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GC RNA Probe
RNA Probe Chlam/Neis STD Panel
Gonorrhoeae RNA Probe
Detecting Neisseria gonorrhoeae
This test is not intended for use in medico-legal applications.
**This test can be used for prepubescent children (<14 years) only. Primary test is the in-house test code GC-NAT or GC-NAM for cervical, endocervical, vaginal, and urine sources. For ocular or peritoneal fluid sources, refer to test code MGRNA to Mayo.**
Specimen source is required.
Submit only 1 of the following specimens:
Specimen Type: EndocervixCollection Instructions:1. Specimens must be collected using the Aptima Collection Unisex Swab.2. Use cleaning swab (white shaft) to remove excess mucus from endocervix and discard.3. 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.4. Place second swab into 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 collection date and time.6. Transport and store swab container at 2 to 30 degrees C (refrigerate temperature is preferred) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.
Specimen Type: VaginalCollection Instructions:1. Specimen must be collected using the Aptima Multitest Swab Specimen Collection Kit.2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.3. Place 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 collection date and time.5. Transport and store swab container at 2 to 30 degrees C (refrigerate temperature is preferred) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.
Specimen Type: Urethra (Males Only)Collection Instructions:1. Specimen must be collected using the Aptima Collection Unisex Swab.2. Patient should not have urinated for at least 1 hour prior to collection.3. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.4. 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.5. Place swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.6. Cap tube securely, and label tube with patient's entire name and collection date and time.7. Transport and store swab container at 2 to 30 degrees C (refrigerate temperature is preferred) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.
Specimen Type: UrineCollection 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 tube at 2 to 30 degrees C (refrigerate temperature is preferred) within 30 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.
Specimen Type: ThinPrep Specimen (Endocervix)Collection Instructions:1. Aliquot ThinPrep specimen for this test 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 transport tube at 2 to 30 degrees C (refrigerate temperature is preferred) within 60 days of collection. If longer storage is needed, freeze at -20 to -70 degrees C for 12 months.
Specimen Type: Oral/throat or rectal/analCollection Instructions:1. Swab site using Aptima Collection Multitest Swab or Aptima Collection Unisex Swab. Specimens must be collected using either 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 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 and store swab container (refrigerate temperature is preferred) within 60 days of collection.
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
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, 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 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:
-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.
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.
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 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 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 testing 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.
A positive result indicates the presence of nucleic acid from Neisseria gonorrhoeae and supports a diagnosis of gonorrhea.
A negative result indicates that nucleic acid from N gonorrhoeae was not detected. A negative result does not exclude the possibility of infection. If clinical indications strongly suggest gonococcal infection, additional specimens should be collected for testing.
A result of indeterminate 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.