STD Test Specifications
- General Test Description
- Identigene uses the Gen-Probe APTIMA Combo 2 Assay,
which is a target amplification nucleic acid probe for the
qualitative detection and differentiation of ribosomal RNA
(rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae
to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease.
- The assay may be used to test both male and female urine specimens
from individuals with or without symptoms.
- Historically, several methods for chlamydia and gonorrhea
detection have been utilized in the clinical laboratory,
including cell culture, direct fluorescent antibody testing,
and enzyme immunoassay. More recent methodologies for chlamydia
and gonorrhea detection include direct DNA probe assays and nucleic acid
amplification test (NAAT) DNA probe assays. Cell culture was once considered
to be the “gold standard” for detection of these organisms. Scientific
publications have demonstrated that the NAAT DNA probe technologies have
a higher clinical sensitivity than culture. Culture has been
replaced in many laboratories by direct DNA probe and NAATs.
- The GEN-PROBE APTIMA Combo 2 Assay is a second generation
NAAT that utilizes target capture, Transcription-Mediated
Amplification (TMA), and Dual Kinetic Assay (DKA) technologies
to streamline specimen processing, amplify target rRNA, and
detect amplicon, respectively.
- General Considerations
- The Identigene test is only for Chlamydia trachomatis
and/or Neisseria gonorrhoeae and does not test for other
sexually transmitted diseases, such as Syphilis, Trichomonas,
Herpes Simplex Virus (HSV), Human Papilloma Vvirus (HPV)
or Human Immunodeficiency Virus (HIV).
- Chlamydia and gonorrhea infections other than the urinary
and genital tract will not be detected with this test (i.e.
infections in the throat, rectum or the eye).
- Urine specimen sampling is not designed to replace regular
cervical exams and endocervical specimens for diagnosis of
female urogenital (genital and urinary) infections. A female
may have cervicitis, urethritis, other urinary tract infections,
or vaginal infections due to other causes or concurrent infections
with other agents.
- This test is not intended for the evaluation of suspected
sexual abuse or for other medico-legal indications.
- Therapeutic failure or success cannot be determined with
this test, since nucleic acid may persist following appropriate
- Specimen Specific Considerations
- Reliable results are dependent on adequate specimen collection
and carefully following the specimen collection instructions.
- Use only supplied or specified materials provided in the
collection kit. Other materials have not been validated for
use with this test and may give inaccurate results.
- Urine is the only acceptable specimen for this test.
- Urine specimens have been evaluated for interference by
blood, commonly used vitamins, minerals, and over-the-counter
pain relievers. The data indicate that there is no assay
interference by these substances.
- The effects of tampon use and douching have not been assessed
for their impact on the detection of Chlamydia or gonorrhea.
- Urine transport tubes used beyond their stated expiration
date may not provide valid results.
- Collecting more than 30 CC (approximately half of the
urine collection cup) of urine may adversely affect test
- Failure to include name and date of birth on the urine
transport tube may delay testing.
- Collecting the urine specimen within one hour after the
last urination may cause a false negative result.
- Cleaning the areas around the genitals for women prior
to specimen collection may adversely affect test results.
- Urine must be transferred to the urine transport tube
within 24 hours of the collection. Failure to do so may result
in specimen degradation and inaccurate results.
- Urine transport tubes received with liquid levels above
or below the two black indicator lines on the tube label
will be rejected and will require recollection.
- Specimens collected from affected partners should be taken
at separate times. The collection of multiple specimens,
particularly if those specimens are positive, may increase
the risk of specimen to specimen contamination.
- Specimens collected but not received by the laboratory
within 30 days will require recollection.
- Test Specific Considerations
- Results may be affected by the following:
- Improper specimen collection
- Improper specimen storage or transport
- Laboratory error
- Very low levels of Chlamydia or gonorrhea in
the urine specimen.
- Substances or chemicals in the specimen that may
interfere with the assay.
- The Identigene STD test for Chlamydia and gonorrhea
provides only qualitative results (Positive or Negative
result) and does not provide information about the
severity of an infection.
- Considerations for negative results
- If negative results from the specimen do not fit
with the clinical symptoms, retesting may be necessary.
- Symptoms in women
- Painful urination
- Unusual vaginal discharge
- Nausea, vomiting & fever
- Bleeding between periods
- Belly or abdominal pain
- Symptoms in men
- Painful urination
- Unusual discharge from the penis
- Itching around the penis
- A negative result does not preclude
a possible infection because results
are dependent on adequate specimen
collection, absence of test inhibitors,
and sufficient organism or nucleic
acid to be detected.
- As is true for all urine test
methods, a negative result for a
female who is clinically suspected
of having a chlamydial or gonococcal
infection does not rule out the presence
of Chlamydia or gonorrhea in the
urogenital tract. Testing of an endocervical
specimen is recommended in such cases.
Please see your doctor for testing with an endocervical
- Considerations for positive results
- If you receive a positive result,
but believe that the result may be
in error, it is recommended that
you follow-up with your own doctor
for counseling, retesting and possible
- A false positive can occur due
to contamination of the urine specimen
at the time of collection or during
- A positive specimen obtained
from a patient after therapeutic
treatment does not necessarily indicate
the presence of an active Chlamydia
or gonorrhea infection.
- Safety Precautions
- Use caution when handling and
- When handling urine or urine transport
- Do not ingest. If ingested, contact
- Avoid contact with skin, eyes,
or mucous membranes.
- If contact with skin or eyes occurs,
wash or rinse area thoroughly with
- If contact with mucous membranes
occurs, contact poison control at
- If the urine or urine transport
buffer is spilled, dilute the spill
with water and wipe with a paper
towel. Paper towels can be disposed
in regular trash.
- Wash your hands thoroughly after
collecting the specimen and/or cleaning
up a spill.
LIT-4085-A © 2010 IDENTIGENE, llc.