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HelpTest Code CTCON Chlamydia trachomatis Confirmation, Nucleic Acid Amplification, Varies
Ordering Guidance
This test should be ordered only on prior Chlamydia trachomatis positive samples or on a new collection from a patient who previously tested positive for C trachomatis by the Hologic Aptima Combo 2 assay (eg, CGRNA / Chlamydia trachomatis and Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies; CTRNA / Chlamydia trachomatis, Nucleic Acid Amplification, Varies; MCTGC / Chlamydia trachomatis and Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies; MCRNA / Chlamydia trachomatis, Miscellaneous Sites, Nucleic Acid Amplification, Varies ) or by an alternative C trachomatis molecular assay.
Additional Testing Requirements
A prior positive Chlamydia trachomatis result from the Hologic Aptima Combo 2 assay or another C trachomatis molecular assay is required prior to performing this test.
Shipping Instructions
If submitting a previously tested specimen that resulted as positive for Chlamydia trachomatis, ensure that the specimen is tightly capped with a non-penetrable cap on the specimen transport tube. Maintain recommended storage and shipping requirements indicated below.
Necessary Information
Specimen source is required.
Specimen Required
If testing is being performed on a previously tested specimen that resulted as positive, submit that specimen.
If testing is being performed on a newly collected specimen, submit only 1 of the following specimens:
Specimen Type: Ocular (corneal/conjunctiva)
Supplies:
-Aptima Unisex Swab Collection Kit (T583)
-Aptima Multitest Swab Specimen Collection Kit (T584)
Container/Tube: Aptima Multitest Swab or Aptima Collection Unisex Swab
Specimen Volume: 1 Swab
Collection Instructions:
1. Swab site using Aptima Multitest Swab or Aptima Collection Unisex Swab. Specimens must be collected using either of these options.
Note: The white swab provided within the collection kit is a cleaning swab and should not be used for collection. Discard the white cleaning swab.
2. Place collection swab in transport tube provided in collection kit.
3. Snap off swab at score line so it fits into closed tube.
4. Cap tube securely and label tube with patient's entire name and collection date and time.
5. Maintain swab container at 2 to 30° C (refrigerate temperature is preferred), transport within 60 days of collection.
Specimen Type: Vaginal
Supplies: Aptima Multitest Swab Specimen Collection Kit (T584)
Container/Tube: Aptima Multitest Swab
Specimen Volume: 1 Swab
Collection Instructions:
1. Specimen must be collected using the Aptima Multitest Swab Specimen Collection Kit.
2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.
3. Place pink swab into transport tube provided in collection kit.
4. Snap off pink swab at score line so it fits into closed tube.
5. Cap tube securely, and label tube with patient's entire name and collection date and time.
6. Maintain swab container at 2 to 30° C (refrigerate temperature is preferred) and transport within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.
Specimen Type: Urethra (Males Only)
Supplies: Swab, Aptima Unisex Swab Collection Kit (T583)
Container/Tube: Aptima Unisex Swab
Specimen Volume: Swab
Collection Instructions:
1. Specimen must be collected using the Aptima Unisex Swab Collection Kit.
2. Patient should not have urinated for at least 1 hour prior to collection.
3. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.
4. Once inserted, rotate blue swab gently at least 1 full rotation using sufficient pressure to ensure swab comes into contact with all urethral surfaces. Allow blue swab to remain inserted for 2 to 3 seconds.
5. Place blue swab in transport tube provided in collection kit.
6. Snap off blue swab at score line so it fits into closed tube.
7. Cap tube securely, and label tube with patient's entire name and collection date and time.
8. Maintain swab container at 2 to 30° C (refrigerate temperature is preferred) and transport within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.
Specimen Type: Urine
Supplies: Aptima Urine Transport Tube (T582)
Container/Tube: Aptima urine specimen transport tube
Specimen Volume: 15 to 20 mL
Collection Instructions:
1. Patient should not have urinated for at least 1 hour prior to specimen collection.
2. Patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.
3. Within 24 hours of collection. transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube.
4. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation at Mayo Clinic Laboratories.
5. Maintain urine specimen transport tube at 2 to 30° C (refrigerate temperature is preferred) and transport within 30 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.
