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Mayo Clinic Laboratories

Epic Test Code SCCTV Chlamydia trachomatis, Self-Collect, Amplified RNA, Vaginal


Specimen Required


Only orderable as part of a profile. For more information see SCCGV / Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Vaginal.

 

Specimen Type: Vaginal

Supplies: Aptima Vaginal Swab Self-Collection Kit (T1001)

Container/Tube: Aptima Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Specimens must be collected in a healthcare setting by the patient using the Aptima Multitest Swab (provided in T1001 or available separately).

2. Provide patient with the Aptima Vaginal Swab Self-Collection Kit or Aptima Multitest Swab and collection instructions.

3. Instruct patient to collect the specimen following the instructions provided with the kit and then return swab to the healthcare professional once complete.

4. Once patient returns the specimen, ensure the tube is securely capped, 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) and transport within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for up to 12 months.


Useful For

Detecting Chlamydia trachomatis using vaginal swabs collected by the patient in a healthcare setting

 

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

Only orderable as part of a profile. For more information see SCCGV / Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Vaginal.

 

Transcription-Mediated Amplification

Reporting Name

C trach, RNA, SelfCollect, Vagina

Specimen Type

Varies

Specimen 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

Transport tubes containing a cleaning swab or more than 1 swab Reject
No swab present in Aptima vial 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 and 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.

Reference Values

Only orderable as part of a profile. For more information see SCCGV / Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Vaginal.

 

Negative

Interpretation

A positive result indicates the presence of nucleic acid from Chlamydia trachomatis.

 

A negative result indicates the absence of C trachomatis nucleic acid. A negative result does not exclude the possibility of infection. If clinical indications strongly suggest chlamydial infection, additional specimens should be collected for testing.

 

A result of inconclusive indicates that a new specimen should be collected.

 

The predictive value of an assay depends on the prevalence of the disease in any specific population. In settings with a high prevalence of sexually transmitted infections, positive assay results have a high likelihood of being true-positive results. In settings with a low prevalence of sexually transmitted infections, or in any setting in which a patient's clinical signs and symptoms or risk factors are inconsistent with chlamydial urogenital infection, positive results should be carefully assessed, and the patient retested by other methods if appropriate.

Cautions

The performance of this assay has not been evaluated in adolescents younger than 14 years.

 

This report is intended for clinical monitoring or management of patients; it is not intended for use in medico-legal applications.

 

Appropriate specimen collection and handling is necessary for optimal assay performance.

 

Results should be interpreted in conjunction with other laboratory and clinical information.

 

A negative test result does not exclude the possibility of infection. Improper specimen collection, concurrent antibiotic therapy, presence of inhibitors, or low numbers of organisms in the specimen (ie, below the sensitivity of the test) may cause false-negative test results.

 

In low-prevalence populations, positive results must be interpreted carefully, as false-positive results may occur more frequently than true-positive results in this setting.

 

In general, this assay should not be used to assess therapeutic success or failure since nucleic acids from these organisms may persist for 3 weeks or more following antimicrobial therapy.

 

No interference is expected due to:

-Blood

-Lubricants and spermicides

 

The effects of tampon use, douching, specimen types other than those listed in Specimen Required, and specimen collection variables have not been determined.

 

This assay detects plasmid-free variants of Chlamydia trachomatis.

 

This assay does not detect Chlamydia pneumoniae or other Chlamydia species.

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87491

NY State Approved

Yes