Intended Use
The 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. PLATE 8×12/12×8-well per plate:
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. CONTROL- (1×0.5ml per vial) preserv.0.1% ProClin:
NEGATIVE CONTROL: 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. CONTROL+ (1×0.5ml per vial) preserv.0.1% ProClin:
POSITIVE CONTROL: 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.
4. HRP CON (1×14ml per vial) preserv.0.1% ProClin:
HRP-CONJUGATE: 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.
5. WASH BUF 20× (1×50ml per bottle) DILUTE BEFORE USE! detergent Tween-20:
WASH BUFFER: 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 before use. Once diluted, stable for 1 week at room temperature, or for 2 weeks when stored at 2-8°C.
6. CHROM SOL A (1×8ml per vial)
CHROMOGEN SOLUTION A: Colorless liquid filled in a white vial with green screw cap. Urea peroxide solution. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
7. CHROM SOL B (1×8ml per vial)
CHROMOGEN SOLUTION B: Colorless liquid filled in a black vial with black screw cap. TMB (Tetramethyl benzidine), N,N- dimethylformamide. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
8. STOP SOL (1×8ml per vial)
STOP SOLUTION: Colorless liquid in a white vial with yellow screw cap.
Diluted sulfuric acid solution (0.5M H2SO4).
Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
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 the 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.
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