C-Reactive Protein HS CRP One Step Rapid Test Kit Strip Cassette High Sensitivity

High Sensitivity C-reactive Protein HS CRP One Step Rapid Test Kit Strip Cassette Blood Cardiovascular Disease

INTENDED USE
The CRP Rapid Test Kit (Whole Blood/Serum/Plasma) is used for semi-quantitative determination and monitoring of CrP concentrations in whole blood/serum/plasma specimens.

INTRODUCTION

The CRP C-Reactive Protein Semi-Quantitative Rapid Test Kit (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.

PRINCIPLE

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.

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. 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.

The CRP C-Reactive Protein Semi-Quantitative 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).

MAIN CONTENTS
• Rapid test Cassette with desiccant.
• Disposable pipettes.
• Buffer.
• Instructions for use.

STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.

PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.

OPERATION

Allow test device, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch and buffer to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Transfer 2 drops of serum or plasma (approximately 50 µL) to the specimen well of the device with the provided disposable pipette, and then start the timer.

OR

Transfer 3 drops of whole blood specimen (approximately 75 µL) to the specimen well of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.

OR

Allow 3 hanging drops of fingerstick whole blood specimen to fall into the center of the specimen well (S) on the device, then add 1 drop of buffer and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

4. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

PERFORMANCE

Intra-Assay

Within-run precision has been determined by using replicates of 10 tests for each of three lots using CRP specimen levels at 1 mg/L, 3 mg/L, 10 mg/L. The specimens were correctly identified >98% of the time.

Inter-Assay

Between-run precision has been determined by using CRP specimen levels at 1 mg/L, 3 mg/L, 10 mg/L of CRP in 10 independent assays. Three different lots of the CRP C-Reactive Protein Semi-Quantitative Rapid Test Device (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >98% of the time.

Interfering Substances

The following substances do not interfere with the test results at the indicated concentrations: human albumin at 110 mg/mL, bilirubin at 6 mg/mL, hemoglobin at 10 mg/mL, cholesterol at 5 mg/mL and triglycerides at 15 mg/mL

For detailed information, pls contact Dewei person for instruction manual.