Test Catalog

Test Id : GCRNA

Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies

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

Detection of Neisseria gonorrhoeae

 

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

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.

No

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

Neisseria gonorrhoeae Amplified RNA

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

GC RNA Probe

RNA Probe Chlam/Neis STD Panel

Gonorrhoeae RNA Probe

Gonorrhea

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRC17 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:

 

Swab specimen 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.

 

Supplies: Swab, Aptima Male/Female Collection (T583)

Specimen Type: Endocervix

Container/Tube: Aptima Collection Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Use cleaning swab (white shaft) to remove excess mucus from endocervix and discard.

2. Insert second swab (blue shaft) 1 to 1.5 cm into endocervical canal, and rotate swab gently for 30 seconds. Avoid touching vaginal wall when removing swab.

3. Place second swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

4. Cap tube securely, and label tube with patient's entire name, and date and time of collection.

5. Transport and store swab container at 2 to 30 degrees C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.

 

Supplies: Swab, Aptima Multitest Swab Specimen Collection Kit (T584)

Specimen Type: Vaginal

Container/Tube: Aptima Collection Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.

2. Place swab into 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 date and time of collection.

4. Transport and store swab container at 2 to 30 degrees C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.

 

Supplies: Swab, Aptima Male/Female Collection (T583)

Specimen Type: Urethra (Males Only)

Container/Tube: Aptima Collection Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Patient should not have urinated for at least 1 hour prior to collection.

2. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.

3. Once inserted, rotate swab gently at least 1 full rotation using sufficient pressure to ensure swab comes into contact with all urethral surfaces. Allow swab to remain inserted for 2 to 3 seconds.

4. Place swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

5. Cap tube securely, and label tube with patient's entire name, and date and time of collection.

6. Transport and store swab container at 2 to 30 degrees C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.

 

Supplies: Aptima Urine Transport Tube (T582)

Specimen Type: Urine (Males and Females)

Container/Tube: Aptima Urine Specimen Transport Tube

Specimen Volume: 15-20 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. Transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided within 24 hours of collection. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation at Mayo Clinic Laboratories.

4. Transport and store urine specimen transport container at 2 to 30 degrees C (refrigerate is preferred temperature) within 30 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.

 

Supplies: Aptima Thin Prep Transport Tube (T652)

Specimen Type: ThinPrep Specimen (Endocervix)

Container/Tube: ThinPrep (also called PreservCyt) Collection Kit

Specimen Volume: 1 mL

Collection Instructions:

1. Aliquot ThinPrep specimen for Chlamydia and/or Neisseria testing before processing for Pap smear. For each specimen, use a new pair of clean gloves.

2. Vortex ThinPrep/PreservCyt vial 3 to 10 seconds. Within 1 minute of vortexing:

a. Transfer 1 mL of specimen into the Aptima Specimen Transfer Tube using a disposable transfer pipette or a pipette tip containing a filter (aerosol barrier or hydrophobic plug).

b. Process only 1 ThinPrep and transfer tube set at a time.

c. Recap Aptima Specimen Transfer Tube tightly and gently invert 3 times to mix.

3. Label Aptima transfer tube with appropriate label.

4. Use remainder of ThinPrep specimen for Pap testing.

5. Transport and store specimen transfer container at 2 to 30 degrees C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.

 

Supplies:

Swab, Aptima Male/Female Collection (T583)

Swab, Aptima Multitest Swab Specimen Collection Kit (T584)

Specimen Type: Oral/throat or rectal/anal

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.

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

Endocervix in PreservCyt: 1mL

Urine: 2 mL

Swabs (Endocervical, Urethral, Vaginal, Oral/throat, Anal/Rectal): Entire collection

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Midstream urine specimen; Overfilled or underfilled urine transport tubes; Specimen collected into a SurePath device; Transport tubes containing a cleaning swab or more than 1 swab 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

Detection of Neisseria gonorrhoeae

 

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 and is a common sexually transmitted infection (STI).(1,2) 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, and/or rectal discharge. Potential 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 STI, inconsistent condom use, new or multiple sex partners, and women in certain demographic groups, such as those in communities with high STI prevalence).(1,2)

 

Routine bacterial culture was previously considered the gold standard test for diagnosis of N gonorrhoeae infection. However, the bacteria 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.(2-5) Immunoassays and non-amplification DNA tests are also available for N gonorrhoeae detection, but these methods are significantly less sensitive and specific than NAAT.(2-5)

 

Improved screening and performance of NAAT testing has resulted in an increased number of accurately diagnosed cases.(2-5) Improved detection rates result from both the increased performance of the assay and the 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 complications 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 rRNA of Neisseria gonorrhoeae.

 

A negative result indicates that rRNA for N gonorrhoeae 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 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

Care must be taken to avoid cross-contamination during handling of PreservCyt solution liquid Pap specimens. If testing PreservCyt specimens processed with the ThinPrep 2000 processor, it is important to follow procedures to reduce the risk for cross-contamination during Pap processing such as bleaching of the PreservCyt filter cap and changing gloves between each sample. Refer to the ThinPrep 2000 Processor Operator's Manual and the Aptima specimen for more guidance.

 

The performance of endocervical, vaginal, and male urethral swab specimens, male and female urine specimens, and PreservCyt solution liquid Pap specimens has not been evaluated in adolescents less than 16 years of age. The performance of vaginal swab specimens has not been evaluated in pregnant women.

 

This report is intended for use in 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.

 

The presence of mucous does not interfere with this assay. However, this test requires endocervical cells, and if excess mucous is not removed prior to collection, adequate numbers of these cells may not be obtained.

 

No interference is expected with swab specimens due to:

-Blood

-Lubricants and spermicides

 

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

 

Testing of urine specimens with this method is not intended to replace cervical exam and endocervical sampling for diagnosis of urogenital infection; infections may result from other causes or concurrent infections may occur.

 

Testing urine specimens as the sole test for identifying female patients with gonococcal infections may miss some infected individuals.

 

Performance estimates for urine specimens are based on evaluation of urine obtained from the first part of the urine stream; performance on midstream collections has not been determined.

 

This assay has not been shown to cross-react with commensal (nonpathogenic) Neisseria species in the oropharynx.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Centers for Disease Control and Prevention. 2002. Reporting of laboratory-confirmed chlamydial infection and gonorrhea by providers affiliated with three large Managed Care Organizations-United States, 1995-1999. MMWR Morb Mortal Wkly Rep. 2002;51:256-259

2. Centers for Disease Control and Prevention: Sexually Transmitted Diseases Treatment Guidelines, 2015. MMWR Morb Mortal Wkly Rep. 2015;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

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 rRNA 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. 501798. Hologic, Inc; Rev 002 03/2017)

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.

Tuesday 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

14 days

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

Jacksonville

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 Regional Manager. 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 cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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
GCRNA Neisseria gonorrhoeae Amplified RNA 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.
SRC17 SOURCE: 31208-2
34875 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