Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA, Conjunctiva

13525

1 conjunctival swab in APTIMA® Transport Tube or UTM or VCM

1 swab

Specimens must be collected using an APTIMA(R) Multi-Test collection kit (orange label), APTIMA(R) Unisex Swab Specimen Collection Kit (white label), or UTM or VCM. To ensure collection of an adequate specimen, epithelial cells lining the conjunctiva should be obtained. To that effect, a cleaning swab should be used to remove and discard excess mucus prior to specimen collection. Submit one swab per collection tube.

Note: Results from the Aptima® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.

For a complete list of assay limitations we recommend that you review the manufacturers package insert,
https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng

Room temperature

Aptima Transport Tube
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days

UTM and VCM
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days

Transport tube with no swab • Transport tube with 2 swabs • Transport tube containing cleaning swab • Transport tube submitted with swab inverted • Aptima tubes with pierced foil lids • Aptima transport tube with non-Aptima swabs

Set up: Daily; Report available: 1-2 days

This assay is intended for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in ocular (conjunctival) specimens from patients suspected of having infectious conjunctivitis caused by C. trachomatis or N. gonorrhoeae. It does not detect Chlamydophila (Chlamydia) pneumoniae or other Chlamydia species.

C. trachomatis and N. gonorrhoeae are two of the most common causes of sexually transmitted infections, and both organisms can cause infectious conjunctivitis. Newborns are especially at risk for C. trachomatis or N. gonorrhoeae conjunctivitis if born to a mother with a genital infection.

Symptoms of C. trachomatis or N. gonorrhoeae conjunctivitis may include eye redness, eye lid swelling, and discharge. Symptoms in newborns infected at birth typically appear within two weeks.

A Not Detected (negative) result means that C. trachomatis or N. gonorrhoeae RNA was not present in the specimen above the limit of detection. A negative result does not rule out the possibility of infection and should not be used as the sole basis for patient management decisions.

1. CDC Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR July 23, 2021.
2. Conjunctivitis (Pink Eye) in Newborns. Centers for Disease Control and Prevention. Last Reviewed: January 4, 2019. https://www.cdc.gov/conjunctivitis/newborns.html#:~:text=Conjunctivitis%20(Pink%20Eye)%20in%20Newborns&text=Newborns%20with%20symptoms%20of%20conjunctivitis,conjunctivitis%20can%20be%20very%20serious
3. Kreisel, K. et al. Keeping an Eye on Chlamydia and Gonorrhea Conjunctivitis in Infants in the United States, 2010-2015. Sex Transm Dis. 2017 Jun; 44(6): 356-358.