Trichomonas Vaginalis: Common, Curable and in The Diagnostic Spotlight

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Trichomonas vaginalis: Common, curable and in the diagnostic spotlight
Article in Clinical laboratory science: journal of the American Society for Medical Technology · March 2014
DOI: 10.29074/ascls.27.1.53 · Source: PubMed
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FOCUS: MOL ECULAR DIAGN OSIS O F SEXUALLY TRANSMITTED INFECTIONS
Molecular Diagnosis of Sexually Transmitted

Infections: A Diverse and Dynamic Landscape
CHRIS L. MCGOWIN, RODNEY E. ROHDE, GERALD REDWINE
ABBREVIATIONS: CDC - Centers for Disease making these infections a significant public health and
Control and Prevention, CT/NG - C. trachomatis and economic concern. At least 25 urogenital and
N. gonorrhoeae, FDA - Food and Drug reproductive tract diseases have infectious etiologies that
Administration, HPV - Human Papilloma Virus, LDT are transmitted through sexual contact and the CDC
- laboratory-developed test; MDx - molecular conservatively estimates approximately 110 million STIs
diagnostics, NAAT - nucleic acid amplification test, exist among American men and women.2 The roughly
NGU - non-gonococcal urethritis, PCR - polymerase 20 million incident cases in the USA alone have direct
chain reaction, PID - pelvic inflammatory disease, POC costs for treatment that top more than $15 billion.2,3
- point of care, STD - sexually transmitted disease, STI Sexually transmitted pathogens are extraordinarily
- sexually transmitted infection, TMA - transcription adapted to life in the urogenital tract. This is
mediated amplification exemplified by the fact that all STIs can persist long-
term in the face of extensive and complex host innate
INDEX TERMS: Molecular diagnostics, diagnostics, and adaptive immune responses. This is particularly
sexually transmitted disease, sexually transmitted true in females who disproportionately bear the
infection, Trichomonas vaginalis, trichomoniasis, prevalence and pathological sequelae of STIs with
Human Papilloma Virus, HPV, cervical cancer, inflammatory syndromes like pelvic inflammatory
Mycoplasma genitalium, non-gonococcal urethritis, disease (PID), tubal infertility and several pregnancy-
NGU, cervicitis related complications such as preterm birth and
spontaneous abortion. Polymicrobial syndromes like
Clin Lab Sci 2014;27(1):40 bacterial vaginosis and some cases of PID are now
recognized as significant medical concerns and have also
Chris L. McGowin, PhD, Louisiana State University contributed directly to our understanding of the
Health Sciences Center, Department of Microbiology, microbiome and its impact on reproductive health. This
Immunology and Parasitology, New Orleans, LA FOCUS series of articles has been dedicated to three
organisms that creatively illustrate the spectrum and
Rodney E. Rohde, PhD, MS, SV, SM(ASCP)CM, MBCM, importance of molecular diagnostics (MDx) for STIs:
Clinical Laboratory Science Program, College of Health Mycoplasma genitalium, Human Papilloma Virus
Professions, Texas State University, San Marcos, TX (HPV), and Trichomonas vaginalis.
Gerald Redwine MEd, MT(ASCP), Clinical Labora- The last twenty years have been dynamic and exciting
tory Science Program, College of Health Professions, Texas for the field of molecular diagnostics. Since the
State University, San Marcos, TX introduction of the first FDA-approved nucleic acid
amplification test (NAAT) for C. trachomatis and N.
Address for Correspondence: Chris L. McGowin, PhD, gonorrhoeae (CT/NG) in the early 1990’s, the market
Louisiana State University Health Sciences Center, and technologies have burgeoned and have been led
Department of Microbiology, Immunology and Parasi- largely by diagnostic tests for STIs. Currently, more
tology, 1901 Perdido St.; MEB 6214, New Orleans, LA than 25 FDA-approved NAATs exist for CT/NG alone,
70112-2822, 504 568-7281, cmcgow@lsuhsc.edu and the menu is rapidly expanding to include new STIs
like M. genitalium and pathogens of renewed
More than 300 million curable sexually transmitted importance like T. vaginalis. Collectively, the field of
infections (STIs) are acquired each year worldwide1 STI diagnostics is enormous, both in the diverse array
40 VOL 27, NO 1 WINTER 2014 CLINICAL LABORATORY SCIENCE
FOCUS: MOLECULAR DIAGNOSIS OF SEXUALLY TRANSMITTED INFECTIONS
of testing platforms and in the magnitude of tests efforts as more FDA-approved tests are moved to
performed worldwide. As such, the market for STI market in the USA. Considering the widespread and
diagnostics is continually evolving as organism targets subjective occurrences of vaginitis and related
are combined into multiplex assays, alternative syndromes, it is also anticipated that requests for T.
specimen types are approved, and new or emerging STIs vaginalis testing will soon be as common or exceed
are identified. In contrast, the molecular methodologies those of CT/NG thereby further expanding the breadth
have remained relatively unchanged since the mid- and STI testing loads in diagnostic laboratories.
1990s relying primarily upon signal amplification
technologies including transcription mediated Unlike the other organisms discussed in this FOCUS
amplification (TMA) and polymerase chain reaction series, M. genitalium is a sexually transmitted urogenital
(PCR). Collectively, these commercial nucleic acid pathogen for which no FDA tests have been approved.
amplification test (NAAT) platforms have moved In lieu of not having standardized tests for widespread
dichotomously in recent years towards high-throughput use, clinical researchers have relied upon laboratory-
tests for high-volume screening, and point of care developed tests (LDTs) to establish the basic
(POC) tests for more rapid turn-around time of results. epidemiology and disease spectra of M. genitalium
Medium to high-throughput platforms serve hospital infections in men and women. In this respect, the
and reference laboratories that handle a high volume of strides and enormous financial means necessary to
test requests, whereas POC tests are geared more establish and rationalize the need for a diagnostic test
towards primary care and/or STD clinics. must be considered. For STIs, an inherent difficulty
exists for linking pathogenic organisms with symptoms
Although high-throughput platforms are responsible for or specific sign of disease because a substantial
the vast majority of clinical screening and diagnosis of proportion of subjects are asymptomatic. Up to 75% of
STIs worldwide, POC tests have the ability to provide women with C. trachomatis infections lack any
rapid “while you wait” results thus facilitating symptoms and so no link between infection and clinical
immediate initiation of therapy if indicated. This outcome can be made in a substantial number of those
paradigm is particularly useful in clinical settings where, infected with the pathogen. As such, very large cohorts
after receiving test results from a reference or hospital can be required to demonstrate a significant link
laboratory, a follow up visit several days later is unlikely between STIs and certain signs/symptoms of disease.
(e.g. urban STD clinics). POC tests also aid to reduce Despite the required efforts and significant financial
the common practice of syndromic management – the investment, the rationale for development and
presumptive stat treatment of a group of marketing of a FDA-approved M. genitalium NAAT is
signs/symptoms in the absence of STI test results and strong and discussed in this FOCUS series. Without
based solely on the most likely etiologic agent(s). widespread availability of an optimized and validated
Complications of this approach are discussed in the M. test, a substantial gap remains in our ability to
genitalium article in this FOCUS series whereby the informatively manage very common inflammatory
current stat treatment guidelines for male non- urogenital syndromes for both men and women. A
gonococcal urethritis (NGU) and non-gonococcal FDA-cleared test for M. genitalium would not only
cervicitis may be enhancing the development of enhance the accuracy of patient treatment, but would
antibiotic resistance in this prevalent and emerging STI. also support the growing research community by
facilitating clinical investigations of pathogenesis,
For decades, POC tests have been employed to aid in epidemiology and optimized therapeutic strategies.
the accurate management of vaginitis caused by T. These types of studies are absolutely imperative for
vaginalis and are discussed in the accompanying article expanding our understanding of M. genitalium as a
in the series. It has been clear that T. vaginalis is a urogenital pathogen.
priority pathogen for recent commercial efforts in the
field of STI diagnostics. We now appreciate the very In sharp contrast to M. genitalium, much is known
large proportion of asymptomatic T. vaginalis infections about human papilloma virus (HPV) and its vaccine-
in women, and it is expected that this organism will be preventable role in cervical cancer. A vast and
an exceedingly common component of STI screening expanding market exists for HPV testing since NAATs
VOL 27, NO 1 WINTER 2014 CLINICAL LABORATORY SCIENCE 41

