Chlamydia trachomatis/Neisseria gonorrhoeae antigen detection

TEST NAME Chlamydia trachomatis / Neisseria gonorrhoeae antigen detection by Nucleic Acid Amplification (NAAT)
DISEASE/DISORDER Chlamydia trachomatis and/or Neisseria gonorrhoeae
ALTERNATIVE NAME(S) Chlamydia, CT; GC, Gonorrhea
METHODOLOGY Aptima Chlamydia trachomatis and Neisseria gonorrhoeae detection assay by nucleic acid amplification (NAAT) using the Hologic Panther System
SPECIAL INSTRUCTIONS This assay is not approved for use in patients < 14 years of age. 
ORDERING INFORMATION

PTBMIS:

URINE:     

Test Order Code:    GENPU   

Test Order Description:     GEN PROBE, URINE

UROGENITAL PENILE SWAB:     

Test Order Code  GENPP     

Test Order Description:     GEN PROBE, UROGENITAL PENILE SW

ENDOCERVICAL:     

Test Order Code:    GENPE     

Test Order Description:     GEN PROBE ENDOCERVICAL

THROAT:     

Test Order Code:    GENPO     

Test Order Description:     GEN PROBE THROAT

VAGINAL:     

Test Order Code   GENPV     

Test Order Description:     GEN PROBE VAGINAL

ANAL:     

Test Order Code:    GENPA     

Test Order Description:     GEN PROBE ANAL

TDH-DLS Requisition:   PH-4182 Clinical Submission Requisition Form

Specimen Requirements


Patient Preparation
  • Refer to manufacturer instructions provided with collection kits for specific patient preparation information.
  • Only the following specimen types will be accepted for testing: Clinician-collected endocervical, vaginal, throat, rectal, and male urethral swabs, female and male urine, patient-collected vaginal swab. 
  • Specimens must be collected using the specified Aptima Specimen Collection Kit. 
Specimen Collection
  • Aptima Urine Specimen Collection Kit: female and male urine.
  • Aptima Multitest Swab Specimen Collection Kit: vaginal, throat, and rectal specimens.
  • Aptima Unisex Swab Specimen Collection Kit: endocervical and male urethral specimens.
  • Refer to appropriate specimen collection kit package insert for collection instructions.
  • Do not touch or mark upon the collection vials’ pierceable foil cap.
Specimen Processing
  • After collection, place patient sample in biohazard bag with absorbent material using care not to touch the foil cap.
Specimen Labeling
  • Specimen should be labled with at least two unique patient identifiers and specimen source and match accompanying test order.
Specimen Storage and Preservation
  • After collection, place patient sample in an individual biohazard bag with absorbent material using care not to touch the foil cap. 
  • All specimens for an individual patient may be combined in one biohazard bag.
  • Store and transport at 2 - 30°C; must arrive within 72 hours of collection. If specimens will not arrive at the laboratory within 72 hours, specimens may be stored at 4-30°C for up to 30 days. 
  • If longer storage is needed, freeze specimens in the Aptima specimen transport tube within seven (7) days of collection at -20°C to -70°C to allow testing up to twelve (12) months after collection.
Specimen Transportation
  • Specimens must be placed in an individual biohazard bag with absorbent material and should be shipped to the laboratory on the day of collection. 
  • All specimens for an individual patient may be combined in one biohazard bag.
  • Store and transport at 2 - 30°C; must arrive within 72 hours of collection. If specimens will not arrive at the laboratory within 72 hours, specimens may be stored at 4-30°C for up to 30 days. 
  • All infectious substance shipments must conform to U.S. Department of Transportation (DOT) Hazardous Materials Regulations (HMR 49 C.F.R. Parts 171-180). 
Specimen Acceptability and Rejection
  • Specimens collected from patients <14 years of age will be rejected.
  • If expiration date on tube is prior to collection date, specimen will be rejected. 
  • Specimens received in improper collection kits and/or from unapproved specimen sites will be rejected.
  • Urine specimens that are filled above or below the urine collection tube’s fill lines will be rejected.
  • Specimens received with no swab, two swabs, a cleaning swab, and/or a swab not supplied by Hologic will be rejected. 
  • Cadaveric patient specimens will be rejected. 
  • Specimens with clerical errors in the lab order or on the specimen tube will be rejected.
  • Unlabeled or improperly identified specimens will be rejected. 
  • Specimens transported or stored at incorrect temperatures will be rejected.
  • Specimens received past manufacturer's viability from the date of collection will be rejected. 
Testing Location
  • Nashville
  • Knoxville