Chlamydia, N. gonorrhoeae, Urogenital (Aptima)

APT

11363

Chlamydia trachomatis RNA, TMA, Urogenital
Neisseria gonorrhoeae RNA, TMA, Urogenital

1 vaginal swab in Aptima® Transport Tube or
1 endocervical or urethral swab in Aptima® Transport Tube or
2 mL urine in Aptima® Transport Tube or
1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Transfer Tube or
0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube

1 vaginal swab in Aptima® Transport • 1 endocervical or urethral swab in Aptima® Transport • 2 mL urine in Aptima® Transport • 1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube • 0.5 mL SurePath™ fluid in Aptima® Transfer Tube

Vaginal Swab: Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label).

Endocervical or Urethral Swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.

Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.

Labs performing cytology: Aliquot PreservCyt® ThinPrep® solution before performance of liquid based cytology testing.

PreservCyt® ThinPrep®: Transfer 1 mL PreservCyt® ThinPrep® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).

SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).

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

PreservCyt® (ThinPrep®) in Aptima® Transport Tube
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year

Liquid cytology (Preservcyt® Preservative (ThinPrep®)
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

SurePath™ Preservative Fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

Urine in Aptima® Transport Medium
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year

Transport tubes with 2 swabs • Transport tubes with Non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in viral transport media • Urine samples where the fluid level is not between the black fill lines • PreservCyt® ThinPrep® material previously processed for cytology • PreservCyt® ThinPrep® with excess mucus

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

C. trachomatis infections are the leading cause of sexually transmitted diseases in the United States. C. trachomatis is known to cause cervicitis, pelvic inflammatory disease (PID), epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences of Chlamydial infections are severe if left untreated. Approximately half of Chlamydial infections are asymptomatic.
Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected.