Chemiluminescence immunoassay is the type of immunoassay employing chemiluminescence. It is sensitive, reliable and widely used in clinical diagnostics. However, traditional chemiluminescence immunoassay have significant drawbacks in point-of-care testing (POCT), such as large equipment footprint, complicated operation, and potential reagent waste. Therefore, single-use chemiluminescence analyzers and kits have been developed, specifically tailored for POCT applications. Microfluidic immunoassay, on the other hand, is the type of immunoassay utilizing the innovative microfluidic technology. Microfluidic immunoassay kits are single-use, and offer sensitive, reliable diagnostic results in a rapid way, which is designed for POCT. Both are excellent technologies for POCT immunoassay, still differences arise in detection performance and ease of use due to their distinct technical principles.

1. Technological Principle

1. Microfluidic immunoassay analyzer and kits precisely control fluid flow within channels or chambers on micrometer (μm) to nanometer (nm) scales through microfluidic technology. With the antibodies pre-coated, the kits can detect antigens in microliter of analyte through antigen-antibody binding, and the signal is read out via an optical sensor in the analyzer.
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3. Single-use chemiluminescence immunoassay (CLIA) is the immunoassay that combines chemiluminescence with immunochemical reactions. CLIA utilizes chemical probes which generate light emission through chemical reaction to detect antigens/antibodies. Single-use CLIA is single-use reagent cartridge prefilled with reagent, buffer, etc, which is designed for point of care testing. 

2. Operational Procedure

1. Microfluidic immunoassay kits: The main reaction reagents are dried and sealed into the microfluidic kits. Because the reagents are in dried form, they remain stable, and each kit is equipped with built-in quality control. As a result, no additional calibration is needed, making it convenient for end users. For JIEZLAB’s microfluidic immunoassay analyzer and kits,  only three steps are needed to perform the test, add 50µL blood sample in, load the kit, run the test. All test results will be available within 12 minutes. Calibration is preprinted on each kit, end users only need to scan the barcode to load the calibration into the analyzer. 
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3. Single-use chemiluminescence immunoassay kits: Liquid chemiluminescence reagents are pre-sealed into the cartridges. Due to the instability of liquid reagents, calibration is required as an additional step for users and consumes additional kits. Additionally, many kits specify plasma or serum as the sample type because whole blood samples will interfere the detection. This results in extra operational steps and eventually a longer detection time.

3.Quantitative Analysis

1. Microfluidic immunoassay kits: When the whole blood sample is applied, plasma is separated and then quantitated for analysis. All process is driven through the centrifuge module in the analyzer. JIEZLAB’s microfluidic immunoassay analyzer uses time resolved fluorescence as detection method. The microfluidic immunoassay kits have plasma separation and quantitation microfluidic structure, meanwhile, the selected biotin and streptavidin system is applied. All above factors contribute to accurate results. 
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3. Single-use chemiluminescence immunoassay kits: When the whole blood sample is applied, it requires Hematocrit (HCT) correction in order to eliminate the variations of individual HCT. Without HCT correction, accurate quantitative results can’t be guaranteed.

4. Application Scenarios

1. Microfluidic immunoassay analyzers are small in size and light in weight, making them portable. They are ideal for primary healthcare units, clinical departments, emergency, and other similar settings.
3. Single-use chemiluminescence immunoassay analyzers are relatively smaller and lighter than traditional chemiluminescence immunoassay analyzers. Although they are not fully portable, they are still designed for point-of-care use.

Both microfluidic immunoassay analyzers and kits, as well as single-use chemiluminescence immunoassay analyzers and kits, can deliver accurate and reliable results. However, in terms of ease of operation and device portability, microfluidic immunoassay analyzers and kits have the advantage.

The comparisons of Microfluidic Immunoassay analyzers and kits from JIEZLAB and Single-Use Chemiluminescence Immunoassay analyzers and kits in the market are outlined: