Morbidity and Mortality Weekly Report

Recommendations and Reports / Vol. 63 / No. 2 March 14, 2014 

Recommendations for the Laboratory-Based 

Detection of Chlamydia trachomatis and 

Neisseria gonorrhoeae — 2014 

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention
Recommendations and Reports

CONTENTS

Introduction ............................................................................................................1

Methods....................................................................................................................3

Recommendations................................................................................................4

Conclusion............................................................................................................ 14

Appendix .............................................................................................................. 18

Front cover photo: Laboratorians testing bacterial isolates for antimicrobial resistance (Photo/Association of Public Health Laboratories).

The MMWR series of publications is published by the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC), 

U.S. Department of Health and Human Services, Atlanta, GA 30333.

Suggested Citation: [Author names; first three, then et al., if more than six.] [Report Title]. MMWR 2014;63(No. RR-#):[inclusive page numbers].

Centers for Disease Control and Prevention

Thomas R. Frieden, MD, MPH, Director

Harold W. Jaffe, MD, MA, Associate Director for Science

Joanne Cono, MD, ScM, Director, Office of Science Quality 

Chesley L. Richards, MD, MPH, Deputy Director for Public Health Scientific Services

Michael F. Iademarco, MD, MPH, Director, Center for Surveillance, Epidemiology, and Laboratory Services

MMWR Editorial and Production Staff (Serials)

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Matthew L. Boulton, MD, MPH, Ann Arbor, MI

Virginia A. Caine, MD, Indianapolis, IN

Barbara A. Ellis, PhD, MS, Atlanta, GA

Jonathan E. Fielding, MD, MPH, MBA, Los Angeles, CA

David W. Fleming, MD, Seattle, WA

William E. Halperin, MD, DrPH, MPH, Newark, NJ

King K. Holmes, MD, PhD, Seattle, WA

Timothy F. Jones, MD, Nashville, TN

Rima F. Khabbaz, MD, Atlanta, GA

Dennis G. Maki, MD, Madison, WI

Patricia Quinlisk, MD, MPH, Des Moines, IA

Patrick L. Remington, MD, MPH, Madison, WI

William Schaffner, MD, Nashville, TN
Recommendations and Reports

Recommendations for the Laboratory-Based Detection of 

Chlamydia trachomatis and Neisseria gonorrhoeae — 2014

Prepared by

John R. Papp, PhD1

Julius Schachter, PhD2

Charlotte A. Gaydos, DrPH3

Barbara Van Der Pol, PhD4

1Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC

2University of California at San Francisco, San Francisco, California

3Johns Hopkins University, Baltimore, Maryland 4University of Alabama at Birmingham, School of Medicine, Birmingham, Alabama

Summary

This report updates CDC’s 2002 recommendations regarding screening tests to detect Chlamydia trachomatis and Neisseria 

gonorrhoeae infections (CDC. Screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections—2002. 

MMWR 2002;51[No. RR-15]) and provides new recommendations regarding optimal specimen types, the use of tests to detect rectal 

and oropharyngeal C. trachomatis and N. gonorrhoeae infections, and circumstances when supplemental testing is indicated.

The recommendations in this report are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease 

control personnel who must choose among the multiple available tests, establish standard operating procedures for collecting and 

processing specimens, interpret test results for laboratory reporting, and counsel and treat patients. 

The performance of nucleic acid amplification tests (NAATs) with respect to overall sensitivity, specificity, and ease of specimen 

transport is better than that of any of the other tests available for the diagnosis of chlamydial and gonococcal infections. Laboratories 

should use NAATs to detect chlamydia and gonorrhea except in cases of child sexual assault involving boys and rectal and 

oropharyngeal infections in prepubescent girls and when evaluating a potential gonorrhea treatment failure, in which case culture 

and susceptibility testing might be required. NAATs that have been cleared by the Food and Drug Administration (FDA) for the 

detection of C. trachomatis and N. gonorrhoeae infections are recommended as screening or diagnostic tests because they have 

been evaluated in patients with and without symptoms. Maintaining the capability to culture for both N. gonorrhoeae and 

C. trachomatis in laboratories throughout the country is important because data are insufficient to recommend nonculture tests in 

cases of sexual assault in prepubescent boys and extragenital anatomic site exposure in prepubescent girls. N. gonorrhoeae culture 

is required to evaluate suspected cases of gonorrhea treatment failure and to monitor developing resistance to current treatment 

regimens. Chlamydia culture also should be maintained in some laboratories to monitor future changes in antibiotic susceptibility 

and to support surveillance and research activities such as detection of lymphogranuloma venereum or rare infections caused by 

variant or mutated C. trachomatis.

Introduction

Chlamydia trachomatis

Chlamydia trachomatis infection is the most common 

notifiable disease in the United States with >1.3 million 

infections reported to CDC in 2010 (1). The majority of 

persons with C. trachomatis infection are not aware of their 

infection because they do not have symptoms that would 

prompt them to seek medical care (2). Consequently, screening 

is necessary to identify and treat this infection. Direct 

medical costs of C. trachomatis infections were estimated at 

Corresponding preparer: John R. Papp, PhD, National Center for 

HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. 

Telephone: 404-639-3785; E-mail: jwp6@cdc.gov. 

$516.7 million in 2008 (2012 dollars) (3). The direct costs 

associated with C. trachomatis infections and their sequelae 

have decreased in recent years as sequelae have been managed 

in a less-costly manner and ectopic pregnancies have been 

increasingly managed medically (4). Also of importance are 

the tangible costs, including the lost productivity, and the 

intangible costs, including psychological and emotional injury 

caused by infertility and ectopic pregnancy (5).

Untreated C. trachomatis infections can lead to serious 

complications. In older observational treatment studies, up to 

30% of women with untreated C. trachomatis infections developed 

pelvic inflammatory disease (PID) (6,7). Of these women, the 

majority had symptoms that were too mild or nonspecific to 

cause them to seek medical treatment. Regardless of symptom 

intensity, the consequences of PID are severe. Left untreated, 20% 

of those with symptomatic PID might become infertile; 18% will 

MMWR / March 14, 2014 / Vol. 63 / No. 2 1
Recommendations and Reports

experience debilitating, chronic pelvic pain; and 9% will have a 

life-threatening tubal pregnancy (8). The importance of subclinical 

PID became apparent with observations that most of the women 

with tubal factor infertility or ectopic pregnancy who had serologic 

evidence of chlamydial infection apparently had no history of PID 

(9,10). C. trachomatis infection during pregnancy might lead to 

infant conjunctivitis and pneumonia and maternal postpartum 

endometritis (11). Among men, urethritis is the most common 

illness resulting from C. trachomatis infection. Complications (e.g., 

epididymitis) affect a minority of infected men and rarely result 

in reproductive health sequelae (12).

C. trachomatis infections of the rectum can result from 

unprotected anal intercourse and are typically asymptomatic 

but might progress to proctocolitis (13,14). Ocular infections 

can result in conjunctivitis in neonates and adults (15). Sexually 

acquired reactive arthritis also has been reported as a possible 

consequence of C. trachomatis infection (16).

Neisseria gonorrhoeae

N. gonorrhoeae infections are the second most common notifiable 

communicable disease in the United States with 309,341 cases 

being reported to CDC in 2010 (1). Gonococcal infections tend 

to cause a stronger inflammatory response than C. trachomatis but 

are typically asymptomatic in women until complications such as 

PID develop (17). In men, the majority of urethral infections cause 

urethritis with painful urination and, less commonly, epididymitis 

or disseminated gonococcal infection (17).

Subsets of men who have sex with men (MSM) engage in risky 

sexual behaviors (e.g., having sex with multiple, anonymous partners 

and unprotected oral and rectal sex), often leading to infections 

at these extragenital sites. MSM might have a high prevalence of 

sexually transmitted infections especially at these extragenital sites, 

which can be a public health problem because of the potential for 

enhancing HIV transmission (18). CDC recommends routine 

laboratory screening of genital and extragenital sites for all sexually 

active MSM at risk for infection (19).

Purpose of This Report

This report updates CDC’s 2002 recommendations regarding 

screening tests to detect C. trachomatis and N. gonorrhoeae infections 

(20) and provides new recommendations regarding optimal specimen 

types, the use of tests to detect rectal and oropharyngeal C. trachomatis

and N. gonorrhoeae infections, and information regarding when 

supplemental testing is indicated (Box 1). These recommendations 

are intended for use by clinical laboratory directors, laboratory staff, 

clinicians, and disease control personnel who must choose among 

the multiple available tests, establish standard operating procedures 

for collecting and processing specimens, interpret test results for 

laboratory reporting, and counsel and treat patients.

BOX 1. Summary of recommendations

•	 Nucleic acid amplification tests (NAATs) that are 

cleared by the Food and Drug Administration (FDA) 

are recommended for detection of genital tract 

infections caused by Chlamydia trachomatis and 

Neisseria gonorrhoeae infections in men and women 

with and without symptoms. For detecting these 

infections of the genital tract, optimal specimen types 

for NAATs are vaginal swabs from women and first 

catch urine from men. Older nonculture tests and 

non-NAATs have inferior sensitivity and specificity 

characteristics and no longer are recommended.

•	 NAATs have not been cleared by FDA for the detection of rectal and oropharyngeal infections caused by 

C. trachomatis and N. gonorrhoeae. CDC is recommending NAATs to test for these extragenital infections based on increased sensitivity, ease of specimen 

transport and processing. Because these specimen 

types have not been cleared by FDA for use with 

NAATs, laboratories must establish performance 

specifications when using these specimens to meet 

Clinical Laboratory Improvement Amendments 

(CLIA) regulatory requirements and local or state 

regulations as applicable prior to reporting results for 

patient management. Positive reactions with nongonococcal Neisseria species have been reported with 

some NAATs, particularly with oropharyngeal 

specimens. Alternate target testing using NAATs 

without reported crossreactivity might be needed to 

avoid false positive gonorrhea results when using these 

tests with these specimens.

•	 Routine repeat testing of NAAT-positive genital tract 

specimens is not recommended because the practice does 

not improve the positive predictive value of the test. 

•	 Laboratory interpretation of test results should be 

consistent with product inserts for FDA-cleared tests 

or have met all federal and state regulations for a 

modified procedure if the laboratory has changed the 

cutoff values or testing algorithm. This approach 

provides the most appropriate information to the 

clinician, who is ultimately responsible for assessing 

test results to guide patient and partner management.

•	 N. gonorrhoeae culture capacity is still needed for 

evaluating suspected cases of treatment failure and 

monitoring antimicrobial susceptibility.

•	 C. trachomatis and N. gonorrhoeae culture capacity 

might still be needed in instances of child sexual 

assault in boys and extragenital infections in girls. 

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Recommendations and Reports

Methods

In 2008, CDC and the Association of Public Health 

Laboratories (APHL) convened an independent work group to 

evaluate available information and make suggestions for CDC 

to consider in the development of recommendations for the 

laboratory diagnosis of C. trachomatis and N. gonorrhoeae in 

the United States. Members of the work group* were selected 

on the basis of published expertise in the field of C. trachomatis

and N. gonorrhoeae diagnostics or were public health laboratory 

directors, sexually transmitted diseases (STD) clinicians, CDC’s 

Division of STD Prevention, and representatives of the Food and 

Drug Administration (FDA) or the Centers for Medicaid Services 

(CMS). Four members of the work group, including three who 

served as co-authors, previously had published papers in which 

they acknowledged receiving financial support from diagnostic 

test manufacturers for test evaluations. These potential conflicts 

of interest were disclosed and managed in accordance with the 

editorial standards of the journals that published the scientific 

reports. In addition, in August 2013, to maintain objectivity 

and to confirm that the recommendations were evidence 

based, a second independent panel of microbiologic, statistical, 

and clinical experts reviewed the draft recommendations. 

Approximately 6 months before a meeting held at CDC during 

January 13–15, 2009, work group members were asked by 

conference call to identify key questions regarding chlamydia and 

gonorrhea laboratory diagnostics that emerged from literature 

reviews and discussed the information available to answer those 

questions. Work group members were assigned key questions 

to research (see Appendix) and, with the assistance of CDC 

and APHL staff, conducted an extensive Medline database of 

peer-reviewed literature published during January 1, 2000–

January 1, 2009. The Medline database was searched using 

the terms “Chlamydia trachomatis” or “chlamydia” “Neisseria 

gonorrhoeae” or “gonorrhea” or “lymphogranuloma venereum” 

or “LGV” and “infection” or “reproductive tract” or “specimen” 

or “urogenital specimen” or “urine” or “rectum” or “pharynx” 

or “oropharynx” or “culture” or “nucleic acid amplification” or 

“nucleic acid probe” or “enzyme immunoassay” or “detection” 

or “performance” or “screening” or “adolescent” or “prevalence” 

or “confirmation” or “repeat testing” or “pediatric” or “sexual 

assault” or “sexual abuse” or “point of care” or “serology.” The 

key questions were categorized into three principal areas of 

laboratory diagnostics: 1) performance characteristics of tests, 

2) screening applications, and 3) laboratory confirmation of test 

results. Monthly conference calls or e-mail message exchanges 

were conducted with work group members researching key 

questions in each principal area to ensure progress and adequate 

support in obtaining relevant publications. Work group 

members assigned to address key questions developed tables of 

evidence from peer-reviewed publications and presented these 

tables at the in-person meeting held in January 2009. Each key 

question was introduced, and publications were discussed in 

terms of strengths, weaknesses, and overall relevance of the data 

to the key questions. Scientific publications with findings derived 

from studies with an analytic plan involving a patient’s infected 

status were included in developing these recommendations. 

Studies using discrepant analysis were excluded. All work group 

members agreed with these inclusion and exclusion criteria 

because they approach design characteristics used by FDA when 

evaluating diagnostic tests for marketing in the United States. 

During the meeting, each topic was presented by the assigned 

work group member, and an open forum followed to allow all 

work group members and ad hoc attendees to discuss the merits 

of publications used to address the key questions. At the end of 

each discussion, a recommendation was proposed and adopted 

for consideration by CDC if there were no objections from 

the work group members. Following the in-person meeting, 

the same database was searched periodically for subsequently 

published articles for the work group to consider by e-mail 

and/or teleconference calls. A writing team was formed to draft 

the recommendations generated from these discussions, and 

the senior CDC author was responsible for the overall content. 

Testing Technologies

Multiple laboratory test options can be used to detect 

chlamydia and gonorrhea although some might not be 

recommended for routine use based on performance. Direct 

detection of the pathogen using culture or nonculture methods 

is possible. Of the nonculture tests available, only nucleic acid 

amplification testing (NAAT) is recommended for routine 

use whereas other tests (e.g., enzyme immunoassays, nucleic 

acid probe tests, and genetic transformation tests) are not 

recommended. Serologic tests that detect a systemic immune 

response to infection are not recommended because of the lack 

of precision for the detection of an active infection.

Since 2002, improvements in chlamydia and gonorrhea 

NAAT technologies have enabled significant implementation 

and expansion of screening programs using less invasive 

specimen collection. Although these changes have created 

opportunities for more rapid and accurate chlamydia and 

gonorrhea diagnosis and a broader understanding of key 

populations at risk, they also might have created challenges 

(e.g., increased laboratory costs and physical design constraints 

requiring unidirectional specimen processing to minimize 

contamination when laboratories attempt to incorporate new 

technologies into their existing test repertoire). *A list of the members of the work group appears on page 19. 

MMWR / March 14, 2014 / Vol. 63 / No. 2 3
Recommendations and Reports

The performance of NAATs with respect to overall sensitivity, 

specificity, and ease of specimen transport is better than that of 

any of the other tests available for the diagnosis of chlamydial 

and gonococcal infections (21–30). Culture for C. trachomatis

and N. gonorrhoeae was long the reference standard against 

which all other diagnostic tests were compared. However, better 

tests have been needed because of difficulties in maintaining 

the viability of organisms during transport and storage in the 

diverse settings in which testing is indicated. In addition, the 

tissue culture methods for C. trachomatis isolation are difficult 

to standardize, technically demanding, expensive, and relatively 

insensitive. Thus, diagnostic test manufacturers developed 

nonculture tests. The first nonculture tests for C. trachomatis

and N. gonorrhoeae included enzyme immunoassays (EIAs), 

which detect specific chlamydial or gonococcal antigens, and 

direct fluorescent antibody (DFA) tests for C. trachomatis, 

which use fluorescein-conjugated monoclonal antibodies that 

bind specifically to bacterial antigen in smears. These antigendetection tests were followed by nucleic acid hybridization 

tests, which detect C. trachomatis–specific or N. gonorrhoeae–

specific deoxyribonucleic acid (DNA) or ribonucleic acid 

(RNA) sequences. With the availability of these nonculture 

tests, some of which could be automated, screening programs 

for C. trachomatis were initiated, and screening programs 

for N. gonorrhoeae began to change from culture to using 

the more convenient and, for remote settings, more reliable 

nonculture methods. The primary drawback of these tests, 

especially for C. trachomatis, was that they failed to detect a 

substantial proportion of infections (30–39). This changed 

with the introduction of NAATs that amplify and detect 

C. trachomatis–specific or N. gonorrhoeae–specific DNA or 

RNA sequences. These tests are approximately 20%–35% more 

sensitive than the earlier nonculture tests (30–39).

This report emphasizes the importance of maintaining the 

capability to culture for both N. gonorrhoeae and C. trachomatis in 

laboratories throughout the country because there are insufficient 

data to recommend nonculture tests in cases of sexual assault 

in boys and extragenital site exposure in girls. N. gonorrhoeae

culture is required as a test of cure to evaluate suspected cases 

of gonorrhea treatment failure and to monitor developing 

resistance to current treatment regimens. Test of cure should 

be done when clinically indicated only (i.e., not part of routine 

care). Chlamydia culture capability also should be maintained 

in some laboratories to monitor future changes in antibiotic 

susceptibility and to support surveillance and research activities 

such as detection of lymphogranuloma venereum (LGV) or rare 

infections caused by variant or mutated C. trachomatis such as 

the type recently described in Sweden (40,41).

Recommendations

Tests to Detect C. trachomatis and 

N. gonorrhoeae

Isolation and identification of Chlamydia trachomatis.

Specimen collection swabs for C. trachomatis culture must have 

a plastic or wire shaft and either rayon, dacron, or cytobrush tip. 

Other materials might inhibit isolation. Specimen collection for 

C. trachomatis culture is invasive requiring insertion of a swab 

2–3 cm into the male urethral or 1–2 cm into the endocervical 

canal followed by two or three rotations to collect sufficient 

columnar or cuboidal epithelial cells. Following the collection, 

culture samples should be stored in an appropriate transport 

media such as sucrose phosphate glutamate buffer or M4 media 

(Thermal Scientific, Lenexa, Kansas) and transported at ≤4°C to 

the laboratory within 24 hours of collection to maximize recovery 

of viable organisms. If transport is delayed >24 hours, the transport 

media containing the specimen should be stored at -70°C. 