have been integrated into the 2012 cervical cancer professionals play an integral role in the health care
management algorithms. HPV testing is unique among system by providing diagnostic services that not only
the STIs in that the test results are linked to the risk of directly impact therapeutic management of patients, but
developing high-grade cervical dysplasia, rather than also by offering their expertise in interpretation of the
simply the presence/absence of the target organism. results in the exploding growth of MDx assays and
Although HPV is by far the most common STI and menus of tests available to physicians. In that light,
etiology of cervical cancer, infections are transient in these professionals should have a basic grasp on the basis
young women and detection of high-risk HPV types and rationale for a diagnostic test, and generally
very rarely leads to cervical cancer. Therefore, HPV appreciate the downstream effects of reporting a
testing is only one part of a carefully designed series of positive/negative result. Finally, educators must become
algorithms that employ cytological screening leaders in preparing clinically competent laboratory
(Papanicolaou or “Pap” smear) combined with professionals by providing them with opportunities to
downstream colposcopic and histologic examinations. expand their training and understanding of MDx.4
For many years, cervical cancer screening has been These concepts are discussed in the context of three
recommended on an annual basis, but the recently important STIs with the goal of highlighting timely and
updated guidelines have substantially increased the pertinent affairs in the evolving field of STI diagnostics.
interval between screenings for most women. Adoption
of these guidelines has extensive physiological and REFERENCES
psychological ramifications for millions of American
women now and in the coming years. In an 1. World Health Organization. Prevalence and incidence of
selected sexually transmitted infections, Chlamydia trachomatis,
accompanying article in this FOCUS series, we distill Neisseria gonorrhoeae, syphilis, and Trichomonas vaginalis:
the current paradigm for cervical cancer screening in the methods and results used by the WHO to generate 2005
USA, and address how HPV test results contribute to estimates. Geneva, Switzerland: World Health Organization,
managing women with high-risk HPV infections and/or 2011.
2. Satterwhite CL, Torrone E, Meites E, et al. Sexually
cervical dysplasia.
transmitted infections among US women and men: prevalence
and incidence estimates, 2008. Sex Transm Dis 2013;40(3):
Together, this four article series is aimed to inform 187-93.
laboratory professionals, business thought leaders, 3. Owusu-Edusei Jr. K, Chesson HW, Gift TL, et al. The
medical/health educators, healthcare professionals, and estimated direct medical cost of selected sexually transmitted
infections in the United States, 2008. Sex Transm Dis
the clinical diagnostics field at large about the past, 2013;40(3):197-201.
current and future paradigms for STI management. For 4. Rohde RE, Falleur DM, Kostroun P. Molecular Diagnostics
each pathogen, we have included a very brief summary CLS Course Design: Making it Real. Clin Lab Sci
and explanation of the clinical rationale that has led us 2009;22(1):9-15.
to the current practices in the field. Medical laboratory

More than just a test result - Molecular screening of

Human Papilloma Virus for contemporary
management of cervical cancer risk
LEARNING OBJECTIVES tory Science Program, College of Health Professions, Texas

1. Discuss the historical and epidemiological State University, San Marcos, TX
background of Human Papilloma Virus (HPV)
2. Define current evidence based guidelines for HPV Address for Correspondence: Chris L. McGowin, PhD,
diagnosis and management Louisiana State University Health Sciences Center,
3. Justify the epidemiological and clinical rationale for Department of Microbiology, Immunology and Parasi-
HPV testing in the management of cervical cancer tology, 1901 Perdido St.; MEB 6214, New Orleans, LA
70112-2822, 504 568-7281, cmcgow@lsuhsc.edu
ABBREVIATIONS: ACS - American Cancer Society,
ASCP - American Society for Clinical Pathology, Human Papilloma Virus (HPV) is the most common
ASCCP - American Society for Colposcopy and sexually transmitted infection (STI), and currently is the
Cervical Pathology, ASCUS - atypical squamous cells of only vaccine-preventable etiology of urogenital disease.
undetermined significance, CIN - cervical As an STI, HPV is an independent risk factor for
intraepithelial neoplasia, FDA - Food and Drug virtually all cases of cervical cancer and is associated
Administration, HPV - Human Papilloma Virus, HR- with anogenital and orolabial warts. Importantly,
HPV - high-risk HPV, HSIL - high-grade squamous infection with HPV is a necessary factor in the
intraepithelial lesions, LSIL - low-grade squamous development of squamous cervical neoplasia despite the
intraepithelial lesions, MDx - molecular diagnostics, fact that most infections and dysplastic abnormalities
NAAT - nucleic acid amplification test, NPV - negative will not progress to malignant transformation.1-3 Over
predictive value, PPV - positive predictive value, STD - 100 genotypes of HPV have been identified of which
sexually transmitted disease, STI - sexually transmitted less than 50% are transmitted sexually.4 Of the
infection. urogenital HPV types, several have been associated
directly with the enhanced risk of cervical cancer.4 In
INDEX TERMS: Molecular diagnostics, HPV, Human 2012, updated guidelines for cervical cancer screening
Papilloma Virus, sexually transmitted disease, sexually were put forth by the US Preventative Services Task
transmitted infection, cervical cancer, co-testing, nucleic Force (USPSTF) and the combined partnership of the
acid amplification test, NAAT American Society for Colposcopy and Cervical
Pathology (ASCCP), the American Cancer Society
Clin Lab Sci 2014;27(1):43 (ACS) and the American Society for Clinical Pathology
(ASCP). Collectively these guidelines lengthened the
Chris L. McGowin, PhD, Louisiana State University time interval between cervical cancer screens and
Health Sciences Center, Department of Microbiology, increased the age to begin screening. These evidence-
Immunology and Parasitology, New Orleans, LA based recommendations indicate the use of either
cytology alone or in combination with an FDA-
Rodney E. Rohde, PhD, MS, SV, SM(ASCP)CM, MBCM, approved HPV test stratified primarily by age, but also
Clinical Laboratory Science Program, College of Health by the interval since last screen and hysterectomy status.
Professions, Texas State University, San Marcos, TX Compared to cytological investigation alone, co-testing
can more informatively direct the need for and method
Gerald Redwine MEd, MT(ASCP), Clinical Labora- of treating precancerous lesions by more accurately

assessing a woman’s risk for developing cancer. This This balance has been addressed epidemiologically to
article aims to concisely summarize the current identify the most appropriate population of women for
guidelines for managing cervical cancer screening, and whom testing is performed. High HPV prevalence
addresses how HPV test results are incorporated into without a ≥CIN3 lesion is common among western
the clinical decision making algorithms. populations in women up to 30 years of age. After age
30, HR-HPV prevalence declines sharply but the rate of
Role of HPV Testing in Cervical Cancer Screening CIN progressively increases. In addition, regardless of
HPV plays a critical role in cancers of the lower age, women who have no cytological abnormalities and
anogenital tract. Several types of HPV are classified as are negative for HR-HPV are at an extremely low risk
high-risk (HR-HPV) due to their enhanced oncogenic of ≥CIN3. Therefore, using data from several
potential and stronger associations with cervical cancer randomized controlled trials, the current indication for
relative to low-risk types. FDA-approved HPV tests HPV nucleic acid amplification test (NAAT) screening
target HR-HPV types and so “HPV testing” in this is for women beginning at age 30 and only in
article and in published guidelines refers to specific combination with cytology as detailed below.
identification of one or more HR-HPV types; testing
for low-risk types (classified as non-oncogenic) has no Summary of Current Cervical Cancer Screening
role in managing cervical cancer. Traditional to Guidelines
Papilloma viruses, HPV replication is maintained in The USPSTF9 and ASCCP/ACS/ASCP guidelines10 are
differentiated squamous epithelia resulting in transient generally consistent and summarized as follows: 1)
low-grade lesions that can lead to abnormalities in the screening of women less than 21 years of age is not
cervical epithelium. These lesions can be detected by recommended; 2) women 21-29 years of age should be
cytological or histologic investigation (e.g. Papanicolaou screening with cytology alone every three years and, if
smear or biopsy, respectively). The Papanicolaou smear ASCUS is diagnosed, HPV testing is done prior to
examines cells collected from the cervix and results are colposcopy; 3) among women aged 30-65, cytology and
reported using the Bethesda system where squamous HPV co-testing is recommended every five years, or
abnormalities are parsed into three main groups: cytology screening alone every three years; 4) women
atypical squamous cells of undetermined significance over the age of 65 who have had adequate negative prior
(ASCUS), and low-grade or high-grade squamous screening and no recent (20 years) history of ≥CIN2
intraepithelial lesions (LSIL or HSIL). In contrast to should not be screened for cervical cancer; 5) women of
cytology, histologic evaluation of the cervix facilitates any age following a hysterectomy with removal of the
identification of architectural changes to the epithelium. cervix, who have no history of ≥CIN2, should not be
Non-invasive cervical squamous cell abnormalities are screened for cervical cancer; and 6) cervical cancer
graded as cervical intraepithelial neoplasia (CIN 1, CIN screening practices should not change on the basis of
2 or CIN 3) as determined by the severity of the cell HPV vaccination status. The guidelines summarized
changes and extent to which the normal epithelium is herein reflect only a portion of the full
displaced by dysplastic cell growth. recommendations that are very detailed and outlined
graphically in a scenario-specific manner on the ASCCP
Several studies have shown that HPV testing is more website (www.asccp.org). Special consideration is
sensitive but less specific than cytological examination required for certain populations of women including
alone for identifying high-grade lesions.5 This is the case those that are pregnant whereby surgical management
because HR-HPV infections are known to be transient of CIN can lead to pre-term delivery in some cases.11-13
in a substantial proportion of women and not all Therefore, pregnant women and young women with
infections will lead to dysplasia. As such, HPV testing CIN, must be counseled by their physician to weigh the
has the ability to indirectly identify high-grade CIN risks of treating cervical dysplasia compared to the risk
lesions identified initially using Pap cytology.6,7 Perhaps for cancer during observation.
more importantly, it is known that most CIN1 lesions
will not lead to cancer8 and so a balance must be Critical Considerations for HPV testing
managed between transient HPV infections and those The increase in time interval between screening visits is
associated with or likely to lead to high-grade dysplasia. arguably the most significant advantage of applying

