【Product Name】 Dection Kit for treponema pallidum antibody (Enhanced chemiluminescence immunoassay)

【registration certificate number】 国械注准20163401109

      This product is used for the qualitative detection of treponema pallidum (anti-TP) in human serum in vitro.

      Treponema (TP) is slender, 5-15 x 0.1-0.2um, resembling fine spring, spiral bending rule, an average of 8-14, both ends pointed straight. Under the electron microscope showed treponema pallidum structure is complex, from outside to inside is divided into: outer membrane (mainly composed of protein, sugar and lipid), axis wire (mainly composed of protein), cylindrical bacteria (including cell wall, cell membrane and cytoplasm contents), general dyes are not easily colored. Treponema pallidum has a life cycle, divided into particle phase, spherical body phase and spiral body phase, an average of about 30 hours proliferation of generation, the life cycle is related to    the disease cycle, the insidious onset and chronic course of the disease.

       This kit uses double antigen sandwich method. Microplate was pre-coated with high-purity recombinant Treponema pallidum antigen, add the sample to be tested, and then add horseradish peroxidase-labeled recombinant antigen. If there are antibodies to be detected, the complex antigen - antibody - enzyme antigen will form. Add luminescent substrate and HRP to generate luminescent signal.

一. Clinical stages:

Early syphilis: infection time within 2 years, including primary syphilis, secondary syphilis, and early latent syphilis.

Late syphilis: infection time at more than 2 years, also known as tertiary syphilis.

Latent syphilis: no symptoms in clinic, but blood test is abnormal .

Congenital syphilis: Early, 2 years old, it is similar to secondary syphilis; Late, 2 years old, it is similar to tertiary syphilis; Congenital latent syphilis (<2 years old is an early congenital latent syphilis, greater than 2 years old is congenital latent syphilis)

二．Symptoms:

Syphilis is the most complicated venereal disease, but its treatment is relatively simple.

The characteristics of primary syphilis: a typical clinical manifestations occurred after injection 2-4 weeks is the appearance of chancre: the wine hard lump of genital sites appear, shallow ulcer, painless, with chondroid hardness, 1-2 cm in diameter, perimeter uplift the middle sag, the surface is clean, no dirt, no seepage discharge and the surrounding lymph node enlargement, it will heal itself after 2-6 weeks.

The characteristics of secondary syphilis: syphilitic rash usually occurs 3 to 4 weeks after the fade of the chancre, equivalent to 9 to 12 weeks after infection.Secondary syphilis is Treponema pallidum through the lymph nodes into the bloodstream and cause extensive damage to the body. In addition to causing skin damage, it can also infringe the internal organs and nervous system.

The second stage of syphilis can have influenza-like syndrome (headache, low heat, limb acid trapped) before the rash, which lasts for about 3-5 days and then subsides after the rash.

The skin damage of secondary syphilis can be divided into whole body skin, mucous membrane occurrence symmetrical rash, spot rash, papule, pustule rash and so on. Mucous membrane can produce mucosal spot, flat wet wart, its infectivity is strong.

Tertiary syphilis.Happened in 2 ~ 3 years or even 10 years after the infection, the skin is gum-like swollen, it still can involve bones, joints, heart, blood vessels, it is manefested as aortic inflammation, aortic valve insufficiency, aortic aneurysm and so on, invasion of the nerves can cause spinal tuberculosis, and the whole body paralysis (paralytic dementia). Congenital syphilis is an early congenital syphilis, which is equal to the second phase, but it is heavier. Late congenital syphilis is similar to the acquired, but rarely occurs in the heart, blood vessels and neuropathy. It is mainly for the substantial keratitis, the nerve deafness, the hutchinson's teeth (the central incisor of the upper incisors, the lower is big, the width is equal), the pedicle tibia and so on.

The characteristics of tertiary syphilis are as follows:

① Occurred late (2-15 years after infection), long course of disease, if it is not treated, it can maintain as long as 10-30 years, or even life;

② The symptoms are complex and can involve any tissue organ, including the skin, mucous membrane, bone, joint and internal organs. It is more likely to infringe the nervous system and it is easily confused with other diseases and difficult to diagnose.

③ In the body and skin lesions, there is little treponema pallium, and the  infectivity is weak, but the destruction of tissue is strong, which often leads to tissue defects and organ damage, which can lead to disability and even life.

④ Although the treatment is effective, the damaged tissue organ cannot be repaired.

⑤ The serum reaction of syphilis was not stable, the negative rate was over 30%, and the cerebrospinal fluid was often changed.

Latent syphilis (recessive syphilis): according to the course of disease is divided into the early stage (the course is less than 2 years) and the late stage (the course is more than 2 years), there is no clinical symptom, but the serological test is positive.

Congenital syphilis (it is certainly that mother has syphilis).

Clinical laboratory, physical examination center.