The specimen is inoculated by centrifugation onto a confluent 

monolayer of McCoy, HeLa 229, or Buffalo green monkey kidney 

cells that support growth of C. trachomatis (42–46). Once the 

specimen has been inoculated, 2μg/ml of cycloheximide should 

be added to the growth medium to suppress protein synthesis 

by the host eukaryotic cell (47). Inoculated cells are harvested 

after 48–72 hours of growth; infected cells develop characteristic 

intracytoplasmic inclusions that contain substantial numbers of 

C. trachomatis elementary and reticulate bodies.

The cell monolayers are reacted with either genus specific or 

species-specific fluorescein-conjugated monoclonal antibodies 

to allow specific visualization of the chlamydial inclusions 

with an epifluorescent microscope. Cell culture detection 

of C. trachomatis is highly specific if a C. trachomatis major 

outer membrane protein (MOMP)–specific stain is used. 

Monoclonal antibodies directed against the family-specific 

lipopolysaccharide (LPS) of Chlamydiaceae cost less but might 

stain bacteria that share LPS antigens. LPS stains might be 

suitable for routine use, but a species-specific (MOMP) stain 

is recommended in situations requiring increased specificity 

(48–50). Less specific inclusion-detection methods using 

iodine or Giemsa stain are not recommended (48–50).

Cell culture methods vary among laboratories, resulting 

in substantial interlaboratory variation in performance (51). 

The shell vial method of culture uses a larger inoculum with 

a reduced risk for crosscontamination and therefore provides 

better accuracy than the 96-well microtiter plate method 

(42,43). In certain laboratories, higher sensitivities are 

obtained by performing a blind pass in which an inoculated 

cell monolayer is allowed to incubate for 48–72 hours, after 

which the monolayer is disrupted and used to inoculate a fresh 

4 MMWR / March 14, 2014 / Vol. 63 / No. 2
Recommendations and Reports

monolayer that is stained after 48–72 hours of incubation to 

allow for another cycle of growth (49).

Despite the technical difficulties, cell culture, when 

performed by an experienced analyst, was the most sensitive 

diagnostic test for chlamydial infection until the introduction 

of NAATs (28,52). The relatively low sensitivity, extended 

testing turnaround time, difficulties in standardization, labor 

intensity, technical complexity, stringent specimen collection 

and transport requirements, and relatively high cost are 

disadvantages of cell culture isolation of C. trachomatis. 

Recommended procedures for C. trachomatis isolation and 

culture detection using a species specific stain must be followed 

when using this test in cases of suspected child sexual assault 

in boys and extragenital infections in girls.

Isolation and identification of N. gonorrhoeae. Because of its 

high specificity (>99%) and sensitivity (>95%), a Gram stain of 

a male urethral specimen that demonstrates polymorphonuclear 

leukocytes with intracellular Gram-negative diplococci can 

be considered diagnostic for infection with N. gonorrhoeae

in symptomatic men. However, because of lower sensitivity, 

a negative Gram stain should not be considered sufficient 

for ruling out infection in asymptomatic men. In addition, 

Gram stains of endocervical specimens, pharyngeal, or rectal 

specimens also are not sufficient to detect infection and therefore 

are not recommended. Specific testing for N. gonorrhoeae is 

recommended because of the increased utility and availability 

of highly sensitive and specific testing methods and because a 

specific diagnosis might enhance partner notification.

If multiple specimens are being collected from an anatomic 

site, N. gonorrhoeae culture specimens should be obtained first; 

this sequence maximizes the load collected, which increases 

the likelihood of a successful culture (39). Specimens collected 

for gonorrhea culture should be obtained by using swabs with 

plastic or wire shafts and rayon, Dacron, or calcium alginate tips. 

Other swab material such as wood shafts and cotton tips might 

be inhibitory or toxic to the organism and should be avoided. 

Although collection of epithelial cells is less important for culture 

detection of N. gonorrhoeae, 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. In cases of urethritis, collection of the 

exudate is sufficient for N. gonorrhoeae culture. 

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.

Methods of gonococcal culture have been described elsewhere 

(39,56). Specimens from normally nonsterile sites are streaked 

on a selective (e.g., Thayer-Martin or Martin-Lewis) medium 

and specimens from sterile sites are streaked on nonselective 

(e.g., chocolate agar) medium. Culture media for N. gonorrhoeae

isolation include a base medium supplemented with chocolatized 

(heated) equine or bovine blood to support the growth of the 

gonococcus. Commercially prepared chocolate agar containing 

synthetic hemin and growth factors for N. gonorrhoeae are available 

from various vendors. Selective media differ from routine culture 

media in that they contain antimicrobial agents (i.e., vancomycin, 

colistin, and nystatin or another antifungal agent) that inhibit 

the growth of other bacteria and fungi. Using selective media 

might improve isolation if the anatomic source of the specimen 

normally contains other bacterial species although some strains of 

N. gonorrhoeae have been demonstrated to be inhibited on selective 

media (57). Inoculated media are incubated at 35°C–36.5°C in 

an atmosphere supplemented with 5% CO2 and examined at 24 

and 48 hours postcollection. Supplemental CO2 can be supplied 

by a CO2 incubator, candle-extinction jar using unscented candles 

(e.g., votive candles) or CO2-generating tablets.

Isolates recovered from a genital specimen on selective 

medium that are Gram-negative diplococcus- and oxidasepositive might be presumptively identified as N. gonorrhoeae

(39). A presumptive identification indicates only that a Gramnegative, oxidase-positive diplococcus (e.g., any Neisseria

species or Branhamella catarrhalis) might be isolated from 

such specimens. Certain coccobacilli, including Kingella 

denitrificans, might appear to be Gram-negative diplococci 

in Gram-stained smears. A confirmed laboratory diagnosis of 

N. gonorrhoeae requires additional biochemical tests (Table 1). 

A presumptive test result is sufficient to initiate antimicrobial 

therapy, but additional tests must be performed to confirm the 

identity of an isolate as N. gonorrhoeae (39).

Culture for N. gonorrhoeae is inexpensive to perform from 

genital sites and is specific and sensitive if the specimen is 

collected and transported properly to the laboratory. However, 

it is less than ideal for routine diagnostics because of stringent 

collection and transport requirements, and confirmation might 

take several days from time of specimen collection. The primary 

advantage of isolating N. gonorrhoeae by culture is the ability 

to characterize the isolate further by antimicrobial susceptibly 

MMWR / March 14, 2014 / Vol. 63 / No. 2 5
Recommendations and Reports

TABLE 1. Characteristics of gram-negative, oxidase-positive Neisseria and related species of human origin

Species

Acid from

Superoxol

Reduction 

of nitrate

Polysaccharide 

from sucrose

Tributyrin 

Glucose Maltose Lactose Sucrose Fructose hydrolysis

N. gonorrhoeae + - - - - + - - -

N. meningitidis + + - - - + - - -

N. lactamica + + + - - + - - -

N. cinerea* - - - - - + - - -

N. polysaccharea + + - - - + - - -

N. subflava† + + - V V + - V -

N. sicca + + - + + + - + -

N. mucosa + + - + + + + + -

N. flavescens - - - - - + - + -

N. elongata§ - - - - - - - - -

Branhamella catarrhalis - - - - - + + - +

Kingella denitrificans + - - - - - + - -

Abbreviations: + = strains typically positive but genetic mutants might be negative; - = negative; V = variable.

* Certain strains grow on selective media for the isolation of N. gonorrhoeae. † Includes biovars subflava, flava, and perflava. N. subflava biovar perflava strains produce acid from sucrose and fructose and produce polysaccharide from sucrose; 

N. subflava biovar flava strains produce acid from fructose; N. subflava biovar flava and N. subflava biovar subflava do not produce polysaccharide.

§ Rod or coccobacillus. 

testing and genetic analysis if necessary. Cephalosporins 

are the sole class of antibiotics recommended for the 

treatment of N. gonorrhoeae infections in CDC’s 2010 STD 

treatment guidelines (available at http://www.cdc.gov/std/

treatment/2010/default.htm) (19), and the availability of 

gonoccocal culture capacity at the local level is an important 

consideration if a patient fails therapy (58).

Antibiotic susceptibility testing. Gonorrhea treatment is 

complicated by the ability of N. gonorrhoeae to develop resistance 

to antimicrobial therapies. Genetic mutations and/or acquisition 

of genetic material from closely related bacteria species might 

result in antibiotic-resistant N. gonorrhoeae. Plasmid mediated 

resistance to penicillin can be conferred by extrachromosomal 

genes encoding for β-lactamase that destroys penicillin (59,60). 

Resistance to tetracycline also might occur when the organism 

acquires an extrachromosomal gene from streptococcus, the 

tetM gene that allows for ribosomal protein synthesis that is 

normally impaired by tetracycline (61). Testing for these plasmid 

genes provides limited information because genetic changes in 

the chromosome also might confer resistance to penicillin and 

tetracycline in addition to spectinomycin and fluoroquinolones 

(62,63). Testing specimens for genetic alterations in the 

chromosome requires a complete understanding of the complex 

and multiple mechanisms associated with resistance. For example, 

chromosomal-mediated resistance to penicillin can alter penicillin 

binding, penetration, or efflux (64). Resistance to fluoroquinlones 

results from mutations in DNA gyrase (gyrA) or topoisomerase 

(parC) resulting in decreased drug penetration and increased efflux 

(65,66). Penicillin-, tetracycline-, and fluoroquinolone-resistant 

N. gonorrhoeae isolates now are disseminated widely throughout 

the United States and globally (67). These antimicrobial agents 

no longer are recommended regimens for N. gonorrhoeae

treatment, and thus susceptibility testing is not needed to make 

recommendations for clinical management. Laboratory capacity 

for N. gonorrhoeae culture and antibiotic susceptibility testing is 

critical to monitor for emerging resistance. Updated information 

regarding N. gonorrhoeae antibiotic susceptibility testing is available 

from CDC at http://www.cdc.gov/std/gisp.

