During 1997 universal testing of Chlamydia trachomatis (CT) was implemented in study, sentinel, and
clinic sites in Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin. All persons who tested
positive were treated if located. The clinic sites were strategically located to encompass rural/urban,
multicultural populations and various income brackets. Family planning and sexually transmitted disease
clinics participated in the study. Behavioral, clinical, laboratory and demographic data were collected for
one year using laboratory requisition forms and patient completed questionnaires. In 1998 the Region V
Epidemiologist, John Pfister, analyzed the data collected by each state and presented the findings at a
regional meeting of program collaborators. The data were analyzed by multiple variables looking for
significant trends in prevalence. A computer application was developed so that each state could input
their budget and prevalence data to determine the most appropriate screening criteria.
Region V screening criteria recommendations are formulated by evidence-based data gathered in this
region. Each state has analyzed state specific data and developed recommended screening criteria based
on the state’s data and budget availability to purchase tests.
In the 2002 Sexually Transmitted Diseases Treatment Guidelines, the Centers for Disease Control &
Prevention (CDC) expanded their screening recommendations to include annual screening of sexually
active adolescents (19 years and under), young adult women (20 – 24 years), and other women with a
risk factor for CT. This recommendation is not constricted by state budget limitations. In addition, the
CDC recommends re-screening 3-4 months after treatment for a CT infection. This is not as a “test of
cure” but due to the high risk of re-infection often caused by the patient’s sex partner not being treated
and/or the patient continuing high risk behavior following treatment. Some experts especially
recommend re-screening adolescents due to the high rate of re-infection in this population.
The Region V Screening Criteria Recommendations
Family Planning Clinic
Females
Women should be screened who meet at least one of the following criteria:
Age (based upon data indicators and resources) < 19; < 19 biannually; or < 23
Signs or symptoms
STD Contact
Sex Partner Risk (new sex partners, multiple sex partners, sex partner with other partner)
Prior STD History
Male
Dependent upon agency resources
STD Clinic
Females
Women should be screened who meet at least one of the following criteria:
Age (based upon data indicators and resources) < 21; or < 27
Signs and symptoms
STD Contact
Sex Partner Risk (new or multiple partners, sex partner with other partners)
Female Cytobrush (preferred female collection device for DFA)
Remove excess mucus using cotton or dacron swab. Discard swab.
Insert cytobrush into endocervical canal past squamocolumnar junction. Leave in place 2-5 seconds.
Rotate brush one full turn (360°). Withdraw brush without touching vaginal surfaces.
Place portion of cytobrush containing the specimen across the center of the slide well.
Rotate and twist the brush, moving the brush back and forth across the slide well. Liquid clinging to
the brush will disperse cells across the slide well.
Check coverage.
Label slide.
Air dry completely.
Fix with methanol.
Female Swab
Remove excess mucus using cotton or dacron swab.
Insert second swab into endocervical canal until the tip is not visible.
Rotate swab 360° for 5-10 seconds inside endocervical canal. Withdraw swab without touching
vaginal surfaces.
Prepare slide immediately by rolling one side of swab over top half of slide well and other side of
swab over bottom half of slide well.
Label slide.
Air dry completely.
Fix with methanol.
Male Swab
Collect all other samples first. Preferably no urination one hour prior to collection.
Using manufacturer's male collection kit swab, insert into urethra a minimum of 2-4 cm.
Rotate at least one complete revolution for 2-5 seconds and withdraw swab.
Prepare slide immediately by rolling one side of swab over top half of slide well and other side of
swab over bottom half of slide well.
Label slide.
Air dry completely.
Fix with methanol
2. SYVA MICRO TRAK - ENZYME IMMUNOASSAY (EIA)
Female Swab
Cleanse ectocervix lightly with an extra swab. (You may use one not included in the kit).
Insert kit dacron swab into endocervical canal until tip is not visible.
Rotate swab in the canal for 15-30 seconds.
Remove swab, being careful not to touch vaginal surfaces.
Place swab immediately in labeled transport tube with bar code attached.
Break off shaft of swab at score line.
