Intended Use
This anti-TP ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to Treponema Pallidum in human serum or plasma specimens.
Contents of Kit
1. MICROWELL PLATE: Blank microwell strips fixed on white strip holder. The plate is sealed in aluminum pouch with desiccant. Each well contains recombinant TP antigens. The microwell strips can be broken to be used separately. Place unused wells or strips in the provided plastic sealable storage bag together with the desiccant and return to 2-8°C. Once opened, stable for 4 weeks at 2-8°C.
2. NEGATIVE CONTROL: 1×0.5ml. Yellowish liquid filled in a vial with green screw cap. Protein-stabilized buffer tested non-reactive for anti-TP. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
3. POSITIVE CONTROL: 1×0.5ml. Red-colored liquid filled in a vial with red screw cap. Anti-TP antibodies diluted in protein-stabilized buffer. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
5. HRP-CONJUGATE: 1×14ml. Green-colored liquid in a white vial with red screw cap. Horseradish peroxidase-conjugated recombinant TP antigens. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
6. 20×WASH BUFFER: 1×50ml. Colorless liquid filled in a clear bottle with white screw cap. Buffer solution containing surfactant. The concentrate must be diluted 1 to 20 with distilled/ deionized water beforeuse. Once diluted, stable for 1 week at room temperature, or for 2 weeks whenstored at 2-8°C.
7. CHROMOGEN SOLUTION A: 1×8ml. Colorless liquid filled in a white vial with greenscrew cap. Urea peroxide solution. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
8. CHROMOGEN SOLUTION B: 1×8ml. Colorless liquid filled in a black vial with blackscrew cap. TMB (Tetramethyl benzidine), N,N- dimethylformamide. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
9. PLASTIC SEALABLE BAG: For enclosing the strips not in use 1 unit
10. PACKAGE INSERT: 1 copy
11. CARDBOARD PLATE COVER: 2 sheets To cover the plates during incubation and prevent evaporation or contamination of the wells
Storage
The components of the kit will remain stable through the expiration date indicated on the label and package when
stored between 2-8°C, do not freeze. To assure maximum performance of This anti-TP ELISA, during storage, protect the reagents from contamination with microorganism or chemicals.
General Description
Syphilis is a disease caused by Spirochete bacterium called Treponema Pallidum (TP). If untreated, the organisms move throughout the body and can cause damage to many organs, making syphilis a life-threatening disease if not treated early enough. People who have been infected with Syphilis experience different symptoms during the 3 stages of the disease. Early, which is defined by the presence of the chancre at the site of inoculation. Syphilis may be further divided into primary, secondary, and early latent syphilis; late syphilis includes late latent and the various forms of tertiary Syphilis. The serological response to syphilis involves production of antibodies to a wide range of antigens, including non-specific antibodies and specific anti-TP antibodies. The first detectable response to infection is the production of specific antitreponemal IgM, which can be detected within 4 to 7 days after the chancre appears and until the end of the second week of infection; antitreponemal IgG appears at about four weeks later. By the time that symptoms develop, most patients have detectable IgG and IgM.
Citations
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