Procalcitonin (PCT) Quantization Test Kit (Colloidal Gold) adopts double antibody sandwich method principle and immunochromatography gold labeling technique to rapidly determine Procalcitonin (PCT) in human serum, polyester fiber (or non-woven fabrics) is pre-peridium with gold labeling PCT monoclonal antibody and rat monoclonal antibody, nitrocellulose membrane detection line and quality control line are peridium separately with PCT 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 PCT in specimen is more than 0.25ug/ml, colloidal gold firstly combines with PCT 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 PCT monoclonal antibody to form sandwich of “Au-PCT Ab- PCT Ag- PCT Ab” when it passes detection line, so detection line will show amaranth strip; the deeper the color of detection line, the bigger concentration of PCT 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 PCT 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 PCT monoclonal antibody and rat monoclonal antibody, nitrocellulose membrane detection line and quality control line are peridium separately with PCT 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 PCT diluent to dilute testing specimen by ratio of 1:1 and mix it evenly for using (70ul serum should be mixed with70ul 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)
PCT content in blood <0.5ng/ml means possibility of systemic bacterial infection is small and risk of increasing to severe sepsis/septicopyemia shock is low; PCT content in blood >2ng/ml means possibility of systemic bacterial infection is high and risk of increasing to severe sepsis/septicopyemia shock shock is comparatively high.
If it is local infection or systemic infection patient is in initial stage, the PCT concentration is also possibly low, so you can’t exclude infection if PCT content is <0.5ng/ml. PCT content can also increase lightly when there is no infection, so it should be judged with consideration of patient’s medical history when PCT concentration is lower than 2ng/ml and retest should be done within 6-24 hours.
(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: 0.25μg/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 PCT standard product in 0.25ng/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.