Insert the end of the swab into the center hole of the cap.
Cap tube tightly.
Male Swab
Client should not urinate for one hour before testing.
Express and discard any pus or exudate before testing.
Insert small swab with wire handle 2- 4 cm into the urethra.
Gently rotate swab for 15 seconds.
Remove swab.
Place swab immediately in labeled transport tube with bar code attached.
Break swab handle.
Insert the end of the swab into the center hole of the cap.
Cap tube tightly.
Remember
Columnar epithelial cells must be present for reliable results therefore, do not
sample only discharge/exudate .
Use ONLY the swabs in the kit to collect the
specimens.
Break the kit swab at the score line otherwise the cap may not secure tightly, causing the specimen to
leak/become inadequate for testing.
If transporting by U.S. Post Office, please confirm shipping
requirements for biological specimens, except DFA.
3. GEN-PROBE - NUCLEIC ACID PROBE
Female Swab (Collect specimen after a PAP smear, if being done, and/or wet
mount)
Remove excess mucus from cervical and surrounding mucosa using one of the swabs provided.
Discard the cleaning swab.
Insert second swab from collection kit 1 - 1 1/2 cm into endocervical canal.
Rotate swab 10-30 seconds in endocervical canal to ensure adequate sampling.
Withdraw swab carefully; avoid any contact with vaginal mucosa.
Immediately place swab in specimen collection kit transport tube.
Break swab shaft at scoreline.
Replace cap tightly and label tube.
Transport to the laboratory at 2º C to 25º C as soon as possible after collection. Specimens must
reach the laboratory within 7 days after collection or they will be unsatisfactory for testing.
If transporting by U.S. Post Office, please confirm shipping requirements for biological specimens.
Male Swab
Patient should not have urinated for at least 1 hour prior to sample collection.
Insert swab from the collection kit 2-4 cm into urethra.
Rotate swab gently at least one full rotation for 2-3 seconds. Use sufficient pressure to ensure swab
comes into contact with all urethral surfaces.
Immediately place swab in specimen collection kit transport tube.
Break swab shaft at scoreline.
Replace cap tightly and label tube.
Transport to the laboratory at 2ºC to 25º C as soon as possible after collection. Specimens must
reach the laboratory within 7 days after collection or they will be unsatisfactory for testing.
If transporting by U.S. Post Office, please confirm shipping requirements for biological specimens.
Remember
Columnar epithelial cells must be present for reliable results.
Use ONLY the swabs in the kit to collect the specimens
Do not collect specimens from females with swabs and transports intended for males.
Break the kit swab at the score line otherwise the cap may not secure tightly, causing the
specimen to leak/become inadequate for testing.
4. POLYMERASE CHAIN REACTION (PCR)
Female Swab
Remove excess mucus using one of the large swabs included in specimen collection kit. Discard
swab.
Insert other large swab into endocervical canal unit the tip is not visible.
Rotate the swab 360° for 5-10 seconds inside the endocervical canal. Withdraw swab without
touching vaginal surfaces.
Place swab in Specimen Transport Media tube, vigorously swirl or agitate the swab in the liquid for
15 seconds.
Replace cap tightly and label tube.
Male Swab
Preferably no urination one hour prior to collection.
Using manufacturer’s male collection kit swab, insert into urethra a minimum of 2-4 cm.
Rotate at least one complete revolution for 2-5 seconds and withdraw swab.
Place swab in the Specimen transport Medium tube, vigorously swirl or agitate the swab in the liquid
for 15 seconds.
Replace cap tightly and label tube.
Male Urine
Collect all other samples first. Preferably no urination one hour prior to collection.
Collect first 15-20 ml urine in collection cup.
Replace cap tightly and label cup.
Remember
columnar epithelial cells must be present for reliable results
use ONLY the swabs in the
kit to collect the specimens
do not collect specimens from females with swabs and transports intended
for males
break the kit swab at the score line otherwise the cap may not secure tightly, causing the
specimen to leak/become inadequate for testing.
Remove excess mucus from cervical os and surrounding mucosa using cleaning swab in package
(white shaft swab in package with red printing). Discard this swab.
