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Fapon's one-stop chemiluminescence immunoassay solution offers the equipment, reagents, and materials required for running efficient and accurate CLIA-based diagnostics.
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Empower Your Clinical Lab With Chemiluminescence Immunoassays

Automated chemiluminescence immunoassays facilitate rapid and accurate detection of target analytes in patient samples, enabling rapid diagnosis and treatment

Fapon Biotech
Published:Aug 15, 2023
|3 min read
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Sandeep K. Vashist, PhD, is the senior global IVD product director at Fapon Biotech. He has held senior management roles in large IVD companies such as Perkin Elmer (IDS), Labsystems Diagnostics, and Bristol Myers Squibb. He has also been chief of the Research Advisory Board at Sensing Self Pte Ltd., Singapore, and advisory board member at Calciscon AG, Switzerland. Vashist invented and pioneered many CE-certified and/or FDA-approved IVD products, devices, and technologies. 

What is a chemiluminescence immunoassay (CLIA)?

CLIA is a widely used assay formats that detects a chemiluminescence light signal resulting from an antibody-antigen interaction. To begin the process, magnetic beads are linked to a capture antibody that binds the target antigen. Then, a detection antibody conjugated to a chemiluminescent label binds to the target antigen. When the trigger solutions are added, the resulting chemiluminescent signal confirms the presence of the target antigen. This is the sandwich immunoassay format of CLIA. But for the detection of small molecules, a competitive immunoassay format of CLIA is used where the CLIA label-bound competitor competes with the specific target antigen for binding to the capture antibody-bound magnetic beads. Therefore, CLIA can detect biomarkers in a patient sample that enables reliable diagnosis for a wide range of diseases.

What are the clinical applications of CLIA?

Fapon has developed over 80 different CLIA tests for various clinical applications. These tests can be used in healthcare facilities to detect and monitor cancers, endocrinological conditions, fertility biomarkers, autoimmune disorders, and infectious diseases.

What are the advantages of equipment like the Fapon CLIA Analyzer Shine i8000/9000 in the clinical lab?

The high throughput of the analyzer is beneficial for the clinical lab for rapid and reliable clinical diagnosis. Each machine can handle approximately 900 tests per hour, and four different units can be combined to give a throughput of ~3,600 tests per hour.

The results are also highly reproducible. The CLIA Analyzer Shine i8000/9000 doesn’t require extensive maintenance, which limits variation between users or assays. Fapon employs hydrophilic acridinium ester as the chemiluminescent label, which has a high quantum yield. 

Fapon advertises a “one-stop-solution.” What does this mean for clinical labs?

Think of the “one-stop solution” like a supermarket where you can get everything from bread to eggs. Fapon ’s one-stop solution offers all equipment, materials, and reagents, which is needed for CLIA development and testing. However, labs can also use their raw materials and reagents, if they prefer. The setup is compatible with all CLIA materials, allowing clinical labs to use materials they already have and only purchase the additional necessary components. This is hugely empowering for the smaller labs that might not have access to certain equipment or reagents and choose to supplement with Fapon’s equipment. It also supports lab-developed tests, which are developed by clinical scientists in a clinical diagnostic lab.

What future applications of CLIA excite you the most?

The addition of artificial intelligence (AI) and lab automation to CLIA is very exciting, in my opinion. We are working on a wide range of diseases, providing raw materials and reagents to hundreds of IVD partners worldwide, who are working in the fields of allergy, sepsis, infectious disease, and autoimmunity, among others. These topics are complex and the combination of CLIA and AI is advancing the development of more effective clinical diagnostic algorithms and the discovery of better biomarkers. The interest in these fields is high—and it is only getting higher.