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Virology / Serology - Chlamydia / Gonorrhea Frequently Asked Questions

Frequently Asked Questions

  1. What patient populations are tested with the APTIMA Combo 2 test for CT/GC?
  2. What is the proper order for specimen collection?
  3. What about urine testing?
  4. What about testing of male patients?
  5. What about females with hysterectomies?
  6. How do we order more CT/GC NAAT collection kits?
  7. How do we get more DHHS Form #4011 forms?
  8. What happens if we submit a specimen with an incorrectly broken vaginal swab?
  9. How should labels be placed on the transport tube?
  10. Why must Section 9 of DHHS Form #4011 be completed?
  11. What if only CT is requested? What if only GC is requested?
  12. What are the instructions for shipping specimens using the double mailers?
  13. What are the sensitivity, specificity and predictive values of the APTIMA Combo 2 assay?
  14. Does blood interfere with assay performance?
  15. Can we get test results from this website by “reported date” as well as by “individual name” or “SSN”?
  16. What are the guidelines for follow-up testing with the APTIMA assay for Chlamydia and Gonorrhea?
  17. Are chlamydia cultures still done at the State Laboratory?
  18. Who do we contact if we have more questions or need further clarification?
  1. What patient populations are tested with the APTIMA Combo 2 test for CT/GC?
    All prenatal patients, symptomatic females, and asymptomatic females under 25 years of age are tested for both Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Additional testing criteria was added in 2007 to include vaginal swab samples from women to retest for Chlamydia/Gonorrhea at three months post-treatment, from women due to sex partner referral, from women with high risk history (i.e. new partner, multiple partners, etc.), and for Chlamydia testing prior to IUD insertion.
  2. What is the proper order for specimen collection?
    Collect the specimen for CT/GC NAAT testing in the order sequence recommended by your current clinical protocols.
  3. What about urine testing?
    Urine testing for C. trachomatis and N. gonorrhoeae is available on a limited basis to pre-approved, select sites.
  4. What about testing of male patients?
    Specimens from male patients are not being accepted at this time. The State Laboratory accepts vaginal swab specimens only from females who fit the testing criteria previously stated.
  5. What about females with hysterectomies?
    Females with hysterectomies that present with clinical symptoms of CT infections should automatically receive empherical treatment for CT. Although NAAT testing is not recommended, a vaginal swab collection kit can be used for sample collection if testing is needed for any reason.
  6. How do we order more CT/GC NAAT collection kits?
    Collection kits can be ordered by clicking on Order Supplies Online on the main website page. The vaginal swab kits are packaged and sold in boxes of 50. A minimal order is 1 box of swabs (50 swabs).
  7. How do we get more DHHS Form #4011 forms?
    Download the PDF - DHHS Chlamydia/Gonorrhea Detection Form #4011 (PDF, 180 KB). All State Laboratory forms can be accessed from this website, downloaded, and printed on site from the forms page. Please use white paper only.
  8. What happens if we submit a specimen with an incorrectly broken vaginal swab?
    If a specimen is submitted with an incorrectly broken swab or no swab, it will be rejected. Please refer to Specimen Collection for the proper collection procedure for collecting vaginal swab specimens. These procedures can also be found (1) inside the lid of the box containing the collection swabs, (2) on the packaging of the swab itself, and (3) by viewing the Chlamydia/Gonorrhea Vaginal Specimen Collection and Form Training PowerPoint Presentation external link. Care must be taken to break the vaginal swab off correctly at the marked scoreline after placing the swab into the vaginal swab collection tube. Swabs which are too long or too short cannot be tested and will be rejected by the laboratory.
  9. How should labels be placed on the transport tube?
    Place labels on the transport tubes horizontally (lengthwise). Label should be smooth with no wrinkles and not extend past the bottom of the tube or cover the cap. Do not apply the label in a spiral or flag-like orientation. Alternatively, the patient information may be hand-written on the existing manufacturer’s label.
  10. Why must Section 9 of DHHS Form #4011 be completed?
    The information is used to determine whether or not the specimen meets our criteria for testing. It is imperative that this section of DHHS Chlamydia/Gonorrhea Detection Form #4011 (PDF, 180 KB) be completely filled in. Failure to provide this information may result in delayed testing or rejection of the specimen. The "Signs/Symptoms" and "Pregnancy Status" boxes must be checked even though patients were seen in Prenatal or STD Clinics.
  11. What if only CT is requested? What if only GC is requested?
    The APTIMA Combo 2 Test amplifies and detects both organisms simultaneously. Therefore all specimens are tested for CT and GC and results for both tests are reported. The DHHS Chlamydia/Gonorrhea Detection Form #4011 (PDF, 180 KB) allows for only one option in ordering and that is the combination testing of CT and GC.
  12. What are the instructions for shipping specimens using the double mailers?
    Please see Packing Instructions Using Outer Baggie (PDF, 4.6 MB) for an illustrated tutorial on packaging specimens for shipment. Remember to limit each mailer to 6 CT/GC specimens and stamp the return address on the outside of each mailer.
  13. What are the sensitivity, specificity and predictive values of the APTIMA Combo 2 assay?
    In both the literature review of the assay and the method verification conducted by the State Laboratory, the sensitivity and specificity of the assay in the detection of both CT and GC approaches 100%. However, no test should ever be considered 100% sensitive or 100% specific. Laboratory tests aid the clinician in establishing a diagnosis but should never be the sole criteria used to establish a diagnosis.
  14. Does blood interfere with assay performance?
    Due to the advances in technology that are a part of the APTIMA technology, blood will not interfere with the performance of the assay.
  15. Can we get test results from this website by "reported date" as well as by "individual name" or "SSN"?
    Yes. Here are the steps to get the results:
    1. Click on "Lab Test Results Lookup" on the main page.
    2. Enter log in information and click "Login" link if you have created yourself an account. If you do not have an account, click the "Create New Account" link to create yourself an account.
    3. Click the "Lab Tests" option to get to the lab test search screen.
    4. Click the "Choose Search Type" option to view list of searchable options.
    5. Click the "Reported Date" option from the search type list.
    6. Click the lab test (Chlamydia), enter your EIN, and enter the reported date to search.
    7. If there are test results that match your search criteria, they will be listed for you.
    8. Click on Lab Number (Filing Number) for the test result to view/print result.
  16. What are the guidelines for follow-up testing with the APTIMA assay for Chlamydia and Gonorrhea?
    Follow-up testing for Chlamydia
     The 2010 CDC STD Treatment Guidelines state: "Except in pregnant women, test-of-cure (i.e., repeat testing 3-4 weeks after completing therapy) is not advised for persons treated with the recommended or alternative regimens, unless therapeutic compliance is in question, symptoms persist, or reinfection is suspected.  Moreover, the validity of chlamydial diagnostic testing at <3 weeks after completion of therapy (to identify patients who did not respond to therapy) has not been established.  False-negative results might occur in the presence of persistent infections involving limited numbers of chlamydial organisms.  In addition, NAAT conducted at <3 weeks after completion of therapy in persons who were treated successfully could yield false-positive results because of the continued presence of nonviable organisms.” 

