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The Wampole HS-CRP ELISA is an in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) intended for the quantitative measurement of C-reactive protein (CRP) levels in human serum and plasma. CRP measurements aid in the evaluation of the extent of injury to body tissues.

The Wampole™ HS-CRP ELISA is a Class II in vitro medical diagnostic device that utilizes conventional enzyme-linked immunosorbent assay technology to quantitatively measure the level of C-reactive protein (CRP) in a serum or plasma specimen. The assay kit consists of plastic microwell strips, containing adsorbed monoclonal anti-CRP antibody. CRP in the specimen is captured by the immobilized antibody, forming immobilized immune complexes. After washing away excess specimen, polyclonal anti-CRP antibody that has been conjugated to horseradish peroxidase is added, forming a "sandwich" of monoclonal antibody, CRP antigen, and conjugated polyclonal antibody. After washing, the immobilized CRP sandwich is exposed to tetremethlybenzidine (TMB), a chromogenic substrate that turns from clear to blue in the presence of peroxidase reaction products. The peroxidase reaction is stopped by the addition of dilute sulfuric acid, which also changes the color of the solution from blue to yellow. The optical density of the yellow end product is directly proportional to the amount of bound CRP antigen, and is quantitated on an ELISA reader at 450 nm. Specimen CRP levels are then determined by interpolation from a standard curve of optical density versus CRP concentration.