Insert specimen collection swab (blue shaft swab in package with green printing) into
endocervical canal.
Gently rotate swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate
sampling.
Withdraw swab without touching vaginal surfaces.
Remove cap from swab specimen transport tube and immediately place specimen collection
swab into specimen transport tube.
Carefully break swab shaft at scoreline; use care to avoid splashing contents.
Re-cap swab specimen transport tube tightly.
See Specimen Transport and Storage below.
See Specimen Transport and Storage below.
Male Swab
Patient should not have urinated one hour prior to specimen collection.
Using manufacturer’s male collection kit swab (blue shaft swab in package with green printing),
insert into urethra 2-4 cm.
Rotate swab clockwise for 2-3 seconds in urethra to ensure adequate sampling.
Withdraw swab carefully.
Remove cap from swab specimen transport tube and immediately place specimen collection
swab into specimen transport tube.
Carefully break swab shaft at scoreline; use care to avoid splashing contents.
Re-cap swab specimen transport tube tightly.
Specimen Transport and Storage
After collection, transport and store swab in swab specimen transport tube at 2ºC to 30ºC until tested.
Specimens must be assayed with the GEN-PROBE APTIMA Combo 2 Assay within 60 days of
collection. If longer storage is needed, freeze at -20ºC to -70ºC for up to 90 days after collection.
Male & Female Urine
Patient should not have urinated for at least one hour prior to specimen collection.
Direct patient to provide first-catch urine (approximately 20 to 30 m. of initial urine stream) into
urine collection cup free of any preservatives. Collection of larger volumes of urine may result
in specimen dilution that may reduce test sensitivity. Female patients should not cleanse labial
area prior to providing specimen.
Remove cap from urine specimen transport tube and transfer 2 ml. Of urine into urine specimen
transport tube using disposable pipette provided. The correct volume of urine has been added
when fluid level is between black fill lines on urine specimen transport tube label.
Re-Cap urine specimen transport tube tightly. This is known as the “processed urine specimen”.
See Specimen Transport and Storage below.
Specimen Transport and Storage
After collection, transport the processed urine specimens in the GEN-PROBE APTIMA COMBO 2
Assay urine specimen transport tube at 2ºC to 30ºC and store at 2ºC to 30ºC until tested. Processed
urine specimens should be assayed with the APTIMA Combo 2 Assay within 30 days of collection. If
longer storage is needed, freeze at -20ºC to -70ºC for up to 90 days after collection.
Urine samples that are still in primary collection containers must be transported to lab at 2ºC to 30ºC.
Transfer urine sample into APTIMA Combo 2 Assay urine specimen transport tube within 24 hours of
collection. Store at 2ºC to 20ºC and test within 30 days of collection.
Remove excess mucus from the cervical os with the large-tipped cleaning swab provided in the kit
and discard
Insert 2nd swab from kit into the cervical canal and rotate for 15 – 30 seconds.
Remove the swab carefully. Avoid contact with the vaginal mucosa.
Immediately place the cap/swab into the transport tube. Make sure the cap is tightly secured to the
tube.
Label the tube with patient information and date/time collected.
Male Swab - Urethral Swab Specimen Collection
Insert the Mini-Tip swab from the kit 2-4 cm into the urethra and rotate for 3-5 seconds.
Withdraw the swab and place the cap/swab into the transport tube. Make sure the cap is tightly
secured to the tube.
Label the tube with patient information and date/time collected.
Swab Storage and Transport
The Culturette Direct Collection swab and the Mini-Tip Culturette Direct swab must be stored and
transported to the laboratory and/or test site at 2-27ºC within 4-6 days of collection. Storage up to 4
days has been validated with clinical specimens. Storage up to 6 days has been demonstrated with
seeded specimens. Note: If specimens cannot be transported directly to the testing laboratory under
ambient temperatures (15-27ºC) and must be shipped, an insulated container with ice should be used
with either an overnight or 2-day delivery vendor.
