Advances in Diagnostic Testing for Chlamydia cervicitis

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					    Advances in Diagnostic Testing for Chlamydia                                                                                                  STAFF
                                                                                                                                                  Chlamydia Today is
                                                                                                                                                  produced through the
                                                                                                                                                  Region IX Infertility
    The diagnostic tests for genital       What’s wrong with                         chlamydia screening in community-                            Prevention Project and
    chlamydia infection have changed       the old tests?                            and school-based settings where staff                        funded by the Centers for
    significantly in the past few years.   Older tests include tissue culture,       and space may not be available to                            Disease Control and
    New highly sensitive tests based       antigen detection systems using           perform genital exams. These                                 Prevention.
    on nucleic acid amplification          direct fluorescent antibody (DFA)         innovative approaches in non-clinical
    technology allow non-invasive          or enzyme immunoassay (EIA),              settings increase access to care for                         Region IX IPP Staff
    specimen collection, identify up to    and DNA detection by probe                high-risk groups.                                             Pat Blackburn
    40% more cases of infection, and       hybridization (GenProbe PACE 2).                                                                        Regional IPP Coordinator
    have created new opportunities for                                               Who should be
    innovative screening programs.         Disadvantages of these technologies       screened?                                                     Deborah Glenn-Rogers
                                           include invasive specimen collection,     The U.S. Preventive Services Task                             IPP Infrastructure Support
    What’s New!                            limited sensitivity that can be further   Force recommends routine screening
    The newest chlamydia tests are         compromised by improper specimen          of all sexually active young women                            Genevieve Herreria
    known as nucleic acid amplification    collection because these technologies     (under age 26) for chlamydia.                                 IPP Infrastructure Support
    tests, or NAATs. These tests are       are highly dependent on having            Women older than 25 should be
                                                                                                                                                   Carl Lucania
    based on new diagnostic technolo-      sufficient columnar cells, and the        screened on the basis of symptoms
                                                                                                                                                   Regional Data Manager
    gies, including polymerase chain       need for verification testing and         and high risk behaviors. Pregnant
    reaction (PCR, Roche Amplicor),        quality assurance programs to             women under age 26 should also be                             Shahasp Valentine
    ligase chain reaction (LCR, Abbott     maximize test performance.                screened for chlamydia. Women                                 Graphic Design
    LCx), transcription mediated                                                     who test positive and are treated are
    amplification (TMA, GenProbe           Although tissue culture has 100%          at high risk for re-infection and may                        Center for Health Training
    AmpCT and APTIMA), and strand          specificity, it is labor intensive and    benefit from a repeat test in 3 to 4                         614 Grand Avenue,
    displacement amplification (SDA,       technically difficult. The sensitivity    months.                                                       Suite 400
    Becton Dickinson ProbeTec).            ranges from 75-85%.                                                                                    Oakland, CA 94610
                                                                                     Heidi M. Bauer, MD MS MPH
    NAATs provide excellent                DFA, EIA, and nucleic acid probes           California Department of                                   510.835.3700 tel
    sensitivity (90-95%) and specific-     detect up to 75% of infections and           Health Services                                           510.625.9307 fax
    ity (98-99%) and have markedly         produce false positives in up to 5%.        STD Control Branch
    improved our ability to diagnose       Despite recommendations to                                                                   
    chlamydia infections.                  perform verification assays and           Screening / Chlamydia
                                           negative gray zone testing with EIA       continued from page 1
    More importantly, the increased        and GenProbe, many labs do not            Calculations: The most commonly used                         Acknowledgements
    sensitivity has enabled non-           adhere to these standards. In             test, GenProbe PACE 2, is about 75%
                                                                                     sensitive and 98% specific. That means it                    Thank you:
    invasive specimen collection, such     addition, most clinics using these        misses 25% of infections, and that 2% of                     IPP Newsletter Committee:
    as urine and self-obtained vaginal     older technologies do not have            tests in people without infection will result
                                                                                     in false positives. Given a true prevalence                   Heidi Bauer,
    swabs. These collection methods        quality assurance programs to assess
                                                                                     of 1% among women over 25, if we screen                       Pat Blackburn,
    are more acceptable to patients        specimen adequacy.                        10,000 women, we would want to                                Melanie Deal,
    and allow for testing outside                                                    identify 100 infections (10,000 x 1%). Of
                                           The best tests for                        these 100 infections, 75% will be detected                    Genevieve Herreria,
    traditional clinic settings by                                                   by the test (75% x 100 = 75). These are
                                           screening                                                                                                and
    eliminating the need for painful                                                 the true positives. However, 2% of those
                                           Because chlamydia infections often        without disease ([10,000-100] x 2% =                          Charlotte Kent;
    urethral swabs in men and
                                           produce no symptoms and no                198) will be false positives. Thus, of the                    Gail Bolan,
    uncomfortable pelvic exams in                                                    total 273 positive tests (75 + 198), over
                                           clinical signs, routine screening in                                                                    Monique Brammeier,
    women. Although vaginal swab                                                     two-thirds of these are false positives. That
                                           young women and other high risk           is, only about one in 3 patients over age 25                  Joan Chow,
    specimens are not currently                                                      with a positive test really has chlamydia.
                                           populations is vital to diagnosis and                                                                   Linda Creegan,
    approved by the FDA, laboratories
                                           treatment. The highly sensitive                                                                         Deborah Glenn-Rogers,
    may conduct small studies to
                                           NAATs have exceptional perfor-            Chlamydia Prevalence                                          Carl Lucania,
    validate their utility.                                                          continued from page 2
                                           mance in asymptomatic patients and                                                                      Jamie Miller,
    The hybrid capture assay devel-        are considered the best tests for         2. California Chlamydia Action Coalition, STD Control         Debra Mosure,
                                                                                        Branch of the California Department of Health Services,
    oped by Digene relies on signal        screening.                                   the University of California, San Francisco and            Lisa Schamus,
                                                                                        PricewaterhouseCoopers, LLP Chlamydia Screening &
    amplification of an antibody to a                                                   Treatment Practice Guidelines. December 2001.
    nucleic acid hybrid. Test perfor-      New opportunities for                     3. Fleming DT, Wasserheit JN. From epidemiological
                                                                                        synergy to public health policy and practice: The
                                                                                                                                                   Shahasp Valentine.
    mance is similar to the NAATs,         screening                                    contribution of other sexually transmitted diseases to
                                                                                        sexual transmission of HIV infection. Sex Transm Inf.
    however not all specimen types are     The new NAATs, which can be                  1999;75:3-17.
                                                                                     4. State of California, Department of Health Services,
    FDA-approved.                          performed on urine specimens,                Office of Family Planning. Family PACT Program
                                           provide novel opportunities for              Evaluation Report. January, 2000.
                                                                                     5. Arizona Family Planning Council. Year-end Report. 2001.