HPV testing to cervical cancer screening paradigms. of age and therefore is not recommended. It is
Co-testing with cervical cytology and HPV NAAT is important to remember that, in contrast to many other
recommended every five years compared to every three diagnostic tests where the primary outcome is the
years with cytology alone. This not only reduces the presence/absence of a pathogen, the HPV test’s
economic burden of annual screening, but also should outcome is ultimately linked to cervical dysplasia. It is
serve to reduce the psychological distress when receiving known that PPV is linked directly to prevalence in a
HPV test results and when referred for colposcopy.14 given population, and although the currently available
The required time and associated anxiety for HPV tests are designed to screen the generally healthy
management of cervical abnormalities can be substantial population at large, testing for HPV in women where
and thus underscores the importance of accurate triage precancerous lesions are more prevalent maximizes the
for therapy when low-grade lesions are likely to resolve. PPV of the test. Despite focusing our screening efforts
However, it remains important to continue annual ‘well on women greater than 30 years of age (or younger
woman’ visits since cervical cytology/HPV testing is women with ASCUS cytology), PPVs remain low for
only one component of health maintenance. In HPV testing (10-25%). In order to predict the
addition, properly educating the patient on the updated usefulness of a test prior to implementation, we advise
screening and treatment paradigm is crucial to minimize clinical laboratories to evaluate a test’s performance with
anxiety and confusion regarding these new guidelines. data collected from subjects that most accurately reflect
Many young women will be confused as to why the the population they will be testing (located in the
annual Pap smear is no longer the standard of care, why package insert of all FDA-approved tests).
the interval for cancer screening has changed to once
every three or five years, and the rationale for testing In closing, laboratorians should have expertise on the
only after they reach 30 years of age. In short, the risk test results reported from the clinical laboratory, and
for cervical cancer before age 30 is low, HPV infection therefore should understand how HPV testing fits into
is extremely common in these younger women15 and the cancer risk management algorithm. In the coming
low-grade dysplastic changes will most often resolve years, molecular HPV testing will be an exceedingly
without intervention.16 common request of clinical laboratories. It has never
been more important for medical laboratory
Unlike diagnostic tests such as for C. trachomatis and N. professionals to understand the changing landscape of
gonorrhoeae, HPV test results are only one component MDx as they play a critical role in managing cervical
in the algorithm for managing cervical cancer risk and cancer. This role will increase as MDx are even further
subsequent therapeutic approach. Generally speaking, integrated into the clinical laboratory. Importantly, the
laboratory screening tests are highly sensitive and downstream procedures set into motion based on HPV
developed for use on apparently healthy populations. test results (e.g. colposcopy, biopsy, follow-up visits,
Screening tests are characterized by a very high negative other surgical interventions, etc.) have significant
predictive value (NPV) to very accurately identify ramifications for an enormous number of women
subjects who are truly negative for the target analyte. In regarding reproductive, sexual and psychological health.
contrast, diagnostic tests are designed to help aid in Therefore it remains imperative to closely follow the
identification of an etiology of disease or condition, and evidence-based guidelines provided by the national
as such, are geared to be more specific than sensitive governing entities to accurately and effectively employ
and can be used secondarily to a screening test to HPV testing as the powerful tool it is for cervical cancer
confirm infection. Typically, diagnostic tests should be management.
characterized by very good positive predictive value
(PPV) to accurately identify true positives. REFERENCES
1. Moscicki AB, Schiffman M, Kjaer S, Villa LL. Chapter 5:
In a large trial of women over 30 years of age, cytology Updating the natural history of HPV and anogenital cancer.
Vaccine 2006; 24: 42-51.
had a specificity of 97% compared with 94% for HPV 2. Schiffman M. Integration of human papillomavirus
testing.17 Due to transient HR-HPV infection in vaccination, cytology, and human papillomavirus testing.
younger women, the specificity of HPV testing would Cancer 2007; 111(3): 145-53.
be substantially lower among women younger 30 years 3. Walboomers JM, Jacobs MV, Manos MM, et al. Human
papillomavirus is a necessary cause of invasive cervical cancer
worldwide. J Pathol 1999; 189(1): 12-9. 2012; 16(3): 172-4.

4. Munoz N, Bosch FX, de Sanjose S, et al. Epidemiologic 11. Jakobsson M, Gissler M, Paavonen J, Tapper AM. Loop
classification of human papillomavirus types associated with electrosurgical excision procedure and the risk for preterm
cervical cancer. N Engl J Med 2003; 348(6): 518-27. birth. Obstet Gynecol 2009; 114(3): 504-10.
5. Ronco G, Giorgi-Rossi P, Carozzi F, et al. Results at 12. Sadler L, Saftlas A, Wang W, et al. Treatment for cervical
recruitment from a randomized controlled trial comparing intraepithelial neoplasia and risk of preterm delivery. JAMA
human papillomavirus testing alone with conventional cytology 2004; 291(17): 2100-6.
as the primary cervical cancer screening test. J Natl Cancer I 13. Bruinsma FJ, Quinn MA. The risk of preterm birth following
2008; 100(7): 492-501. treatment for precancerous changes in the cervix: a systematic
6. Cuzick J, Szarewski A, Mesher D, et al. Long-term follow-up review and meta-analysis. BJOG 2011; 118(9): 1031-41.
of cervical abnormalities among women screened by HPV 14. Sharp L, Cotton S, Gray N, et al. Long-term psychosocial
testing and cytology-Results from the Hammersmith study. Int impact of alternative management policies in women with low-
J Cancer 2008; 122(10): 2294-300. grade abnormal cervical cytology referred for colposcopy: a
7. Cuzick J, Clavel C, Petry KU, et al. Overview of the European randomised controlled trial. Brit J Cancer 2011; 104(2): 255-
and North American studies on HPV testing in primary 64.
cervical cancer screening. Int J Cancer 2006; 119(5): 1095- 15. Winer RL, Lee SK, Hughes JP, et al. Genital human
101. papillomavirus infection: incidence and risk factors in a cohort
8. Castle PE, Rodriguez AC, Burk RD, et al. Short term of female university students. Am J Epidemiol 2003; 157(3):
persistence of human papillomavirus and risk of cervical 218-26.
precancer and cancer: population based cohort study. BMJ 16. Moscicki AB, Hills N, Shiboski S, et al. Risks for incident
2009; 339: b2569. human papillomavirus infection and low-grade squamous
9. Whitlock EP, Vesco KK, Eder M, et al. Liquid-based cytology intraepithelial lesion development in young females. JAMA
and human papillomavirus testing to screen for cervical cancer: 2001; 285(23): 2995-3002.
a systematic review for the U.S. Preventive Services Task Force. 17. Mayrand MH, Duarte-Franco E, Rodrigues I, et al. Human
Ann Intern Med 2011; 155(10): 687-97, W214-5. papillomavirus DNA versus Papanicolaou screening tests for
10. Massad LS. New guidelines on cervical cancer screening: more cervical cancer. New Engl J Med 2007; 357(16): 1579-88.
than just the end of annual Pap testing. J Low Genit Tract Dis
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Epidemiological and clinical rationale for

screening and diagnosis of Mycoplasma
genitalium infections
LEARNING OBJECTIVES State University, San Marcos, TX

