Treponema Pallidum (Syphilis) IgM ELISA Kit

Full Name: Treponema Pallidum (Syphilis) IgM ELISA Kit
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: 0.52 DU/mL

BACKGROUND

Treponema pallidum consists of 4 subspecies namely; Treponema pallidum pallidum, T. p. endemicum, T. p. carateum and T. p. pertenue. It is a spirochaete bacterium that is helically coiled between 6–15 µm in length and 0.1–0.2 µm in width which can cause a number of treponemal diseases that include syphilis, bejel, yaws and pinta.

T. p. pallidum is a motile spirochaete which in majority of cases can be caught due to sexual contact where it is able to enter the host via breaches in squamous or through columnar epithelium. It is a disease that is difficult to diagnose early, standard methods such as blood testing and microscopy are used for detection.

INTENDED USE

Human syphilis IgM ELISA kit is a procedure designed for analysing amounts of IgM-class antibodies against treponema pallidum (syphilis-IgM) using serum or plasma samples. This assay has a minimum analytical sensitivity limit of 0.52 DU/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 (IgM).
Sample Diluent.
IgG-RF-Sorbent.
Cut-Off Control (Cal. B).
Negative Control (Cal. A).
Positive Control (Cal. C).
Enzyme Conjugate.
TMB Substrate Solution.
Washing Buffer (20x Conc.).
Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of human IgM against treponema pallidum (syphilis-IgM) using this treponema pallidum IgM ELISA kit was 0.52 DU/mL. The dynamic assay range for this kit was 0.52 – 60 DU/mL.

ASSAY CHARACTERISTICS

– Equivocal: 9 – 11 U
– Cut-Off: 10 U
– Positive: > 11 U
– Negative: < 9 U
– Assay Dynamic Range: 0.52 – 60 DU/mL.
– Analytical Sensitivity: 0.52 DU/mL.
– Specificity of Antigen (Cross Reactivity): No cross-reactivity to Epstein Barr Virus (VCA), Mycoplasma pneumonia, and Borrelia burgdorferi IgM antibodies.
– Interfering Substances: In general, haemolytic, icteric or lipaemic samples should be avoided, but can be tolerated up to at least 4 mg/mL haemoglobin, 0.5 mg/mL Bilirubin, and 30 mg/mL triglycerides.

REFERENCES

Usefulness of IgM-specific enzyme immunoassays for serodiagnosis of syphilis: comparative evaluation of three different assays. J Infect. (2013) 67 (1): 35-42. Bosshard P.P.
Further evaluation of the characteristics of Treponema pallidum-specific IgM antibody in syphilisserofast reaction patients. Diagn Microbiol Infect Dis. (2011) 71 (3): 201-7. Lin L.R., et al.
Early syphilisin a man with a negative Treponema_pallidum enzyme immunoassay-IgM. Int J STD AIDS. (2011) 22 (9): 529-30. McCarty E.J., et al.
Antigens of Treponema pallidum recognized by IgG and IgM antibodies during syphilis in humans. J Infect Dis. (1985) 151 (2): 264-72. Baker-Zander S.A., et al.
Solid-phase hemadsorption assay for IgM antibody to Treponema-pallidumin serum and umbilical cord blood. Clin Lab Sci. (1990) 3 (5): 341-3. Tiensiwakul P.

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