Detection Total Antibody Colloidal Gold Rapid Test To Treponema Pallidum In Human Serum Or Plasma

Self Test Diagnostic Kit For IgM Antibody To 2019-NCoV Rapid Test

INTENDED USE

The Anti-TP ELISA is a qualitative enzyme immunoassay for the in vitro detection of Treponema Pallidum (TP) infection, based on the detection of total antibody to Treponema Pallidum in human serum or plasma. It is intended for screening of blood donors and diagnosing patients related to infection with TP.

Interpretation of test results

To develop color on C line only

To develop color on both C line and T line;

To develop color on T line only

If no C line is developed, the assay is invalid regardless of any color in the T line.

Samples should be processed according to infectious contaminants and samples should be collected again.

Sample requirements

• Serum and plasma samples were collected from the venous blood by conventional method. The treatment of plasma sample: heparin solution, sodium citrate solution and EDTA solution can be used to anticoagulate blood.
• Serum or plasma samples can be stored at 2 ~ 8 ℃ if tests will be done within 5 days, otherwise stored at -20 ℃. No more than 3 times of freeze-thaw.
• The result of haemolysis sample test is invalid.
• Samples containing suspended fibrin or polymer are recommended for centrifugation and supernatant for testing. Hemolytic samples can not be detected.
• There should be no other microbial contamination in the samples to be tested.
• The specimen transfer box should have special identification. After removing the specimen from the sealed bag, it must be sterilized by ultraviolet or 75% ethanol spray.
• Before use, the sample should be kept at room temperature for more than 30 minutes, and the sample should be mixed before freezing.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world