Remember
Columnar epithelial cells must be present for reliable results
Use ONLY the swabs in the kit to collect the specimens
7. BDProbeTec- BD Biosciences
Urine Specimen Collection
Urine Processing Pouches (UPPs)
The following Collection/Storage/Transport instructions apply when no UPP is added at the collection
site.
The patient should not have urinated for at least one hour prior to specimen collection.
Collect specimen in a sterile, plastic, preservative-free specimen collection cup.
The patient should collect the first 15 – 20 ml. of voided urine (the first part of the stream – NOT
MIDSTREAM).
Label with patient identification and date/time collected.
Urine Storage and Transport
Store and transport urine specimens to the test site at 2 - 8ºC within 4-6 days of collection.
Add the UPP to the urine specimen collection cup. Wear gloves when handling the UPP and
urine specimen.
Cap the collection cup and swirl gently to ensure the UPP is completely submerged in urine.
The UPP must be in contact with the urine specimen for at least 2 hours prior to the processing.
Do not freeze the specimen.
NOTE: Specimens must be shipped in an insulated container with ice, using either an overnight or 2-
day delivery vendor. Storage up to 4 days has been validated with clinical specimens. Storage up to 6
days has been demonstrated with seeded specimens.
Male Swab - Urethral Swab Specimen Collection
Insert the Mini-Tip swab from the kit 2-4 cm into the urethra and rotate for 3-5 seconds.
Withdraw the swab and place the cap/swab into the transport tube. Make sure the cap is tightly
secured to the tube.
Label the tube with patient information and date/time collected.
Urine Specimen Collection
The following Collection/Storage Transport instructions apply when UPP is added at the collection site.
The patient should not have urinated for at least one hour prior to specimen collection.
Collect specimen in a sterile, plastic, preservative-free specimen collection cup.
The patient should collect the first 15 – 20 ml. Of voided urine (the first part of the stream –
NOT MIDSTREAM).
Immediately add the UPP to the specimen collection cup. Wear gloves when handling the UPP
and urine specimen.
Cap collection cup and swirl gently to ensure that the UPP is completely submerged in urine.
Label with patient identification and date/time collected.
NOTE: Specimens cannot be transported directly to the testing laboratory under ambient temperatures
(15-27ºC) and must be shipped, an insulated container with ice should be used with either an overnight or 2-day delivery
vendor. Storage up to 4 days has been validated with clinical specimens. Storage up to 6 days has been demonstrated with
seeded specimens.
Store and transport urine specimens containing a UPP to the laboratory or test site at 2 - 8ºC
within 4-6 days of collection or at 15-27ºC within 2 days of collection.
Do not freeze the urine specimen.
The UPP must be in contact with the urine specimen for at least two hours prior to processing.
Which of the following asymptomatic 26-year-old females meets the criteria for Chlamydia
trachomatis screening?
Monogamous relationship for six months, pregnant, having an induced abortion.
Monogamous relationship for one year, does not use a barrier contraceptive method.
New partner in last three months, uses barrier contraception on a regular basis.
A 17-year-old woman who was treated for Chlamydia trachomatis four months ago has
returned for her annual exam. The reason that another CT test is recommended at this visit is:
Teenagers often do not complete their medication.
She may have a resistant strain of chlamydia.
There is a high rate of re-infection among teenage women.
Which of the following statements concerning the collection of cervical specimens for
Chlamydia trachomatis testing is true?
Excess mucous should be removed from the cervix prior to obtaining the specimen.
The swab should be rotated in the endocervix for five seconds to assure adequate sampling.
The specimen for Chlamydia trachomatis testing should be obtained before any other cervical
specimen.
Which of the following statements concerning the collection of male urethral specimens for
Chlamydia trachomatis testing is true?
Insert the swab 2-4 cm into the urethra to obtain the specimen.
Rotate the swab for 30 seconds.
Ask the patient to urinate prior to obtaining the specimen.
Which of the following statements concerning the swabs used to obtain the specimens for
Chlamydia trachomatis testing is true?
A swab with any blood on it should be discarded and another cotton swab should be used.
Excess mucous should be wiped off the swab before placing in the transport tube.
Only the swabs that are supplied with the test kit can be used to collect specimens.