Laboratory Fee Schedule
Procedure: MBB0191A
CPT: 87491, 87591
| Synonym(s): |
Gonorrhea, Chlamydia, Neisseria gonorrhoeae, Chlamydia trachomatis, Combo 2, GC/CT NAAT, Screen |
| Requisition Form |
G-2B |
| Test Description |
Target amplification nucleic acid probe test that utilizes target capture for qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhea (GC) |
| Pre-Approval Needed |
N/A |
| Supplemental Information Required |
N/A |
| Supplemental Form(s) |
N/A |
| Performed on Specimens from (sources) |
Human |
| Sample/Specimen Type for Testing |
The following specimen types may only be collected using the collection kit listed for each:
- Vaginal swab - Aptima® Multitest Swab Collection Kit
- Endocervical swab - Aptima® Unisex Swab Collection Kit
- Urethral swab - Aptima® Unisex Swab Collection Kit
- Urine - Aptima® Urine Specimen Collection Kit
- Rectal swab - Aptima® Multitest Swab Collection Kit
- Throat swab - Aptima® Multitest Swab Collection Kit
|
| Minimum Volume/Size Required |
One correct swab or urine filled between the two black indicator lines on the tube label |
| Storage/Preservation Prior to Shipping |
Endocervical, Vaginal, and Urethral Swabs
- Store swab in transport tube at 2°C to 30°C for up to 60 days after collection.
- For long term storage, freeze swab in transport tube at -20°C to -70°C within 7 days of collection.
Rectal and Throat Swabs
- Store swab in transport tube at 4°C to 30°C OR at -20°C to -70°C for up to 60 days.
Urine Specimens
- Store specimen in transport tube at 2°C to 30°C for up to 30 days.
- For long term storage, freeze at -20°C to -70°C within 7 days of collection for testing up to 12 months after collection.
|
| Transport Medium |
N/A |
| Specimen Labeling |
- Two patient-specific identifiers required on specimen (e.g., patient full name, date of birth, medical record number)
- Three patient identifiers are preferred.
- Patient identifiers on specimen label must exactly match identifiers on submission form (e.g., abbreviated name on label and full name on form is not acceptable.)
- Additional DSHS Laboratory specimen labeling guidelines available online here.
|
| Shipping and Specimen Handling Requirements |
- Ship according to Dangerous Goods Regulations, IATA, and/or CFR 49.
- Category B Biological Substance, UN3373 shipping requirements apply.
- Handle as infectious agent using universal precautions.
- Triple-contain in accordance with federal shipping regulations for infectious agents.
- Submitters are responsible for packaging and shipping specimens according to regulatory requirements.
- Additional DSHS Laboratory specimen shipping guidelines online here.
|
| Method |
Target amplification nucleic acid probe test |
| Turn-around Time |
3 working days |
| Interferences/Limitations |
- Reliable results are dependent on adequate specimen collection.
- A negative result does not preclude a possible infection.
|
| Common Causes for Rejection |
- Unacceptable specimen type or source.
- Improper shipping conditions.
- Urine specimen (stored at 2°C to 30°C) older than 30 days.
- Swab specimen older than 60 days.
- Specimen collected using the wrong collection kit.
- Urine specimen not transferred to transport tube.
- No swab in transport tube.
- Two swabs in transport tube.
- Swab used to collect specimen not supplied by Hologic.
- Urine not filled to between the two black indicator lines on tube label.
- Expired reagents/media/collection container.
- Discrepancies between G-2B submission form and specimen label.
- Missing/incomplete/illegible submission form or label.
|
| Additional Information |
Results from the APTIMA COMBO 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. |