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【Product name】
Generic name:C-Reactive Protein Test Kit (Latex-Enhanced Turbidimetric Assay)
【Packing specification】
50 tests/kit
【Intended use】
It is used for quantitative determination of C-reactive protein in human whole blood / serum / plasma in vitro.
【Test principle】
CRP antigen in blood combines with anti human CRP polyclonal antibody on the surface of latex particles to form latex antibody antigen conjugate. The turbidity of the conjugate at 630nm was measured. When the light passed through the reaction suspension, it was transmitted and detected by a specific protein analyzer. The transmission intensity was proportional to the content of antigen antibody immune complex.
【Kit contents】
Reagent | 50 tests/kit | Major ingredients |
R1 reagent | 1×20ml | Phosphate reaction buffer |
R2 reagent | 1×4ml | Anti human CRP polyclonal antibody was prepared by adsorption coating on latex particles |
RF card | 1 piece | / |
Quality control QC | 200ul | |
Cuvette | 50 cuvette |
【Sample requires】
The whole blood can be collected in the small tubes anticoagulated with EDTA and heparin, and mixed upside down, and analyzed according to the test procedure. If the test cannot be carried out immediately, the whole blood can be stored at 2 ℃ ~ 8 ℃ for 48 hours.
Collect venous blood sample and separate serum, if not analyze immediately, serum can be stored at 2-8 ℃ for 7 days; at - 20 ℃ for seven months.
2. Interfering substances: high concentration of bilirubin, triglyceride, hemoglobin, vitamin-C had no effect on the detection
【Assay procedure】
Reagent | Dose |
Reaction buffer(R1 reagent) | 400μl |
CRP antibody latex combo(R2 reagent) | 80μl |
Sample | 10μl |
2. Operating steps:
(1) When starting it shows “Read card”,put the corresponding lot magnetic card in the reader slot, reading the card correctly, the screen displays the reagent name and lot number, the instrument status indication light is working (yellow-green). Please check carefully.
(2) After confirm the lot number, dispense 10 μ l sample to a colorimetric cuvette which included 400 μ l reaction buffer (R1) and mixing sticker. Do not produce bubbles when dispensing the sample.
(3) Put the colorimetric cuvette in the detection well, gently press the cuvette until it contacts the bottom. The status indication light will be off when the analyzer detects the colorimetric cuvette successfully.
(4) When the analyzer shows “Add [R2]”,dispense 80μl CRP antibody latex combo(R2)in the cuvette. The analyzer will mix automatically and start to detect, it shows: “Testing…”It [shows the result automatically and record the value.
(5) After detecting, move the cuvette. The status indication light will be working (yellow-green). Return to step(2)to detect next sample.
(6) If moving the cuvette out in the process of detecting, the screen shows“ Give up testing”
(7) If the result>81.00mg/L or >120.00mg/L, may use 0.01 mol/L PBS to dilute the sample to 1:5(add 400μl PBS in 100μl sample, input dilution multiply 5, the analyzer can calculate the sample concentration automatically.
【Reference value】
Normal reference range:<10.00mg/L
Recommend laboratories to establish their own reference ranges.
【Interpretation of results】
1.Maloperation: If do not operate accordance with the interface prompts, or moving the cuvette out during testing, it shows "Give up testing". At this point, should take a new cuvette for testing, until it prompts normal operation.
2. Invalid result: when the reagent is expired, the magnetic card of the reagent is also expired. Reading card it shows "Reagent is expired".
Detection range | Serum/plasma:3.00~81.00mg/L Whole blood:3.00~120.00 mg/L |
Accuracy | Use internal quality control plate to test, results deviation ±10% |
Precision | CV≤10% |
【Limitation of the detection method】
1. The reagent only can be used on QR series specific protein analyzer manufactured by HEALES
2. Need to add sample and reagent manually, may make the result deviation because of human operation error.
3. High chyle, turbid sample may cause high blank