C-reactive protein (CRP) Rapid Test Cassette,use of LF Reader,High Accuracy,1-10 μg/mL
| Product features |
Parameters |
| Principle |
Chromatographic Immunoassay |
| Format |
Cassette |
| Specimen |
WB/S/P |
| Certificate |
CE |
| Reading Time |
5 minutes |
| Pack |
10 T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
>99.9 |
| Specificity |
97.50% |
| Accuracy |
97.80% |
| Cut-Off |
1-10 ug/mL |
A rapid test for the diagnosis of inflammatory condition by detecting CRP semi-quantitative in whole blood, serum or plasma that can be performed with the use of the LF Reader.
For professional in vitro diagnostic use only.
INTENDED USE
The CRP Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the semi-quantitative detection of human CRP in whole blood, serum or plasma as an aid in the diagnosis of inflammatory condition. The cutoff of the test is 3μg/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.
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 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.
REAGENTS
The test cassettes include CRP antibody coated particles and CRP antibody coated on the membrane.
PRECAUTIONS
- For professional in vitro diagnostic use only.
- For use exclusively with the LF Reader. Do not interpret test results visually.
- Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
- This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled observing usual safety precautions (e.g., do not ingest or inhale).
- Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
- Read the entire procedure carefully prior to any testing.
- Do not eat, drink or smoke in the area where the specimens and kits are handled.
- Handle all specimens as if they contain infectious agents. Observe established
- precautions against microbiological hazards throughout the procedure and follow standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
- ·Do not interchange or mix reagents from different lots.
- ·Humidity and temperature can adversely affect results.
- ·Used testing materials should be discarded in accordance with local regulations.
DIRECTIONS FOR USE
Bring test, specimens, buffer, and/or controls to room temperature (15-30°C) before use.
1.Exact QR Code from the QR code card for specific information of the test. Use only QR code card provided inside the test kits.
2.Remove the Test Cassette from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.
3.Open the tube with the diluted sample .Transfer 3 drops (approximately 120uL) of mixed specimens to sample well. Start the timer.
4.Wait for the colored lines to appear. The result should be read with the LF Reader at 5 minutes.
5.Do not interpret test results visually
Note: For the LF Reader installation, start up and complete instructions refer to the LF Reader User Manual. Operator must consult the LF Reader User Manual prior to use and become familiar with the processes and quality control procedures.
INTERPRETATION OF RESULTS
Results read by the LF Reader.
The result of positive or negative for C-reactive Protein by LF Reader.
Result could be exported to excel or PDF.
Order Information
| Cat. No. |
Product |
Specimen |
Pack |
| CCR-R402 |
C-reactive protein (CRP) Rapid Test Cassette |
WB/S/P |
10T |
