STD Test Specifications

General Test Description
1. 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.
2. The assay may be used to test both male and female urine specimens from individuals with or without symptoms.
3. 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.
4. 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
1. 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).
2. 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).
3. 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.
4. This test is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.
5. Therapeutic failure or success cannot be determined with this test, since nucleic acid may persist following appropriate antimicrobial therapy.
Specimen Specific Considerations
1. Reliable results are dependent on adequate specimen collection and carefully following the specimen collection instructions.
2. 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.
3. Urine is the only acceptable specimen for this test.
4. 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.
5. The effects of tampon use and douching have not been assessed for their impact on the detection of Chlamydia or gonorrhea.
6. Urine transport tubes used beyond their stated expiration date may not provide valid results.
7. Collecting more than 30 CC (approximately half of the urine collection cup) of urine may adversely affect test results.
8. Failure to include name and date of birth on the urine transport tube may delay testing.
9. Collecting the urine specimen within one hour after the last urination may cause a false negative result.
10. Cleaning the areas around the genitals for women prior to specimen collection may adversely affect test results.
11. 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.
12. 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.
13. 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.
14. Specimens collected but not received by the laboratory within 30 days will require recollection.
Test Specific Considerations
1. Results may be affected by the following:
  1. Improper specimen collection
  2. Improper specimen storage or transport
  3. Laboratory error
  4. Very low levels of Chlamydia or gonorrhea in the urine specimen.
  5. Substances or chemicals in the specimen that may interfere with the assay.
2. 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.
3. Considerations for negative results
  1. If negative results from the specimen do not fit with the clinical symptoms, retesting may be necessary.
    1. Symptoms in women
      1. Painful urination
      2. Unusual vaginal discharge
      3. Nausea, vomiting & fever
      4. Bleeding between periods
      5. Belly or abdominal pain
    2. Symptoms in men
      1. Painful urination
      2. Unusual discharge from the penis
      3. Itching around the penis
  2. 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.
  3. 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 specimen.
4. Considerations for positive results
  1. 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 treatment options.
  2. A false positive can occur due to contamination of the urine specimen at the time of collection or during processing.
  3. 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
1. Use caution when handling and transferring specimen.
2. When handling urine or urine transport buffer,
  1. Do not ingest. If ingested, contact poison control.
  2. Avoid contact with skin, eyes, or mucous membranes.
    1. If contact with skin or eyes occurs, wash or rinse area thoroughly with water.
    2. If contact with mucous membranes occurs, contact poison control at 1-800-222-1222.
    3. 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.
    4. Wash your hands thoroughly after collecting the specimen and/or cleaning up a spill.