Gonorrhea Testing, Diagnosis and Treatment March 2017 Medical Assessment and Policy Team Immigrant, Refugee, and Migrant Health Branch National Center for Emerging and Zoonotic Infectious Diseases Division of Global Migration and Quarantine

Learning Objectives Implement required testing for gonorrhea After this session, you should be able to: Implement required testing for gonorrhea Treat gonorrhea Complete the DS 3026 for gonorrhea

Neisseria gonorrhoeae diplococci from cervical smear Gonorrhea Neisseria gonorrhoeae Neisseria gonorrhoeae diplococci from cervical smear

Gonorrhea Technical Instructions Published May 2016 http://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/technical-instructions/panel-physicians/gonorrhea.html Start date As soon as able after publication No later than October 1, 2016 Based on CDC STD Treatment Guidelines http://www.cdc.gov/std/tg2015/default.htm

Screening for Gonorrhea Medical history Urine NAAT or self-collected vaginal swab NAAT Treatment Nucleic Acid Amplification Test Document NAAT=Nucleic Acid Amplification Test

Men may be asymptomatic Women may be asymptomatic Question 1 Which of the following is true regarding the manifestation of gonorrhea in men and women? Men may be asymptomatic Women may be asymptomatic Men with discharge are at risk of infertility Discharge in women correlates with infertility Both A and B Answer = E

Medical History and Physical Examination Men Burning sensation with urination Discharge Painful or swollen testicles Some men are asymptomatic Women Most are asymptomatic Mild or nonspecific Painful urination Vaginal bleeding between periods

Gonorrhea Complications Men Epididymitis Infertility Women Pelvic inflammatory disease Abdominal pain and fever Abscess Infertility/ Ectopic pregnancy Intrapartum transfer leading to manifestations in infant Blindness Joint infection Sepsis

Physical Examination External genital examination is no longer required for all applicants Genital exam is only required when an applicant tests positive for syphilis in order to stage the disease Must be performed by a physician Cannot be performed by nurse or physician assistant Examination is a visual inspection only

We are using urine NAAT testing for both men and women Question 2 Experience: What type of gonorrhea test is your practice currently using? We are using urine NAAT testing for both men and women We are using culture testing for both men and women We are using another kind of gonorrhea testing I am not a panel physician Answer = A

Which types of samples can be used for gonorrhea culture testing? Question 3 Which types of samples can be used for gonorrhea culture testing? Self-collected vaginal swabs Urine sample Endocervical swabs Blood sample Answer=c

Culture Limitations Requires endocervical swab specimens from women, which can be collected only by a speculum pelvic exam Requires urethral swab specimens from men Swabs must be plastic or wire with rayon, Dacron, or calcium alginate tips Must be transported to laboratory properly and plated on selective media Takes several days for result Not ideal for routine use due to invasive and stringent collection and transport requirements Swabs should be inserted 2–3 cm in the male urethra or 1–2 cm into the endocervical canal followed by two or three rotations. Several nonnutritive swab transport systems are available, and some studies suggest that these transport systems might maintain gonococcal viability for up to 48 hours in ambient temperatures (53–55). However, environmental conditions might vary by location and season, which could affect the viability of gonorrhea in these transport systems; thus, additional local validation of transport conditions might be needed. Culture medium transport systems are preferred because there are some advantages over swab transport systems (e.g., extended shelf life and better recovery because cultivated isolates are being transported rather than a clinical specimen) (39). Culture medium is inoculated with the swab specimen and then placed immediately into a CO2-enriched atmosphere for transportation to the laboratory. Because N. gonorrhoeae has demanding nutritional and environmental growth requirements, optimal recovery rates are achieved when specimens are inoculated directly and when the growth medium is incubated in an increased CO2 environment as soon as possible. Taken from pages 5-6 of Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014

Urine NAAT or culture in men and women Question 4 Which of the following tests are preferred for panel physicians screening for gonorrhea? Urine NAAT in men and women or self-collected vaginal swab NAAT in women Urine NAAT or culture in men and women Urethral DNA probe in men and women Gram stain in symptomatic men and physician-collected vaginal swab NAAT in women Answer=A

Gonorrhea Testing Laboratory testing should be performed on applicants ≥15 years of age Also perform testing on applicants <15 years of age if there is reason to suspect gonorrhea Types of laboratory tests allowed for US panel use Nucleic acid amplification tests (NAAT) Gram stain for symptomatic men

NAAT Available for the detection of genitourinary infection Some NAAT tests involve PCR amplification, but not all, and not all PCR tests are NAAT tests The test you select should be approved by the regulatory authority in the country in which you practice

NAAT CDC recommends panel physicians use NAAT as screening test Urine specimen from men and women Self-collected vaginal swab from women Use self-collected vaginal swab test kit that can also report if human DNA is present Urine tests are what we recommend and involve “first catch”, not “clean catch” urine

