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Synonym(s):
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Gonorrhea/Chlamydia (GC/CT), Amplified RNA
Probe
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Requisition
Form
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G-2B
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Test
Description
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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)
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Pre-Approval
Needed
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N/A
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Supplemental
Information Required
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N/A
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Supplemental
Form(s)
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N/A
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Performed on
Specimens from (sources)
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Human
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Sample/Specimen
Type for Testing
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- 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
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Minimum
Volume/Size Required
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One correct swab or urine filled between
the two black indicator lines on the tube label
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Storage/Preservation
Prior to Shipping
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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.
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Transport
Medium
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N/A
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Specimen
Labeling
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-
Two patient-specific identifiers required (e.g., patient full name, date of birth, Medical record number)
- Identifiers on specimen must exactly match submission form.
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Shipping and
Specimen Handling Requirements
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- 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
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Method
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Target amplification nucleic acid probe
test
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Turn-around Time
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4 days
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Interferences/Limitations
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Reliable results are dependent on adequate
specimen collection.
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| Common Causes for
Rejection
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- 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.
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Additional Information
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Results
from the APTIMA COMBO 2 Assay should be interpreted in conjunction with other
laboratory and clinical data available to the clinician.
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