                         I X
                                         I N F E R T I L I T Y
                                            California                      •
                                                                                    ISSUE 1

                                                                                P R E V E N T I O N
                                                                                           Hawaii                •
                                                                                                                     P R O J E C T

      What is the IPP?
The Infertility Prevention Project
                                            Region IX Infertility Prevention Project
                                            A Word From The Coordinator
(IPP) is a nationwide collaboration             his edition of the Region IX Infertility    California, however, has a new option
between the Office of Population
Affairs (OPA) and the Centers for
Disease Control and Prevention
(CDC) to prevent and control chlamy-
                                            T   Prevention Project newsletter provides
                                                an update to the chlamydia screening
                                            data being submitted from clinic sites
                                                                                            which allows physicians to prescribe
                                                                                            antibiotics for partners of infected clients
                                                                                            without actually seeing the partner. The
dia and its resulting complications.        throughout the Region. You’ll note that         implementation of this approach will be
Throughout the country, the CDC has         chlamydia positivity continues to increase      followed closely in Region IX as well as
set up regional infertility prevention      throughout Region IX.                           across the country. We’ll provide future
advisory committees to support col-
                                                                                            updates on the success of this strategy.
laborative relationships with public        The other two articles in
health laboratories, family planning                                                                          The articles will demon-
                                            this edition focus on who
providers, STD programs, and other
                                            should be screened and              Encouraging partners          strate why all providers are
women’s health providers. These
regional committees set project             with what technology.                                             encouraged to:
                                                                                to be seen by a physi-
priorities, establish regional screen-      Accurate detection of                                             1. Screen all sexually
ing and treatment guidelines, and link      chlamydia infections will           cian and screened for         active women 25 years old
surveillance and epidemiologic              increase if providers focus         chlamydia is still the        and under for chlamydia
activities. Project funds are used to                                                                         at least annually.
                                            screening efforts on sexually           most desirable
screen and treat women for
chlamydial infections, to counsel
                                            active women aged 25 and                                         2. Test women 26 years
                                                                                 approach to partner
women and their partners on safer           under and use the best                                           old and older for chlamy-
sex practices, to refer women for           technology possible.                    management.              dia based on their clinical
other medical services as appropri-                                                                          presentation, reported
ate, and to support the activities          Being sure the partners of
                                                                                            exposure to infection, or risk factors (e.g.,
of the regional committees. The             infected clients are treated before the
Region IX Infertility Prevention
                                                                                            new or multiple partners or a recent history
                                            resumption of sexual contact will also
Advisory Committee is composed                                                              of an STD).
                                            decrease the number of new and repeat
of at least one representative from                                                         3. Use nucleic acid amplification test (NAAT)
                                            chlamydia infections. Encouraging partners
all Title X family planning grantees,
                                            to be seen by a physician and screened for      technology for chlamydia screening when-
STD Program, and public health
laboratory from each of the four            chlamydia is still the most desirable           ever possible.
USPHS Region IX states: Arizona,            approach to partner management.                         — Pat Blackburn
California, Hawaii, and Nevada.                                                                          Region IX IPP Coordinator