Assessing N. gonorrhoeae isolates for antibiotic susceptibility 

requires viable isolates because accurate genetic markers of 

antibiotic resistance to recommended therapies have not been 

documented. Agar plate dilution testing that provides minimum 

inhibitory concentration values of tested antibiotics is the preferred 

method for testing the susceptibility of N. gonorrhoeae but might 

be too difficult to perform in laboratories with limited capacity and 

low testing volumes. Disk diffusion and E-test are simpler methods 

for determining susceptibilities of gonococcal isolates, although 

cefixime E-test strips are not FDA-cleared for use in the United 

States. Isolates that appear to be sess susceptible than the current 

Clinical and Laboratory Standards Institute (CLSI) interpretive 

criteria for susceptible organisms (68) (available at http://www.

cdc.gov/std/gonorrhea/arg/criteria.htm) should be submitted to 

CDC for reference testing using the agar plate dilution method 

because there are no CLSI interpretive criteria for resistance to 

CDC-recommended therapeutic agents. Procedures for agar 

dilution and disk diffusion testing are available at http://www.

cdc.gov/std/gonorrhea/lab/testing.htm. Clinicians who diagnose 

N. gonorrhoeae infection in a patient with suspected treatment 

failure should contact their local or state public health laboratory 

or local clinical laboratory for guidance on submitting specimens 

for culture and susceptibility testing. Local and state public health 

laboratory directors are encouraged to maintain culture and 

antimicrobial susceptibility testing capabilities for N. gonorrhoeae

or identify public health or private laboratories in their area with 

such capacity if they do not perform such testing.

6 MMWR / March 14, 2014 / Vol. 63 / No. 2
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No standard procedures exist to assess in vitro susceptibility 

of C. trachomatis to antibiotics (69). Further research is 

required to determine the relationship between in vitro data 

and outcome of treatment.

Nucleic acid amplification tests (NAATs). As of May 2013, 

five manufacturers had commercially available and FDA-cleared 

NAAT assay platforms for the detection of C. trachomatis

and N. gonorrhoeae in the United States. NAAT assays are 

recommended for detection of urogenital infections caused by 

C. trachomatis and N. gonorrhoeae infections in women and men 

with and without symptoms. These tests have been shown to 

be cost-effective in preventing sequelae due to these infections 

(70–72). A list of FDA-cleared specimen types and transport 

and storage requirements is provided (Table 2). These include 

Abbott RealTime m2000 CT/NG (Abbott Molecular Inc. Des 

Plaines, Illinois), Amplicor and cobas CT/NG test (Roche 

Molecular Diagnostics, Branchburg, New Jersey); Aptima, 

(Hologic/Gen-Probe, San Diego, California); BD ProbeTec ET 

and Qx (Becton Dickinson, Sparks, Maryland), and Xpert CT/

NG Assay (Cepheid, Sunnyvale, California) (Table 2). NAATs 

are designed to amplify and detect nucleic acid sequences that 

are specific for the organism being detected. Similar to other 

nonculture tests, NAATs do not require viable organisms. The 

increased sensitivity of NAATs is attributable to their theoretic 

ability to produce a positive signal from as little as a single copy 

of the target DNA or RNA. This high sensitivity has allowed 

the use of less invasively collected specimens such as first catch 

urines and vaginal swabs to detect shed organisms. Use of such 

specimens greatly facilitates screening.

Commercial tests differ in their amplification methods and 

their target nucleic acid sequences (Table 2). The two Roche tests 

and the Abbott RealTime CT/NG use polymerase chain reaction 

(PCR) and both Becton Dickinson tests use strand displacement 

amplification (SDA) to amplify C. trachomatis DNA sequences 

in the cryptic plasmid that is found in >99% of strains of 

C. trachomatis. The Hologic/Gen-Probe Aptima Combo 2 assay 

for C. trachomatis uses transcription-mediated amplification 

(TMA) to detect a specific 23S ribosomal RNA target. The 

Roche cobas CT/NG test, Abbott, Becton Dickinson, and 

Hologic/Gen-Probe tests detect the new variant of C. trachomatis

(nvCT) strain. These nucleic acid amplification methods also 

are used to detect N. gonorrhoeae, and each manufacturer has 

marketed a duplex assay that allows for simultaneous detection 

of both organisms. The nucleic acid primers used by commercial 

NAATs for C. trachomatis are not known to detect DNA 

from other bacteria found in humans. However, the primers 

employed by the Becton Dickinson N. gonorrhoeae NAATs 

might detect nongonococcal Neisseria species (73–76) (Table 3). 

Most commercial NAATs have been cleared by FDA to detect 

C. trachomatis and N. gonorrhoeae in vaginal and endocervical 

swabs from women, urethral swabs from men, and first catch 

urine from both men and women (Table 2).

Because NAATs are so sensitive, efforts are warranted to 

prevent contamination of specimens in the clinic or spread of 

environmental amplicon in the laboratory. Laboratories should 

follow standard molecular method techniques, clean workspaces 

and equipment frequently, include multiple negative controls 

in each run, and monitor the rate of indeterminate and positive 

results as a change in monthly trends might indicate a need 

to investigate the accuracy of the results. Environmental 

monitoring might be required as recommended by the 

manufacturer. If environmental amplicons are found, robust 

cleaning of the laboratory is needed until negative results are 

obtained. Steps to prevent cross-contamination include proper 

testing of laboratory workflow design and strict adherence to 

testing and quality assurance protocols.

Performance of Tests to Detect 

C. trachomatis and N. gonorrhoeae

Studies assessing the performance of NAATs might include 

test algorithms that use multiple NAATs, nonculture and 

culture tests as reference standards. Regardless of the analytic 

study design, the performance characteristics are relative 

to the standards used at the time of evaluation. When less 

sensitive methods are used as the reference standard, the 

specificity of the test under evaluation is likely to be underestimated. Conversely, the sensitivity of older assays was likely 

overestimated because of the relative poor performance of the 

assays used as standards at the time.

Because no gold standard exists, researchers compared two 

versions of the patient-infected-status algorithm (PISA) to 

assess the performance of NAATs. Using simulations with 

latent-class models, these researchers concluded that PISAbased methods can produce biased estimates of sensitivity 

and specificity that changed markedly as the true prevalence 

changes (77). However, there is no consensus on the optimal 

approach to evaluating the performance of NAATs, and 

better methods are needed (78). Until better methods become 

available, these recommendations support continuing reliance 

on NAATS based on their approval by FDA for indicated 

clinical use.

Simply quoting sensitivity and specificity data from 

package inserts or published studies is not useful because the 

numbers are estimates and are valid only within the context 

of the particular evaluation. Variables that can impact on 

these numbers include what comparison tests were used, in 

which population the evaluation was performed, and whether 

calculations were made on the basis of an infected patient 

standard or a direct comparison of specimens.

MMWR / March 14, 2014 / Vol. 63 / No. 2 7
Recommendations and Reports

TABLE 2. Food and Drug Administration–cleared* specimen types and requirements for the transport and storage of specimens for the detection 

of Chlamydia trachomatis and Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) type

FDA-cleared NAAT FDA-cleared specimen types Specimen transport and storage conditions

Abbott RealTime CT/NG (Abbott Molecular 

Inc., Des Plaines, IL)

Asymptomatic women: clinician-collected vaginal 

swab, patient-collected vaginal swab in a clinical 

setting, and urine.

Asymptomatic men: urine.

Symptomatic women: endocervical swab, 

clinician-collected vaginal swab, patient-collected 

vaginal swab in a clinical setting, and urine.

Symptomatic men: urethral swab and urine.

14 days at 2°–30°C

90 days at -10°C or lower

Thaw frozen specimens at 2°–30°C

Specimens must not undergo more than four freeze/ thaw cycles

Aptima COMBO 2 assay

Aptima CT assay

Aptima GC assay

(Hologic/Gen-Probe Inc., San Diego, CA)

Asymptomatic women: endocervical swab, cliniciancollected vaginal swab, patient-collected vaginal 

swab in a clinical setting, gynecologic specimens 

collected in PreservCyt solution and urine.

Asymptomatic men: urethral swab and urine.

Symptomatic women: endocervical swab, cliniciancollected vaginal swab, patient-collected vaginal 

swab in a clinical setting, gynecologic specimens 

collected in PreservCyt solution and urine.

Symptomatic men: urethral swab and urine.

24 hours at 2°–30°C (urine specimen in primary cup)

30 days at 2°–30°C (urine specimen in Aptima urine transport tube)

60 days at 2°–30°C (swab in Aptima swab transport tube)

12 months at -20° to -70°C (urine specimen and swab specimens 

in respective Aptima transport tubes)

BD ProbeTec ET CT/GC Amplified DNA assay

(Becton Dickinson and Company, Sparks, MD)

Asymptomatic women: endocervical swab and 

urine.

Asymptomatic men: urethral swab and urine.

Symptomatic women: endocervical swab and urine.

Symptomatic men: urethral swab and urine.

30 hours at 2°–30°C (urine specimen in primary cup)

7 days at 2°–8°C (urine specimen in primary cup)

30 days at 2°–30°C (urine specimen in urine processing tube)

60 days at -20°C or lower (neat urine specimen or urine in urine 

processing tube)

6 days at 2°–27°C (swab specimens)

30 days at 2°–8°C (swab specimens)

BD ProbeTec QX CT Amplified DNA assay

BD ProbeTec QX GC Amplified DNA assay

(Becton Dickinson and Company, Sparks, MD)

Asymptomatic women: endocervical swab, 

patient-collected vaginal swab in a clinical setting, 

gynecologic specimens collected in BDSurePath 

or PreservCyt solution and urine.

