Chlamydia trachomatis and Neisseria gonorrhoeae Testing

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infections are two of the most common sexually transmitted infections worldwide. If left untreated in women, CT can spread into the uterus or fallopian tubes and cause pelvic inflammatory disease (PID).  PID can cause permanent damage to the fallopian tubes, uterus, and surrounding tissues.  The damage can lead to chronic pelvic pain, infertility, and potentially fatal ectopic pregnancy (pregnancy outside the uterus).  In pregnant women, there is some evidence that untreated chlamydial infections can lead to premature delivery.  Babies who are born to infected mothers can get Chlamydia infections in their eyes and respiratory tracts.   In men, complications are rare.  CT infection sometimes spreads to the epididymis (a tube that carries sperm from the testis), causing pain, fever, and, rarely, sterility.  N. gonorrhoeae is the causative agent of gonorrheal disease. The majority of gonorrheal infections are uncomplicated lower genital tract infections and may be asymptomatic. However, if left untreated in women, infections can ascend and cause PID.  In men, gonorrhea can cause epididymitis, a painful condition of the testicles that can lead to infertility if left untreated.  If a pregnant woman has gonorrhea, she may give the infection to her baby via the birth canal during delivery.  This can cause blindness, joint infection, or a life-threatening blood infection in the baby.

www.cdc.gov/std/chlamydia
www.cdc.gov/std/gonorrhea
www.dhss.mo.gov/CommunicableDisease/Reports

The Missouri State Public Health Lab uses the APTIMA Combo 2 Assay to test for CT and GC. This assay is a second generation nucleic acid amplification probe test that utilizes target capture, transcription-mediated amplification, and dual kinetic assay technologies to streamline specimen processing, amplify target rRNA, and detect amplicon, respectively. TESTING AVAILABILITY IS LIMITED TO LOCAL HEALTH DEPARTMENTS AND DESIGNATED MIPP (MISSOURI INFERTILITY PREVENTION PROJECT) SITES UNDER THE AUSPICES OF THE DEPARTMENT OF HEALTH AND SENIOR SERVICES (DHSS). The Bureau of Sexually Transmitted Diseases and the MIPP program within DHSS regulate the distribution of specimen collection kits.

The APTIMA Combo 2 assay qualitatively detects C. trachomatis and/or N. gonorrhoeae ribosomal ribonucleic acid (rRNA) in endocervical and male urethral swab specimens, and in female and male urine specimens from symptomatic and asymptomatic individuals. These are the only accepted sites for testing. Swab specimens must be received in the laboratory within sixty days after collection in order to be satisfactory for testing. Urine specimens must be received in the laboratory within 30 days of collection. Urine specimens are only accepted if they are in the Aptima urine transport media. When specimens cannot be mailed on the same day that they are collected, they should be kept refrigerated until they can be mailed.

Testing is performed daily (Monday through Friday).  The normal turn-around time from receipt of the specimen in the laboratory is same day or next day for negative specimens and an additional one to two working days for positive specimens.  Allowance should be considered for transit of the specimen to the laboratory and the mailing of the report back to the submitter. 

Reporting Results
Negative = No rRNA detected for N. gonorrhoeae/C. trachomatis
Positive = rRNA detected for N. gonorrhoeae/C. trachomatis
Indeterminate = submit another specimen
Dual Indeterminate = The attached specimen that you submitted for CT/GC testing has been tested twice and an invalid result has been generated each time due to a sample volume verification error.  It is possible that this patient is positive for either CT or GC or both. 

Action:    If the patient has not been prophylactically treated, please submit another specimen as soon as possible.

Special Instructions:

1. Aptima Combo 2 Assay Collection devices (supplied by the Public Health Laboratory) are the only acceptable devices in which a specimen can be submitted.
2. For urine collection, the patient should not have urinated for at least one hour prior to specimen collection. Using the disposable pipette provided in the kit, transfer 2 mL of urine into the urine specimen transport tube within 24 hours of collection.
3. For endocervical specimens, remove excess mucus from the cervical os using the cleaning swab (white shaft swab in the package). Discard this swab. Use the specimen collection swab (blue shaft swab in the package) to collect the sample. Immediately place the blue swab into the specimen transport tube. Break the swab at the scoreline. Recap the tube tightly.
4. For male urethral specimens, the patient should not have urinated for at least one hour prior to specimen collection. Use only the specimen collection swab (blue shaft swab) to collect sample. Immediately place the blue swab into the specimen transport tube. Break the swab at the scoreline. Recap the tube tightly.

Submission of Specimens
Mailing kits for collection and submission of specimens are available upon request by phone at (573) 522-4991 x 3223 or by sending the completed Requisition for Laboratory Specimen Kits (Lab 19) to the laboratory. SPECIMENS MUST BE SUBMITTED IN THE PROPER MAILING KIT SUPPLIED BY THE STATE PUBLIC HEALTH LABORATORY.

In order to ensure an accurate system of testing and reporting results, proper completion of forms and identification of specimens must be performed by the submitter. Specimens received in the laboratory that are improperly identified will not be tested.