1. Discuss the historical and epidemiological
background of Mycoplasma genitalium Address for Correspondence: Chris L. McGowin, PhD,
2. Justify the clinical rationale for M. genitalium testing Louisiana State University Health Sciences Center,
3. Describe the diagnosis of M. genitalium Department of Microbiology, Immunology and Parasi-
4. Define M. genitalium non-gonococcal urethritis and tology, 1901 Perdido St.; MEB 6214, New Orleans, LA
cervicitis 70112-2822, 504 568-7281, cmcgow@lsuhsc.edu
5. Explain the syndromic management and
antimicrobial resistance associated with M. Mycoplasma genitalium has been the focus of basic
genitalium scientific and synthetic biology research as the organism
with the smallest genome of all known human bacterial
ABBREVIATIONS: CDC - Centers for Disease pathogens. As a sexually transmitted organism,
Control and Prevention, FDA - Food and Drug substantial clinical and epidemiologic evidence now
Administration, HPV - Human Papilloma Virus, LDT exists that warrant further consideration of M.
- laboratory developed tests, MDx - molecular genitalium as a priority for diagnostic testing. In the
diagnostics, NAAT - nucleic acid amplification test, early 1980’s, M. genitalium was first identified from two
NGU - non-gonococcal urethritis, NPV - negative men with symptomatic non-gonococcal urethritis – an
predictive value, PPV - positive predictive value, RUO - inflammatory syndrome most often attributed to
research use only, STD - sexually transmitted disease, infections with Neisseria gonorrhoeae or Chlamydia
STI - sexually transmitted infection, ART - anti- trachomatis. Since then, epidemiologic studies of clinical
retroviral therapy, LOD, limit of detection, LOQ, limit disease, several animal models, and the results of many
of quantification basic scientific investigations point towards M.
genitalium as a urogenital pathogen with significant
INDEX TERMS: Molecular diagnostics, Mycoplasma implications for reproductive and sexual health. It is
genitalium, sexually transmitted disease, sexually now unequivocally known that M. genitalium is found
transmitted infections in approximately 15-25% of patients with non-
gonococcal urethritis (NGU) cases and in more than
Clin Lab Sci 2014;27(1):47 one third of non-chlamydial NGU.1 Importantly, M.
genitalium establishes both acute and chronic infections
Chris L. McGowin, PhD, Louisiana State University in the urogenital tract of men and women. This article
Health Sciences Center, Department of Microbiology, aims to concisely address the rationale for continued
Immunology and Parasitology, New Orleans, LA investigation of M. genitalium as a sexually transmitted
infection (STI) and for the implementation of
Rodney E. Rohde, PhD, MS, SV, SM(ASCP)CM, MBCM, diagnostic testing paradigms in the USA.
Clinical Laboratory Science Program, College of Health
Professions, Texas State University, San Marcos, TX Epidemiology of M. genitalium
As an emerging urogenital pathogen, the vast majority
Gerald Redwine MEd, MT(ASCP), Clinical Labora- of M. genitalium research has been focused on the
tory Science Program, College of Health Professions, Texas epidemiologic characteristics and associations with

disease syndromes – first in men, and more recently in organism and virtually all STI are associated with HIV.
women. With regard to the “emergence” of M. However, the importance of M. genitalium as a co-
genitalium infections, it should be clarified that no factor for HIV disease progression has not been
reports have indicated an increase in prevalence over investigated and very little data exist on management of
time but rather a recent expansion in notoriety as a M. genitalium infection in HIV-positive subjects with or
pathogen. Among sexually transmitted disease (STD) without anti-retroviral therapy (ART). To this end, our
clinic attendees and subjects classified as being at high- current understanding of M. genitalium does not
risk for STI acquisition, the prevalence of M. genitalium warrant special recommendations for screening or
infection is approximately 7% considering studies form therapy in HIV-infected individuals.
several countries worldwide.2 Importantly, the
prevalence parallels that of other bacterial STIs in that it Diagnosis of M. genitalium infection
is tightly linked to characteristic behavioral and Due to the fastidious nature of M. genitalium, culture-
demographic risk factors. As such, the urogenital based isolation of the organism is time-consuming,
prevalence of M. genitalium in high-risk subjects varies labor intensive and, as such, has no diagnostic utility.
from less than 1% to more than 30% depending on the Despite high rates of isolation from nucleic acid
study population.2 In contrast, study cohorts with a amplification test (NAAT)-positive men, culture-based
relatively low risk for acquiring STIs show considerably isolation procedures currently involve co-culture of the
lower rates of infection, ranging from 0 to 4%, with specimen with Vero cells for weeks to months before
most studies less than 1%. Collectively, M. genitalium is reaching a titer suitable for sub-culture or adaptation to
present in high- and low-risk populations at levels axenic (cell-free) growth medium. In turn, virtually
similar to those of C. trachomatis and N. gonorrhoeae. most contemporary clinical studies have relied upon
NAATs for diagnosis. Commercially developed testing
Interest is expanding for understanding the role for M. kits have entered the European market but, to date, no
genitalium in enhanced HIV susceptibility and disease M. genitalium test has acquired FDA approval for use in
progression. African women with M. genitalium the USA. A research use only (RUO) NAAT developed
infection are approximately two and a half times more by GenProbe-Hologic, Inc. has been utilized by select
likely to acquire HIV-1, and co-infection with these two collaborating laboratories. In recent years, this test has
pathogens is common. Positive cross-sectional been utilized extensively for male and female urogenital
associations between HIV and M. genitalium have been specimens and compared to several laboratory
observed in more than 20 studies.3 The biologic developed tests (LDTs) despite not being available
mechanisms for the clinical associations between M. commercially. The optimized LDT platform developed
genitalium and HIV are completely unknown, but by Jensen and colleagues in 200415 has been widely
several important lines of evidence provide a rationale employed in clinical research settings worldwide, and
for investigation of this co-infection scenario. First, M. serves as a validated reference laboratory test for STI
genitalium has been associated with cervical surveillance at the Staten Serum Institut in
inflammation in several studies,1,2,4 whereby Copenhagen, Denmark.
microscopic signs of inflammation are often detected in
the absence of lower reproductive tract symptoms. Given the quality of PCR reagents currently available to
Second, urogenital M. genitalium infections can be researchers and the expansion of molecular diagnostics
chronic thereby providing the potential for long-term (MDx) methods into research and clinical laboratories,
interactions with HIV and/or HIV target cells.5-8 several LDTs have been utilized for investigation of M.
Importantly, experimental in vitro evidence has genitalium. However, without an established gold
consistently shown M. genitalium to be a cause of standard for which to validate these tests, the results
mucosal inflammation with a profile consistent with from epidemiologic studies that employ LDTs should
recruitment of lymphocytes and macrophages to the be interpreted with caution. Ma and colleagues
epithelium.9-14 Considering that macrophages and exemplify this notion in a 2010 study where the authors
CD4(+) T lymphocytes are HIV-susceptible cell types, note considerable variability in targeted genomic loci for
perhaps the association between HIV and M. genitalium several previously published NAATs.16 Such variability
is not surprising since M. genitalium is an inflammatory in the primer/probe target sequence could impact assay

