C-Reactive Protein Semi-Quantiative Rapid Test Device

Intended Use

C-Reactive Protein Semi-Quantiative Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of C-Reactive Protein in whole blood, serum or plasma specimens to aid in evaluating risks of cardiovascular disease.

What is the C-Reactive Protein (CRP) Test use for

C-Reactive Protein (CRP) is a marker of acute phase response to inflammatory disorder. CRP measurements have been used for many years in the management of a variety of clinical situations, such as bacterial infections, ischemic necrosis of tissue, and active inflammatory conditions.1

Recent studies suggest that CRP is a strong predictor of future coronary events in apparently healthy subjects and of prognostic value in patients with acute coronary syndromes.2 As per the American Heart Association (AHA) and Centers for Disease Control and Prevention (CDC), CRP concentrations of 1-3 mg/L signify moderate risk and concentrations greater than 3 mg/L signify high risk for CVD. CRP concentrations below 1 mg/L signify low risk.3.

C-Reactive Protein Semi-Quantiative Rapid Test Device (Whole Blood/Serum/ Plasma) utilizes a combination of colloidal gold conjugate and anti-CRP antibodies to selectively detect CRP in whole blood, serum or plasma. The Minimum Detection Level (MDL) of this test is 1 mg/L (T Line) with reference lines representing values of 3 mg/L (R).

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use it beyond the expiration date.

Precautions

● For professional in vitro diagnostic use only. Do not use it after expiration date.

● The test must remain in the sealed pouch until use.

● Do not eat, drink or smoke in the area where the specimens or kits are handled.

● Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.

● Wear protective clothing such as laboratory coats, disposable gloves or eye protection when specimens are being tested.

● Humidity and temperature can adversely affect results.

● The used test should be discarded according to local regulations.

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