One Step CRP Rapid Test Kit Strip Cassette 5 Mins C Reactive Protein Test Kit Fast Detection Device

C-reactive Protein CRP One Step Rapid Test Kit Strip Cassette Whole Blood Serum Plasma

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
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.

PRINCIPLE

The CRP Rapid Test Kit is an immunochromatographic test, based on two specific antibodies against human CRP. The concentration-dependent formation of test lines allows a rapid semi-quantitative determination of CRP in whole blood samples.

The test device is applied with the test sample which is diluted with buffer solution. The sample now moves through the test strip. If the test sample contains CRP, it attaches to the first anti-CRP antibody which is conjugated with a red gold colloidal for color marking. The red CRP antibody-gold complex, together with the sample liquid, diffuses through the membrane that is pre dispensed with Test line of the second anti-CRP antibody. The CRP-antibody-gold complex is immobilized by the antibodies coated on the membrane leading to the formation of red lines. The intensity of Test Line depends on the CRP concentration in the sample. A test band (T) signal weaker than the reference band (R) indicates that the CRP level in the specimen is between 10-30 mg/L. A test band (T) signal equal or close to the reference band (R) indicates that the CRP level in the specimen is approximately 30 mg/L. A test band (T) signal stronger than the reference band (R) indicates that the CRP level in the specimen is above 30 mg/L. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
 
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.
 
SAMPLE COLLECTION

1. Preparation

Before performing the test, please make sure that all components are brought to room temperature (see storage). Take a vial with buffer solution out of the kit. Mark with patients name or ID. Open the screw cap.

2. Blood Sample Taking

1) Disinfect the finger tip. Use lancet device extract a drop of blood from the finger tip:

2) With the supplied capillary, take a volume of 10μl from the blood drop. It is important that the end-to-end capillary is filled until the upper end. Due to hygienic reasons, hold the capillary with a capillary holder or tweezers. Alternatively, the blood can also be taken with a micro pipette. Please note: In case of using micro pipettes or other capillaries a sample volume of exactly 10μl must be administered.

3) Please dilute the blood sample immediately to avoid clotting.

3. Sample Dilution / Sample Stability

1) Administer the blood-filled end-to-end capillary into the accordingly plastic vial with dilution buffer. Alternatively, the 10μl of blood can be added directly with the micro pipette into the buffer. OR transfer 5μl serum/plasma into the accordingly plastic vial with dilution buffer.

2) Close the vial and shake the sample by hand forcefully for approximately 10 seconds so that the blood is released from the capillary and sample and dilution buffer mix themselves well.

3) Let the diluted sample rest for approximately 1 minute.

4) The sample can then be used immediately or stored for up to 8 hours.

Note: EDTA-, citrate- or heparin- blood can be used as well. Before performing the test, it has to be diluted accordingly with the supplied buffer.

 
OPERATION 

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. Open the vial with the diluted sample and Hold the dropper vertically and transfer 3 drop of diluted sample (approximately 75 mL) to the specimen well (S) of the test device and start the timer.

3. Wait for the red line(s) to appear. Read the results at 5 minutes. Do not interpret the result after 7 minutes. 

 
INTERPRETATION

PERFORMANCE

1. The test was calibrated against the international human CRP reference standard of the WHO 85/506. The detection limit of the CRP Test is adjusted in such a way that a concentration of 10 mg/L in the undiluted specimen material after dilution with the supplied buffer yields a positive red line.

2. If the undiluted specimen contains more than 30 mg/L CRP, the increase test line intensity will be darker than Reference Line (R). With concentrations higher than 80 mg/L CRP, test line intensity will be darker than Control Line (C).

3. These concentration ranges could be confirmed in comparison to a quantitative reference test.

4. Hook effects could not be proven up to a concentration of 2,000 mg/L CRP. At this concentration, the test indicated results of >80 mg/L.

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