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This Medical Device Standard Has Been Officially Implemented
ALLSHENG Release time:2025-08-06 ALLSHENG Source: ALLSHENG Pageviews:131

"Test for Bacterial Endotoxins of Medical Devices-Recombinant Factor C Method" (YY/T1939-2024) has been officially implemented recently.


Advantages of the Recombinant Factor C Method

At present, gel method and photometry assay are two of the most important test methods for bacterial endotoxin test of medical devices. This method has high sensitivity, specificity, accuracy and economy. However, this method needs to use a large amount of horseshoe crab blood to produce reagents, and Chinese horseshoe crab has become a secondary protected animal in China. Therefore, continuing to promote the use of gel method and photometry method is not conducive to the protection and development of horseshoe crab resources. The recombinant factor C method is a supplementary method to bacterial endotoxin testing. The promotion and use of this method can protect the ecological environment and slow down the depletion rate of horseshoe crab resources. Moreover, this method does not have factor G bypass interference and has high specificity.


Test Principle

The recombinant factor C method is for determining endotoxin content by utilizing the fluorescence signal changes during the reaction between recombinant factor C reagents and endotoxins. Recombinant factor C binds to bacterial endotoxins and is activated, transforming from inactive proteasomes to biologically active proteases that recognize and catalyze downstream fluorescent substrates to produce fluorescence signals. The intensity of the fluorescence signal is proportional to the concentration of endotoxins. Measure the fluorescence values of the recombinant factor C reagent and the test sample solution before and after incubation, and calibrate them. Calculate the bacterial endotoxin content in the test sample using a standard curve.


Major Equipments

Fluorescence microplate reader or multi-mode microplate reader, electric drying oven, vortex mixer, etc.


How to Use Feyond-F100 Fluorescence Microplate Reader to Detect Recombinant Factor C Endotoxins

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