Asymptomatic men: urethral swab and urine.

Symptomatic women: endocervical swab, 

patient-collected vaginal swab in a clinical setting, 

gynecologic specimens collected in BDSurePath 

or PreservCyt solution and urine.

Symptomatic men: urethral swab and urine.

30 hours at 2°–30°C (urine specimen in primary cup).

7 days at 2°–8°C (urine specimen in primary cup)

30 days at 2°–30°C (urine specimen in urine processing tube)

180 days at -20°C or lower (neat urine specimen or urine in 

urine processing tube)

30 days at 2°–30°C (endocervical and urethral swab specimens)

180 days at -20°C or lower (endocervical and urethral swab 

specimens)

14 days at 2°–30°C (dry vaginal swab specimens)

30 days at 2°–30°C (expressed vaginal swab specimens)

180 days at -20°C or lower (dry or expressed vaginal swab specimens)

Xpert CT/NG assay

(Cepheid, Sunnyvale, CA)

Asymptomatic women: endocervical swab, 

patient-collected vaginal swab in a clinical setting, 

and urine.

Asymptomatic men: urine.

Symptomatic women: endocervical swab, 

patient-collected vaginal swab in a clinical setting, 

and urine.

Symptomatic men: urine.

24 hours at room temperature (female urine specimen in 

primary cup)

3 days at room temperature (male urine specimen in primary cup)

8 days at 4°C (female and male urine specimen in primary cup)

3 days at 15°–30°C (female urine specimen in Xpert CT/NG 

Urine Transport Reagent tube)

45 days at 2°–15°C (female urine specimen in Xpert CT/NG 

Urine Transport Reagent tube)

45 days at 2°–30°C (male urine specimen in Xpert CT/NG Urine 

Transport Reagent tube)

45 days at 2°–30°C (swab in Xpert CT/NG Swab Transport 

Reagent tube)

cobas CT/NG test

(Roche Diagnostics, Indianapolis, IN)

Asymptomatic women: endocervical swab, patientcollected vaginal swab in a clinical setting, cliniciancollected vaginal swab, gynecologic specimens 

collected in PreservCyt solution and urine.

Asymptomatic men: urine.

Symptomatic women: endocervical swab, patientcollected vaginal swab in a clinical setting, cliniciancollected vaginal swab, gynecologic specimens 

collected in PreservCyt solution and urine.

Symptomatic men: urine.

≤1 yr at 2°– 30°C (swab or urine specimen in cobas PCR media)

24 hrs at 2°–30°C (Neat male urine specimen prior to addition 

to cobas PCR media)

Cervical specimens collected in PreservCyt Solution may be 

stored at 2°–30°C for up to 12 months. Aliquots (≥1mL) of 

cervical specimens collected in PreservCyt Solution may be 

stored in 13 mL round-based Sarstedt tubes for up to 4 weeks 

at 2°–30°C.

* FDA-cleared NAATs and specimen types as of January 1, 2014.

8 MMWR / March 14, 2014 / Vol. 63 / No. 2
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TABLE 3. Chlamydia trachomatis and Neisseria gonorrhoeae Nucleic Acid Amplification Test (NAAT) target sequences and possible false reactions, 

by test type

FDA-cleared NAAT Nucleic acid target for C. trachomatis Nucleic acid target for N. gonorrhoeae

Abbott RealTime CT/NG 

(Abbott Laboratories, Abbott Park, IL)

Two distinct specific sequence regions within the 7,500 base 

pair C. trachomatis cryptic plasmid DNA.

The test does not detect plasmid free C. trachomatis.

No false-positive tests based on analytical specificity testing.

48 base pair sequence within the Opa gene of 

N. gonorrhoeae.

No false-positive tests based on analytical specificity 

testing.

Aptima COMBO 2 assay

Aptima CT assay

Aptima GC assay

(Hologic/Gen-Probe Inc., San Diego, CA)

Specific region within the 23S rRNA from C. trachomatis 

(Aptima Combo 2 assay).

Specific region with the 16S rRNA from C. trachomatis (Aptima 

CT assay).

Both the Aptima Combo 2 assay and APTIMA CT assay detects 

nvCT.

The test does not detect plasmid-free C. trachomatis.

No false-positive tests based on analytical specificity testing.

Specific region within the 16S rRNA from N.gonorrhoeae

(Aptima Combo 2 assay).

Specific region with the 16S rRNA from N. gonorrhoeae that 

is distinct from the Aptima Combo 2 assay target (Aptima 

GC assay).

No false-positive tests based on analytical specificity 

testing.

BD ProbeTec ET CT/GC Amplified 

DNA assay

(Becton Dickinson and Company, 

Sparks, MD)

One distinct sequence within the 7,500 base pair 

C. trachomatis cryptic plasmid DNA.

The test does not detect plasmid-free C. trachomatis.

No false-positive tests based on analytical specificity testing.

Chromosomal pilin gene-inverting protein homologue.

Neisseria cinerea, Neisseria subflava and Neisseria lactamica 

might result in false-positive test results based on 

analytical specificity testing.

BD ProbeTec QX CT Amplified 

DNA Assay

BD ProbeTec QX GC Amplified 

DNA Assay

(Becton Dickinson and Company, 

Sparks, MD)

One distinct sequence within the 7,500 base pair 

C. trachomatis cryptic plasmid DNA.

The test does not detect plasmid-free C. trachomatis.

No false-positive tests based on analytical specificity testing.

Chromosomal pilin gene-inverting protein homologue.

N. cinerea and N. lactamica might result in false-positive test 

results based on analytical specificity testing.

Xpert CT/NG Assay

(Cepheid, Sunnyvale, CA)

One distinct C. trachomatis chromosomal DNA sequence.

No false-positive tests based on analytical specificity testing.

The test detects plasmid-free C. trachomatis.

Two distinct chromosomal sequences each with a different 

reporter. Both sequences have to be detected to obtain a 

positive N. gonorrhoeae result.

No false-positives based on analytical specificity testing

cobasCT/NG test

(Roche Diagnostics, Indianapolis, IN)

CT primers CP102 and CP103 to define a sequence of 

approximately 206 nucleotides within the cryptic plasmid 

DNA of C. trachomatis.

CT primers CTMP101 and CTMP102 to define a sequence of 

approximately 182 nucleotides within the chromosomal DNA 

of C. trachomatis.

No false-positive tests based on analytical specificity testing.

The test detects plasmid-free C. trachomatis.

NG primers NG514 and NG519 to define a sequence of 

approximately 190 nucleotides (DR-9A) from the 

DR-9 region.

NG primers, NG552 and NG579, to define a second 

sequence of approximately 215 nucleotides (DR-9B) from 

the DR-9 region.

No false-positive tests based on analytical specificity 

testing.

Nevertheless, despite the absence of a criterion standard, 

valid generalizations can be made. All diagnostic tests 

including NAATs can generate inaccurate results, and it is 

important for laboratorians and clinicians to understand test 

limitations. Certain false positives and false negatives can occur 

as a consequence of specimen collection, test operation, and 

laboratory environment. However, NAATs are far superior in 

overall performance compared with other C. trachomatis and 

N. gonorrhoeae culture and nonculture diagnostic methods. 

NAATs offer greatly expanded sensitivities of detection, usually 

well above 90%, while maintaining very high specificity, 

usually ≥99%. NAATs typically detect 20%–50% more 

chlamydial infections than could be detected by culture or 

earlier nonculture tests (20). The increment for detection of 

gonococcal infections is somewhat less.

Detection of Genitourinary C. trachomatis

and N. gonorrhoeae Infections in Women

Screening programs have been demonstrated to reduce both 

the prevalence of C. trachomatis infection and rates of PID in 

women (79,80). Sexually active women aged ≤25 years and 

women aged >25 years with risk factors (e.g., those who have 

a new sex partner or multiple partners) should be screened 

annually for chlamydial infections (81).

The prevalence of gonorrhea varies widely among 

communities and populations; health-care providers should 

consider local gonorrhea epidemiology when making screening 

decisions. Although widespread screening is not recommended, 

targeted screening of young women (i.e., those aged ≤25 years) 

at increased risk for infection is a primary component of 

gonorrhea control in the United States because gonococcal 

infections among women are frequently asymptomatic. For 

sexually active women, including those who are pregnant, the 

MMWR / March 14, 2014 / Vol. 63 / No. 2 9
Recommendations and Reports

U.S. Preventive Services Task Force (USPSTF) recommends 

that clinicians provide gonorrhea screening only to those 

at increased risk for infection (e.g., women with previous 

gonorrhea infection, other STDs, new or multiple sex partners, 

and inconsistent condom use; those who engage in commercial 

sex work and drug use; women in certain demographic groups; 

and those living in communities with a high prevalence 

of disease). USPSTF does not recommend screening for 

gonorrhea in women who are at low risk for infection (81).

For female screening, specimens obtained with a vaginal swab 

are the preferred specimen type. Vaginal swab specimens are as 

sensitive as cervical swab specimens, and there is no difference in 

specificity (82–87). Self-collected vaginal swabs are equivalent in 

sensitivity and specificity to those collected by a clinician (83,88). 

