Chlamydia trachomatis by NAT, Conjunctival (Sendout)

Useful For:

• Detection of Chlamydia trachomatis in non-FDA-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.

Interpretation:

A positive result indicates the presence of rRNA Chlamydia trachomatis. This assay does detect plasmid-free variants of C trachomatis.

A negative result indicates that rRNA for C trachomatis 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 chlamydial infection, positive results should be carefully assessed and the patient retested by other methods, if appropriate.

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, lubricants and spermicides.

This assay does not detect Chlamydia pneumoniae.

Collect ocular specimens using the Aptima Unisex or Aptima Multitest Swab kit (formerly known as the Aptima Vaginal Swab Kit).

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 swab in the Aptima swab transport tube. Snap off swab at score line so the swab fits into the closed tube.
3. Cap tube securely, and label tube with patient's entire name, date of birth, and the date and time of collection.

Outside Laboratories: Refrigerate Aptima swab after collection.

Stability: Refrigerated (preferred): 60 days; Frozen: 1 year; Ambient: 60 days.

Refrigerate Aptima swab.

Result-at-Entry:

• RCHLAS (Chlamydia by NAT, Conjunctival Specimen): <Enter specimen source>

Specimen Codes:

• EYE (Eye)
• EYE-LT (Eye, Left)
• EYE-RT (Eye, Right)

Sendouts:

• Order Mayo Test: MCRNA.
• Interfaced: Yes [Interface: 601; Worksheet: MARF]

Stability: Refrigerated (preferred): 60 days; Frozen: 1 year; Ambient: 60 days.

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