Gonococcal Isolate Surveillance Project (GISP) and Enhanced GISP (eGISP) protocol
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Gonococcal Isolate Surveillance Project (GISP) and Enhanced GISP (eGISP) protocol

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      In 2019, Gonorrhea was the second most commonly reported notifiable disease in the United States (US) with over 616,392 cases reported to the Centers for Disease Control and Prevention (CDC). The treatment and control of infections due to Neisseria gonorrhoeae have been complicated by the organism’s ability to acquire antimicrobial resistance. The Gonococcal Isolate Surveillance Project (GISP), established in 1986, has functioned as the national surveillance system of antibiotic resistant gonorrhea in the US. It was established not only to monitor susceptibility trends in N. gonorrhoeae strains, but also to function as a rational basis for the selection of gonococcal therapies. GISP data of susceptibility trends from male gonococcal urethral isolates have provided critical data for the CDC's STD Treatment Guidelines, directly informing gonorrhea treatment recommendations in 1989, 1993, 1998, 2002, 2006, 2007, 2010, 2012, 2015, 2020, and 2021. In 2013, CDC released Antibiotic Resistance Threats in the United States, the first report to look at the burden and threats posed by antibiotic resistance on human health, which named antibiotic-resistant gonorrhea among the three most urgent threats of its kind in the country. This report was later updated in 2019 and maintained gonorrhea as one of its urgent threats in the US. In 2014, the White House developed the National Strategy to Combat Antibiotic-Resistant Bacteria (CARB), calling for the prevention, detection, and control of antibiotic resistance. Using CARB funds, the Antimicrobial Regional Laboratory Network (ARLN), a network of seven regional public health laboratories that provides cutting-edge antimicrobial resistance laboratory support, was established in 2016. The CDC Division of STD Prevention (DSTDP) supports activities that aim to slow the development of antimicrobial-resistant (AMR) gonorrhea and prevent its spread. To build robust capacity for culture-based antimicrobial susceptibility testing (AST) and genomic sequencing of N. gonorrhoeae isolates, four laboratories in the ARLN were funded for N. gonorrhoeae activities. Starting in 2017, these four laboratories began functioning as the regional laboratories for GISP. In 2017, GISP was also expanded in a subset of clinical sites to conduct N. gonorrhoeae surveillance in nonurethral isolates (i.e., pharyngeal, rectal, and endocervical isolates) and to evaluate the burden of urethritis/cervicitis associated with N. meningitidis through surveillance of urethral and non-urethral isolates. The Enhanced Gonococcal Isolate Surveillance Program (eGISP) was established to help understand if the pharynx and/or rectum may be anatomic niches that select for or foster resistance and to evaluate if gonococcal susceptibility patterns may vary between men and women. Additionally, Neisseria species, including the two pathogens N. gonorrhoeae and N. meningitidis, have similar morphology on culture and Gram stain, requiring species-specific confirmatory tests to distinguish the Neisseria species. Given that N. meningitidis urethritis/cervicitis is not a reportable disease in the US, and that labs do not routinely test genitourinary specimens for N. meningitidis, additional data on the epidemiology and biology of N. meningitidis urethritis/cervicitis are needed. In 2021, a new surveillance component was added to eGISP to include the evaluation of known resistanceassociated genetic markers from remnant nucleic acid amplification tests (NAAT). This molecular surveillance project was added to improve the identification of resistant gonorrhea in a culture-independent manner. Culture remains the best way to detect novel AMR mutations in gonorrhea, but molecular surveillance has the potential to increase the availability of resistant gonorrhea detection in the US, especially in locations without culture capacity. gisp-egisp-protocol-august-2021.pdf
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