medical detection; with the development of biomedical research, especially genomics and post-genomics results (high-resolution two-dimensional electrophoresis combined with mass spectrometry) which highly promote the research on disease-related markers, more and more items will be detected via immunoassay in the medical practice.
Rapid test maker Hangzhou Clongene Biotech and diagnostics product distributor Gold Colloid on Friday said they inked a deal to distribute Clongene's in vitro diagnostics products in the US.
Chemiluminescence immunoassay reagent has become the mainstream product in the field of immunoassay and is widely used in clinical in vitro diagnosis due to its advantages such as high sensitivity, good specificity, a wide range of measurements, high degree of supporting automation, and excellent precision and accuracy.
There are multiple classification criteria for immunodiagnostic techniques, the most commonly used of which are classified into labeled immunoassays and non-labeled immunoassays according to whether they are labeled or not.
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