sensitivity thereby rendering false-negative results and inflammation defined microscopically by urethral
inaccurate interpretation of prevalence and disease leukocytosis. Symptoms manifest typically as dysuria or
associations. In lieu of an FDA-approved test, localized itching, with urethral discharge being the most
researchers and reference labs have pushed forward common clinical sign of urethritis. As the most
using LDTs with anticipation of an approved test common urogenital syndrome in men, NGU is strongly
marketed in the USA soon. Since organism culture is associated with infection by C. trachomatis, M.
the current ‘gold standard’ for M. genitalium detection, genitalium, T. vaginalis and Herpes Simplex Virus.
it is recognized that the clinical trial(s) for FDA However, no infectious or non-infectious etiology can
submission will be lengthy and costly for the first be identified in up to 40% of cases,17 and thus
NAAT submitted for approval. underscores the current misunderstandings of the
exceedingly common syndrome in men.
In the mean time, as LDTs are validated within clinical
laboratories for internal use, it is imperative to Cervicitis, an inflammatory syndrome of the uterine
implement only thoroughly scrutinized tests where cervix, has several parallel characteristics with male
strict and accurate criteria are used in development. urethritis and diagnosis similarly relies upon signs of
Performance characteristics that must be assessed and purulent discharge and/or microscopic leukocytosis. It
defined include specificity, sensitivity, positive is important to note that cervicitis is most often
predictive value (PPV) (the probability that those diagnosed on clinical exam since few symptoms exist
testing positive are indeed positive), negative predictive unless cervical mucopus is severe and results in vaginal
value (NPV) (accurately identifying uninfected discharge. Unlike for male urethritis, a standardized
individuals), and assay reproducibility. Without a gold- clinical definition has yet to be established for cervicitis
standard NAAT comparator, the value of some of these and, as such, variable combinations of overt and
performance points are limited, but accurately defining microscopic signs have been employed. Despite the
the limit of detection (LOD) and limit of quantification heterogeneity and some conflicting results from
(LOQ) for each assay system is imperative for previous studies, the evidence for M. genitalium as a
interpreting the validity of the test. In short, the current cause of cervical inflammation is stronger than for any
lack of a standardized and FDA-approved NAAT is an other female reproductive tract syndrome. In studies
impediment to our continued investigation of M. where microscopic criteria were considered independent
genitalium disease. Filling this gap in the diagnostic of non-microscopic criteria, all studies have shown a
testing menu in the USA would aid directly in positive association with cervicitis.2 In contrast, studies
providing more informed and appropriate therapy to using non-microscopic criteria (e.g. mucopus, edema,
the enormous number of patients with urogenital erythema, post-sample bleeding) less frequently
disease for which M. genitalium is a plausible etiology. demonstrated an association between M. genitalium and
cervicitis.4 Many of these discrepancies are attributed to
M. genitalium NGU and cervicitis the variable clinical definition of cervicitis. When
Virtually all studies of both symptomatic and diagnosed based on microscopic criteria alone, the true
asymptomatic men support the fact that M. genitalium importance and pathological consequences of cervicitis
is a common etiology of NGU independent of C. as a syndrome is generally misunderstood regardless of
trachomatis.1 In the pooled analysis of more than 35 the etiology. In contrast, cervicitis with purulent
independent studies of M. genitalium conducted by discharge (mucopurulent cervicitis) clearly indicates an
Taylor-Robinson and Jensen, the combined odds ratio inflammatory disease state requiring intervention.
was 5.5 (95% CI: 4.3-7.0) for NGU and 7.6 (95% CI: Although cervical infection by M. genitalium could lead
5.5-10.5) for non-chlamydial NGU. In this light, the to purulent discharge, it is important to remember that
US Center for Disease Control and Prevention (CDC) cervical discharge may be secondary to upper
recognizes M. genitalium as an etiology of NGU despite reproductive tract inflammation or pelvic inflammatory
the absence of an FDA-approved diagnostic test. disease (PID) for which M. genitalium has been
Current STD treatment guidelines can be found at implicated in several studies.1,2,4,18 Taken together,
http://www.cdc.gov/std/treatment/2010/. Urethritis is continued clinical and laboratory investigation of lower
most often characterized by acute and/or chronic genital tract inflammation is imperative for

understanding the role of STI pathogens like M. An ideal diagnostic and treatment paradigm would
genitalium in reproductive health. include point of care (POC) testing for STIs thereby
eliminating syndromic management and presumptive
Syndromic management and antimicrobial resistance antibiotic therapy of NGU and non-gonococcal
Implementation of a widespread screening and cervicitis. Unfortunately, with exception to HIV and
treatment program for M. genitalium in the USA is a Trichomonas vaginalis (discussed in an accompanying
distant reality with insufficient rationale and data to article in this series), POC diagnostics are still far
compute the necessary cost-effectiveness analyses. This outnumbered by high-throughput hospital and
is owed in part to the lack of a commercially available reference laboratory testing platforms with longer turn-
testing platform, and also because additional around times. The current CDC-recommended
randomized treatment trials are needed to accurately treatment strategy of male NGU and non-gonococcal
establish the most effective treatment paradigms. With cervicitis indicates stat dosing of azithromycin or a
these shortcomings, this begs the question of whether seven-day doxycycline regimen, which is tailored to
M. genitalium testing is even warranted if syndromic eradicating C. trachomatis infection. The rationale for
management using CDC-recommended paradigm is this is seemingly clear since C. trachomatis is responsible
effective for M. genitalium and routinely utilized. In the for approximately 25% of non-gonococcal cervicitis and
STD clinic setting, management of men with urethritis NGU.17 However, M. genitalium is also associated with
is among the top services provided to attendees. 15-25% of male NGU cases and thus is an important
Common for male urethritis and lower reproductive consideration in presumptive treatment.1
tract inflammation in women, syndromic management
is the practice of directing therapeutic intervention Several contemporary studies have shown that a single 1
based solely on syndrome-related signs and symptoms gram dose of azithromycin is markedly more effective
in the absence of STI test results. This practice is nearly than doxycycline for clinical cure of M. genitalium
universal in STD clinics because NAAT results have infection.1 A recent study of NGU showed only a 67%
turn-around times of hours to days, and it is imperative clearance rate for M. genitalium using the single 1 gram
to begin treatment at the initial visit since the patients dose.19 In addition, several studies have highlighted the
do not readily follow up. Stat dosing, that is providing potential for stat dosing to induce drug resistance
antibiotics at the clinic based on syndromic associated with treatment failure.20-27 It seems that the
interpretation, is a widely utilized component of this single 1 gram dose is not sufficient for clearance of
treatment paradigm because 1) compliance is assured; infection in many individuals because extending the
2) STD clinic attendees often have no financial means dosing paradigm to five days substantially increases cure
to fill a prescription; and 3) in the absence of diagnostic rates as discussed below. Therefore, knowing that up to
test results, several potential etiologic agents can be 25% of NGU is associated with M. genitalium
managed with a single antibiotic. infection, and that microbiologic cure rate in a recent
double-blind treatment trial was 40% for 1 g of
Arguably the most important step in syndromic azithromycin, it is estimated that approximately 10% of
management of urogenital disease in men and women is men with NGU could potentially benefit from testing
determining whether N. gonorrhoeae is present during and modified therapy regimen. This estimate is likely a
the initial clinic visit. Gram staining of urethral smears conservative one because many clinics still utilize
for microscopic identification of N. gonorrhoeae is a doxycycline as the first line therapy with even higher
widely used point of care procedure that, despite some rates of treatment failure.1 Rather than stat
concerns about sensitivity, remains an essential practice azithromycin, one such regimen would be extended
for discerning gonococcal urethritis or cervicitis from azithromycin dosing such as 500 mg on day one
NGU or non-gonococcal cervicitis. This test is generally followed by 250 mg daily on days two through five; this
regarded as the preferred means for concurrently has cure rates between 85-100%.1 Patients failing
documenting inflammation and the presence of Gram- extended azithromycin therapy should be treated with
negative intracellular diplococci. Subjects without signs moxifloxacin for which few cases of treatment failure
of N. gonorrhoeae infection are typically managed have been reported.28 It should be noted that the
syndromically. superiority of moxifloxacin (400 mg for up to 10 days)

is accepted in the field, but has not been evaluated in implications of chlamydial infection could not be
clinical trials and is based primarily on observational assessed without clinicians and researchers having access
studies. to a validated diagnostic test, and this is true for M.
genitalium as well.
With the absence of reliable and differential
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dependent pathway. Clin Vaccine Immunol 2009; 16(12):
infections in women are often asymptomatic, together
1750-7.
with the fact that several studies have shown 10. McGowin CL, Annan RS, Quayle AJ, et al. Persistent
associations with more severe upper tract sequelae, Mycoplasma genitalium Infection of Human Endocervical
differential diagnosis of M. genitalium could have Epithelial Cells Elicits Chronic Inflammatory Cytokine
substantial impact of women’s health when used as a Secretion. Infect Immun 2012; 80(11): 3842-9.
11. McGowin CL, Ma L, Martin DH, Pyles RB. Mycoplasma
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In conclusion, although the true extent to which M. from human genital epithelial cells. Infect Immun 2009; 77(3):
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genitalium infection of human vaginal and cervical epithelial
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23. Jensen JS, Bradshaw CS, Tabrizi SN, et al. Azithromycin

