Syphilis

Reverse testing algorithm

Primary stage Secondary stage Latent stage Tertiary stage
Symptoms painless genital ulcers (chancre)
  • Skin rash covering the whole body (25 % of infected)
  • Fever, generalized lymphadenopathy, hepatitis, spleno-megaly, periostitis, arthritis, and glomerulonephritis are possible
asymptomatic 10 % of untreated patients:
  • Gummatous syphilisa
  • Late neurosyphilisb
  • Cardiovascular syphilisc
Treponemal IgM rising high declining negative
Treponemal IgG rising high high high
Non-treponemal IgM/IgG* rising high high (untreated)
declining (treated)
high (untreated)
low (treated)

* antibodies against cellular lipids (mostly cardiolipin)
a Nodules/plaques or ulcers.
b Meningitis, cranial nerve dysfunction, meningovascular syphilis (stroke, myelitis), and parenchymatous neurosyphilis (general paresis, tabes dorsalis).
c Aortic regurgitation, stenosis of coronary ostia, and aortic aneurysm.

Adapted from:

  1. U.S. Department of Health and Human Services, Department of Health and Human Services, Centers for Disease Control and Prevention (CDC). Syphilis CDC Fact Sheet. [Internet; updated 2023 Apr; cited 2023 Nov]. Available from: https://www.cdc.gov/std/syphilis/stdfact-syphilis-detailed.htm.
  2. Peeling RW and Ye H. Diagnostic tools for preventing and managing maternal and congenital syphilis: an overview. Bull World Health Org. 2004;82:439-46.
Product Description Tests Product page
Elecsys® Syphilis a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of total antibodies against bacterial TpN15, TpN17 and TpN47 in human serum and plasma 100
Elecsys® Syphilis a) 200
Elecsys® Syphilis b) 300
RPR2 c) lmmunoturbidimetric assay for the quantitative determination of syphilitic anti-lipid antibodies in human serum and plasma 250
TPLA2 c) lmmunoturbidimetric assay for the quantitative determination of anti-Tregonema pallidum antibodies in human serum and plasma 250

a) for use on the cobas® e 411 analyzer and the cobas® e 601 / 602 modules
b) for use on the cobas 402 and cobas® e 801 analytical units
c) for use on the cobas® c 501/502 clinical chemistry analyzers

Adapted from:

  1. Peeling RW, et al. Syphilis. Nat Rev Dis Primers. 2017;3:17073.
  2. Janier M, et al. European Guideline on the Management of Syphilis. J Eur Acad Dermatol Venereol. 2014;28:1581-93.
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Step 1

Perform treponemal test

Treponemal test
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Step 2

Perform non-treponemal test

Non-treponemal test
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Step 3

Perform second treponemal test

Treponemal test
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Summary

No serologic evidence of syphilis

No further action is needed in most cases.
​​​​​​​Does not rule out incubating or early primary infection.

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Summary

Confirmed infection

​​​​​​​
Consider the clinical background and history of the patient before initiating treatment.

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Summary

Syphilis unlikely
Consider clinical picture and patient history as this result could represent an early infection if the first treponemal assay is more sensitive OR a false positive result from the first assay.

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Summary

Syphilis infection

Current untreated or previously treated infection

Clinical background and patient history, including past antibody titers, are necessary to determine whether the infection is past, current, or potentially early.

Step
Result
Interpretation
1
Treponemal test = ...
waiting for input
1

Treponemal test = non-reactive

No serologic evidence of syphilis

1

Treponemal test = reactive

Possible syphilis infection
​​​​​​​

Perform non-treponemal test.

2
Non-treponemal test = ...
waiting for input
2

Non-treponemal test =
​​​​​​​non-reactive

Treated syphilis, very recent infection, or biological false positive treponemal test result
Perform second treponemal test. The second treponemal test should utilize a unique platform and/or antigen, different than the first treponemal test.

2

Non-treponemal test = reactive

Confirmed syphilis infection​​​​​​​

3
2nd treponemal test = ...
waiting for input
3

2nd treponemal test =
​​​​​​​non-reactive

Syphilis unlikely

Consider clinical picture and patient history as this result could represent an early infection if the first treponemal assay is more sensitive OR a false positive result from the first assay.

3

2nd treponemal test = reactive

Syphilis infection​​​​​​​

End of test sequence