Detection of Neisseria gonorrhoeae in non-FDA-approved specimen types

Aptima Multitest swab specimen collection kit

1. Swab site using Aptima Multitest swab specimen collection kit 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 swab in transport tube provided in collection kit.
3. Snap off swab at score line so swab fits into closed tube.
4. Cap tube securely
5. Label tube with patient's entire name, and date and time of collection.

Aptima Multitest swab specimen collection kit

Screw cap plastic container (sterile)

1. Transfer 1.0 mL specimen into the Aptima Specimen transfer tube (Mayo T652) within 24 hours of collection
2. Cap tube securely
3. Label tube with patient's entire name, 2nd unique identifier and date and time of collection

Aptima Specimen transfer tube (Mayo T652)

Eye/ocular swab:

Refrigerated (preferred) - 60 days

Ambient - 60 days

Frozen - 365 days

Peritoneal fluid:

Refrigerated (preferred) - 30 days

Ambient - 14 days

Frozen - 365 days

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability

Transcription Mediated Amplification

Negative

Cautions

• 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.
• No interference is expected with swab specimens due to blood or lubricants and spermicides.

Interpretation

• A positive result indicates that rRNA of Neisseria gonorrhoeae is present in the specimen tested and strongly supports a diagnosis of chlamydial/gonorrheal infection.
•  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 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.
• 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.

Medical necessity