    Follow-up testing for Gonorrhea
     The 2010 CDC STD Treatment Guidelines state: "Patients diagnosed with uncomplicated gonorrhea who are treated with any of the recommended or alternative regimens do not need a test-of-cure (i.e., repeat testing 3-4 weeks after completing therapy).  Patients who have symptoms that persist after treatment should be evaluated by culture for N. gonorrhoeae, and any gonococci isolated should be tested for antimicrobial susceptibility. N. gonorrhoeae infection is prevalent among patients who have been diagnosed with and treated for gonorrhea in the preceding several months.  Most infections result from reinfection rather than treatment failure, indicating a need for improved patient education and referral of sex partners.  Clinicians should advise patients with gonorrhea to be retested 3 months after treatment.  If patients do not seek medical care for retesting in 3 months, providers are encouraged to test these patients whenever they next seek medical care within the following 12 months, regardless of whether the patients believe that their sex partners were treated.  Retesting is distinct from test-of-cure to detect therapeutic failure, which is not recommended."
  17. Are chlamydia cultures still done at the State Laboratory?
    Chlamydia cell cultures are no longer performed at the State Laboratory. This procedure, if needed, is available from commercial reference laboratories.
  18. Who do we contact if we have more questions or need further clarification?
    Please feel free to contact Myra Brinson or Mary Noel Dodd at (919) 733-7544 if you have further questions or are in need of assistance.

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Last Modified: September 12, 2011 2:11 PM