Cervical samples are acceptable when pelvic examinations are 

done, but vaginal swab specimens are an appropriate sample 

type, even when a full pelvic exam is being performed. Cervical 

specimens collected into a liquid cytology medium for Pap 

screening are acceptable for NAATs that have been cleared by 

FDA for such specimen types (Table 2). However, following 

Pap screening, there should be a clinical indication for reflex 

additional testing of liquid cytology specimens for chlamydia and 

gonorrhea since these specimen types are more widely used in 

older populations at low risk for infection. First catch urine from 

women, while acceptable for screening, might detect up to 10% 

fewer infections when compared with vaginal and endocervical 

swab samples (82,87,89) (Box 2). 

Detection of Genitourinary C. trachomatis

and N. gonorrhoeae Infections in Men

C. trachomatis and N. gonorrhoeae control efforts in men 

differ substantially from those recommended for women. 

Although chlamydia prevalence data have provided a basis 

for setting age guidelines for routine annual screening and 

behavioral guidelines for targeted screening in women (11), 

no such consensus has been reached regarding control program 

definitions in men who have sex with women (12). Although 

there are no recommendations to screen heterosexual men, it 

USPSTF suggests testing to test sexually active heterosexual 

men in clinical settings with a high prevalence of C. trachomatis

(e.g., STD clinics, adolescent clinics, and detention and 

correctional facilities) and among persons entering the Armed 

Forces or the National Job Training Program (81).

The prevalence of N. gonorrhoeae varies widely among 

communities and populations; health-care providers should 

consider the local gonorrhea epidemiology when making 

screening recommendations. There is insufficient evidence for 

or against routine screening for gonorrhea in sexually active 

heterosexual men at increased risk for infection (81). However, 

BOX 2. Chlamydia trachomatis and Neisseria gonorrhoeae testing in women

•	 Nucleic acid amplification tests (NAATs) are the 

recommended test method.

•	 A self- or clinician-collected vaginal swab is the 

recommended sample type. Self-collected vaginal 

swab specimens are an option for screening women 

when a pelvic exam is not otherwise indicated.

•	 An endocervical swab is acceptable when a pelvic 

examination is indicated.

•	 A first catch urine specimen is acceptable but might 

detect up to 10% fewer infections when compared 

with vaginal and endocervical swab samples.

•	 An endocervical swab specimen for N. gonorrhoeae

culture should be obtained and evaluated for antibiotic 

susceptibility in patients that have received CDCrecommended antimicrobial regimen as treatment, and 

subsequently had a positive N. gonorrhoeae test result 

(positive NAAT ≥7 days after treatment), and did not 

engage in sexual activity after treatment. 

it is not recommended to screen for gonorrhea infections in 

men at low risk for infection (81).

Overwhelming evidence described the performance of male 

first catch urine samples as equivalent to, and in some situations 

superior to, urethral swabs (23,90). Use of urine samples is 

highly acceptable and might improve the likelihood of uptake 

of routine screening in men (Box 3). 

Detection of Extragenital C. trachomatis

and N. gonorrhoeae Infections in 

Men and Women

Infections with C. trachomatis and N. gonorrhoeae are common 

in extragenital sites in certain populations such as MSM. Because 

extragenital infections are common in MSM, and most infections 

are asymptomatic (91), routine annual screening of extragenital 

sites in MSM is recommended. No recommendations exist 

regarding routine extragenital screening in women because 

studies have focused on genitourinary screening, but rectal and 

oropharyngeal infections are not uncommon.

A 2003 study that assessed NAATs for diagnosing 

C. trachomatis and N. gonorrhoeae infections in multiple 

anatomic sites in MSMs (91) used Becton Dickinson’s 

ProbeTec NAAT, which had been validated previously for 

such use. Among 6,434 MSM attending an STD clinic or a 

gay men’s clinic, the study found that the prevalence by site for 

C. trachomatis was 7.9% for the rectum, 5.2% urethral, and 

1.4% pharyngeal; and prevalence by site for N. gonorrhoeae

10 MMWR / March 14, 2014 / Vol. 63 / No. 2
Recommendations and Reports

BOX 3. Chlamydia trachomatis and Neisseria gonorrhoeae testing in men

•	 Nucleic acid amplification tests (NAATs) are the 

recommended test method.

•	 A first catch urine is the recommended sample type 

and is equivalent to a urethral swab in detecting 

infection.

•	 A urethral swab specimen for N. gonorrhoeae culture 

should be obtained and evaluated for antibiotic 

susceptibility in patients who have received CDCrecommended an antimicrobial regimen as treatment, 

and subsequently had a positive N. gonorrhoeae test 

result (positive NAAT ≥7 days after treatment), and did 

not engage in sexual activity after treatment. 

was 6.9% for the rectum, 6% urethral, and 9.2% pharyngeal. 

The great majority (84%) of the gonococcal and chlamydial 

rectal infections were asymptomatic. More than half (53%) 

of C. trachomatis and 64% of N. gonorrhoeae infections 

were at nonurethral sites and would have been missed if the 

traditional approach to screening of men by testing only 

urethral specimens had been used.

The scope of the problem of extragenital infection in MSM 

is not known at the national level. In 2007, CDC coordinated 

an evaluation of MSM attending several community-based 

organizations and public or STD clinics and found that of 

approximately 30,000 tests performed, 353 (5.4%) MSM 

were positive for rectal infection with N. gonorrhoeae, and 

468 (8.9%) were positive for rectal C. trachomatis. Pharyngeal 

N. gonorrhoeae tests were positive for 759 MSM (5.3%), and 

54 (1.6%) were positive for C. trachomatis (92).

In the United Kingdom, some studies on screening MSMs 

have been performed using NAATs (93,94), and in one study 

of 3,076 MSM attending an STD clinic, there was an 8.2% 

prevalence of infection with C. trachomatis in the rectum and 

5.4% in the urethra. The majority (69%) of the men with 

C. trachomatis were asymptomatic, stressing the need for 

screening (94).

A study that compared culture to two NAATs (Hologic/

Gen-Probe’s Aptima Combo2 [AC2]) and Becton Dickinson’s 

ProbeTec) for the detection of C. trachomatis and N. gonorrhoeae

in pharyngeal and rectal specimens collected from 1,110 MSM 

being seen in an STD clinic confirmed all NAAT positive 

results when either the original test or a test using alternate 

primers was positive (95). For oropharyngeal N. gonorrhoeae,

sensitivities were 41% for culture, 72% for SDA, and 84% for 

AC2; and for rectal N. gonorrhoeae, sensitivities were 43% for 

culture, 78% for SDA, and 93% for AC2. For oropharyngeal 

infections with C. trachomatis (for which only nine infections 

were detected), sensitivities were 44% for culture, 67% 

for SDA, and 100% for AC2; for rectal C. trachomatis,

sensitivities were 27% for culture, 63% for SDA, and 93% 

for AC2. Specificities were >99.4% for all specimens, tests, 

and anatomic sites. The number of infections detected was 

more than doubled when a more sensitive NAAT was used as 

compared with the use of standard culture. Other researchers 

also have demonstrated the superiority of NAATs as compared 

with culture for diagnosing C. trachomatis and N. gonorrhoeae

in rectal and oropharyngeal sites (36,75,76).

Although commercially available NAATs are recommended 

for testing genital tract specimens, they have not been cleared 

by FDA for the detection of C. trachomatis and N. gonorrhoeae

infections of the rectum and oropharynx (Box 4). Results 

from commercially available NAATs can be used for patient 

management if the laboratory has established specifications for 

the performance characteristics according to CLIA regulations 

(96). If a moderate complexity test such as the GeneXpert is 

modified in any manner, the test defaults to high complexity 

and the laboratory must meet all high complexity CLIA 

requirements, including those for personnel. Certain NAATs that 

have been demonstrated to detect commensal Neisseria species 

in urogenital specimens might have comparable low specificity 

when testing oropharyngeal specimens for N. gonorrhoeae. Thus, 

a N. gonorrhoeae NAAT that does not react with nongonococcal 

commensal Neisseria species is recommended when testing 

oropharyngeal specimens (Table 3).

BOX 4. Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

infections in the rectum and oropharynx

•	 Nucleic acid amplification tests (NAATs) are the 

recommended test method for rectal and 

oropharyngeal specimens.

•	 Laboratories must be in compliance with CLIA for 

test modifications since these tests have not been 

cleared by the FDA for these specimen types.

•	 Commensal Neisseria species commonly found in the 

oropharynx might cause false positive reactions in 

some NAATs, and further testing might be required 

for accuracy.

•	 A rectal or oropharyngeal swab specimen for 

N. gonorrhoeae culture should be obtained and evaluated 

for antibiotic susceptibility in patients who have received 

CDC-recommended antimicrobial regimen as 

treatment, had a subsequent positive N. gonorrhoeae test 

result (positive NAAT ≥7 days after treatment), and did 

not engage in sexual activity after treatment.

MMWR / March 14, 2014 / Vol. 63 / No. 2 11
Recommendations and Reports

Detection of Genitourinary and 

Extragenital C. trachomatis and 

N. gonorrhoeae Infections in Cases of 

Sexual Assault

Detailed information about evaluation and treatment of 

suspected victims of sexual assault can be obtained from the 

2010 STD treatment guidelines (19). General recommendations 

pertaining only to C. trachomatis and N. gonorrhoeae testing 

are presented here. Examination of victims is required for two 

purposes: 1) to determine if an infection is present so that it can 

be successfully treated and 2) to acquire evidence for potential use 

in a legal investigation. Testing to satisfy the first purpose requires 

a method that is highly sensitive, whereas satisfying the second 

purpose requires a method that is highly specific. Although 

NAATs meet these criteria, acceptance of any test results is 

determined by local legal authorities. Local legal requirements 

and guidance also should be sought for maintaining and 

documenting a chain of custody for specimens and results that 

might be used in a legal investigation and for which test results 

are accepted as evidence.

