Transcript Region II Infertility Prevention Project New York City

Region II
Infertility Prevention Project
New York City, New York
December 12-13, 2007
Richard Steece, Ph.D., D(ABMM)
National Infertility Prevention Project
[email protected]
Region II
Infertility Prevention Project
• Alternate Swabs
•Rectal swabs
•Pharyngeal swabs
•Vaginal swabs
•Penile swabs
• Multiplex Tests
• Utilization of Single Test Technology
Nucleic Acid Amplification Tests
(NAATS)
– Polymerase Chain Reaction (PCR)
• Roche
– Strand Displacement Amplification
(SDA)
• Becton Dickinson
– APTIMA Combo 2 Assay (TMA)
• GenProbe
– APTIMA CT and GC (TMA)
• GenProbe
Alternate Swabs
• Rectal swabs
• Pharyngeal swabs
– CDC/FDA
• Dr. Papp – CDC
• Laboratory Guidelines
– Consultation
VERIFICATION OF THE
GENPROBE APTIMA COMBO 2
ASSAY FOR THE DETECTION OF
C. trachomatis and N. gonorrhoeae
FROM RECTAL AND
PHARYNGEAL SWABS
THOMAS R. SHARPTON, MS, SM(ASCP)
CHIEF, VIROLOGY SECTION
UTAH PUBLIC HEALTH LABORATORIES
Alternate Swabs
• Vaginal Swabs - as specimens for
the diagnosis of chlamydia
infections
– Self-obtained vaginal swabs (SOV)
Vaginal Swabs as Specimens for
the Diagnosis of Chlamydial
Infections
– APTIMA Combo 2 Assay (TMA)
• GenProbe
– APTIMA CT and GC (TMA)
• GenProbe
– FDA cleared – “Patient-collected vaginal swab
specimen application is limited to health care
facilities where support/counseling is available
to explain the procedures and precautions.”
The Importance of Self-Obtained
Vaginal Specimens for Detection of
Sexually Transmitted Infections (STI)
The National Institute of
Allergy and Infectious Diseases
Diagnostics Workshop
Organized by:
Diagnostics Working Group
of the Sexually Transmitted Infections
and Topical Microbicides
Cooperative Research Centers of NIAID
June 27, 2006
Bethesda, MD
Workshop Goal
Review published data and current field
practices to support test development
and FDA clearance for self-obtained
vaginal specimens (SOVs) for STI testing
For detection of STIs in
women, self-obtained vaginal
specimens perform…
…as well as clinician-obtained specimens
…better than urine
…as well as or better than cervical swabs
INTERNET RECRUITED HOME
SAMPLING FOR CHLAMYDIA USING
SELF-OBTAINED VAGINAL
SAMPLES: CAN WE REACH
POPULATIONS AT RISK?
Charlotte A. Gaydos, MS, DrPH
Associate Professor
Division of Infectious Diseases
Johns Hopkins University
23rd IUSTI Europe
Cavtat/Dubrovnik Croatia
OBJECTIVES
•To ascertain whether use of the
Internet to recruit women to perform
home vaginal sampling for Chlamydia
trachomatis can reach at-risk women
•To determine prevalence, behavioral
risk factors, and satisfaction for this
type of outreach screening
METHODS-Use of the Kit
•Website: www.iwantthekit.org
•Program: began 2004
•Publicity: Papers, Magazines, Radio, Flyers
•Kits mailed to homes from email/phone
requests: total requested since 2004: 3249
•Kits contained consent form, swab,
instructions, questionnaire, contact
form, return mailer
•Returned: 30.6%
METHODS- Use of the Female Kit
•Vaginal swabs mailed in a dry state
•Each swab aliquot tested by a multiple
nucleic acid amplification tests (NAATs) for
CT & GC
PCR (Roche)
SDA (Becton Dickinson)
TMA (GenProbe)
•Two different positive NAAT results
required to call a sample positive
RESULTS- Use of the Female Kit
•Analysis of vaginal swabs:
Requested by Internet email: 95.2%, Phone: 4.8%
•Of 930 tested through July 13, 2007
86 (9.3%) CT positive*
13 (1.4%) GC positive*
*(6 co-infected w/ CT and GC)
•Of 259 tested for Trichomonas since Sept:
20 (7.7%) positive**
** (1 co-infected w/ CT and GC)
Other Sites
• Spokane Regional Health District
• Washington State Public Health
Department
• San Francisco City Public Health
Department
Alternate Swabs
• Penile swabs
– Meatal swabs
Use of the Internet for Screening Males
for Sexually Transmitted Diseases:
Prevalence, Satisfaction,
and Risk Factors
Charlotte A. Gaydos1, MS, DrPH
Mathilda Barnes1, BS
Bulbul Aumakhan1, MD
Billie Jo Wood1, MS
Patricia Rizzo-Price1, MS
Nicole Quinn1 , BS
