Intended Use

The CRP Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for thesemi-quantitative detection of C-reactive protein in whole blood, serum or plasma.
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.
The CRP Rapid Test Cassette (Whole Blood/Serum/Plasma) is a semi-quantitative, membrane based immunoassay for the detection of C-reactive protein in whole blood, serum or plasma. During testing,the specimen is dropped into the specimen well and reacts with the particle conjugated with CRP antibody, and the mixture migrates upward on the membrane chromatographically by capillary action to react with anti-CRP antibody pre-located on the membrane and generate a purple line. The number of lines depends on the CRP concentration in the sample. The more CRP is contained in the sample, the more color lines become visible. The control line serves as a procedural control and indicates that sufficient volume of specimen has been added and membrane wicking has occurred.
Specification
| Read time | 5-8 min |
|
Shelf life |
36 months |
| Store temperature | 2-30℃ |
| Operation temperature | 15-30℃ |
| Sensitivity | 99.4% |
| Specificity | 97.1% |
| Accuracy | 98.5% |
Why To Test
1. What is CRP?
C-reactive protein (CRP) is an acute-phase protein produced by the liver in response to inflammation, infection, or tissue damage. It acts as a key biomarker for immune system activation, with levels rising significantly within hours of an inflammatory trigger .
2. What is CRP Testing?
CRP testing involves a rapid immunochromatographic assay (e.g., lateral flow test strip) that quantitatively or semi-quantitatively measures CRP concentration in human blood (whole blood, serum, or plasma). The test uses antibodies specific to CRP to generate a visible or instrument-read signal, with results typically available within 5–15 minutes .
3. Why Test CRP?
Detect Inflammation: Elevated CRP indicates acute inflammation, helping differentiate bacterial from viral infections (e.g., CRP > 10–50 mg/L suggests bacterial infection) .
Monitor Disease Severity: CRP levels correlate with inflammation intensity:
< 10 mg/L: Normal or mild inflammation (e.g., viral infection)
10–50 mg/L: Moderate inflammation (e.g., bacterial infection)
50 mg/L: Severe inflammation (e.g., sepsis, major tissue damage) .
Guide Treatment: Supports clinical decisions on antibiotic use or further diagnostics .
Test Method

(Please refer to the illustration above)
Positive(+):One color line appears in the control region (C). One color line appears in the test region
(T) least.
Test line(T) Semi quantitative result
Only T1 appears CRP level is 10mg/L at least
Only T1 and T2 appear CRP level is 40mg/L at least
T1 ,T2 and T3 appear CRP level is above 80mg/L
Negative(-):One color line appears in the control region (C). No apparent purple line appears in the
test region (T).Negative result showed: There was not CRP in the sample, or the content of CRP below
the detectable range.
Test line(T) Semi quantitative result
No line CRP level is lower than 10mg/L
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.
Catalog
|
Product Name |
Model |
Catalog Number |
Components |
Sample Type |
Strip Type |
|
The CRP Rapid Test (Whole Blood/Serum/Plasma) |
FS21-101 |
FS21-101-1 |
Test Cassettes Droppers Package insert Buffer |
Serum or Plasma or venipuncture Whole Blood specimen |
Cassette |
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