  I N S I D E                                 R E P R I N T             P E R M I S S I O N

    Prevalence                      1           is granted for all articles provided that Chlamydia Today and the authors are
    Screening                       1           credited. Please direct corrections, comments, questions, and/or suggestions to:
    Resources                       2               Chlamydia Today, Center for Health Training
    Save the Date                   2               614 Grand Avenue, Suite 400, Oakland, CA 94610
                                                    Phone: 510.835.3700, Fax: 510.625.9307, E-mail:
    Advances in Testing             3
        Region IX
        Chlamydia                                                                                                               Screening For Chlamydia
        Prevalence                                                                                                              Are You Screening All Your Clients For Chlamydia?
                                                                                                                                If So, WHY?
Chlamydial infections are the most                           women screened in family planning                                  Analysis of the Region IX IPP partners or a recent history of
common reportable communicable                               clinics in Region IX in 2000,                                      2000 data shows that in family an STD. In fact, any chlamydia
disease in the United States.1 They                          California had the highest chlamy-                                 planning clinics, women 26 and testing among women over age
are among the most prevalent of all                          dia positivity (7.3%), followed by                                 older had lower chlamydia posi- 25 should be medically justified
sexually transmitted diseases (STDs)                         Nevada (6.4%), Hawaii (5.1%) and                                   tivity rates than women 25 and based on their clinical presen-
and, since 1994, have comprised                              Arizona (5.0%).                                                    younger (Figure 1). Despite the tation (e.g., mucopurulent
the largest proportion of all STDs                                                                                              low prevalence in women 26 cervicitis), reported exposure to
reported to the Centers for Disease                                        Even though chlamydia positivity is                  and older, a                                                                                      infection, or
Control and Prevention (CDC).                                              increasing, available data show that                 significant                                                                                       risk factors.
                                                                                                       many of the              number of
                                                                                                       women who                chlamydia
                                                                                                                                                                                                                                  F u r t h e r-
                                                                                                       are at risk for          tests were
                                                                                                                                                                                                                                  more, tests
                                                                                                       this infection           performed
                                                                                                                                                                                                                                  are not per-
                                                                                                       are still not            in this age
                                                                                                                                                                                                                                  fect. Over-
                                                                                                       being screened.          group. Fig-
                                                                                                                                                                                                                                  screening in
                                                                                                       In California,           ure 2 shows Figure 1. Family Planning* Females CT
                                                                                                       chart review             that a high % Pos By State and Age Group, 2000
                                                                                                                                                                                                                                  with less
                                                                                                       data suggest             percentage *HI represents primary care with family planning visit
                                                                                                       that 47% of                              Source: California Department of Health Services, STD Control Branch, Infertility
                                                                                                                                of chlamy- Prevention Project. Graphic provided by Monique Brammeier.
                                                                                                       female clients           dia tests
                                                                                                                                                                                                                                  more false
                                                                                                       aged 25 years            were per-
Figure 1. Chlamydia – Positivity among 15-24 year old                                                  or younger who                                                                                                             than true
women tested in family planning clinics by state, 2000                                                                          formed in
Note: States reported chlamydia positivity data on at least 500 women aged 15-24 years screened during
                                                                                                       were new to              Region IX
2000 except for Minnesota and Rhode Island.                                                            their provider           IPP family
SOURCE: Regional Infertility Prevention Programs; Office of Population Affairs; Local and State STD
Control Programs; Centers for Disease Control and Prevention                                           were screened            planning
                                                                                                                                                                                                                                  on the preva-
                                                                                                       for chlamydia            clinics for
                                                                                                                                                                                                                                  lence and
The majority of chlamydia                                                  in Family PACT FY 97/98.4 In                         women 26
                                                                                                                                                                                                                                  test being
infections are asymptomatic and,                                           Arizona, the Arizona Family                          and older,