Trichomonas vaginalis: Common, curable and in

the diagnostic spotlight
LEARNING OBJECTIVES tology, 1901 Perdido St.; MEB 6214, New Orleans, LA
1. Discuss the historical and epidemiological spectra 70112-2822, 504 568-7281, cmcgow@lsuhsc.edu
of Trichomonas vaginalis.
2. Define the clinical characteristics of trichomoniasis Trichomonas vaginalis is the most common curable
in men and women. sexually transmitted infection (STI) worldwide.1 The
3. Explain the methods for clinical diagnosis of T. 2001-2004 National Health and Nutrition
vaginalis infection. Examination Surveys (NHANES) report that American
4. Compare and contrast the treatment strategies for women between the ages of 14 and 49 are infected with
trichomoniasis in women. T. vaginalis with a prevalence of approximately 3% -
greater than that of C. trachomatis and N. gonorrhoeae.2,3
ABBREVIATIONS: CDC - Centers for Disease Additional studies have highlighted that, unlike
Control and Prevention, FDA - Food and Drug Clamydia trachomatis and Neisseria gonorrhoeae, T.
Administration, MDx - molecular diagnostics, NAAT - vaginalis affects all age groups and the prevalence is
nucleic acid amplification test, NGU - non-gonococcal highest in women over 40 years of age.4-7 Annually, it is
urethritis, NHANES - National Health and Nutrition estimated that more than half of the approximately 248
Examination Surveys, PID - pelvic inflammatory million new T. vaginalis infections occur in males
disease: POC - point of care, PPV - positive predictive worldwide.1 However, the majority of prevalent T.
value, STD - sexually transmitted disease, STI - sexually vaginalis infections are detected in women, which is
transmitted infection consistent with the chronic nature of these infections in
the female urogenital tract. Most infections in women
INDEX TERMS: Molecular diagnostics, sexually are asymptomatic, however T. vaginalis has been linked
transmitted disease, sexually transmitted infections, to lower and upper reproductive tract disease syndromes
Trichomonas vaginalis, trichomoniasis including vaginitis, cervicitis and pelvic inflammatory
disease (PID). Pregnancy-related complications include
Clin Lab Sci 2014;27(1):53 pre-term birth and infertility. In men, T. vaginalis is
most commonly a cause of non-gonococcal urethritis
Chris L. McGowin, PhD, Louisiana State University (NGU) but infections tend to be transient and
Health Sciences Center, Department of Microbiology, frequently asymptomatic. In this article, we concisely
Immunology and Parasitology, New Orleans, LA discuss the current knowledge on T. vaginalis
epidemiology and the developing trends in diagnosis of
Rodney E. Rohde, PhD, MS, SV, SM(ASCP)CM, MBCM, this incredibly prevalent STI.
Clinical Laboratory Science Program, College of Health
Professions, Texas State University, San Marcos, TX Disease spectrum of T. vaginalis infections
Currently, trichomoniasis is not a notifiable disease in
Gerald Redwine MEd, MT(ASCP), Clinical Labora- the USA and so therefore, compared to other STIs,
tory Science Program, College of Health Professions, Texas relatively little is known about the epidemiology and
State University, San Marcos, TX pathogenesis of T. vaginalis infections. The spectrum of
disease in women is characterized by symptoms of
Address for Correspondence: Chris L. McGowin, PhD, vaginitis including discharge, and localized vulvar
Louisiana State University Health Sciences Center, pruritus. Classical disease signs include purulent vaginal
Department of Microbiology, Immunology and Parasi- discharge, and vaginal and vulvar erythema. The urethra
is commonly infected with accompanying symptoms of Although both techniques rely upon a trained
dysuria in women with vaginal infection. In addition, microscopist, wet mount microscopy and culture
colpitis macularis, or “strawberry cervix” is a highly methods are highly specific for T. vaginalis detection
specific sign of infection but is only accurately (>99%)11,13 primarily due to the characteristic tumbling
diagnosed during colposcopy. The dogmatic notion that motility of viable organisms.
T. vaginalis infections are overtly symptomatic in
women has been unequivocally overturned. In fact, up Microscopy-based techniques were followed by the first
to 80% of T. vaginalis infections are asymptomatic in generation of nucleic acid amplification tests (NAATs).
women depending on the clinical setting.3 Despite the Collectively, NAATs have dramatically enhanced our
asymptomatic nature of infection, T. vaginalis has been understanding of T. vaginalis epidemiology,
linked to several inflammatory syndromes in women pathogenesis, and helped to identify a previously
thus highlighting the importance for screening underappreciated population of asymptomatic
initiatives in subjects at risk for STIs. T. vaginalis infections in men and women. Contemporary NAATs
infection in women is also associated with increased are both highly specific and sensitive, and several have
susceptibility to HIV acquisition and HIV shedding in been adapted to high-throughput instrumentation.
co-infected individuals. In males, T. vaginalis is most Unlike microscopy, NAATs require no subjective
commonly a cause of NGU but infection is frequently interpretation of the test results and have faster turn-
asymptomatic and the majority of cases are reported to around times compared to culture. Enhanced sensitivity
clear spontaneously within 10 days.8-11 Together, the is the clear advantage of NAATs compared to culture
importance of asymptomatic males as transmitters to and wet mount microscopy. The most widely used
women is enormous since T. vaginalis infections in culture methods utilize the InPouch TV (BioMed
women, with or without symptoms, can persist for at Diagnostics, White City, OR) device or inoculation of
least several months.11 Like the bacterial STIs, specimen material into Diamond’s medium. These tests
complicated T. vaginalis infections in men can lead to are moderately sensitive ranging from 44-75%13 and
more severe inflammatory outcomes including require three to seven days before results are available.
prostatitis, urethral stricture, epididymitis and
infertility.12 It was not until the late 1990’s when the first NAAT
was FDA-approved for diagnostic testing in the USA.
Diagnosis of Trichomoniasis Currently, development and implementation of T.
The history of T. vaginalis diagnostics dates back to the vaginalis testing platforms into clinical laboratories are
early part of the 19th century when motile organisms top industry priorities in the realm of STI diagnostics.
were visible on wet mount preparations of vaginal swab As of this 2014 publication, only two NAATs are FDA-
specimens. Strikingly, direct microscopic observation approved and marketed for T. vaginalis detection in the
remained the standard of diagnostic care until in vitro USA: 1) the APTIMA TV test (GenProbe, Inc., San
culture methods were introduced in 1949.11 Several Diego, CA) for use on the TIGRIS and PANTHER
studies have reported low sensitivities of T. vaginalis platforms; and 2) the ProbeTec Trichomonas vaginalis
detection using wet mount microscopy that range from Qx Amplified DNA Assay for use on the BD Viper
44-68%.13 In addition, sensitivity can be negatively platform (Beckton Dickinson, Franklin Lakes, NJ).
impacted by even short time intervals (10-30 minutes) Targeting a conserved region of 16s rRNA molecules,
between swab collection and microscopic examination.14 the APTIMA TV test utilizes the combined
Despite low sensitivity and the need for rapid technologies of transcription medicated amplification
processing, microscopy remains the most commonly (TMA) and a hybridization protection assay (HPA). By
used technique for diagnosis of trichomoniasis due to targeting a high-copy transcript in the T. vaginalis cell,
ease and cost-effectiveness. Culture of trichomonads the FDA-approved APTIMA TV test is characterized by
from female urogenital specimens using Diamond’s very high sensitivity values ranging from 95-100%
broth medium is substantially more sensitive compared depending on the specimen type and gold standard
to wet mount microscopy (96% vs. 36-82%, comparator.13 According to the manufacturer’s package
respectively)11 but requires additional supplies and insert, sensitivity values range from 92-100% for the
equipment including an incubator for growing cultures. ProbeTec Trichomonas vaginalis Qx Amplified DNA

