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tPSA Rapid Test Kit
● Instrumentation:
MKF-101 fluorescent immunoanalyzer
MKF-201 Portable dry fluorescence immunoassay analyzer
MKF-202 fluorescent immunoanalyzer
● Detection time: 5 minutes
● Storage: Room temperature (4-30°C)
● Shelf life: 24 months
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INTENDED USE
tPSA Rapid Test Kit is used for the in vitro quantitative determination of total prostate-specific antigen (tPSA) in human whole blood, plasma and serum.
It is mainly used for dynamic monitoring of malignant tumour patients to assist in judging the disease process or treatment effect, and cannot be used as the basis for early diagnosis or confirmation of malignant tumour, and is not used for tumour screening in the general population.
SUMMARY
Prostate specific antigen (PSA) is synthesised and secreted into semen by prostate epithelial cells and is one of the major components of seminal plasma, with a molecular weight of approximately 34 KDa [1].It was extracted and purified from prostate tissue in 1979. This protein is found only in the cytoplasm of prostate epithelial cells, ductal epithelium and mucus and has chymotrypsin-like and trypsin-like activities [2]. If measurements show an elevated PSA, the possibility of underlying disease must next be considered [3].PSA is a specific marker for prostate cancer and one of the few organ-specific tumour markers available [4]. In addition to being used as a test and early detection of prostate cancer, blood PSA can also be used for post-treatment surveillance.After prostate surgery, PSA concentration can gradually decrease to normal.If the concentration does not decrease after surgery or increases again after decreasing, tumour metastasis or recurrence should be considered.
PRINCIPLE
This reagent uses immunofluorescence double antibody sandwich method to quantitatively detect the concentration of total prostate specific antigen (tPSA) in human whole blood, plasma and serum samples. After the diluted sample is added dropwise to the sample wells of the reagent, the total prostate-specific antigen (tPSA) in the sample and the rare-earth fluorescence-labelled anti-tPSA monoclonal antibody I combine to form an immunoreactive complex, which moves along the nitrocellulose membrane and is captured by the anti-tPSA monoclonal antibody II in the detection zone of the nitrocellulose membrane, forming a detection signal. II, forming a detection signal. The more to-be-tested substances in the sample forming the detection signal, the more complexes accumulate on the detection line, and the fluorescencesignal intensity reflects the amount of to-be-tested substances captured. At the end of the reaction, the amount of the substance to be measured in the sample can be measured by the dry fluorescence immunoassay analyser. Rare earth fluorescently labelled antibodies not captured in the detection zone move forward along the nitrocellulose membrane and bind to the quality control antibody in the quality control zone to form a quality control signal.
MAIN COMPONENTS
The kit contains the corresponding number of test cassettes for each package specification: the test cassette consists of a test strip shell and a test strip, which consists of a binding pad (containing fluorescent microsphere-labelled anti-free prostate-specific antigen antibody and chicken IgY), a nitrocellulose membrane (C-wire wrapped with a quality control antibody and another anti-free prostate-specific antigen antibody), a sample pad, an absorbent paper, and a PVC plate.
Diluent solution: composed of phosphate, preservative, etc., pH=7.4
Note: Components in kits of different lot numbers are not inter changeable.
Calibration Traceability: National Standard for Prostate Specific Antigen (PSA) Immunoassay 150543-202106
APPLICABLE INSTUMENT
1.MKF-101 fluorescent immunoanalyzer
2.MKF-201 Portable dry fluorescence immunoassay analyzer
3.MKF-202 fluorescent immunoanalyzer
SAMPLE REQUIREMENTS
This product requires the collection of human whole blood, serum or plasma samples for testing.
1.Whole blood collection: blood is collected using an anticoagulant tube, and the collected blood sample is added and shaken well and set aside. The sample should not be frozen and should be tested as soon as possible after collection. If the test cannot be completed within 12 hours, it should be stored at 2°C to 8°C for no more than 2 days.
2.Serum or plasma collection: Serum and plasma should be separated as soon as possible afterblood collection to avoid haemolysis. Separated serum and plasma should be tested as soon as possible, if the test can not be completed within 12 hours, placed in 2 ℃ ~ 8 ℃ storage, not more than 7 days. Long-term storage should be placed in -20 ℃ frozen, not more than 6 months.
Samples should not be frozen or thawed more than 3 times.
Samples must be returned to room temperature before testing. Cryopreserved samples must be completely thawed, mixed well, and brought to room temperature before use, and repeated freezing and thawing should be avoided.
关键词:
test kit
rapid test kit
antigen test kit
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