                                                                                                                                                                                                                                  used, a posi-
therefore, go undetected. The                                              Planning Council reported that in                                     Figure 2. Family Planning* Females %                                             tive test may
                                                                                                                                especially ofTotalTested By State and Age Group,
medical costs and potential health                                         2001, 73% of female clients aged                     in California 2000
                                                                                                                                                                                                                                  be more likely
consequences of infection are                                              25 years or younger were screened                    and Hawaii. *HI represents primary care with family planning visit
                                                                                                                                                                                                                                  to be a false
greatest in women, who because of                                          for chlamydia during an initial or                                    Source: California Department of Health Services, STD Control Branch, Infertil-
                                                                                                                                Not only is ity Prevention Project. Graphic provided by Monique Brammeier.
undetected and untreated disease,                                          annual exam visit.5 Since the IPP                    this practice
                                                                                                                                                                                                                                  than a true
may develop serious short-term and                                                                                              wasting valuable resources
                                                                                                                                                                                          positive (see Calculations). A
long-term complications.2 Addi-                                                                                                 but it may actually do harm to
                                                                                                                                                                                          positive chlamydia test in a
tionally, chlamydia may contribute                                                                                              patients.
                                                                                                                                                                                          woman without disease can be
substantially to the spread of hetero-                                                                                                                                                    devastating, causing a great
sexually acquired HIV infection.3                                                                                               We use the term “screening” to deal of anxiety, and possible
                                                                                                                                indicate testing that is done in relationship problems.
In 2000, the CDC reported that                                                                                                  the absence of symptoms or
the median state-specific chlamydia                                                                                             signs. In contrast, diagnostic test-
                                                                                                                                                                                          For all these reasons, asymptom-
test positivity among 15- to 24-                                                                                                ing should be performed when-
                                                                                                                                                                                          atic women over the age of 25
year-old women screened in family                             Figure 2. Chlamydia – Trends in                                                                                             should not be routinely screened
                                                              positivity among 15-44 year old                                   ever a patient presents with
planning clinics was 5.2% (range:                                                                                                                                                         for chlamydia. Providers should
                                                              women tested in family planning                                   symptoms or signs consistent
2.3% to 15.8%, Figure 1). The                                 clinics in Region IX, 1996-2000                                   with chlamydia or a history of a
                                                                                                                                                                                          carefully consider the indications
CDC also reports a trend of increasing                        Note: Trends adjusted for changes in laboratory test method and
                                                                                                                                potential exposure to chlamydia.
                                                                                                                                                                                          for screening and testing. Doing
                                                              associated increases in test sensitivity.
chlamydia positivity for Region IX                            SOURCE: Regional Infertility Prevention Programs; Office of
                                                                                                                                                                                          so will reduce the risks and costs
(Figure 2). In 1996, the chlamydia                            Population Affairs; Local and State STD Control Programs;
                                                              Centers for Disease Control and Prevention
                                                                                                                                Currently, Region IX IPP Clinical associated with over-screening.
positivity among 15- to 44-year-old                                                                                             Guidelines do not recommend
                                                              Advisory Committee recommends                                                                                               Heidi M. Bauer, MD MS MPH
women tested in family planning                                                                                                 routine screening for chlamydia
                                                                                                                                                                                            California Department of
clinics in Region IX was 5.1%,                                that all sexually active female clients                           of women over age 25. Screen-                                  Health Services
whereas in 2000 the chlamydia                                 25 years or younger be routinely                                  ing women over age 25 may be STD Control Branch
positivity in the Region had increased                        screened for chlamydia, there is                                  individualized based on risk
to 6.2%* Among 15-24 year-old                                                 continued next page                               factors, such as new or multiple                                  Calculations continued page 3

