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Test Code SYPHSCRN Syphilis Screen Total Antibodies with Reflex, Serum

Additional Codes

Cerner

NextGen

Syphilis Screen Total Ab w/Reflex, Serum

Syphilis Screen Total Ab w/Reflex, Serum

Alternate Name(s)

T. pallidum antibody

Treponemal

Useful For

Syphilis is a sexually transmitted bacterial disease caused by the spirochete Treponema pallidum. Symptoms, particularly in the early stages of infection, may be mild. In the early stages (primary syphilis) symptoms include a small, painless, but highly infectious sore, with swelling in nearby lymph nodes. The sore develops ten days to three months after infection and lasts for two to six weeks. A few weeks after the sore disappears, the next stage (secondary syphilis) develops. Symptoms include a sore throat or a non-itchy skin rash, often on hands and feet. This stage resolves in a few weeks. Symptoms may come and go but the disease can remain latent and symptomless for years. If diagnosed early, syphilis can be easily treated with antibiotics, however, if it is not treated, syphilis can progress to a more dangerous form or the disease (tertiary syphilis) causing serious conditions such as stroke, paralysis, blindness or even death. The infection may be passed congenitally from mother to unborn child, causing birth defects or fetal death. Serological tests for Treponema pallidum may aid in the early diagnosis of syphilis. Specific IgM is detectable towards the end of the second week of infection and IgG after about four weeks. By the time symptoms develop most patients have detectable anti-treponemal antibodies. Current serological tests include the non-treponemal Venereal Disease Reference Lab (VDRL) test, the Rapid Plasma Reagin (RPR) test, and the more specific anti-treponemal fluorescent treponemal antibody-absorbed test (FTA-abs) and enzyme immunoassay (EIA) tests. More recently, EIAs using recombinant Treponema pallidum proteins have been introduced. The presence of antibodies to Treponema pallidum (TP) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of syphilis infection.

Methodology

Immunometric technique is used.

Patient Preparation

None

Collection Instructions

Standard phlebotomy practices.

Specimen Requirements

Container

Serum

 or 

 

Stability

Storage

Temperature

Stability

Room Temperature

<30°C

≤ 7 days

Refrigerated

 2-8°C

≤ 7 days

Frozen

≤-20 °C

4 weeks, up to 5 freeze-thaw cycles

Rejection Criteria

Lipemic Specimen

Result Reporting and Reference Values

Reference Range

Non-reactive, all ages/genders

State Reporting

All Reactive results will be reported to the State through the Laboratory Information System automatically.

Reflex Testing

Limitations

  • The results from this or any other diagnostic test should be used and interpreted only in the context of the overall clinical picture. A non-reactive test result does not exclude the possibility of recent exposure to Treponema pallidum. Levels of anti-Treponema pallidum antibodies may be below the cutoff in early infection.
  • A reactive test result for treponemal antibodies is not diagnostic of syphilis without additional serologic testing and a full clinical evaluation.
  • False reactive results can be expected with any test kit. The proportion of these falsely reactive specimens is dependent upon the specificity of the test kit, specimen integrity, and the characteristics of the local population being screened.
  • Results in samples from immunosuppressed patients or from patients with disorders leading to immunosuppression should be interpreted with caution.
  • The detection of treponemal antibodies may indicate recent, past, or successfully treated syphilis. This test cannot distinguish between active and treated infection and therefore may not be used to determine response to therapy, relapse, or reinfection.
  • Assay interference due to circulating antibodies against yaws, pinta, and bejel has not been evaluated. Cross-reactivity with these treponemal disease conditions is to be expected with treponemal antibody tests.
  • A non-reactive test result does not completely rule out the possibility of an infection with Treponema pallidum. Serum or plasma samples from very early (pre-seroconversion) phase or the late phase of a syphilis infection can occasionally yield negative findings.
  • Heterophilic antibodies in serum or plasma may cause interference in immunoassays. These antibodies may be present in blood samples from individuals regularly exposed to animal or who have been treated with animal serum products. Results which are inconsistent with clinical observations indicate the need for additional testing.
  • Certain drugs and clinical conditions are known to alter antibody concentrations in vivo. For additional information, consult the laboratory.

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