Treponema Pallidum (Syphilis) IgG ELISA Kit

Full Name: Treponema Pallidum (Syphilis) IgG ELISA Kit
Reactivity: Human
Sample Type: Serum
Sensitivity: 0.69 U/mL

BACKGROUND

Treponema pallidum is a spirochaete bacterium which consists of many sub-species and these are responsible for causing many treponemal diseases for example syphilis, pinta, bejel or yaws. They are helically coiled microorganism which are 0.1–0.2 µm (width) and 6–15 µm (long), also consisting of a cytoplasmic and an outer membrane. Currently, there are 4 known sub-species Treponema pallidum pallidum (causes syphilis), T. p. carateum (causes pinta), T. p. endemicum (causes endemic syphilis or bejel) and T. p. pertenue (causes yaws).

T. p. pallidum is a motile spirochaete which is usually acquired as a results of sexual contact, it is able to enter the host through columnar epithelium or breaches in squamous. This can be transmitted to the fetus via the transplacental passage during the last stages of pregnancy (known as congenital syphilis). Clinically syphilis is difficult to diagnose early, its confirmation tends to be either through blood tests or by using microscopy methods in order to make a direct visual inspection. However, it is not possible to distinguish the different stages of the disease using these diagnostic tests.

INTENDED USE

Human syphilis IgG ELISA kit is intended for detecting levels of human IgG class of antibodies against treponema pallidum (syphilis-IgG) using serum. This assay has a minimum analytical sensitivity limit of 0.69 U/mL.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

Treponema Pallidum Coated Microplate (IgG).
Negative Control (Cal. A).
Cut-Off Control (Cal. B).
Positive Control (Cal. C).
Conjugate.
Sample Diluent.
TMB Substrate Solution.
Washing Buffer (20x Concentrated).
Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of human IgG against treponema pallidum (syphilis-IgG) using this syphilis IgG ELISA kit was 0.69 U/mL. The dynamic assay range for this kit is 0.69 U/mL – 60 U/mL.

ASSAY CHARACTERISTICS

– Negative: < 9 U
– Cut-Off: 10 U
– Equivocal: 9 – 11 U
– Positive: > 11 U
– Assay Dynamic Range: 0.69 U/mL – 60 U/mL.
– Analytical Sensitivity: 0.69 U/mL.
– Specificity of Antigen (Cross Reactivity): No cross-reactivity to Fasciola, Strongyloides, Ascaris, Schistosoma, Trichinella and Giarda lamblia.
– Interfering Substances: Haemoglobin (up to 4 mg/mL), Bilirubin (up to 0.5 mg/mL) and Triglyceride (up to 30 mg/mL) have no influence on the assay results.

REFERENCES

Establishment and Evaluation of a One-Step Microplate Chemiluminescence Immunoassay to Detect IgG Antibody Against Treponema Pallidum. J Clin Lab Anal. (2015) 29 (6): 493-7. Liu L., et al.
Treponema pallidum-specific antibody expression for the diagnosis of different stages of syphilis. Chin Med J (Engl). (2013) 126 (2): 206-10. Sun R., et al.
Changes of serum IgG antibody reactivity to protein antigens of Treponema pallidumin-syphilis patients after treatment. J Korean Med Sci. (1989) 4 (2): 63-9. Kim D.K., et al.
Ig class and IgG subclass responses to Treponema pallidumin patients with syphilis. J Clin Immunol. (1988) 8 (2): 128-39. Baughn R.E., et al.
Use of the Treponema pallidum-specific captia syphilis IgG assay in conjunction with the rapid plasma reagin to test for syphilis. J Clin Microbiol. (1997) 35 (5): 1141-3. Reisner B.S., et al.

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