     WHAT’S NEW?
     The 2002 STD Treatment Guidelines have been released and are                   ment, and partner management. The training is designed to reinforce
     available through a link at <                 screening for chlamydia among asymptomatic sexually active young
     default.htm> or you may order a copy of the guidelines from the same           women. Medical providers may receive 2 units of continuing medical
     web site. Any changes or updates to the Guidelines will be posted              education for FREE. Through the training, providers will also have
     there as well as information about issues that affect STD Treatment.           access to chlamydia screening tools, guidelines and online resources.
     Included in these updated guidelines are new alternative regimens for
                                                                                    IPP IN YOUR STATE
     early syphilis; an expanded section on the diagnosis of genital herpes
                                                                                    If you have a question about the IPP in your state, please contact
     (including type-specific serologic tests); new recommendations for
                                                                                    Genevieve Herreria, 510.835.3700,
     treatment of recurrent genital herpes among persons infected with
     human immunodeficiency virus (HIV); and inclusion of hepatitis C               WEBSITES WORTH A LOOK:
     as a sexually transmitted infection. Recommendations are provided              California Chlamydia Action Coalition
     for vaccine-preventable STDs, including hepatitis A and hepatitis B.      
     In addition, these guidelines emphasize the emergence of quinolone-            Chlamydia Screening & Treatment Practice Guidelines
     resistant Neisseria gonorrhoeae and implications for treatment.           
                                                                                    CDC Division of Sexually Transmitted Diseases
     In response to the increase in fluoroquinolone-resistant gonorrhea in
                                                                                    CDC Sexually Transmitted Disease Surveillance 2000
     California, the California State Department of Health Services Sexually
     Transmitted Disease Control Branch issues the following recommenda-
                                                                                    CDC Chlamydia Prevalence Monitoring Project Annual Report
     tions: (1) Avoid the use of fluoroquinolones to treat gonorrhea in Cali-
     fornia. (2) Use cephalosporins as the antibiotic of choice to treat uncom-
                                                                                    2002 National STD Prevention Conference Media Releases
     plicated gonococcal infections. California providers only: See attached
     New California Gonorrhea Treatment Guidelines for more details.
                                                                                    American Social Health Association
     CHLAMYDIA ONLINE TRAINING                                                 
     A case-based chlamydia online training will be available on the                California STD/HIV Prevention Training Center
     California STD/HIV Prevention Training Center website                     
     <> on July 1, 2002.                               Public Health Foundation (Distance learning clearinghouse)
     This chlamydia course includes two interactive case discussions that           Center for Health Training
     review clinical significance, epidemiology and risk factors, sexual his-  
     tory taking, rationale for chlamydia screening, diagnostic tests, treat-

  Save the Dates:                                                                 August 9, 2002
  July 17, 2002
  Overview of STDs for Clinicians, Long Beach, CA (7 CMEs / 8.1 CEUs)             Working Effectively with Teens in a Clinic Setting, Phoenix, AZ
                                                                                  (Flinn Foundation)
  Practicing clinicians learn epidemiology, diagnosis, treatment, and
  management of STDs. This course is presented in an interactive, skills-         Topics will include coercion, assessment and counseling, parental
  focused, syndrome-based format. Limited registration assures an                 involvement, teen friendly atmosphere and interviewing, and CPS
  appropriate student-to-faculty ratio. For more information, contact the         reporting protocols. For more information, contact the Arizona Family
  California STD/HIV Prevention Training Center at (510) 883-6600.                Planning Council at (602) 258-5777.

Region IX Chlamydia Prevalence continued
room to improve screening efforts  women seeking care are screened?               factors may explain the increase in      information systems for reporting;
in the Region.                     Are clients seeking emergency                  chlamydia rates: the expansion of        as well as the continuing high
                                   contraception, pregnancy or HIV                chlamydia screening activities; use      burden of the disease.
What strategies can your clinic    tests screened for chlamydia? Each             of increasingly sensitive diagnostic
                                                                                                                           1. Groseclose SL, Zaidi AA, DeLisle SJ, Levine WC, St. Louis
come up with to increase screening of us has a role in decreasing                 tests, such as nucleic acid amplifica-      ME. Estimated incidence and prevalence of genital
for chlamydia among women 25       chlamydia positivity in the Region.            tion tests; increased emphasis on           Chlamydia trachomatis infections in the United States,
                                                                                                                              1996. Sex Transm Dis 1999; 26:339-344.
and under? How can you ensure      What can you do?                               case reporting from providers and
that all sexually active young                                                                                                                        continued next page
                                      *A combination of the following             laboratories; improvements in the

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