C Reactive Protein (CRP) Quantization Test Kit (Colloidal Gold) adopts double antibody sandwich method principle and immunochromatography gold labeling technique to rapidly determine C reactive protein (CRP) in human serum, polyester fiber (or non-woven fabrics) is pre-peridium with gold labeling CRP monoclonal antibody and rat monoclonal antibody, nitrocellulose membrane detection line and quality control line are peridium separately with CRP monoclonal antibody and anti-rat IgG antibody. During determination, serum specimen is dropped within sampling-adding area of test paper, then mixture chromatography upwards because of capillary effect. If concentration of CRP in specimen is more than 0.5ug/ml, colloidal gold firstly combines with CRP antigen in specimen to form compound during chromatography process and then the compound move forwards along strip because of chromatography effect, the compound combines with pre- peridium CRP monoclonal antibody to form sandwich of “Au-CRP Ab- CRP Ag- CRP Ab” when it passes detection line, so detection line will show amaranth strip; the deeper the color of detection line, the bigger concentration of CRP in specimen. Dissociated gold rat monoclonal antibody is combined with anti-rat IgG antibody at quality control line which will show amaranth strip, this strip is the standard to judge whether sampling adding amount is accurate or not and chromatography is normal or not.
Different batches of product calibration card includes standard curve information of product for corresponding batches, it is inspected in detector after adding sampling, signal is captured by collecting gray value of detection line; detector automatically compares and analyzes gray value with standard curve and you can get CRP content in specimen.
Model & Spec.
CRP test paper strip
It is composed of test paper strip, plastic card, drying agent and aluminum foil bag while test paper strip is constituted by plastic substrate, colloidal gold pad, cellulose membrane, sampling adding pad and absorption pad. Colloidal gold pad is pre-peridium with gold labeling CRP monoclonal antibody and rat monoclonal antibody, nitrocellulose membrane detection line and quality control line are peridium separately with CRP monoclonal antibody and anti-rat IgG antibody.
PCB printed circuit card
Phosphate Buffer solution and bovine serum albumin
(Storage Condition and Validity Period)
2-30℃ and keep in dark and dry place for storage. Validity period of this product is 12 months since production date. It can be kept for 1 hour in humidity of under 65% after unsealing and it should be used immediately after unsealing if humidity is above 65%.
Can be applied at GICA Test Strip Intelligent Detector produced by Nantong Egens Biotechnology Co., Ltd. (model: ES-SC-3)
1. Collect venous blood sampling under aseptic condition and separate serum as soon as possible to avoid hemolysis
2. Fresh specimen should be used during inspection. Specimen can be stored at 2-8℃ for 7 days and at -20℃ for long term cryopreservation if the specimen can’t be inspected in time.
3. Specimen should be recovered to room temperature before inspection; specimen stored in cryopreservation should be completely melted, re-warming and mixing evenly before using.
You must read whole instructions for this product and GICA Test Strip Intelligent Detector completely before testing.
1. Get Specimen for testing from storage condition, balance it to room temperature and give number to it.
2. Using CRP diluent to dilute testing specimen by ratio of 1:200 and mix it evenly for using (1ul serum should be mixed with 200ul diluent)
3. Get test paper card package from packing box, open aluminum foil bag, get out test paper card and place it evenly on platform
4. Add 70ul diluted specimen into sampling adding hole of test card
5. 8 minutes after sampling adding, please place kit at detector, choose point-of-care testing and quantitative result can be read, testing result can be showed on display screen
6. Save and print out inspection result
(Interpretation of Testing Result)
Cardiovascular disease risk assessment:
Blood CRP levels are 1 3 mu g/ml for moderate risk, >3μg/ml is high risk
Assessment of infection:
10-25μg/ml is possible virus infection, >25μg/ml is possible bacteria infection.
(Limitation of Testing Method)
Some antibody which has some composition of kit may affect testing result and it should be judged together with patient’s medical history and other laboratory reports, this kit just provides auxiliary diagnosis. Clinic definite diagnosis should be made comprehensively by professionals with consideration of clinical symptoms and auxiliary tests.
(Product Performance Index)
1. Testing range: 0.5μg/ml-100μg/ml
Choose a high concentration standard product and a low concentration standard product in testing range, test every standard product for 10 times and make a statistic for CV value
3. Linear dependence: linear coefficient r2 for CRP standard product in 0.5ng/ml-100ng/ml range should be ≥0.98
4. Specimen of bilirubin (30mg/dl) and triglyceride concentration(1000mg/dl)are tested, phenomenon of cross reaction has not been found yet and testing result of this reagent is not affected. But hemolysis specimen has interference with test result and should be avoided.
1. This test paper card can only be used for in vitro diagnosis testing.
2. Testing environment can’t be in too high temperature, too high humidity or too dry.
3. Unsealed testing paper strip or card should be tested as soon as possible and can’t stay in air for too long time to avoid invalidation because of damp. Please don’t use it if inner packing is broken.
4. Kit should be kept in room temperature without damp. Specimen stored in cryopreservation only can be used after being balanced to room temperature
5. Operation should be done the same as inspection regulations of infectious disease laboratory.
6. Please do labeling working to avoid confusion when a lot of specimens are tested.
7. This test paper card is only for one-time in vitro diagnosis testing and can’t be reused after using. Don’t freeze it or use out of validity period.