NAATs for C. trachomatis and N. gonorrhoeae are preferred 

for the diagnostic evaluation of adult sexual assault victims, 

from any sites of penetration or attempted penetration (97,98). 

Data on use of NAATs for detection of N. gonorrhoeae in 

children are limited. Consultation with an expert is necessary 

before use of NAATs for this indication in children to minimize 

the possibility of positive reactions with nongonococcal 

Neisseria species and other commensals. NAATs can be used as 

alternative to culture with vaginal specimens or urine specimens 

from girls. Culture remains the preferred method for urethral 

specimens from boys and extragenital specimens (pharynx and 

rectum) in boys and girls.

Using highly specific tests is critical with prepubescent 

children for whom the diagnosis of a sexually transmitted 

infection might lead to initiation of an investigation for child 

abuse. Specimen collection for culture for N. gonorrhoeae

includes the pharynx and rectum in boys and girls, the 

vagina in girls, and the urethra in boys. Cervical specimens 

are not recommended for prepubertal girls. For boys with a 

urethral discharge, a meatal specimen discharge is an adequate 

substitute for an intra-urethral swab specimen. Standard culture 

procedures must be followed. Gram stains are inadequate to 

evaluate prepubertal children for N. gonorrhoeae and should not 

be used to diagnose or exclude N. gonorrhoeae. Specimens from 

the vagina, urethra, pharynx, or rectum should be streaked 

onto selective media for isolation of N. gonorrhoeae, and all 

presumptive isolates of N. gonorrhoeae should be identified 

definitively by at least two tests that involve different principles 

(e.g., biochemical, enzyme substrate, or serologic). Isolates 

should be preserved to enable additional or repeated testing.

Cultures for C. trachomatis can be collected from the 

rectum in both boys and girls and from the vagina in girls. 

The likelihood of recovering C. trachomatis from the urethra 

of prepubertal boys is too low to justify the trauma involved 

in obtaining an intraurethral specimen. However a meatal 

specimen should be obtained if urethral discharge is present. 

Pharyngeal specimens for C. trachomatis are not recommended 

for children of either sex because the yield is low, perinatally 

acquired infection might persist beyond infancy, and culture 

systems in some laboratories use antibody stains that do not 

distinguish between C. trachomatis and C. pneumoniae. All 

specimens must be retained for additional testing, if necessary, 

regardless of a positive or negative test result.

Only standard culture systems for the isolation of 

C. trachomatis should be used. The isolation of C. trachomatis

should be confirmed by microscopic identification of inclusions 

by staining with fluorescein-conjugated monoclonal antibody 

MOMP specific for C. trachomatis; stains using monoclonal 

antibodies directed against LPS should not be used. EIAs 

are not acceptable confirmatory methods. Isolates should be 

preserved. Nonculture tests for C. trachomatis such as EIAs 

and DFA are not sufficiently specific for use in circumstances 

involving possible child abuse or sexual assault. NAATs can 

be used for detection of C. trachomatis in vaginal specimens 

or urine from girls. No data exist on the use of nucleic acid 

amplification tests in boys and extragenital specimens (rectum) 

in boys and girls. Culture remains the preferred method for 

extragenital sites in these circumstances.

Detection of lymphogranuloma 

venereum Infections

Serologic testing for LGV is not widely available in the 

United States. The chlamydial complement fixation test 

(CFT), which measures antibody against group-specific 

lipopolysaccharide antigen, has been used as an aid in the 

diagnosis of LGV. A CFT titer ≥1:64 typically can be measured 

in the serum of patients with bubonic LGV (99). The microimmunofluorescence (MIF) test was initially developed for 

serotyping strains of C. trachomatis isolated from the eye 

and genital tract but was soon adapted to measure antibody 

responses in patients with chlamydial infections. Although 

the original MIF method was complicated, involving the 

titration of sera against numerous antigens, it was found to 

have many advantages when compared with the CFT (99). 

The MIF test can be used detect type-specific antibody and 

different immunoglobulin classes. The MIF test is more 

sensitive than the CFT with a larger proportion of patients 

12 MMWR / March 14, 2014 / Vol. 63 / No. 2
Recommendations and Reports

developing an antibody response and at higher titer. Patients 

with LGV tend to have broadly crossreactive MIF titers that 

are often greater than 1:256 (99). Microtiter plate format 

enzyme immunoassays have been developed but comparative 

performance data are lacking. Serologic test interpretation for 

LGV is not standardized, tests have not been validated for 

clinical proctitis presentations, and C. trachomatis serovarspecific serologic tests are not widely available. More detailed 

information concerning the diagnosis and treatment of LGV 

has been published (19).

Genital and lymph node specimens (i.e., lesion swab or bubo 

aspirate) can be tested for C. trachomatis by culture, direct 

immunofluorescence, or nucleic acid detection. Commercially 

available NAATs for C. trachomatis detect both LGV and 

non-LGV C. trachomatis but cannot distinguish between 

them. Additional molecular procedures (e.g., PCR-based 

genotyping) can be used to differentiate LGV from non-LGV 

C. trachomatis, but these are not widely available (100–104).

For patients presenting with proctitis, C. trachomatis NAAT 

testing of a rectal specimen is recommended. While a positive 

result is not definitive diagnosis of LGV, the result might aid 

in a presumptive clinical diagnosis of LGV proctitis.

Additional Considerations

Supplemental testing of NAAT-positive specimens. In 

2002, CDC recommended that consideration be given to 

performing an additional test routinely after a positive NAAT 

screening test for C. trachomatis and N. gonorrhoeae (20). 

This approach was advised to improve the positive predictive 

value (PPV) of a NAAT screening test. This was particularly 

important when the test was used in a population with a low 

prevalence of infection. However, studies since 2002 addressing 

the utility of routine repeat testing of positive specimens 

demonstrated >90% concurrence with the initial test for either 

C. trachomatis or N. gonorrhoeae (105–107). Therefore, routine 

additional testing following a positive NAAT screening test 

for C. trachomatis no longer is recommended by CDC unless 

otherwise indicated in the product insert. Some NAATs might 

detect nongonococcal Neisseria species (Table 3). When these 

NAATs are used, consideration should be given to retest these 

specimens with an alternate target assay if the anatomic site 

from which the specimen was collected is typically colonized 

with these commensal organisms, e.g., oropharyngeal 

specimens. As with any diagnostic test, if there is a clinical or 

laboratory reason to question a test result, a repeat test should 

be considered.

Test interpretation. The laboratory should interpret and 

report results according to the manufacturer’s package insert 

instructions In the event of discordant results from multiple 

tests, the report should indicate the results of both the initial 

and any additional tests. An interpretation of “inconclusive,” 

“equivocal,” or “indeterminate” would be most appropriate. 

A new specimen should be requested for testing in these 

situations. All test results should be interpreted by clinicians 

within the context of the patient-specific information to 

determine appropriate patient management.

Test of cure. Culture is the only method that can be used 

to properly assess the efficacy of antibiotic therapy because 

commercial NAATs are not FDA-cleared for use as a test of 

cure. Residual nucleic acid from bacteria rendered noninfective 

by antibiotics might still give a positive C. trachomatis

NAAT up to 3 weeks after therapy (108,109). Detection of 

N. gonorrhoeae nucleic acid has been observed for up to 2 weeks 

following therapy although the vast majority of patients who 

were treated effectively for gonorrhea had a negative NAAT 

1 week after treatment (110). However, data from these studies 

were derived from older NAATs and should be repeated with 

current NAATs.

Pooling of specimens. The superior performance 

characteristics of NAATs for detection of C. trachomatis

and N. gonorrhoeae have led some researchers to pool urine 

specimens in an attempt to reduce the higher material costs 

associated with their use (111–113). Samples of individual 

specimens are first combined into a pool, which is then tested 

by a NAAT. If the pool is negative, all specimens forming 

the pool are reported as negative. If the pool is positive, a 

second aliquot of each specimen that contributed to the pool 

is tested individually. The potential cost-savings with pooling 

increases with decreasing prevalence of infection, because more 

specimens can be included in a pool without increasing the 

probability of a pool testing positive. The number of specimens 

pooled to achieve the greatest cost savings for a particular 

prevalence can be calculated (111). Available evidence indicates 

that pooled aliquots from up to 10 urine specimens can be 

a cost-effective alternative to testing individual specimens 

without any loss of sensitivity or specificity (111). Savings from 

reduced reagent costs have ranged from 40% to 60% (111). 

However, the increased complexity of the pooling protocol 

might require more personnel time to deconstruct positive 

pools for individual specimen testing. The use of pooled 

specimens for testing is not cleared by FDA and, therefore, the 

CLIA requirements applicable to modifying a test procedure 

must be met before implementation and reporting results 

intended to guide patient care. Laboratories must be aware that 

the process of pooling specimens requires extensive handling of 

samples which increases the potential for cross-contamination. 

Studies for pooling clinical specimens other than urine are 

required before extending this recommendation.

MMWR / March 14, 2014 / Vol. 63 / No. 2 13
Recommendations and Reports

Tests Not Recommended for Routine Use

Direct fluorescent antibody (DFA) tests .This assay should 

not be used for routine testing of genital tract specimens. 

Rather, DFA tests are the only FDA-cleared tests for ocular 

C. trachomatis infections. Depending on the commercial 

product used, the antigen that is detected by the antibody in 

the C. trachomatis DFA procedure is either the MOMP or 

LPS molecule. Specimen material is obtained with a swab or 

endocervical brush, which is then rolled over the specimen well 

of a slide. After the slide has dried and the fixative applied, 

the slide can be stored or shipped at ambient temperature. 

