quickly and easily CRP Rapid Diagnostic Test, diagnosis of myocardial infarction (MI), gold colloidal method

Intended Use:

The CRP Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human CrP in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI). The cutoff of the test is 10 μg/ml.

Summary:

C-reactive Protein (CrP) in patient’s sera has been found in association with acute infections, necrotic conditions and a variety of inflammatory disorders. There is a strong correlation between serum levels of CrP and the onset of the inflammatory process. Monitoring the levels of CrP in patient’s sera indicates the effectiveness of treatment and the assessment of patient recovery. It is used in particular to differentiate bacterial infections from virus infections

Test Principle:

The CrP Rapid Test Cassette (Whole Blood/Serum/Plasma) detects C-reactive Protein through visual interpretation of color development on the internal cassette. The sample now moves through the test cassette from bottom to top. If the test sample contains CrP, it attaches to the anti-CrP antibody which is conjugated with a red gold colloidal for color marking. The more CrP is contained in the sample, the more red lines become visible. A red line should always appear in the control (C) line area. It serves as a procedural control, confirming that sufficient specimen volume was used and indicates an adequate membrane wicking and proper procedural technique.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not

open the pouch until ready to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Open the tube with the diluted sample .Transfer 3 drops of mixed specimens to sample well. Start the timer.

4. Wait for the colored lines to appear. The result should be read at 5 minutes. Do not interpret the results at 10 minutes.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.