INTENDED USE

This product is a C-Reactive Protein (CRP) / Serum Amyloid A (SAA) fluorescent immunochromatographic assay UNCUT SHEET (semi-finished product). It is NOT a final finished reagent and CANNOT be used directly for clinical sample testing.

This UNCUT SHEET must undergo subsequent processing steps, including cutting and card assembly, to be manufactured into CRP/SAA combined test cards (finished reagent kit). Only after such processing may it be used in conjunction with a compatible fluorescence immunoassay analyzer for the in vitro quantitative detection of C-Reactive Protein (CRP) and Serum Amyloid A (SAA) in human serum, plasma, or whole blood samples.

Clinically, the combined detection of CRP and SAA is primarily intended for the auxiliary diagnosis and differential diagnosis of infectious diseases: when both SAA and CRP are elevated, bacterial infection is suggested; when SAA is elevated while CRP is not elevated or only mildly elevated, viral infection is suggested. Combined detection can improve the sensitivity and specificity for differentiating bacterial from viral infections, and is helpful for guiding rational clinical medication and therapeutic monitoring.

This UNCUT SHEET is intended solely for internal use by the manufacturer. It shall not be registered, sold, or used clinically as an independent medical device, and shall not be used directly for human sample testing.