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CDC Immigration Requirements: Technical Instructions for Syphilis for Civil Surgeons

Preface

The medical screening for syphilis among persons applying for adjustment of status to permanent resident and others required by law to have a 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 civil surgeons with a method for recording findings from the medical examination onto Form I-693, Report of Medical Examination and Vaccination Record, and provide additional guidance for the civil surgeon in classifying applicants.

The Instructions in this document supersede all previous Technical Instructions, Updates to the Technical Instructions, memoranda and letters to civil surgeons. 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 Civil Surgeons webpage for more information about the medical examination of applicants conducted in the United States.

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 or 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 civil surgeons. All tests used by civil surgeons 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 Form I-693 at Part 7, Civil Surgeon Worksheet, Section 1B. Communicable Diseases, Syphilis.  Positive or reactive results on screening tests should be confirmed using a treponemal test.  The following tests are permitted 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 testing must be performed at the time of conducting the immigration medical examination. Civil surgeon sites that are independent of US health departments must not refer applicants to a health department for syphilis testing; all screening and confirmatory tests ordered by these sites must be performed independently of a health department.  Tests performed elsewhere, or prior to the civil surgeon’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. Civil surgeons 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 result. 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 civil surgeon.
  • Applicants understand that civil surgeons must include the test results on the paperwork they complete.

If the applicant consents, civil surgeons should perform HIV testing.

Syphilis Screening Results

  • 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, they are classified as Class B.
  • The evaluation is complete when the required aspects of the medical examination have been completed and the applicant can be assigned a syphilis classification.

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.

Treponemal Test Results
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

Civil surgeons must treat syphilis according to CDC’s Sexually Transmitted Diseases (STD) Treatment Guidelines, which are periodically updated.

  • Details of treatment must be provided in Part 7, Civil Surgeon Worksheet, Section 1.B., Communicable Diseases, and Syphilis of Form I-693.
  • 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 the Treatment 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 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 civil surgeons 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 by the treating physician; this follow-up does not have to occur before finalizing the medical examination or 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. The Application for Waiver of Grounds of Inadmissibility Form (I-601) 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. 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

The original Report of Medical Examination and Vaccination Record, must be completed in its entirety, signed, and placed in a sealed envelope for submission to the Department of Homeland Security (DHS), Citizenship and Immigration Services (USCIS) office. This includes assigning a classification on the I-693 if an applicant is Class A or Class B for syphilis.

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

For applicants requiring syphilis treatment, the civil surgeon is required to document the following on Form I-693 at Part 7, Civil Surgeon Worksheet, Section 1.B., Communicable Diseases, Syphilis:

  • 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
DHS Department of Homeland Security
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
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