Assay among both symptomatic and asymptomatic paradigms for men are lacking considering the
women when compared to a composite comparator of substantial number of incident infections.
wet mount and culture. The ProbeTec assay utilizes
strand displacement assay (SDA) technology as Treatment of T. vaginalis infections
described previously.15 Taken together, modern NAATs Effective therapies for T. vaginalis infections are
substantially improve sensitivity of T. vaginalis available for men and women diagnosed with
detection from several specimen types, and serve both as trichomoniasis. The current CDC-recommended first-
diagnostic and screening tools in symptomatic and line therapy for T. vaginalis infection is a single 2-gram
asymptomatic women. Unfortunately, no NAAT has dose of metronidazole or tinidazole – both of which are
been approved for T. vaginalis detection in men. FDA-approved for trichomoniasis therapy in men and
However, as clinical research clarifies the value of women. Current recommendations for patients who fail
screening in asymptomatic men and women, combined stat metronidazole are to treat with a single dose of
with the high frequency of vaginitis, it is predicted that tinidazole or an extended regimen of metronidazole
the volume of NAATs for T. vaginalis will exceed those (500 mg twice daily for seven days). Fortunately,
for Chlamydia trachomatis and Neisseria gonorrhoeae in treatment failures are infrequent following single dose
the coming years. metronidazole therapy in patients for whom re-infection
can be excluded. In short, non-susceptibility rates to the
In contrast to high-throughput NAATs typically run at currently available therapies are low,9 and parasitological
hospital or reference laboratories, point of care (POC) cure rates are high (86-100%) in women.16 Failure of
tests for STIs facilitate the initiation of treatment during the recommended second line regimens should be
the initial clinic visit. This approach ensures compliance followed by treatment with oral metronidazole or
with the treatment regimen since most first line tinidazole at 2 grams daily for five days. In patients with
therapies are single STAT doses of antibiotics. Ideally, persistent T. vaginalis infection after extended
POC tests allow differentiation of etiologic agents to metronidazole/tinidazole regimens, a combination of
substantially reduce the number of patients that are oral and topically applied agents have been anecdotally
managed syndromically. In the accompanying effective and may be indicated in cases of chronic
Mycoplasma genitalium article in this series, we describe treatment failure.16
how POC testing could substantially reduce syndromic
management of NGU in men and non-gonococcal Subjects with T. vaginalis infection are up to twice as
cervicitis in women where treatment guidelines fall likely to acquire HIV infection17 thus underscoring the
short to effectively treat all causative agents. Over the global importance for continued investigation of this
last decade, POC tests for T. vaginalis have been prevalent STI. Interestingly, a recent randomized
available that utilize either immunochromatographic clinical trial showed that women with HIV responded
test strips (OSOM Trichomonas Rapid Test; Sekisui better to extended metronidazole (500 mg twice daily
Diagnostics, California, USA) or non-amplification for seven days) compared to a single 2-gram dose and
nucleic acid detection technology (BD Affirm VPIII; had lower rates of re-infection upon follow up.18 It is
Beckton Dickinson, Maryland, USA). The sensitivities possible that special considerations should be applied to
of the rapid diagnostic tests parallel those of culture- subjects with HIV, AIDS or are immunocompromised.
based tests and are consistently higher than wet mount However, data are lacking regarding T. vaginalis disease
microscopy (40-95%).13 Despite lower sensitivity, the and therapies in HIV-positive individuals despite high
positive predictive value (PPV; the ability to detect truly rates of co-infection.
positive subjects) for the available POC tests can be
increased to levels of contemporary NAATs by using Conclusions
them in populations where prevalence is high (e.g. As the most common parasitic protozoan infection in
women with signs of disease). As for NAATs, no FDA- developed countries, T. vaginalis infections are
approved POC tests are available for T. vaginalis widespread and disproportionally affect women in both
diagnosis in men. Unfortunately, wet mount prevalence and disease sequelae. Considering the
microscopy is insensitive for detection of trichomonads substantial proportion of asymptomatic infections, the
from male urogenital specimens and, in general, testing true impact of T. vaginalis testing will be realized fully

when these assays are used as screening tests in both correlates of Trichomonas vaginalis among incarcerated persons
men and women. In lieu of relatively low sensitivities, assessed using a highly sensitive molecular assay. Sex Transm
Dis 2010;37(3);165-8.
POC tests for T. vaginalis including wet mount 6. Miller WC, Swygard H, Hobbs MM, et al. The prevalence of
microscopy remain valuable tools to initiate stat therapy trichomoniasis in young adults in the United States. Sex
in clinical settings where follow up is unlikely. Transm Dis 2005;32(10);593-8.
Interestingly, because T. vaginalis infections are more 7. Schwebke JR, Burgess D. Trichomoniasis. Clin Micro Rev
2004;17(4);794-803.
common in women over 40 years of age, the apparent
8. Paisarntantiwong R, Brockmann S, Clarke L, et al. The
risk for pathological sequelae without symptoms is high relationship of vaginal trichomoniasis and pelvic inflammatory
and efforts to screen should be guided to all age groups disease among women colonized with Chlamydia trachomatis.
rather than specifically to young adults. We still have Sex Transm Dis 1995;22(6);344-7.
much to learn regarding the epidemiology and 9. Cudmore SL, Delgaty KL, Hayward-McClelland SF, et al.
Treatment of infections caused by metronidazole-resistant
pathogenesis of T. vaginalis infections. With FDA- Trichomonas vaginalis. Clin Micro Rev 2004;17(4);783-93.
approved NAATs entering clinical laboratories in the 10. Schwebke JR, Rompalo A, Taylor S, et al. Re-evaluating the
USA and abroad, we are on the cusp of a deeper treatment of nongonococcal urethritis: emphasizing emerging
understanding of clinical disease and optimized pathogens--a randomized clinical trial. Clin Infect Dis
2011;52(2);163-70.
therapeutic approaches in both men and women.
11. Poole DN, McClelland RS. Global epidemiology of
Trichomonas vaginalis. Sex Transm Dis 2013;89(6);418-22.
REFERENCES 12. Holmes KK. 1999. Sexually Transmitted Diseases, Third
1. World Health Organization. Prevalence and incidence of Edition. New York: McGraw-Hill Press.
selected sexually transmitted infections, Chlamydia trachomatis, 13. Hobbs MM, Sena AC. Modern diagnosis of Trichomonas
Neisseria gonorrhoeae, syphilis, and Trichomonas vaginalis: vaginalis infection. Sex Transm Dis 2013;89(6);434-8.
methods and results used by the WHO to generate 2005 14. Kingston MA, Bansal D, Carlin EM. 'Shelf life' of Trichomonas
estimates. Geneva, Switzerland: World Health Organization, vaginalis. Int J STD AIDS 2003;14(1);28-9.
2011. 15. Little MC, Andrews J, Moore R, et al. Strand displacement
2. Allsworth JE, Ratner JA, Peipert JF. Trichomoniasis and other amplification and homogeneous real-time detection
sexually transmitted infections: results from the 2001-2004 incorporated in a second-generation DNA probe system,
National Health and Nutrition Examination Surveys. Sex BDProbeTecET. Clin Chem 1999;45(6);777-84.
Trans Dis 2009;36(12);738-44. 16. Bachmann LH, Hobbs MM, Sena AC, et al. Trichomonas
3. Sutton M, Sternberg M, Koumans EH, et al. The prevalence of vaginalis genital infections;progress and challenges. Clin Infect
Trichomonas vaginalis infection among reproductive-age Dis 2011;53 Suppl 3;S160-72.
women in the United States, 2001-2004. Clin Infect Dis 17. Kissinger P, Adamski A. Trichomoniasis and HIV interactions:
2007;45(10);1319-26. a review. Sex Transm Infect 2013;89(6);426-33.
4. Andrea SB, Chapin KC. Comparison of Aptima Trichomonas 18. Kissinger P, Mena L, Levison J, et al. A randomized treatment
vaginalis transcription-mediated amplification assay and BD trial: single versus 7-day dose of metronidazole for the
affirm VPIII for detection of T. vaginalis in symptomatic treatment of Trichomonas vaginalis among HIV-infected
women: performance parameters and epidemiological women. JAIDS 2010;55(5);565-71.
implications. J Clin Micro 2011;49(3);866-9.
5. Freeman AH, Katz KA, Pandori MW, et al. Prevalence and

