CDC Immigration Requirements: Technical Instructions for Syphilis for Panel Physicians

Preface

The medical screening for syphilis among aliens applying for immigrant or refugee status, as well as non-immigrants who are required to have an overseas medical examination, hereafter referred to as applicants, is an essential component of the immigration-related medical evaluation. Because syphilis may be challenging to diagnose and treat, these Instructions provide panel physicians a method for recording findings from the medical examination, as well as provide additional guidance for the panel physician in classifying applicants.

The Instructions in this document supersede all previous Technical Instructions, Updates to the Technical Instructions, memoranda and letters to panel physicians, and memoranda and letters to international refugee resettlement organizations. These Instructions are to be followed for syphilis screening and treatment among all applicants, and are effective as of July 1, 2018.

Visit the Technical Instructions for Panel Physicians webpage for more information about the medical examination for applicants for U.S. immigration.

Key Concepts

  • All applicants 15 years of age or older must be tested for evidence of syphilis.
  • Applicants younger than age 15 must be tested if there is reason to suspect infection with syphilis or if there is a history of syphilis.

Syphilis Screening

Syphilis is a sexually transmitted, systemic disease caused by the bacterium Treponema pallidum subspecies pallidum. The disease has often been called “the great imitator” because of its wide variety of signs and symptoms, with different stages having different clinical manifestations. There are three infectious stages (primary, secondary, and early latent disease) and two noninfectious stages (late latent and tertiary disease). Untreated syphilis can progress and lead to serious long-term sequelae and, rarely, death.

Medical History

Obtaining the applicant’s medical history should include inquiring about prior history and treatment for syphilis; a sexual partner with syphilis; or any history of painless sores on the genitals, anus, or mouth or a rash on the body, especially on the palms of the hands or soles of the feet.

Physical Examination

If the history or serologic tests are suggestive, a physical examination may be warranted that should include an evaluation for mouth sores (chancres) or rashes on the body, particularly on the palms of the hands or soles of the feet (a characteristic of syphilis infection that is unusual in other conditions). A genital examination is not required unless the applicant has a medical history suggestive of recent syphilis diagnosis, physical examination findings consistent with early syphilis (e.g., rash, oral lesions), or positive nontreponemal and treponemal test results; these applicants should also undergo an evaluation for genital, anal, or perianal sores to help determine the stage of syphilis.  Sores consistent with syphilis are typically painless, indurated, clean-based genital, rectal or oral ulcers. Regional lymphadenopathy may be present in primary or secondary syphilis. Applicants with reactive serologic tests consistent with syphilis should be asked specifically about, and evaluated for clinical symptoms or signs suggestive of neurosyphilis (e.g., cranial nerve dysfunction, meningitis, stroke, acute or chronic altered mental status, loss of vibration sense, and auditory or ophthalmic abnormalities). Neurosyphilis can occur at any stage of infection.

Histories or clinical signs suggesting syphilis in children must be properly evaluated with serologic testing.  Physical examination findings of congenital syphilis in infants may include nonimmune hydrops, jaundice, hepatosplenomegaly, rhinitis, skin rash, and pseudoparalysis of an extremity. In older children, signs of untreated congenital infection may include interstitial keratitis (5-20 years of age), eighth cranial nerve deafness (10-40 years of age), Hutchinson teeth (peg-shaped, notched central incisors), anterior bowing of the shins, frontal bossing, mulberry molars, saddle nose, rhagades (linear scars around the mouth), and Clutton’s joints (symmetric, painless swelling of the knees).

Laboratory Testing

Although various laboratory testing approaches exist for syphilis screening, CDC continues to recommend the traditional testing algorithm starting with a nontreponemal test rather than a reverse testing algorithm starting with a treponemal test.  The traditional algorithm is the approach that must be used by panel physicians. All tests used by panel physicians must be conducted by appropriately trained technologists following standard operating procedures in a qualified laboratory that is enrolled in an external quality assurance program (e.g., proficiency testing) program.

