Syphilis: Treponemal Antibodies With Reflex to RPR and RPR Titer, Reverse Screening and Diagnosis Algorithm

Treponema pallidum (Syphilis) Screening Cascade
Syphilis: Treponemal Antibodies With Reflex to RPR and RPR Titer, Reverse Screening and Diagnosis Algorithm
TEST: 082345
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CPT: 86780
Updated on 09/19/2023
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Synonyms

  • Syphilis
  • Trep-Sure™
  • Treponemal

Test Includes

Reflex to qualitative rapid plasma reagin (RPR) on positives

Expected Turnaround Time

1 - 4 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Documents

For more information, please view the literature below.

Improved Syphilis Reverse Screening Cascade: Earlier Detection With Fewer Ambiguous Results

Specimen Requirements

Specimen

Serum

Volume

1 mL

Minimum Volume

0.5 mL (Note: This volume does not allow for repeat testing.)

Container

Red-top tube or gel-barrier tube

Storage Instructions

Room temperature

Room temperature

Room temperature

Room temperature

Room temperature

Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Causes for Rejection

Hemolysis; lipemia; gross bacterial contamination; plasma specimen

Test Details

Use

This test is intended to support screening and diagnosis of syphilis infections. This test aligns with the CDC-supported reverse serologic testing algorithm for syphilis using a combination of both treponemal and nontreponemal antibody tests. The reverse syphilis testing algorithm begins with a treponemal antibody assay. Positive samples reflex to RPR (nontreponemal). If the RPR is positive, RPR titer will be determined. If the RPR is negative, a second treponemal antibody assay will be performed to confirm the presence of treponemal antibodies. Interpretation of results obtained must take into account patient symptoms and clinical history.

Serological test for screening for syphilis infection. This panel includes a Treponema-specific test which may be positive in all stages of syphilis. It may be positive with treponemal infections other than syphilis (bejel, pinta, yaws). Like FTA-ABS and TP-PA, once positive, it remains so; it cannot be used to judge the effectiveness of treatment.

This test is intended to support screening and diagnosis of syphilis infections. This test aligns with the CDC-supported reverse serologic testing algorithm for syphilis using a combination of both treponemal and nontreponemal antibody tests. The reverse syphilis testing algorithm begins with a treponemal antibody assay. Positive samples reflex to RPR (nontreponemal). If the RPR is positive, RPR titer will be determined. If the RPR is negative, a second treponemal antibody assay will be performed to confirm the presence of treponemal antibodies. Interpretation of results obtained must take into account patient symptoms and clinical history.

Limitations

Treponemal antibodies typically persist for life despite treatment; thus, this assay cannot be used to monitor reponse to treatment or to assess treatment outcomes. False positive treponemal antibody results have been observed in individuals with nonsyphilis treponemal infections (bejel, pinta, yaws).

The test is not applicable to CSF.

Treponemal antibodies typically persist for life despite treatment; thus, this assay cannot be used to monitor reponse to treatment or to assess treatment outcomes. False positive treponemal antibody results have been observed in individuals with nonsyphilis treponemal infections (bejel, pinta, yaws).

Methodology

Enzyme immunoassay (EIA) with reflex to charcoal flocculation if reactive

Additional Information

Treponemal antibody (CIA)

RPR

RPR titer

Treponemal antibody (EIA)

Interpretation

Nonreactive

Not done

Not done

Not done

No laboratory evidence of syphilis. If recent exposure is suspected, submit a new sample for testing in 2-4 weeks.

Reactive

Nonreactive

Not done

Nonreactive

Treponemal antibodies not confirmed. Inconclusive for syphilis; potential early syphilis, possible false positive. If recent exposure is suspected, submit a new sample for testing in 2-4 weeks. If clinical suspicion is low no further evaluation is necessary.

Reactive

Nonreactive

Not done

Reactive

Treponemal antibodies detected. Consistent with past or current (potential early) syphilis. Clinical evaluation should be performed to identify current signs and symptoms or past history of infection. If past history of treatment reported, no further management is needed unless symptomatic or recent exposure suspected. If no symptoms or past history of treatment, and if recent exposure is suspected, submit a new sample for testing in 2-4 weeks.

