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Test Order
Test Order
HIV-1/2 Antibody (International Only) Rapid Test CDC-10339
Synonym(s)
HIV, RT
CDC Pre-Approval Needed
Supplemental Information Required
Specimens must be accompanied with complete requisition form(s).
CDC Form 0.753: Application for Permit to Import or Transport Etiological Agents, Hosts, or Vectors of Human Disease and Requisition Form
Supplemental Form
None
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
Plasma and serum
Minimum Volume Required
Plasma and serum 0.5 mL (2.0 mL recommended)
Collection, Storage, and Preservation of Specimen Prior to Shipping
Plasma: The appropriate anticoagulant for whole blood collection is EDTA.
If testing is to be performed within 7 days keep specimen refrigerated at 2-8 °C. If testing is to be performed after 7 days, keep specimen frozen at -20 °C or colder.
Transport Medium
Specimen should be transported in a plastic screw-cap vial
Specimen Labeling
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. The results reported should NOT be used for diagnosis, treatment, assessment of health or management of the individual patient.
Shipping Instructions which Include Specimen Handling Requirements
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday - Friday.
Ship to:
<Insert CDC Point of Contact>
Centers for Disease Control and Prevention
RDSB/STATT Unit 100
1600 Clifton Road, NE
Atlanta, GA 30329
<Insert CDC Point of Contact's Telephone Number>
All specimens must be shipped in accordance with all applicable local, state and federal regulations. Upon shipment, submitter should send an e-mail to the CDC POC providing shipping company, shipped date and package tracking number.
Methodology
Immuno-chromatography
Turnaround Time
13 Weeks
Interferences & Limitations
Do not use specimens after more than 5 freeze-thaw cycles. Specimen will be rejected if improperly labeled or unlabeled, without documentation or with discrepant documentation, insufficient volume, unacceptable preservatives, and specimen that have leaked in transit or otherwise shown evidence of contamination.
Additional Information
Turn around times are dependent on batch specimen:
Batch with less than 200 specimens - within 50 days
Batch with 200-600 - within 70 days
Batch with greater than 600 specimens - within 90 days
CDC Points of Contact
Version
1.3
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