A nontreponemal test (i.e., Venereal Disease Research Laboratory [VDRL] or Rapid Plasma Reagin [RPR]) should first be used for screening. Positive or reactive results on screening tests must have a quantitative titer result reported (e.g. 1:8) and documented on the Medical History and Physical Examination Worksheet (DS-3026).  Positive or reactive results on screening tests should be confirmed using a treponemal test.  The following tests are allowed to be used for confirmatory testing:  T. pallidum passive particle agglutination (TP-PA) assay, Treponema pallidum haemagglutination (TPHA) test, enzyme immunoassays (EIAs), chemiluminescence immunoassays (CIAs), fluorescent treponemal antibody absorbed (FTA-ABS) tests, immunoblots (use products of this test that are either approved by the U.S. Food and Drug Administration [FDA] or recommended by the World Health Organization [WHO]), or rapid treponemal assays (use products of this test that are either US FDA-approved or WHO-recommended).  Testing must be performed in this order.

Syphilis tests must be performed at the time of the screening medical examination and at the laboratory stated in the panel physician agreement. Tests performed elsewhere, or prior to the panel physician’s examination of the applicant, are not acceptable.

Children with history of physical stigmata suggesting syphilis infection should have a nontreponemal test performed, followed by a confirmatory treponemal test, if positive. Older infants (aged ≥1 month) and children who are identified as having reactive serologic tests for syphilis should have maternal serology and records reviewed to assess whether they have congenital or acquired syphilis and whether they have been previously treated. Any child at risk for untreated congenital syphilis should be treated, and recommended to have a full evaluation, which may include CSF analysis, complete blood count and differential, and long-bone radiographs, depending upon previous documented evaluation. Dark field microscopic examination of suspicious lesions or body fluids (e.g., nasal discharge) also should be performed. Panel physicians should refer to CDC’s Sexually Transmitted Diseases (STD) Treatment Guidelines for specific guidance on testing in children.

Testing for HIV should be recommended for all applicants diagnosed with positive nontreponemal and treponemal test results. The consent for HIV testing should include the following:

  • Applicants understand they do not have to be tested for HIV.
  • Applicants understand that if they would like to be tested for HIV, they do not have to be tested for HIV by a panel physician.
  • Applicants understand that panel physicians must include the test results on the paperwork they complete.

If the applicant consents, panel physicians should perform HIV testing.

Syphilis Screening Results and Travel Clearance

  • Applicants with a positive (or reactive) nontreponemal screening test (i.e. RPR or VDRL) and a negative treponemal-specific confirmatory test are No Class for syphilis.
  • Applicants with a positive (or reactive) nontreponemal screening test (i.e. RPR or VDRL) and a positive treponemal-specific confirmatory test are Class A for syphilis and will remain Class A until treated.
  • After completing treatment, applicants are classified as Class B.
  • The evaluation is complete when the required aspects of the medical examination have been completed and the applicant is assigned a syphilis classification.
  • Travel clearances for syphilis are valid for the same length of time as the applicant’s tuberculosis screening evaluation.

It is important that syphilis be correctly diagnosed. Correct diagnosis of syphilis will ensure that affected applicants receive appropriate treatment minimizing long-term sequelae and reducing further spread of the disease.

Table 1.  Nontreponemal and treponemal test results and syphilis classifications.

Nontreponemal and treponemal test results and syphilis classifications
Treponemal Test Results
Nontreponemal Test Results Reactive Non-Reactive
Reactive > 1:8
  • Likely false positive RPR or VDRL
  • Unlikely syphilis (If suggestive history or clinical signs, consider repeat treponemal test and non-treponemal titer)
  • No Class
Reactive < 1:8
  • Possible early syphilis
  • Possible serofast reaction
  • Possible very old, untreated syphilis
  • Class A
    See CDC STD Tx Guidelines
  • Likely false positive RPR or VDRL
  • No Class
Non-reactive
  • Treponemal tests should not be performed
  • No Class

Syphilis Treatment

Panel physicians must treat syphilis following CDC’s Sexually Transmitted Diseases (STD) Treatment Guidelines, which are periodically updated.

