Stop the silent infection Neisseria gonorrhoeae Prevent transmission by knowing screening guidelines Screening reduces serious risk to men and women Neisseria gonorrheae is the second most common bacterial sexually transmitted disease in the U.S. with approximately 700,000 new infections annually. Most infected individuals are asymptomatic and those with Neisseria gonorrhoeae infections are frequently co-infected with Chlamydia trachomatis. If left untreated, severe complications can occur in both symptomatic and asymptomatic infections. In males, a painful condition called epididymitis may lead to sterility. Complications in females include pelvic inflammatory disease (PID), infertility, ectopic pregnancy, chronic pelvic pain, or if pregnant, passing the infection to the infant. Clinical Indicators of Gonorrhea Infection Annual Screening Guidelines for Gonorrhea (http://www.cdc.gov/std/) Frequency of Symptoms Burning and pain when urinating Increased urinary frequency or urgency Discharge Painful or swollen testicles Lower Abdominal Pain Fever, Nausea, Sore Throat Common Sites of Infection Males Females Very common Rare Common Rare Common Rare Common Rare Less Common Not applicable No Yes* Yes Yes urethra, urethra, anus, cervix, anus, throat, throat, eyes eyes *In women, this typically indicates the development of pelvic inflammatory disease (PID). Centers for Disease Control and Prevention • All sexually active females with high risk factors* (including those who are pregnant) • All sexually active females with high risk factors* (including those who are pregnant) US Dept. of Health and • Insufficient evidence to Human Services recommend for or against US Preventative Services routine screening in men with high risk factors.* Task Force USPSTF • Recommends against routine screening in men and women without high risk factors.* *High Risk Factors: new or multiple sex partners, history of sexually transmitted diseases, inconsistent condom use, exchanging sex for money or drugs, etc. See reverse side for male and female collection options. Beaumont Laboratory 800-551-0488 B E A U M O N T L A B O R AT O RY 800-551-0488 Optimal detection methods must be utilized Nucleic Acid Amplification Tests (NAATs) are currently recommended by the U.S. CDC as the primary testing option for the detection of Gonorrhea infections. NAATs provide superior test sensitivity and equivalent test specificity when compared to traditional culture-based methods. Several FDA-approved NAATs are available for use and most can simultaneously detect Chlamydia trachomatis as well. Collection options: Swabs: Female Endocervical: • Preferred: BD ProbeTec™ Female Endocervical Specimen Collection Kit. • Acceptable: M4-RT, UVT or UTM Transport Medium. • Test Code: Gonorrhea only – INGG Both chlamydia and gonorrhea – ICNG Male Urethral: • Preferred: BD ProbeTec™ Male Urethral Specimen Collection Kit. • Acceptable: M4-RT, UVT or UTM Transport Medium. • Test Code: Gonorrhea only – INGG Both chlamydia and gonorrhea – ICNG Urine (male or female): • Preferred: 15-20 mL (first void) urine, clean catch in sterile container. NOTE: First void urine is preferred. Midstream urines have decreased clinical sensitivity and are of limited diagnostic value • Test Code: Gonorrhea only – INGG Both chlamydia and gonorrhea – ICNG ThinPrep (Pap Smear) Female Endocervical: • Protocol: –Endocervical brush – ¼ to ½ turn –Spatula – one complete turn –Broom-like device – complete turn; 3 to 5 times • Test Code: Gonorrhea only – INGG Both chlamydia and gonorrhea – ICNG There is insufficient data to recommend stand-alone NAAT (non-culture) tests in cases of sexual assault in boys and extragenital anatomic site exposures in girls. Culture and NAAT should be used in these settings. P7855k4_7855_082712 Performance Characteristics of NAAT at Beaumont Laboratory: BD ProbeTec™ Qx Amplified DNA Test Specimen Type Sensitivity Specificity Endocervical 98.5 99.7 Swab Male Urethral 100 99.1 Swab Female Urine 96.9 99.5 Male Urine 100 98.9 ThinPrep 95.3 99.9 (PreservCyt) PPV NPV 95.9 99.9 95 100 93.1 93.9 99.8 100 100 99.9 Note ThinPrep with chlamydia and/or gonorrhea •Ct and/or Ng must be ordered separately and at the time of collection –Cannot add-on a Ct/Ng order to a processed Pap •Ct and/or Ng results will be reported separately. Results will not be included on the combined Pap/HPV report. Treatment guidelines •Please refer to the 2010 Sexually Transmitted Diseases Treatment Guidelines by the U.S. Centers for Disease Control and Prevention: http://www.cdc.gov/std/treatment/2010/default.htm • Test-of-Cure is not recommended. If desired, wait at least 3 weeks after completion of therapy to minimize the chance of a false positive NAAT result due to the presence of non-viable organism. • If you suspect treatment failure, culture-based identification and antimicrobial susceptibility testing is recommended. For more information or questions on Neisseria gonorrhoeae molecular diagnostic testing please contact Bobby Boyanton, M.D. or a Customer Service Agent at 800-551-0488. BE AUMONT L ABOR ATORY • 80 0 - 551- 0488
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