Specimen Type: Oropharynx/Pharynx/Throat
Supplies: Aptima Multitest Swab Collection Kit (T584)
Container/Tube: Aptima Collection Multitest Swab
Specimen Volume: Swab
Collection Instructions:
1. Specimens must be collected using Aptima Multitest Swab Specimen Collection Kit.
2. Swab site using Aptima Collection Multitest Swab (pink shaft).
3. Place pink swab in transport tube provided in collection kit.
4. Snap off pink swab at score line so it fits into closed tube.
5. Cap tube securely and label tube with patient's entire name and collection date and time.
6. Maintain swab container at either 4 to 30° C (refrigerate temperature is preferred) or -20 to -70° C, and transport within 60 days of collection.
Specimen Type: Rectal/Anal
Supplies: Aptima Multitest Swab Collection Kit (T584)
Container/Tube: Aptima Multitest Swab
Specimen Volume: Swab
Collection Instructions:
1. Specimens must be collected using Aptima Multitest Swab Specimen Collection Kit.
2. Insert swab into rectum about 3 to 5 cm past anal margin and gently rotate swab for 10 seconds.
3. Place collection swab in transport tube provided in collection kit.
4. Snap off swab at score line so it fits into closed tube.
5. Cap tube securely and label tube with patient's entire name and collection date and time.
6. Maintain swab container at either 4 to 30° C (refrigerate temperature is preferred) or -20 to -70° C, and transport within 60 days of collection.
Useful For
Detecting Chlamydia trachomatis
This test is not intended for use in medico-legal applications.
This test is not useful for the detection of other Chlamydia species.
Method Name
Transcription-Mediated Amplification
Reporting Name
C trachomatis Confirm, RNA, VariesSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | APTIMA VIAL | |
| Ambient | APTIMA VIAL | ||
| Frozen | APTIMA VIAL | ||
Reject Due To
| Midstream urine specimen | Reject |
| Clean catch urine specimen | Reject |
| Overfilled urine transport tubes | Reject |
| Multiple sources on single tube | Reject |
| Transport tubes containing a cleaning swab or more than 1 swab | Reject |
Clinical Information
Chlamydia is caused by the obligate intracellular bacterium Chlamydia trachomatis and is the most prevalent sexually transmitted infection (STI) caused by bacteria in the United States. In 2020, over 1.5 million documented cases were reported to the Centers for Disease Control and Prevention (CDC). Given that 3 out of 4 infected women and 1 out of 2 infected men are initially asymptomatic, the actual prevalence of disease is thought to be much greater than reported. C trachomatis causes genitourinary infections in women and men and may be associated with dysuria as well as vaginal, urethral, or rectal discharge. In women, complications include pelvic inflammatory disease, salpingitis, and infertility. Approximately 25% to 30% of women who develop acute salpingitis become infertile. Complications among men are rare but include epididymitis and sterility. Rarely, genital chlamydial infection can cause arthritis with associated skin lesions and ocular inflammation (Reiter syndrome). C trachomatis can be transmitted from the mother during delivery and is associated with conjunctivitis and pneumonia in the newborn. Finally, C trachomatis may cause hepatitis and pharyngitis in adults.
Once detected, the infection is easily treated by a short course of antibiotic therapy. Annual chlamydia screening is now recommended for all sexually active women aged 25 years or younger and for older women with risk factors for infection, such as a new sex partner or multiple sex partners. The CDC also recommends that all pregnant women be given a screening test for chlamydia infection. Repeat testing for test-of-cure is not recommended after treatment with a standard treatment regimen unless patient compliance is in question, reinfection is suspected, or the patient's symptoms persist. Repeat testing of pregnant women, 3 weeks after completion of therapy, is also recommended to ensure therapeutic cure, although residual nucleic acid may remain in the absence of active infection.
Improved screening rates and increased sensitivity of nucleic acid amplification testing have resulted in an increased number of accurately diagnosed cases. Improved detection rates result from improved performance characteristics of the assays and patients' easy acceptance of urine testing. Early identification of infection enables sexual partners to seek testing and treatment as soon as possible and reduces the risk of disease spread. Prompt treatment reduces the risk of infertility in women.
Per CDC guidance, a positive C trachomatis result in a child undergoing evaluation for an STI should be confirmed because of the risk of a false positive result due to the overall low prevalence of STIs in this patient population. An initial positive result should be confirmed by re-testing the sample using an assay targeting an alternative C trachomatis gene region, or by collecting and testing a new sample.
Reference Values
Negative
Day(s) Performed
Monday through Sunday
Report Available
1 to 4 daysSpecimen Retention Time
7 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
87491
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CTCON | C trachomatis Confirm, RNA, Varies | 43304-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| SRC20 | SOURCE: | 31208-2 |
| 623155 | C trachomatis Confirm, RNA, Varies | 43304-5 |