Description
INTENDED USE
The Calbiotech Treponima pallidumIgG ELISA Kit is intended for the detection of IgG antibody to Treponimapallidum in human serum or plasma.
SUMMARY AND EXPLANATION OF THE TEST
Treponema pallidum is the causative agent of syphilis a contagious andinfectious systemic disease characterized by periods of active floridmanifestations and by years of symptomless latency. Syphilis is traditionallyclassified as acquired or congenital, each being further subdivided on thebasis of the natural course of the disease. In acquired syphilis, infection isusually transmitted by sexual intercourse. The incubation period ofsyphilis can vary from 1 to 13 weeks, but usually from 3 – 4weeks. Untreated patients with primary or secondary syphilis having activelesions are the most infectious, and the risks of contagion are greatest duringthe first 2 years of infection. Virtually every organ and tissue of thebody is affected, including most body fluids. Over 80% of patients havemucocutaneous lesions, 50% have generalized enlargement of the lymph nodes, andabout 10% have lesions of the eyes, bones and joints, meninges, liver, andspleen. Mild constitutional symptoms of malaise, headache, anorexia,nausea, aching pains in the bones, and fatigability are often present.Congenital syphilis is the result of passage of T. pallidum across theplacenta. Clinical manifestations may be present at birth but are moreoften seen at 3 weeks to 6 months of age. Two types of antibodies areproduced by T. pallidum: nontreponemal antibodies (reagin) andtreponemal antibodies. ELISA for detection of IgG and IgM antibodies isbecoming the Gold standard for the diagnosis of syphilis.
PRINCIPLE OF THE TEST
Diluted patient serum is added to wells coatedwith purified antigen. IgG specific antibody, if present, binds to theantigen. All unbound materials are washed away and the enzyme conjugate isadded to bind to the antibody-antigen complex, if present. Excess enzymeconjugate is washed off and substrate is added. The plate is incubated toallow the hydrolysis of the substrate by the enzyme. The intensity of thecolor generated is proportional to the amount of IgG specific antibody in thesample.
