Test Catalog

Test Id : SCGCT

Not Orderable

Neisseria gonorrhoeae, Self-Collect, Nucleic Acid Amplification, Throat

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting Neisseria gonorrhoeae using throat swabs collected by the patient in a healthcare setting

 

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

Method Name
A short description of the method used to perform the test

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

 

Transcription-Mediated Amplification 

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

N gonor, RNA, SelfCollect, Throat

Aliases
Lists additional common names for a test, as an aid in searching

Gonorrhea

Gonorrhoeae

Neisseria gonorrhoeae RNA amplification

Neisseria gonorrhoeae RNA Probe

Specimen Type
Describes the specimen type validated for testing

Varies

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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

 

Specimen Type: Oropharynx/pharynx/throat

Supplies: Aptima Throat Swab Self-Collection Kit (T1002)

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 T1002 or available separately).

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

3. Instruct patient to collect the specimen following the instructions provided 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 either 4 to 30 degrees C (refrigerated temperature is preferred) or -20 to -70 degrees C, and transport within 60 days of collection.

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

Transport tubes containing a cleaning swab or more than 1 swab Reject
No swab present in Aptima vial 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 Ambient APTIMA VIAL
Refrigerated (preferred) APTIMA VIAL
Frozen APTIMA VIAL

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting Neisseria gonorrhoeae using throat swabs collected by the patient in a healthcare setting

 

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Gonorrhea is caused by the bacterium Neisseria gonorrhoeae. It is a very common sexually transmitted infection (STI) with over 677,000 cases of gonorrhea reported to the Centers for Disease Control and Prevention (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 Throat 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 Chlamydia 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/or 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.

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

 

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of nucleic acid from Neisseria gonorrhoeae and strongly supports the diagnosis of gonorrheal infection.

 

A negative result indicates the absence of N gonorrhoeae nucleic acid. 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 settings in which a patient's clinical signs and symptoms or risk factors are inconsistent with gonococcal urogenital infection, positive results should be carefully assessed, and the patient retested by other methods (eg, culture for N gonorrhoeae) if appropriate.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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 specimen types other than those listed in Specimen Required and specimen collection variables have not been determined.

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:10.1128/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 combine 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

No

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.

1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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.

87591

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
SCGCT N gonor, RNA, SelfCollect, Throat 43305-2
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.
621933 Neisseria gonorrhoeae amplified RNA 43305-2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports