Synonym(s):
|
Gonorrhea/Chlamydia (GC/CT), Amplified RNA
Probe
|
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
|
- Vaginal swabs- Aptima Multitest Swab Collection Kit
- Endocervical-Aptima Unisex swabs Collection Kit
- Urethral swabs- Aptima Unisex swabs Collection Kit
- Urine specimens-Aptima Urine Collection Kit
- Oral-Aptima Multitest Swab Collection Kit
- Rectal- Aptima Multitest Swab Collection Kit
- Nasopharyngeal- Aptima Multitest Swab Collection Kit
- Penile Meatal- 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
|
Swab
- Store in a specimen transport tube at 2°C to 30°C for up to 60 days
- Extragenital (rectal and oral) store at 4-30°C for up to 60 days
- For long term storage is needed, freeze at -20°C to -70°C.
Urine
- Store in urine specimen in a transport tube at 2°C to 30°C for up to 30 days
- For long term storage, freeze at -20°C to -70°C.
|
Transport
Medium
|
N/A
|
Specimen
Labeling
|
-
Two patient-specific identifiers required (e.g., patient full name, date of birth, Medical record number)
- Identifiers on specimen must exactly match submission form.
|
Shipping and
Specimen Handling Requirements
|
- Ship according to Dangerous Goods Regulations,
IATA, and/or CFR 49.
- Handle
as infectious agent using universal precautions.
- Triple
contain in accordance with federal shipping regulations for infectious
agents.
Additional forms & resources
|
Method
|
Target amplification nucleic acid probe
test
|
Turn-around Time
|
3 working days
|
Interferences/Limitations
|
Reliable results are dependent on adequate
specimen collection.
|
Common Causes for
Rejection
|
- unacceptable
specimen type or source
- improper shipping conditions
- expired media or
collection container
- discrepancies between specimen label and/or submission
form
- incomplete or missing submission form
- wrong swab submitted (white)
- no
swab
- two swabs
- a swab not supplied by Gen-Probe
- urine not filled
between the two black indicator lines on tube 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.
|