Chemiluminescence immunoassay (CLIA)
Antigen–antibody detection read by light emission, replacing ELISA, radioimmunoassay and fluorescence immunoassay with higher sensitivity — China's domestic instruments and reagents reached commercial scale by 2024 in over 700 medical institutions.
1 · What it gives
Chemiluminescence immunoassay combines specific antigen–antibody binding with chemiluminescence to detect biomarkers in samples. It replaces ELISA, radioimmunoassay and fluorescence immunoassay thanks to superior sensitivity and specificity. Domestic Chinese CLIA instruments and reagents reached commercial scale by 2024, used in over 700 medical institutions.
2 · What it replaces 6
3 · How to implement 3 steps
- 1BindBind the biomarker with a specific antibody.
- 2Emit lightTrigger the chemiluminescent label.
- 3ReadRead the light signal as the biomarker level.
4 · Who delivers
Matched suppliers (matched automatically)
| Shield Biological Projects | Israel | Producer | active |
| BM GreenTech Berhad | Malaysia | Research / RTO | active |
| Asia Biogas | Indonesia | Services / consulting | active |
| Changzhou Ding En Biodegradable Material Co., Ltd. | China | Producer | active |
| Hebi Renyuan Biotech Devp. Co.,Ltd | China | Producer | active |
| Jiangsu Jland Biotech | China | Producer | active |
| Yara | Norway | Producer | active |
| Abbott Laboratories | United States | Producer | active |
| Becton Dickinson | United States | Producer | active |
| Cryoport Systems | United States | Producer | active |
| Envirotainer | Sweden | Producer | active |
| GE HealthCare Technologies | United States | Producer | active |
Leading companies and institutes (from the brief)
Roche Diagnostics and Meso Scale Discovery are named as major companies commercialising electrochemiluminescence immunoassays. Others are matched by the portal under Diagnostics.
5 · Rules & route to market
state registration ~10-15 working days after expert assessment; new substances need notification
Information, not legal advice — confirm the procedure for your product. (2026-10-06)
United States
The sources reviewed on 2026-10-16 identified no the US regulator or standard specific to this technology. Treat the route as case-by-case and ask for a check.
European Union
The sources reviewed on 2026-10-16 identified no the EU regulator or standard specific to this technology. Treat the route as case-by-case and ask for a check.
China
In China, CLIA devices follow guidelines including GB/T 42062 (risk management) and YY/T 0664 (software safety).
6 · Money: tenders & grants
7 · Tech stack & innovations
Main risks from the sources (for ECL-based systems): high toxicity and poor biocompatibility of some systems, and possible electrical damage to samples from high voltage.
Sources 5
- Dxhx.pku.edu.cn — www.dxhx.pku.edu.cn 2026-10-16
- Zgsy.cbpt.cnki.net — zgsy.cbpt.cnki.net 2026-10-16
- Pubs.rsc.org — pubs.rsc.org 2026-10-16
- Caivd org.cn — www.caivd-org.cn 2026-10-16
- Kjt.fujian.gov.cn — kjt.fujian.gov.cn 2026-10-16