Reactive

Reactive

1:1 or greater

Not done

Treponemal and nontreponemal antibodies detected. Consisted with current or pasy syphilis. Clinical evaluation should be performed to identify current signs and symptoms or past history of infection.

References

Association of Public Health Laboratories (APHL). Suggested Reporting Language for Syphilis Serological Testing, 2nd ed. August 2020. Accessed via APHL website at https://www.aphl.org/programs/infectious_disease/std/Pages/Syphilis.aspx.
Workowski KA, Bachman LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187.34292926
Association of Public Health Laboratories Laboratory Diagnostic Testing for Treponema pallidum: Expert Consultation Meeting Summary Report. Atlanta, Ga, January 13-15, 2009.
Ballard R. Changing Times in Syphilis Serology. Atlanta, Ga: Centers for Disease Control and Prevention, Association of Public Health Laboratories, Laboratory Learning Links Teleconference Series, 2008.
Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance, 2008. Atlanta, Ga: CDC, November 2009.
Cox DL. Letter to Phoenix Biotech, April 21, 2006. Cited with permission.
Dang Q, Feng J, Lu X, et al. Evaluation of specific antibodies for early diagnosis and management of syphilis. Int J Dermatol. 2006 Oct; 45(10):1169-1171.17040431
Knight CS, Crum MA, Hardy RW. Evaluation of the LIAISON chemiluminescence immunoassay for diagnosis of syphilis. Clin Vaccine Immunol. 2007 Jun; 14(6):710-713.17460119
Lehnus & Associates Consulting. K053570-Response 1 for TREP-SURE Treponemal Antibody EIA. [letter] East Stroudsburg, Pa: Lehnus, May 4, 2006.
Miranda APF, Sato NS. Profile of anti-Tp47 antibodies in patients with positive serology for syphilis analyzed by Western blot. Braz J Infect Dis. 2008 Apr; 12(2):139-143.18641851
Sambri V, Marangoni A, Eyer C, et al. Western immunoblotting with five Treponema pallidum recombinant antigens for serologic diagnosis of syphilis. Clin Diagn Lab Immunol. 2001 May; 8(3):534-539.11329453
Singh AE, Wong T, De P. Characteristics of primary and late latent syphilis cases which were initially nonreactive with the rapid plasma reagin as screening test. Int J STD AIDS. 2008 Jul; 19(7)464-468.18574118
Sloma CR, Stier TJ, Majewski DW, et al. Comparative evaluation of Capture®-S and TREP-SURE™ assays for serologic detection of syphilis in blood donors, May 11, 2007, abstract N° 07-AB-407-AABB.
Stanford Hospital and Clinics, Stanford Medical Center. New ELISA screening for syphilis . . . flipping the treponemal paradigm. Lab Letter. 2007 Nov-Dec; 3(4):1-2.
Tramont EC. Treponema pallidum (Syphilis). In: Mandell GL, Douglas RG Jr, Bennett JE, eds. Principles and Practice of Infectious Diseases. 2nd ed. Hoboken, NJ: John Wiley & Sons;1985.
TREP-SURE™, Anti-Treponema EIA Screen. [Package insert] Mississauga, Ontario, Canada: Phoenix Bio-Tech; 2010.
US Preventive Services Task Force. Screening for syphilis infection in pregnancy: US Preventive Services Task Force reaffirmation recommendation statement. Ann Intern Med. 2009 May 19; 150(10)705-709.19451577
Association of Public Health Laboratories (APHL). Suggested Reporting Language for Syphilis Serological Testing, 2nd ed. August 2020. Accessed via APHL website at https://www.aphl.org/programs/infectious_disease/std/Pages/Syphilis.aspx.
Workowski KA, Bachman LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187.34292926

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
082345 T pallidum Screening Cascade 47236-5 082356 T pallidum Antibodies 47236-5
Reflex Table for T pallidum Antibodies
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 006099 RPR 006097 RPR 20507-0
Reflex 2 006476 RPR, Quant 006476 RPR, Quant 31147-2
Reflex Table for T pallidum Antibodies
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 006099 RPR 006097 RPR 20507-0
Reflex 2 163038 T pallidum Antibody, EIA 163038 T pallidum Antibody, EIA 34147-9

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