This rapid gold Immunoassay Kit for Treponema Pallidum (TP) antibody is an in-vitro immunoassay for the qualitative detection of Anti-TP antibody present in the human serum or plasma in just one step. It is used for diagnosis of early infection and epidemic survey.
This test kit uses a one-step method to detect anti-TP antibodies in serum or plasma. The purified specific recombinant TP antigen is immobilized on the nitrocellulose membrane at the test line region and another specific TP-Ag conjugate to the colloidal-gold is coupled on the label pad. For performing the test, a sample should be added to the sample well of the test card. The sample then flows through to the label pad and if it contains an Antibody to Treponema Pallidum, the antibody bind to the antigen coated on the colloidal gold particles and form antibody-antigen-gold complexes. These complexes then move on the nitrocellulose membrane by the capillary action toward the test line region where it reacts with specific recombinant TP antigen to produce a pink line on the membrane. A second red line will always appear in the result window, it indicates that the test has been correctly performed and the test device is functioning properly. If an antibody to Treponema Pallidum (TP) is not present or lower than the detection level of the test, only the control line will be visible. If the control line is not developed, the test is invalid. The color intensity reflects the antibody intensity present in the sample; the test is fast and easy to operate.
Antibody to Treponema Pallidum test card or strip
Each cassette or strip contains a test strip with TP antigen on the test region of the membrane and colored Treponema Pallidum antigen-gold conjugate pad.
SAMPLE COLLECTION AND PRESERVATION
Blood serum samples are routinely prepared from the vein and blood plasma sample are prepared with the routine amount of anticoagulants such as heparin or sodium citrate. Samples should be stored at 2 to 8oC and used within 5 days without interfering with the assay performance. Storage for long-term of specimens requires being stored at -20oC or colder is recommended. Repeated freezing and thawing of specimens should be avoided as it may cause erroneous results. Samples with cloud or precipitation should be centrifuged or filtered before testing. Prevent serum from bacterial contamination during the collection and storage.
Bring the membrane plate and samples to room temperature between 20 to 30oC before testing (approximately 30 minutes).
Remove the test cassette or strip from the foil pouch and place the plate on a flat surface.
Add 2 drops (80 to 100 L) of the sample to the sample well or sample pad.
Read the result between 20 to 25minutes, a strong positive sample may show results early.
INTERPRETATION OF RESULTS
Positive: 2 pink lines appear in both C and T region
Negative: Only 1 pink line appears in the C region
Invalid: The control line next to the test line is not visible within 20minutes after the addition of the sample.
It is used for qualitative and assistant diagnosis. Confirmation of the infection should refer to other clinical diagnosis.
Both plate and the sample should be brought at room temperature between 20 to 25oC.
Test sample must be fresh.
Reading the result after 25 minutes is invalid.
Diluted sample may generate a false positive result.
Bacterial contamination, serious hemolysis, jaundice and high lipid blood will cause the wrong result. The sample should be re-collected.
Wrong result can be caused by the expired kit or problematic samples.
The shelf life is of 24months and does not use the kit beyond its expiry date.