Continuing Education Questions

WINTER 2014
1. Recent research has shown that HPV testing is 6. The current recommendation to increase the time
_____ sensitive but less specific than cytological interval between HPV testing is because it is
examination alone for identifying high-grade important to _____.
cervical lesions. a. wait until the cancer is fully manifested
a. less b. reduce false alarms due to transient infections
b. more with high-risk HPV, and self-correcting low-
c. not grade dysplasia in younger populations
d. falsely c. understand that HPV has recently been shown
to not be linked to cervical cancer
2. In the broad spectrum of quality assurance, HPV d. reduce economic burden of cervical cancer
testing by laboratorians has consequences in which screening to assist health insurance issues for
of the following patient health issues? STD prevention
a. Chemistry disorders
b. Autoimmune disorders 7. What happens with the risk of cervical
c. Reproductive disorders intraepithelial neoplasia (CIN) upon reaching the
d. Endocrinology disorders age of 30 in western cultures?
a. The risk increases
3. Epidemiologically HPV is an independent risk b. The risk sharply decreases
factor in most cases of _________. c. The risk is about the same
a. mucopurulent cervicitis d. There is no relationship
b. cervical cancer
c. nasopharyngeal carcinoma 8. In women 30-65 years of age, co-testing with
d. non-gonococcal urethritis cervical cytology and HPV NAAT is recommended
every _____ years compared to every three years
4. Up to ______ of T. vaginalis infections are with cytology alone.
asymptomatic in women depending on the clinical a. two
setting. b. four
a. 80% c. five
b. 50% d. ten
c. 25%
d. 10% 9. M. genitalium is a sexually transmitted organism
with the _________ genome of all known human
5. What attribute does HPV have that is not shared bacterial pathogens.
with M. genitalium, T. vaginalis or any other STD? a. smallest
a. An association with increased susceptibility to b. largest
HIV c. most resistant
b. The most common curable STD d. least resistant
c. The only vaccine-preventable etiology of
urogenital disease 10. What clinical syndrome was M. genitalium
d. HPV is linked to reproductive disorders associated with when it was first identified and
isolated?
a. asymptomatic gonococcal urethritis

b. asymptomatic non-gonococcal urethritis 15. Culture of M. genitalium has no clinical diagnostic

c. symptomatic non-gonococcal urethritis utility due to the fastidious nature or the organism
d. symptomatic gonococcal urethritis that can take months to isolate. As a result, which
diagnostic method(s) is/are employed in clinical
11. Which of the following characteristics are accurate research studies?
regarding M. genitalium? a. None; the USA FDA has not approved a test
a. Culture-based isolation of the organism is for M. genitalium
relatively quick, not labor intensive, and is the b. RUO NAATs and LDTs
gold standard for diagnostic utility c. LDTs only
b. Culture-based isolation of the organism is time- d. RUO NAATs only
consuming but not labor intensive, and as such
is often chosen as the diagnostic tool 16. Which clinical syndrome is M. genitalium currently
c. Culture-based isolation of the organism is identified as an etiologic agent by the US Center for
impossible and animal models are required for Disease Control and Prevention (CDC)?
culture a. NGU related to C. trachomatis
d. Culture-based isolation of the organism is time- b. Non-chlamydial NGU and non-gonococcal
consuming, labor intensive, and has no cervicitis
diagnostic utility c. Pre-term birth and pregnancy-related
complications
12. Which other STIs have a similar prevalence in high- d. Vaginitis and vaginal discharge
risk and low-risk populations as compared to M.
genitalium? 17. What is the relationship between M. genitalium and
a. C. trachomatis and N. gonorrhoeae cervical inflammation based on current research?
b. HIV and N. gonorrhoeae a. M. genitalium is a cause of cervical
c. HPV and HIV inflammation
d. HIV, HPV, and N. gonorrhoeae b. M. genitalium and C. trachomatis equally causes
cervical inflammation
13. Research has linked M. genitalium infections with c. M. genitalium does not cause cervicitis, but
_______ and _______, both of which have does cause urethritis
significant implications in sexual and reproductive d. Only C. trachomatis causes cervical
health. inflammation
a. monocytes, macrophages
b. HIV-1 infection, monocytes 18. Cervicitis is similar to urethritis in that it ______,
c. HIV-1 infection, cervical inflammation but differs in pathological sequelae.
d. cervical inflammation, macrophages a. has a standardized clinical definition
b. can be diagnosed with microscopic
14. Current research indicates that M. genitalium is a quantification of leukocytes
cofactor for HIV acquisition, which provides c. has the same number of symptoms
rationale for futher research, but d. seldom presents mucopus
a. this co-infection scenario is not well established
and M. genitalium infection should not be 19. What is the primary clinical syndrome and etiologic
treated regardless of HIV infection status agent targeted in stat antibiotic dosing when N.
b. does indicate treatment only if the patient does gonorrhoeae is ruled out as the causative agent of
not receive anti-retroviral therapy (ART) for cervicitis?
HIV infection a. Non-gonococcal cervicitis caused by C.
c. does not currently warrant specialized screening trachomatis
or treatment in patients with HIV b. Non-gonococcal cervicitis caused by M.
d. does indicate treatment when lymphocytes and genitalium
macrophages are observed in the epithelium

c. Non-gonococcal cervicitis caused by M. 24. Which female reproductive tract diseases are
genitalium and C. trachomatis associated with T. vaginalis infection?
d. Broad spectrum treatment for all possible a. Cervicitis, toxoplasmosis, and pelvic
causative agents inflammatory disease (PID)
b. Vaginitis, toxoplasmosis, and PID
20. Why are syndromic management and stat dosing of c. PID, toxoplasmosis, and cervicitis
antibiotics two commonly used practices in high- d. Cervicitis, vaginitis, and PID
risk clinical settings?
a. Several potential etiologic agents can be 25. Colpitis macularis or “_____________” is a highly
managed with a single antibiotic specific sign of T. vaginalis infection but is only
b. Stat dosing allows physicians the freedom to accurately diagnosed during colposcopy.
not screen for STDs a. pelvic inflammatory disease
c. Patient compliance of antibiotic therapy is not b. strawberry cervix
assured c. vulvar pruritus
d. Stat dosing assures no allergic reactions will d. vaginitis including discharge
take place
26. How does the sensitivity of POC tests for T.
21. What is the CDC recommended antibiotic(s) vaginalis utilizing immunochromatographic test
regimen for treatment of NGU and non- strips or non-amplification nucleic acid detection
gonococcal cervicitis? technology compare with microscopy and cultures?
a. Coumadin aimed at treating C. trachomatis a. Higher than microscopy, equal to culture
b. 1 g azithromycin (stat) or seven days of b. Equal to microscopy, equal to culture
doxycycline aimed at treating C. trachomatis c. Equal to microscopy, slightly less than culture
c. 500 mg azithromycin on day one followed by d. Higher than microscopy, higher than culture
five daily 250 mg azithromycin doses aimed at
treating C. trachomatis and M. genitalium 27. How many FDA approved NAATs currently exist
d. 400 mg moxifloxacin for 10 days aimed at for T. vaginalis detection from female urogenital
treating C. trachomatis and M. genitalium specimens?
a. Only one
22. In cases of chronic NGU and non-gonococcal b. Two
cervicitis, which of the following therapeutic c. Three
approaches would most effectively treat both C. d. Three, with another being evaluated
trachomatis and M. genitalium?
a. A seven day regimen of doxycycline 28. What is the recommended treatment for T.
b. 1 g azithromycin (stat), or seven days of vaginalis infections?
doxycycline a. A single 2-gram dose of metronidazole or
c. 500 mg azithromycin on day one followed by tinidazole for men and women
five daily 250 mg azithromycin doses b. A single 2-gram dose of metronidazole for men,
d. 400 mg moxifloxacin daily for seven to ten days and a single 2-gram dose of tinidazole for
women
23. Unlike C. trachomatis and N. gonorrhoeae, T. c. 400 mg moxifloxacin daily for 10 days for men
vaginalis affects all age groups and the prevalence is and women
highest in women over ____ years of age d. No treatment is necessary since T. vaginalis
a. 16 infections are transient in men and women
b. 20
c. 30 29. Currently, _______________ is not a notifiable
d. 40 disease in the USA.
a. C. trachomatis infection
b. T. vaginalis infection

c. N. gonorrhoeae infection dysplastic changes will most often _______without

d. Treponema pallidum (syphilis) infection intervention and the risk for cervical cancer is low.
a. Resolve
30. While HPV infection is extremely common in b. Metastasize
younger women (before age 30), low-grade c. Increase
d. Cause side effects

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Trichomonas vaginalis: Common, curable and in the diagnostic spotlight

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Molecular Diagnosis of Sexually Transmitted

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LEARNING OBJECTIVES tory Science Program, College of Health Professions, Texas

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worldwide. J Pathol 1999; 189(1): 12-9. 2012; 16(3): 172-4.

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Epidemiological and clinical rationale for

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Trichomonas vaginalis: Common, curable and in

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Continuing Education Questions

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b. asymptomatic non-gonococcal urethritis 15. Culture of M. genitalium has no clinical diagnostic

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c. N. gonorrhoeae infection dysplastic changes will most often _______without

60 VOL 27, NO 1 WINTER 2014 CLINICAL LABORATORY SCIENCE

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