TP/Syphilis antibody rapid Test kit (Serum/Plasma/Whole Blood)
TP /Syphilis Rapid Test Kit
SUMMARY
The general method of detecting infection with TP is used for in vitro qualitative detection of Syphilis (TP) Antibody in human whole blood, serum or plasma samples.The test is based on Colloidal gold method and can give a result within 15 minutes.
INTENDED USE
The One Step TP Test is a Colloidal Gold enhanced,.Clinically, this product is mainly used for the auxiliary diagnosis of Treponema pallidum infection. This product is for medical personnel use only.
PRINCIPLE OF THE PROCEDURE
The product adopts the principle of double antigen sandwich. When the sample contains Treponema pallidum antibody, the Treponema pallidum antibody in the sample reacts with the colloidal gold labeled-syphilis recombinant antigen 1 on the binding pad to form a labeled antigen-antibody complex. The complex is chromato-graphed forward through capillary action and is captured by the recombinant syphilis antigen 2 coated on detecticn area(T line) of the nitrocellulose membrane,and a red band appears. The complex continues to be chromatographed upward, and the chicken lgY colloidal gold marker is captured by the goat anti-chicken lgY antibody coated on the quality control area (C line)of nitrocellulose membrane, and a red band appears. When the content of the analyte in the sample is lower than the minimum detection limit, the detection area(T line) does not develop color.
MAIN COMPONENT
1.Test pad, individually packaged in aluminum foil bag(1piece/bag,1/5/10/25/50 piece(s)/kit)
2.Disposable plastic straw(1picce/bag,1/5/10/25/50 piece(s)/kit)
3.Medical waste bag(1picce/bag,1/5/10/25/50 piece(s)/kit)
4.Instruction manual(1copy/bag,1 copy/kit)
Note: The components in the kits of different batch numbers are not interchangeable.
OPTIONAL COMPONENTS
口Sample diluent (1 piece/bag,1/5/10/25/50 piece(s)/kit)
口Alcohol cotton pad(1 piece/bag,1/5/10/25/50 piece(s )/kit)
口 Blood collection needle(1 piece/bag,1/5/10/25/50 piece(s)/kit)
MATERIALS REQUIRED BUT NOT PROVIDED
Positive and negative controls (available as a separate item)
STORAGE & STABILITY
The original packaging should be stored in a dry place at 4-30℃ protected from light, and do not freeze.
WARNINGS AND PRECAUTIONS
The kit is stable within the expiration date printed on the labeling. The test pad should be used within l hour under the condition of 4-30℃and humidity<65%after the aluminum foil bag is unpacked. It is recommended to use it immediately under high temperature or high humidity conditions.
SAMPLE COLLECTION AND STORAGE
2. Sample storage
2.1 Whole blood; Anticoagulant tubes are used for blood collection, and common anticoagulants can be used; if whole blood samples cannot be used immediately after collection, they can be stored at 2-8°C for 3 days,and the samples cannot be frozen.
2.2 Serum/plasma: The sample can be stored at 2-8℃ for 7 days, and it should be stored at -20℃ for long-term storage.
3.Only non-hemolyzed samples should be used.Severely hemolyzed samples should be resampled.
4 The refrigerated samples must be retuned to room temperature before the test. The frozen samples should be completely thawed, rewarmed, and mixed evenly before use. Do not freeze and thaw repeatedly
ASSAY PROCEDURE
1) Using the enclosed plastic dropper for the sample, dispense 1 drop (10μl) of Whole Blood /Serum / Plasma to the circular sample well of the test card
2) Add 2 drops of Sample Diluent to the sample well, immediately after the specimen is added, from the dropper tip diluent vial (or all contents from the single test ampule).
3) Interpret test results at 15 minutes.
Notes:
1) Applying a sufficient amount of sample diluent is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of diluent to the sample well.
2) The positive results could appear as soon as one minute for a sample with high levels of TP antibodies.
3) Do Not Interpret results after 20 minutes
READING THE TEST RESULTS
1) Positive: Both a purplish red test band and a purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
2) Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.
3) Invalid result: There should always be a purplish red control band in the control region, regardless of the test result. If a control band is not seen, the test is considered invalid. Repeat the test using a new test device.
Note: It is normal to have a slightly lightened control band with very strong positive samples, as long as it is distinctly visible.
LIMITATION
1) Only clear, fresh, free flowing Whole Blood /Serum / Plasma can be used in this test.
2) Fresh samples are best but frozen samples can be used. If a sample has been frozen, it should be allowed to thaw in a vertical position and checked for fluidity. Whole Blood can not be frozen.
3) Do not agitate the sample. Insert a pipette just below the surface of the sample to collect the Specimen.
