The Calbiotech Treponima pallidum IgM ELISA Kit is intended for the detection of IgM antibody to Treponima pallidum in human serum or plasma.

Treponema pallidum is the causative agent of syphilis a contagious and infectious systemic disease characterized by periods of active florid manifestations and by years of symptomless latency. Syphilis is traditionally classified as acquired or congenital, each being further subdivided on the basis of the natural course of the disease. In acquired syphilis, infection is usually transmitted by sexual intercourse. The incubation period of syphilis can vary from 1 to 13 weeks, but usually from 3 – 4 weeks. Untreated patients with primary or secondary syphilis having active lesions are the most infectious, and the risks of contagion are greatest during the first 2 years of infection. Virtually every organ and tissue of the body is affected, including most body fluids. Over 80% of patients have mucocutaneous lesions, 50% have generalized enlargement of the lymph nodes, and about 10% have lesions of the eyes, bones and joints, meninges, liver, and spleen. 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 the placenta. Clinical manifestations may be present at birth but are more often seen at 3 weeks to 6 months of age. Two types of antibodies are produced by T. pallidum: nontreponemal antibodies (reagin) and treponemal antibodies. ELISA for detection of IgG and IgM antibodies is becoming the Gold standard for the diagnosis of syphilis.

Diluted patient serum (serum diluent contains sorbent to remove Rheumatoid Factor and human IgG interference) is added to wells coated with purified antigen. IgM specific antibody, if present, binds to the antigen. All unbound materials are washed away and the enzyme conjugate is added to bind to the antibody-antigen complex, if present. Excess enzyme conjugate is washed off and substrate is added. The plate is incubated to allow the hydrolysis of the substrate by the enzyme. The intensity of the color generated is proportional to the amount of IgM specific antibody in the sample.