INTENDED USE
Babio® Treponema Pallidum Antibody Test Kit (Colloidal Gold) is intended for qualitative detection of antibodies to Treponema pallidum (TP) in whole blood, serum and plasma samples. It is intended for use in medical institutions by trained staff as an aid for the diagnosis of clinical conditions related to infection with T. pallidum (also known as syphilis).
Syphilis is a disease caused by Spirochete bacterium called Treponema pallidum (TP).TP is a spirochete bacterium with an outer envelpoe and a cytoplasmic membrane. According to the Center for Disease Control (CDC), the number of cases of syphilis infection has markedly increased since 1985. Multiple clinical stages and long periods of latent,asymptomatic infection are characteristic of Syphilis. If untreated, the TP move throughout the body and can cause damage to many organs, making syphilis a life-threatening disease if not treated early enough.
Treponema Pallidum Antibody Test Kit (Colloidal Gold) is an immunological diagnostic test used for detection of treponema pallidum antibody based on the colloidal gold-immunochromatography assay. This method is rapid and convenient to use and requires few equipment.It can be performed within 15-20 minutes by minimally skilled personnel.
1. Allow the test device,diluent, specimen to equilibrate to room temperature (15-30℃) prior to testing.
2.Remove the test device from the sealed pouch. Place the test device on a clean, flat surface.
3.Label the device with specimen number.
4.Using a Disposable Dropper, transfer serum, plasma or whole blood. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10-30μl) to the specimen well(S) of the test device, and immediately add 2 drops of diluent (approximately 70-100μl). Make sure there are no air bubbles.
5.Set up a timer. Read the results in 15 minutes.
Do not interpret the result after 20 minutes. To avoid confusion, discard the test device after interpreting the result. If you need to store it for a long time, please take a photo of the result.
Materials Provided
Model: Test Card, Test Strip
Positive:a red line appears at the position of the quality control line (C line) and the detection line (T line) , which indicates the test result of treponema pallidum antibody in the sample was positive.
Negative: If only the C band is present, indicates that no treponema pallidum antibody is detected in the specimen. The result is negative.
Invalid: The control line fails to appear.Review the procedure and repeat the procedure with a new kit. If the problem persists, discontinue using the test kit immediately and contact your local distributor.