The laboratory should process the slide <7 days after the 

specimen has been obtained. Staining consists of flooding 

the smear with fluorescein-labeled monoclonal antibody that 

binds to C. trachomatis elementary bodies. Stained elementary 

bodies are then identified by fluorescence microscopy. Only 

C. trachomatis organisms will stain with the anti-MOMP 

antibodies used in commercial kits. The anti-LPS monoclonal 

antibodies will react with family-specific epitopes found 

within the LPS of Chlamydiaceae and might cross-react with 

LPS of other bacteria. The procedure requires an experienced 

microscopist and is labor-intensive and time-consuming. No 

DFA tests exist for the direct detection of N. gonorrhoeae in 

clinical specimens.

Nucleic acid hybridization/probe tests. Two nucleic acid 

hybridization assays are FDA-cleared to detect C. trachomatis

or N. gonorrhoeae: the Hologic/Gen-Probe PACE 2 and the 

Digene Hybrid Capture II assays. Both the PACE and Hybrid 

Capture assays can detect C. trachomatis or N. gonorrhoeae

in a single specimen. The Hybrid Capture assay is not 

widely available and the PACE 2C test was discontinued 

December 31, 2012.

Nucleic acid genetic transformation tests. The Gonostat 

test (Sierra Diagnostics, Incorporated, Sonora, California) 

uses a gonococcal mutant that grows when genetically 

altered by DNA extracted from a swab specimen containing 

N. gonorrhoeae. N. meningitidis causes false-positive results 

(114). The test has received limited evaluation in published 

studies (115–118), which included an evaluation of its use 

with mailed specimens (117). Amplified and hybridization 

tests that detect N. gonorrhoeae nucleic acid have better 

performance characteristics than the Gonostat test. The 

gonorrhea nucleic acid genetic transformation test might have 

some utility in settings that lack the stringency for gonorrhea 

culture. However, it is not recommended as an alternative test 

to N. gonorrhoeae NAATs. A genetic transformation test is not 

available for detection of C. trachomatis infection.

Enzyme immunoassay (EIA) tests. A substantial number 

of EIA tests have been marketed for detecting C. trachomatis

infection. The performance and cost characteristics of EIA 

tests for N. gonorrhoeae infection have not made them 

competitive with other available tests (56). C. trachomatis

EIA tests detect chlamydial LPS, and there is the potential 

for false-positive results caused by crossreaction with LPS of 

other microorganisms. Manufacturers have developed blocking 

assays that verify positive EIA test results to improve specificity. 

None of the EIAs are as sensitive or specific as NAATs, and 

their use is discouraged.

Serology tests. Serology has little, if any, value in testing for 

uncomplicated genital C. trachomatis infection. It should not 

be used for screening because previous chlamydial infection 

might or might not elicit a systemic antibody response. 

Infections caused by LGV serovars of C. trachomatis tend 

to invade to the draining lymph nodes resulting in a greater 

likelihood of detectable systemic antibody response and might 

aid in diagnosis of inguinal (but not rectal) disease (99). The 

complement fixation test was classically used for this purpose 

but has been replaced by the more sensitive species-specific 

microimmunofluorescence test. A serologic screening or 

diagnostic assay is not available for N. gonorrhoeae.

Conclusion

Technological evolution in clinical laboratory diagnostics 

has advanced considerably by allowing for the direct molecular 

detection of a pathogen in a clinical specimen rather than relying 

on isolation and cultivation. This approach has decreased the 

time required to identify a pathogen because the laboratory 

is no longer limited by the growth kinetics of the organism. 

Therefore, patients can be evaluated and if infected can be 

treated promptly, thereby diminishing progression to disease 

and disrupting transmission. As with all changes in laboratory 

technology, a synthesis of scientific evidence is required for 

an informed decision regarding the implementation of a new 

or improved test platform. Previous CDC recommendations 

to use NAATs for the detection of chlamydia and gonorrhea 

as the standard laboratory test remain. These updated CDC 

recommendations now specify that vaginal swabs are the 

preferred specimen for screening women and include the use of 

rectal and oropharyngeal specimens among populations at risk 

for extragenital tract infections. FDA clearance is important 

for widespread use of a test, and it is important that clearance 

be obtained for NAAT use with rectal and oropharyngeal 

specimens, and with vaginal swabs collected in other than 

clinic settings.

Future revisions to these recommendations will be influenced 

by the development and marketing of new laboratory tests, 

or indications of existing tests, for chlamydia and gonorrhea. 

14 MMWR / March 14, 2014 / Vol. 63 / No. 2
Recommendations and Reports

Improvements in molecular tests that continue to decrease 

detection time and decrease the test complexity might facilitate 

the use of NAATs in non-traditional laboratory settings such as 

physician offices, health fairs, school clinics, or other outreach 

venues. Shifting chlamydia and gonorrhea diagnostics from 

laboratories might require new recommendations on test 

application or reporting positive cases of reportable diseases. 

Periodic updates to these recommendations will be available 

on the CDC Division of STD Prevention website (http://

www.cdc.gov/std).

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MMWR / March 14, 2014 / Vol. 63 / No. 2 17
Recommendations and Reports

Appendix 

Key Questions Reviewed by the Work Group and Member(s) Responsible 

for Literature Summary

Performance Characteristics

•	 Does the sensitivity and specificity of available tests for C. trachomatis and N. gonorrhoeae vary with respect to anatomic site 

from which the specimen was collected and/or specimen type?

– Joan Chow, DrPH, California Department of Public Health, Richmond, California

– Katherine Whitaker, PhD, Food and Drug Administration, Rockville, Maryland

•	 What recommendations should be made for the detection of C. trachomatis and N. gonorrhoeae infections of the genital tract, 

rectum, and throat?

– Gary Budnick, MHS, Connecticut Department of Public Health Laboratory, Hartford, Connecticut

– Steven Shapiro, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC

– Rick Steece, PhD, Infertility Prevention Project Laboratory Consultant, Pierre, South Dakota

•	 What test recommendations should be made for the diagnosis of suspected LGV infections (inguinal and rectal presentations)?

– Lisa Steele, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC

Screening Applications

•	 What specimen types are optimal for of C. trachomatis and N. gonorrhoeae screening purposes?

– Charlotte Gaydos, DrPH, Johns Hopkins University, Baltimore, Maryland

– Sarah Guerry, MD, Los Angeles County Department of Health Services, Los Angeles, California

– Barbara Van Der Pol, PhD, Indiana University School of Public Health, Bloomington, Indiana

•	 What parameters should be considered when selecting a C. trachomatis and N. gonorrhoeae test for screening purposes?

– George Dizikes, PhD, Illinois Department of Public Health, Chicago, Illinois

– Robert E Johnson, MD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC

– Scott Zimmerman, DrPH, Erie County Public Health Laboratory, Buffalo, New York

Economic Considerations

•	 What economic considerations might influence laboratory testing?

– Thomas Gift, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC

Laboratory Confirmation

•	 What approaches, if any, can be used to derive a definitive laboratory confirmation of C. trachomatis and N. gonorrhoeae?

– Yetunde Fakile, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC

– Dennis Ferrero, MPH, Department of Biological Sciences, University of the Pacific, Stockton, California

– Rick Steece, PhD, Infertility Prevention Project Laboratory Consultant, Pierre, South Dakota

– Barbara Van Der Pol, PhD, Indiana University School of Public Health, Bloomington, Indiana

18 MMWR / March 14, 2014 / Vol. 63 / No. 2
Recommendations and Reports

Work Group Members

As of January 2009

Chair: John R. Papp, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, Atlanta, Georgia.

Presenters: Gary Budnick, MHS, Connecticut Department of Public Health Laboratory, Hartford, Connecticut; Joan Chow, DrPH, California Department 

of Public Health, Richmond, California; George Dizikes, PhD, Illinois Department of Public Health, Chicago, Illinois; Dennis Ferrero, MPH, Department of 

Biological Sciences, University of the Pacific, Stockton, California; Charlotte Gaydos, DrPH, Johns Hopkins University, Baltimore, Maryland; Sarah Guerry, 

MD, Los Angeles County Department of Health Services, Los Angeles, California; Rick Steece, PhD, Infertility Prevention Project Laboratory Consultant, 

Pierre, South Dakota; Barbara Van Der Pol, PhD, Indiana University School of Public Health, Bloomington, Indiana; Katherine Whitaker, PhD, Food and 

Drug Administration, Rockville, Maryland; Scott Zimmerman, DrPH, Erie County Public Health Laboratory, Buffalo, New York; Yetunde Fakile, PhD, 

Thomas Gift, PhD, Robert E Johnson, MD, Steven Shapiro, Lisa Steele, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, 

CDC, Atlanta, Georgia;

Consultants: Stefanie Akselrod, MS, Food and Drug Administration, Rockville, Maryland; James Beebe, PhD, San Luis Obispo County Health Agency, 

San Luis Obispo, California; Julius Schachter, PhD, University of California, San Francisco, California; Shari Shea, MPH, Association of Public Health 

Laboratories, Silver Spring, Maryland; Melissa Singer, MPH, Centers for Medicare and Medicaid Services, Baltimore, Maryland; Dean Willis, DrPH, Florida 

Department of Health (Retired), Jacksonville, Florida; Kimberly Workowski, MD, Lisa Steele, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and 

TB Prevention, CDC and Emory University, Atlanta, Georgia; Kelly Wroblewski, MPH, Association of Public Health Laboratories, Silver Spring, Maryland.

MMWR / March 14, 2014 / Vol. 63 / No. 2 19


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