Pamela Whittle2, BS
M. Terry Hogan1, MPH
1.Johns Hopkins University
2. Baltimore City Health Department
Baltimore, Maryland
Background
•www.iwantthekit.org is an Internet based
educational program for recruiting sexually
active persons to collect samples at home
for screening themselves for chlamydia,
gonorrhea and trichomonas
•Women (N = 993) have been screened
since 2004
•Screening for men began in Sept
2006 (N = 93)
OBJECTIVES
•To ascertain if males would request home
sampling kits for STDs via the Internet for
collection of urogenital samples at home
•To determine the perception and opinions
of the participants about the program
•To measure STD prevalence, demographics,
and behavioral risk factors of males users
METHODS
•Kits: consent form, swab, instructions,
questionnaire, contact form, return mailer
•Kits mailed to patient’s home after
email/phone request
•Urine and self-collected penile swabs tested
TMA APTIMA (GenProbe) transport media used
Urine collected on Copan Uriswab “sponge stick”
Penile swab was “flocked swab” (Copan)
•Kits returned by U.S. mail
•Samples tested for chlamydia, gonorrhea,
and trichomonas using nucleic acid
amplification tests (NAATs, TMA, GenProbe)
Results (N=93)
•Men returned 21.1% of requested kits; all but 3
men submitted the penile swab along w/ urine; all
but 12 used Internet to request kits; others phone
•Prevalence
CT:
GC:
Trichomonas
19.4%
0%
1.3%
•Good agreement between urine & penile swabs:
4 penile swabs chlamydia positive were
negative by urine; others in agreement
•Median age (p=0.12)
•for CT infected was 21.5 yr. (mean 22.3, range 16-36)
•for CT uninfected was 23 yr. (mean 27.3, range 17-63)
Other Studies
Male “Self Collected” Glans/Urethral Dry
Swab Specimens Tested with the Becton
Dickinson ProbeTec ET System Detects
Chlamydia trachomatis (CT) and
Neisseria gonorrhoeae (NG)
Dennis Ferrero, Diane Schultz, Nancy Burgess,
Stephen Willis, and Stef Argintean
107th General Meeting of the American Society of
Microbiology. 2007. Abstract C-116
j
Results
• 284 male patients attending an STD
cllinic were tested for CT and GC using
clinician collected swab (CCS), first
void urine (FVU), and self-collected
glans/urethral swab (SCS)
• 51 positive specimens for either CT and
GC (CT prevalence 12%, GC prevalence
5.6%)
• Overall sensitivity of SCS was 91% with
a specificity of 99%
Multiplex Tests
• What is a Multiplex Test?
– “Test which can detect one or more
agents from a single specimen, in a
single run”
• E.g. GenProbe Aptima Combo 2
Multiplex Tests
• CDC – DSTDP – Laboratory Branch
– Developed an in-house Multiplex PCR
test for genital ulcer disease
(syphilis, chancroid, and HSV)
Utilization of Single Test Technology
• What is single test technology?
– Single test to detect CT used to screen for
CT
• Cost savings
• Don’t routinely test for GC
• Don’t use NAAT for GC, may use culture
– Single test to increase positive predictive
value (PPV), e.g. repeat test, supplemental
or “confirmatory test”
Repeat Testing
• Theoretical Consideration
(2002 CDC Guidelines)
– Test a second specimen with a different test that
uses a different target, antigen, or phenotype and
different format.
– Test the original specimen with a different test that
uses a different target, antigen, or phenotype and a
different format.
• e.g. screen with Gen-Probe Aptima Combo 2 (AC2), retest
with Gen-Probe Aptima CT or Roche Amplicor or Becton
Dickinson ProbeTec
– Repeat the original test on the original specimen
with a blocking antibody or competitive probe
– Repeat the original test on the original specimen
• e.g. screen with AC2, retest with AC2.
Utilization of Single Test Technology
• Sixteen (16) public health laboratories
use AC2 and/or ACT and AGC
• Fifty-eight (58) private laboratories use
AC2 and/or ACT and AGC
• Most laboratories (public and private)
that use ACT and/or AGC use in
conjunction with AC2
• Seven (7) US Non-Public health
laboratories and 5 public health
laboratories use ACT with AC2 and
without AGC