C-Reactive Protein Concentration, 1 x 96 Assays

FOR RESEARCH USE ONLY.

Product Name: C-Reactive Protein Concentration

Sample Type: Serum

# of Samples: 1X96 Assays

Intended Use: The hsCRP ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases

Principles of the assay: The hsCRP ELISA is based on the principle of a solid phase enzyme-linked immunosorbent assay.24 The assay system utilizes a unique monoclonal antibody directed against a distinct antigenic determinant on the on the CRP molecule. This mouse monoclonal anti-CRP antibody is used for solid phase immobilization (on the microtiter wells). A goat anti-CRP antibody is in the antibody-enzyme (horseradish peroxidase) conjugate solution. The test sample is allowed to react simultaneously with the two antibodies, resulting in the CRP molecules being sandwiched between the solid phase and enzyme-linked antibodies. After a 45-minute incubation at room temperature, the wells are washed with water to remove unbound labeled antibodies. A tetramethylbenzidine (TMB) reagent is added and incubated for 20 minutes, resulting in the development of blue color. The color development is stopped with the addition of 1N HCl changing the color to yellow. The concentration of CRP is directly proportional the color intensity of the test sample. Absorbance is measured spectrophotometrically at 450 nm.

Summary and Explanation of Test:  Storage and Stability: 1. Store the unopened kit at 2-8C upon receipt and when it is not in use, until the expiration shown on the kit label. Refer to the package label for the expiration date.
2. Keep microtiter plate in a sealed bag with desiccant to minimize exposure to damp air.

Storage and Stability: 1. Store the unopened kit at 2-8C upon receipt and when it is not in use, until the expiration shown on the kit label. Refer to the package label for the expiration date.
2. Keep microtiter plate in a sealed bag with desiccant to minimize exposure to damp air.

Limitation of the Test: 1. Reliable and reproducible results will be obtained when the assay procedure is carried out with a complete understanding of the package insert instructions and with adherence to good laboratory practice.
2. The results obtained from the use of this kit should be used only as an adjunct to other diagnostic procedures and information available to the physician.
3. Serum samples demonstrating gross lipemia, gross hemolysis, or turbidity should not be used with this test.
4. The wash procedure is critical. Insufficient washing will result in poor precision and falsely elevated absorbance readings.
5. Patient samples may contain human anti-mouse antibodies (HAMA) that are capable of giving falsely elevated or depressed results with assays that utilize mouse monoclonal antibodies. This assay has been designed to minimize interference from HAMA-containing specimens. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution.