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Epic Test Code LAB4400 Syphilis Treponema Pallidum Total Antibody Assay with Reflex

Performing Location(s)

BMC

Synonyms

Treponemal Antibody IgG and IgM, syphilis antibody

Specimen Type

Serum

Preferred Container

Gold or Red top

Blood Tube Draw Volume

Min 50% draw volume  

Minimum Volume to Submit for Testing

2 mL Serum

Separate tube is required to perform the test and subsequent reflex testing based on the Reverse Sequence Algorithm for Diagnosis of Syphilis.  

Storage Requirements

Primary specimen tubes should be centrifuged within 2 hours of collection followed by transfer of the serum to a labeled plastic, aliquot tube. See Causes of Rejection for temperature requirements.

Transportation Needs

 Deliver specimen to laboratory within 1 hour of collection if unspun. If not possible see "storage Requirements". 

Causes for Rejection

Mislabeled or unlabeled specimen
Less than 50% draw for Vacutainer tubes
Spun or Unspun sample >7 days at 2-8 °C

Spun or Unspun sample >3 days at Room Temperature

Hemolysis > 500 mg/dL HgB
Lipemia > 3000 mg/dL Trig
Bilirubin > 20 mg/dL Bili
Total Protein >12 g/dL

EDTA, Heparin, NaF, Citrate, Oxalate

Limitations

  • In accordance with CDC guidelines, Syphilis TP testing should not be performed on infants aged <30 days.  Order an RPR (LAB494) and batch to OCH if needed.
  • False reactive results can be expected with any test kit based on specificity of the test kit, specimen integrity and the characteristics of the local population being screened
  •  A nonreactive treponemal test result does not exclude the possibility of exposure to or infection with syphilis.
  • A reactive test result for treponemal antibodies is not diagnostic of syphilis without additional serologic testing and a full clinical evaluation.
  • This test cannot distinguish between active and treated infection
  • 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.

Reference Values

 

Diagnostic considerations should be based on treponemal and nontreponemal testing as described in the Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guidelines, 2015.3.  The testing and reporting protocol for Syphilis TP Total Antibody is as follows:
 

Value S/CO

Reported as:

Interpretation

<1.00

Non-Reactive

A nonreactive result does not exclude the possibility of exposure to or infection with syphilis, nor rule out incubating or early primary infection

≥1.00

Reactive

A reactive result for treponemal antibodies is not diagnostic of syphilis without additional serologic testing and a clinical evaluation. Specimen is reflexed to second tier (RPR) testing.

 

Interpretation Table

Patient history

Test and result

Interpretation

Follow-up

TP Ab

RPR

TP-PA

Unknown history of syphilis

Non-reactive

N/A

N/A

No serologic evidence of syphilis

None, unless clinically indicated  (eg, early syphilis)

Reactive

Reactive

N/A

Untreated or recently treated syphilis

See CDC treatment guidelines 

Reactive

Non-reactive

Non-reactive

Probable false-positive screening test

No follow-up testing, unless clinically indicated

Reactive

Non-reactive

Reactive

Possible syphilis (eg, early or latent) or previously treated syphilis

Historical and clinical evaluation required

Known history of syphilis

Reactive

Non-reactive

Reactive or N/A

Past, successfully treated syphilis

Prior syphilis confirm treatment history

TP Ab, Treponemal Antibody; N/A, not applicable; RPR, rapid plasma reagin; TP-PA, Treponema pallidum particle agglutination.

 

Reflex Testing

A confirmatory RPR (Rapid Plasma Reagin) (OCH Lab test, LAB494) is required for every Reactive result, and will be auto-reflexed. When an RPR screen is Negative, the specimen will be sent to the reference laboratory for confirmatory testing TP-PA (LAB3599). If needed, the laboratory will contact patient for redraw.

 

 

Includes

Qualitative determination of Syphilis antibodies (IgG and IgM) directed against Treponema pallidum (TP) in human serum.  See Reflexive Testing above

Days of Analysis

All

Available STAT

No

Additional Information

Syphilis is a NYSDOH reportable disease. The NYSDOH will be notified of all positive cases. This test is not available on a STAT basis or off-hours, weekends or holidays. If an emergency request is necessary, call 3731 for availability. Pathologist approval may be required.

Methodology

Chemiluminescent Microparticle Immuno Assay

CPT Code

86780, if reflexed add 86592 and/or 86780

Last Updated

18-Mar-22 KT