NT-proBNP quantitative detection kit (colloidal gold method) uses the principle of double antibody sandwich method and immunochromatography gold immnnochromatography technique to quickly detect NT-proBNP in whole blood of human beings, coat gold immnnochromatography NT-proBNP monoclonal antibody and mouse monoclonal antibody on polyester fiber (or non-wovens) and respectively coat NT-proBNP monoclonal antibody and mouse monoclonal antibody in detection line and quality control line of nitrocellulose membrane. During measurement, drop the whole blood specimen into test paper sampling area, and the mixture is chromatographed upwardly from the bottom under capillary effect. If NT-proBNP concentration in the sample is higher than 0.25ng/ml, the colloidal gold will first combine with NT-proBNP antigen in the sample in the chromatographic process to form a compound, and then the compound will move forward along the paper slip under chromatography effect and form “Au-NT-proBNP Ab-NT-proBNP Ag- NT-proBNP Ab” sandwiched object in combination with the procated NT-proBNP monoclonal antibodies when passing the detection line, thus displaying amaranthine stripe at the detection line. As NT-proBNP concentration in the sample increases, the color development at the detection line becomes deepened. The free gold immnnochromatography mouse monoclonal antibody is combined with mouse IgG antibody at the quality control line, thus displaying amaranthine stripe at the quality control line to determine whether the amount of sampling added is accurate and whether the chromatography is consistent with the normal standard.
The product calibration card of the corresponding batch includes the standard curve information of the same batch of products and is detected by detector after the sample is added; the signal is obtained by collecting the grey value of the detection line, and the instrument will automatically make comparative analysis to grey value and standard curve to obtain NT-proBNP content in the sample.
Model & Spec.
NT-proBNP Test Card
Composed of test strip, plastic card, desiccant and aluminum foil; the test strip is composed of plastic substrate, colloidal gold pad, cellulose membrane, sample loading pad and absorbent pad. The colloidal gold pad is coated with NT-proBNP monoclonal antibody and mouse monoclonal antibody in advance, and respectively coated with NT-proBNP monoclonal antibody and mouse IgG antibody in detection line and quality control line of nitrocellulose membrane.
Phosphate buffer, BSA (Bovine Serum Albumin)
(Storage Condition and Validity Period)
Keep in a dry and dark place at 2-30℃. The product is valid for 12 months since the date of manufacture, and can keep for 1 hour when the humidity is less than 65% after opening, and should be used after opening when the humidity is higher than 65%.
Apply to colloidal gold immunochromatographic test strip intelligent detector produced by Nantong Egens Biotechnology Co., Ltd. (Model: ES-SC-3).
1. Collect venous blood sample under sterile conditions and avoid hemolysis during acquisition.
2. Try to use immediately at detection. If the sample cannot be detected timely, it can be refrigerated not more than 12 hours at 2-8℃.
3. The sample must be returned to room temperature before inspection.
Read the Instructions for this product and colloidal gold immunochromatographic test strip intelligent detector completely before detection.
1. Remove the sample to be tested under the storage condition, equilibrate to room temperature and number.
2. Dilute the NT-proBNP diluents for detection of sample at the proportion of 1:1 and mix for standby (70μl whole blood is added with 70μl diluents for mixing).
3. Take out the test card from packing box to pack, open the foil packing bag, take out the test card and put on the table.
4. Add 70μl diluted sample to the loading hole of the test card.
5. Time for 8 minutes after loading sample, put the kit in detector, select instant detection to read quantitative result, and display detection result on the display.
6. Save and print the detection result.
(Interpretation of Testing Result)
1. If the content in human blood is less than 0.3ng/ml, the possibility of acute heart failure can be eliminated; if the content is more than 0.3ng/ml, then it can be classified by ages: those under 50 have little possibility of suffering from acute heart failure in case of 0.3ng/ml<NT-proBNP<0.45ng/m and have a high possibility of heart failure in case of >0.45ng/ml; those aged 50-75 have little possibility of suffering from acute heart failure in case of 0.3ng/ml<NT-proBNP<0.9ng/ml and have a high possibility of acute heart failure in case of >0.9ng/ml; and those over 75 have little possibility of suffering from acute heart failure in case of 0.3ng/ml<NT-proBNP<1.8ng/ml and have a high possibility of acute heart failure in case of >1.8ng/ml.
2. For chronic heart failure, if the patients are below 75, the heart failure can be eliminated in case of NT-proBNP content <0.125ng/ml and there may be heart failure in case of NT-proBNP content ≥0.125ng/ml; if the patients are over 75, the heart failure can be eliminated in case of NT-proBNP content <0.45ng/ml and there may be heart failure in case of NT-proBNP content ≥0.45ng/ml.
(Limitation of Testing Method)
Some antibodies containing a composition resisting to kit may affect the inspection results, which should be determined in combination with the patients’ medical history and other laboratory report. This kit only provides auxiliary diagnosis. Clinically definite diagnosis should be given comprehensive judgments by professionals in combination with clinical symptoms and auxiliary examination.
(Product Performance Index)
1. Detection range: 0.1ng/ml-45ng/ml
Respectively select a standard substance of high concentration and low concentration within the detection range, detect each standard substance for 10 times and count up the CV value.
3. Linear dependence: the linear coefficient (r2) of NT-proBNP standard substance within the range of 0.1ng/ml-45ng/ml is ≥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.