In Vitro Diagnostic Industry in China - Immunoassay VI

4    Representative Products

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. The non-labeled include latex particle-enhanced turbidimetric immunoassay; and the labeled include enzyme-linked immunosorbent assay, time-resolved fluoroimmunoassay, colloidal gold technique, and chemiluminescence immunoassay. From the development and application of immunological techniques, labeled immunoassay has become the mainstream.

4.1 Main China-Made Automatic Chemiluminescence Immunoanalyzers

Classical immunoassay techniques included immunological precipitation, immunological agglutination, and complement fixation. At present, immunological agglutination and immunological precipitation are still applied in clinical laboratories. 

Distribution of Automatic Chemiluminescence Immunoanalyzer Manufacturers

There are 126 registered manufacturers of automatic chemiluminescence immuno-analyzers according to statistics of the National Medical Products Administration (NMPA) by December 2023, which may not be exhaustive since some manufacturers provides open chemiluminescence detection systems. Most of the manufacturers adopt magnetic particle-based chemiluminescence immunoassay. Regionally, chemiluminescence immunoassay manufacturers are distributed in the Pearl River Delta Region. If counted by cities, Shenzhen and Beijing gather the most manufacturers, including 19 and 12 automatic chemiluminescence immunoanalyzer manufacturers respectively. 

Distribution of Stand-Alone Detection Speeds of Main Automatic Chemiluminescence Immunoanalyzers

Different customers have different requirements for automatic chemiluminescence immunoanalyzers. The detection speed, reagent position, sample position, and intelligence level are all the main considerations when the customers choose an immunoanalyzer. So far, the automatic chemiluminescence immunoanalyzers made in China may provide stand-alone detection speeds covering LOW (≤ 100 tests/h), MEDIUM (100-180 tests/h), MEDIUM-HIGH (180-280 tests/h), and HIGH (≥ 300 tests/h), basically meeting the needs of different customers. 

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