  • Details of testing and treatment must be provided on the Medical History and Physical Examination Worksheet (DS-3026).
  • Benzathine penicillin G (BPG) is the preferred treatment regimen for syphilis.  Although alternative regimens are known to be effective, applicants should be informed that BPG is the first-line recommendations in U.S. and WHO STD management guidelines.
  • No proven alternatives to injectable penicillin regimens are available for treating neurosyphilis, congenital syphilis, or syphilis in pregnant women. Therefore, infected applicants with a history of penicillin allergy who have neurosyphilis or congenital syphilis, or are pregnant are advised to be desensitized and treated with penicillin if appropriate facilities are available.

Treatment – Post Evaluation

  • Adult applicants treated for syphilis should be informed by panel physicians that they will need follow-up care for clinical and serologic re-evaluation in 6 months (3 months if HIV positive and treated for primary or secondary syphilis).
  • Children should receive follow-up care 2-3 months after treatment; this follow-up does not affect the examination validity period.

Waivers

  • A provision allows applicants undergoing treatment for syphilis to apply for a Class A waiver.
  • Waivers will become unnecessary after completion of treatment, as the applicant will be classified as Class B for syphilis.

A provision allows applicants with a Class A physical disorder to petition for a Class A waiver. If the applicant would like to pursue a waiver, an Application for Waiver of Grounds of Inadmissibility Form (I-601 or I-602 for immigrants or refugees, respectively) must be completed. These waivers are submitted to the Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) on an individual basis. The CDC Division of Global Migration and Quarantine (DGMQ) also reviews the waivers and supporting medical examination to provide an opinion regarding the case to the requesting entity (Department of State or DHS, USCIS). DGMQ’s review of the waiver and supporting medical examination documentation is to ensure that the applicant has been classified properly and that an appropriate U.S. healthcare provider is identified for the applicant. DHS, USCIS has the final authority to adjudicate the waiver request.

Documentation

  • All medical documentation, including any laboratory reports, must be included with the required DS forms.
  • Information recorded on the DS Forms should be in English and typed.
  • Applicants with Class A syphilis should be reported to the U.S. Embassy upon detection by sending all required medical documentation by courier or other secure means.

Department of State (DOS) forms Report of Medical Examination by Panel Physician (DS-2054), Vaccination Documentation Worksheet (DS-3025), Medical History and Physical Examination Worksheet (DS-3026), and Tuberculosis Worksheet (DS-3030) must be completed in their entirety and included in the applicant’s travel packet. This includes assigning a classification on the Report of Medical Examination by Panel Physician form if an applicant is Class A or Class B for syphilis. After completing treatment, the applicant’s classification should be changed from Class A to Class B for syphilis. Incomplete documentation may result in refusal to grant a visa or designation of medical hold status at arrival to U.S. ports of entry.

Please Note: On February 8, 2018, the Syphilis TIs were updated to reflect current laboratory testing to be consistent with CDC Treatment Guidelines.

For applicants requiring syphilis treatment prior to U.S. immigration, the panel physician is required to document the following:

  • Results of treponemal and non-treponemal tests, including titers for nontreponemal tests.  Type of test used should be noted
  • Stage of syphilis based on history and clinical findings
  • Drug regimen received (including doses, dosage units, and administration routes of all medications), start date, completion date, and any periods of interruption.
  • Clinical course, such as clinical improvement or lack of improvement during and after treatment for primary or secondary syphilis, including resolution of symptoms and signs and any drug reactions.

Glossary of Abbreviations

Glossary of Abbreviations
Acronym Full Phrase
CDC Centers for Disease Control and Prevention, United States
CIA Chemiluminescence immunoassay
CSF Cerebral spinal fluid
DGMQ Division of Global Migration and Quarantine
DHS Department of Homeland Security
DOS Department of State
EIA Enzyme immunoassay
FTA-ABS Fluorescent treponemal antibody absorbed
HIV Human immunodeficiency virus
RPR Rapid plasma reagin
STD Sexually transmitted disease
TP-PA T. pallidum passive particle agglutination assay
USCIS United States Citizenship and Immigration Services
U.S. FDA U.S. Food and Drug Administration
VDRL Venereal Disease Research Laboratory
WHO World Health Organization