Chlamydia trachomatis/Neisseria gonorrhoeae (Gonorrhea) antigen detection by Nucleic Acid Amplification (NAAT)
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
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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.
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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.
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Specimen Processing |
- After collection, place patient sample in biohazard bag with absorbent material using care not to touch the foil cap.
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Specimen Labeling |
- Specimen should be labled with at least two unique patient identifiers and specimen source and match accompanying test order.
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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.
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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).
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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.
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Testing Location |
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