Test Id : MCTGC
Chlamydia trachomatis and Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting Chlamydia trachomatis and Neisseria gonorrhoeae in non-US Food and Drug Administration-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 or other Chlamydia species.
Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| MCRNA | C. trach, Misc, Amplified RNA | Yes | Yes |
| MGRNA | N. gonorr, Misc, Amplified RNA | Yes | Yes |
Method Name
A short description of the method used to perform the test
Transcription Mediated Amplification
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Chlamydia trachomatis RNA amplification
Neisseria gonorrhoeae RNA amplification
Gonorrhoeae
Gonorrhea
Specimen Type
Describes the specimen type validated for testing
Varies
Ordering Guidance
This test is used for specimens that are not US Food and Drug Administration (FDA) approved for this assay. Acceptable non-FDA-approved specimen types are ocular swabs, and peritoneal fluid.
For FDA-approved specimen types, order CGRNA / Chlamydia trachomatis and Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies.
Necessary Information
Specimen source is required.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| SRC11 | SOURCE: | |
| SRC22 | SOURCE: |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Submit only 1 of the following specimens:
Specimen Type: Ocular (corneal/conjunctiva)
Supplies:
-Aptima Unisex Swab Collection Kit (T583)
-Aptima Multitest Swab Collection Kit (T584)
Container/Tube: Aptima Multitest Swab or Aptima Unisex Swab
Specimen Volume: 1 Swab
Collection Instructions:
1. Swab site using Aptima Multitest Swab or Aptima Unisex Swab. Specimens must be collected using either one of these Aptima swabs.
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 with the 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 specimen at 2 to 30 degrees C (refrigerate temperature is preferred), transport within 60 days of collection.
Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)
Supplies: Aptima Specimen Transfer Kit (T652)
Container/Tube: Aptima specimen transfer tube
Specimen Volume: 1 mL
Collection Instructions:
1. Transfer 1 mL of peritoneal fluid directly 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. Maintain specimen at 2 to 30 degrees C (refrigerate temperature is preferred), transport within 30 days of collection.
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
See Specimen Required
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Multiple sources on single tube | Reject |
| Fluid collected in ThinPrep vial before aliquoted into Aptima Transfer Tube | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | APTIMA VIAL | |
| Ambient | APTIMA VIAL | ||
| Frozen | APTIMA VIAL | ||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting Chlamydia trachomatis and Neisseria gonorrhoeae in non-US Food and Drug Administration-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 or other Chlamydia species.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 adult.
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 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.
Gonorrhea is caused by the bacterium Neisseria gonorrhoeae. It is a very common STI, with over 677,000 cases of gonorrhea reported to CDC in 2020. Like chlamydia, many infections in women are asymptomatic, and the true prevalence of gonorrhea is likely much higher 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. Complications include pelvic inflammatory disease in women and gonococcal epididymitis and prostatitis in men. Gonococcal bacteremia, pharyngitis, and arthritis may also occur. Infection in men is typically associated with symptoms that would prompt clinical evaluation. Given the risk for asymptomatic infection in women, screening is recommended for women at increased risk of infection (eg, women with previous gonorrhea or other STIs, inconsistent condom use, new or multiple sex partners, and women in certain demographic groups such as those in communities with high STI prevalence). The CDC currently recommends dual antibiotic treatment due to emerging antimicrobial resistance.
Culture was previously considered to be the gold standard test for diagnosis of C trachomatis and N gonorrhoeae infections. However, these 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 considered the reference standard method for diagnosis in most cases. Immunoassays and nonamplification DNA tests are also available for C trachomatis and N gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAAT.
Improved screening rates and increased sensitivity of NAAT 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.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Negative
Interpretation
Provides information to assist in interpretation of the test results
A positive result indicates the presence of nucleic acid from Chlamydia trachomatis and/or Neisseria gonorrhoeae and strongly supports a diagnosis of chlamydial/gonorrheal infection.
A negative result indicates the absence of nucleic acid from C trachomatis and/or N gonorrhoeae. A negative result does not exclude the possibility of infection. If clinical indications strongly suggest gonococcal or 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 gonococcal or chlamydial urogenital infection, positive results should be carefully assessed, and the patient retested by other methods (eg, culture for N gonorrhoeae) if appropriate.
This test has not been shown to cross react with commensal (nonpathogenic) Neisseria species present in the oropharynx.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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 with swab specimens due to:
-Blood
-Lubricants and spermicides
This assay does not detect Chlamydia pneumoniae or other Chlamydia species.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1
2. Adamson PC, Klausner JD. Diagnostic test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal specimens. J Clin Microbiol. 2022;60(4):e0021121. doi:101128/JCM.00211-21
Method Description
Describes how the test is performed and provides a method-specific reference
The Hologic Aptima Combo 2 Assay combines the technologies of target capture, transcription-mediated amplification, and dual kinetic assay. The detection of the ribosomal RNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded chemiluminescent DNA probes are labeled and combined with amplicon to form stable RNA:DNA hybrids. Light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer.(Package insert: APTIMA Combo 2 Assay, AW-25929-001. Hologic, Inc; Rev 002, 06/2023)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Sunday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87491 - Chlamydia trachomatis
87591 - Neisseria gonorrhoeae
87801 - If appropriate for government payers
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| MCTGC | Misc C trach/N gonor Amplified RNA | 64017-7 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| SRC11 | SOURCE: | 31208-2 |
| 34507 | C. trach, Misc, Amplified RNA | 43304-5 |
| 34508 | N. gonorr, Misc, Amplified RNA | 43305-2 |
| SRC22 | SOURCE: | 31208-2 |