Gram Stain Urethral secretions with polymorphonuclear leukocytes with intracellular gram-negative diplococci can be considered diagnostic in symptomatic men This is only an option with symptomatic men, so can’t be used as your primary screening method

She is not admissible to the US until she is treated for chlamydia. Question 5 A 16 year old applicant tests positive for chlamydia during the medical screening. She says tearfully that she has never had sex, doesn’t want treatment and the result must be false. What do you tell her? She is not admissible to the US until she is treated for chlamydia. You are required by CDC to tell her parents she is sexually active. Treatment for chlamydia is not required, and she can refuse, but it is recommended and easy The test must be wrong because teenagers always tell the truth Answer=C

Chlamydia Testing Many gonorrhea tests automatically test for Chlamydia trachomatis Chlamydia is not listed in the diseases of public health significance in 42 Code of Federal Regulations (CFR) part 34 Panel physicians may use test kits that screen for both gonorrhea and chlamydia if gonorrhea stand-alone test kits are unavailable When combined test kits are used, applicants should be informed their chlamydia results do not affect admissibility

Chlamydia Testing (continued) Applicants who test positive for chlamydia only should be offered treatment in accordance with CDC’s Sexually Transmitted Diseases Treatment Guidelines If an applicant is diagnosed and treated for chlamydia, document this in the DS 3026 remarks section (but not under Section 8 where gonorrhea diagnosis and treatment are documented) Give a Class B Other classification for applicants diagnosed and successfully treated for chlamydia

She was treated 4 weeks ago but symptoms did not improve. Question 6 You diagnose gonorrhea in a 17-year old female applicant with painful urination and discharge. Which of the following are factors that may influence the recommended treatment regimen? She was treated 4 weeks ago but symptoms did not improve. Whether or not she’s pregnant Number of partners Number of gram-positive diplococci Answer= A Recommended Regimen Ceftriaxone 250 mg IM in a single dose PLUS Azithromycin 1 g orally in a single dose This regimen is the same if pregnant

Gonorrhea Treatment Uncomplicated infection of the cervix, urethra, rectum, and pharynx Ceftriaxone 250 mg IM in a single dose PLUS Azithromycin 1g orally in a single dose http://www.cdc.gov/std/tg2015/default.htm

Resistance Treatment failure – symptoms that persist after appropriate treatment (longer than 5 days) Culture and drug susceptibility should be performed True treatment failures are uncommon http://www.cdc.gov/std/tg2015/default.htm

Obtain cultures and DSTs because he is likely resistant to treatment. Question 7 You diagnose gonorrhea in a 17-year male applicant. He says he took doxycycline a month ago for gonorrhea and continues to have sex with his partner who has not been treated. What should you do? Obtain cultures and DSTs because he is likely resistant to treatment. Treat him with Ceftriaxone and Azithromycin as you would for any case of gonorrhea Treat him with gemifloxacin and azithromycin None of the above Answer= B Recommended Regimen Ceftriaxone 250 mg IM in a single dose PLUS Azithromycin 1 g orally in a single dose This regimen is the same if pregnant

Gonorrhea Classifications No treatment Class A (Inadmissible) Treatment Class B

Completing the DS 3026 Record screening test information under the Remarks section (Section 10, page 3) Test used Result Record treatment under Section 8

Question 7 You diagnose gonorrhea in a 47-year old male applicant who agrees to be treated. His wife is also an applicant and she is negative for gonorrhea. What should you do next? Tell the wife she must undergo culture testing because her results must not be correct. Tell the husband he should wait 7 days post treatment before having sex, and encourage him to share this information with his wife. Tell the wife she must be treated for gonorrhea or she is inadmissible. Both A and C Answer= B

CDC does not recommend further follow up. Question 8 You treated a 17-year old male applicant with gonorrhea with Ceftriaxone 250mg IM and Azithromycin 1 g orally. Which of the following is true? He should remain class A for gonorrhea until he returns in 2 weeks for retesting. CDC does not recommend further follow up. He should be advised to be retested in 3 months, however, this post-treatment follow up is a recommendation and does not prevent him from immigrating to the US. Answer= C Recommended Regimen Ceftriaxone 250 mg IM in a single dose PLUS Azithromycin 1 g orally in a single dose This regimen is the same if pregnant Ceftriaxone at this dose used alone is 99.2% effective Azithromycin at 2 g is 99.2% effective

Thank you cdcQAP@cdc.gov http://www.cdc.gov/panelphysicians http://www.cdc.gov/std/tg2015/default.htm For more information, please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 Visit: www.cdc.gov | Contact CDC at: 1-800-CDC-INFO or www.cdc.gov/info Email: cdcinfo@cdc.gov Web: www.cdc.gov/info The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases Division of Global Migration and Quarantine

Answers E A C B