Sign in →

Test ID: MCRNA Chlamydia trachomatis, Miscellaneous Sites, Nucleic Acid Amplification, Varies

Reporting Name

C. trach, Misc, Amplified RNA

Useful For

Detection of Chlamydia trachomatis in non-FDA-approved specimen types

 

This test is not intended for use in medico-legal applications.

 

This test is not useful for the detection of Chlamydia pneumoniae.

Specimen Type

Varies


Ordering Guidance


This test is used for specimens that are not FDA approved for this assay. Acceptable non-FDA-approved specimen types are ocular swabs, nasopharyngeal swabs, and peritoneal fluid. For FDA-approved specimen types, order CTRNA / Chlamydia trachomatis, Nucleic Acid Amplification, Varies.



Necessary Information


Specimen source is required.



Specimen Required


Swab specimens must be collected using an Aptima Collection Unisex Swab (T583), or Aptima Collection Multitest Swab (T584). These swabs are contained in the Aptima Collection Kit.

 

Submit only 1 of the following specimens:

 

Supplies:

Swab, Aptima Male/Female Collection (T583)

Swab, Aptima Multitest Swab Specimen Collection Kit (T584)

Specimen Type: Ocular (corneal/conjunctiva)

Pediatric Specimen Type: Nasopharyngeal (NP: only acceptable for patients 6 months old or younger)

Container/Tube: Aptima Collection Multitest Swab (T584) or Aptima Swab Collection System (T583)

Collection Instructions:

1. Swab site using Aptima Collection Multitest Swab or Aptima Collection Unisex Swab.

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. Snap off swab at score line so swab fits into closed tube.

3. Cap tube securely and label tube with patient's entire name and collection date and time.

 

Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)

Container/Tube: Aptima Specimen Transfer Tube (T652)

Specimen Volume: 1 mL

Collection Instructions:

1. Transfer specimen into the Aptima Specimen Transfer Tube within 24 hours of collection.

2. Cap tube securely and label tube with patient's entire name and collection date and time.

 

Container/Tube: Aptima Collection Multitest Swab or Aptima Swab Collection System

Specimen Volume: Swab

Collection Instructions:

1. Swab site using Aptima Collection Multitest Swab or Aptima Collection Unisex Swab.

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. Snap off swab at score line so swab fits into closed tube.

3. Cap tube securely and label tube with patient's entire name and collection date and time.

4. Transport swab container and store (refrigerated is preferred) within 60 days of collection.

 

Supplies: Aptima Thin Prep Transport Tube (T652)

Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)

Container/Tube: Aptima Specimen Transfer Tube

Specimen Volume: 1 mL

Collection Instructions:

1. Transfer specimen into the Aptima Specimen Transfer Tube within 24 hours of collection.

2. Cap tube securely and label tube with patient's entire name and collection date and time.

3. Transport Aptima Specimen Transfer Tube (refrigerated is preferred) within 30 days of collection.


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

Reference Values

Negative

Day(s) Performed

Monday through Saturday

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
MCRNA C. trach, Misc, Amplified RNA 43304-5

 

Result ID Test Result Name Result LOINC Value
SRC11 SOURCE: 31208-2
34507 C. trach, Misc, Amplified RNA 43304-5

Clinical Information

Chlamydia is caused by the obligate intracellular bacterium Chlamydia trachomatis and is the most prevalent sexually transmitted bacterial infection in the United States.(1,2) In 2010, 1.3 million documented cases were reported to the CDC.(2) Given that 3 out of 4 infected women and 1 out of 2 infected men will be asymptomatic initially, the actual prevalence of disease is thought to be much greater than reported. The organism 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.(2) 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. 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 age 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.(2) 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.(2)

 

Culture was previously considered to be the gold standard test for diagnosis of C trachomatis infection.(2) However, organisms are labile in vitro, therefore, precise specimen collection, transportation, and processing conditions are required to maintain organism viability, which is necessary for successful culturing. In comparison, nucleic acid amplification testing (NAAT) provides superior sensitivity and specificity and is now the recommended method for diagnosis in most cases.(3-5) Immunoassays and non-amplification DNA tests are also available for C trachomatis detection, but these methods are significantly less sensitive and less specific than NAAT.(2)

 

Improved screening rates and increased sensitivity of NAAT testing have resulted in an increased number of accurately diagnosed cases.(2) 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.

Interpretation

A positive result indicates the presence of rRNA Chlamydia trachomatis. This assay does detect plasmid-free variants of C trachomatis.

 

A negative result indicates that rRNA for C trachomatis was not detected in the specimen.

 

The predictive value of an assay depends on the prevalence of the disease in any particular population. In settings with a high prevalence of sexually transmitted disease, positive assay results have a high likelihood of being true positives. In settings with a low prevalence of sexually transmitted disease, 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.

Clinical Reference

1. Centers for Disease Control and Prevention. 2014. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae, 2014. MMWR Morb Mortal Wkly Rep. 2014;63:1-18

2. Centers for Disease Control and Prevention: Sexually Transmitted Diseases Treatment Guidelines, 2015. MMWR Morb Mortal Wkly Rep. 2015 Jun 5;64(RR-03):1-137

3. Crotchfelt KA, Pare B, Gaydos C, Quinn TC: Detection of Chlamydia trachomatis by the GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay (AMP CT) in urine specimens from men and women and endocervical specimens from women. J Clin Microbiol. 1998 Feb;36(2):391-394

4. Gaydos CA, Quinn TC, Willis D, et al: Performance of the APTIMA Combo 2 assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in female urine and endocervical swab specimens. J Clin Microbiol. 2003 Jan;41(1):304-309

5. Chernesky MA, Jang DE: APTIMA transcription-mediated amplification assays for Chlamydia trachomatis and Neisseria gonorrhoeae. Expert Rev Mol Diagn. 2006 Jul;6(4):519-525

Report Available

1 to 4 days

Method Name

Transcription Mediated Amplification

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-gisti