With the application of the latex-enhanced immunoturbidimetry and the enzyme immunoassay amplification, the sensitivity of biochemical test items is greatly improved. Representative products applied in the biochemical technology platform in 2019-2020 are as follows:

QuidelOrtho announced Wednesday that it has received approval from Health Canada to market the firm's Triage PLGF test. The test detects a biomarker that can indicate the likelihood of a pregnant person developing preterm preeclampsia.

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.