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Test Order
Test Order
HIV-1/2 Laboratory Algorithm
CDC-10272
Synonym(s)
CDC/APHL HIV Diagnostic Algorithm, HIV Serology Testing with reflex to NAT
CDC Pre-Approval Needed
None
Supplemental Information Required
Include patient clinical history and previous lab results within the CDC 50.34 Specimen Submission Form.
Supplemental Form
None
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
EDTA-treated plasma (preferred) or serum
Minimum Volume Required
2 mL
Collection, Storage, and Preservation of Specimen Prior to Shipping
This test can be performed on EDTA-treated plasma (preferred) or serum.
Whole blood can be stored refrigerated (2-8°C) or room temperature (15-25°C) and must be separated within 24 hours of specimen collection. Separate the plasma or serum from the pelleted red blood cells following the manufacturer’s instructions for the tube used.
Separated plasma or serum may be stored refrigerated (2-8°C) for up to three days or frozen at -20°C or lower for up to 60 days.
Specimen should not have incurred more than two freeze-thaw cycles.
Whole blood can be stored refrigerated (2-8°C) or room temperature (15-25°C) and must be separated within 24 hours of specimen collection. Separate the plasma or serum from the pelleted red blood cells following the manufacturer’s instructions for the tube used.
Separated plasma or serum may be stored refrigerated (2-8°C) for up to three days or frozen at -20°C or lower for up to 60 days.
Specimen should not have incurred more than two freeze-thaw cycles.
Transport Medium
Not applicable
Specimen Labeling
Test subject to CLIA regulations and requires two primary patient identifiers (e.g., patient first and last name, date of birth, unique patient identifier from time of collection, such as medical record number) on the specimen container and on the test requisition.
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 refrigerated separated plasma or serum with refrigerated or frozen cold packs. Ship frozen serum or plasma specimens on dry ice.
Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 77
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]
All samples must be shipped in accordance with all applicable local, state and federal regulations. Upon shipment, submitter should send an email to the CDC POC providing shipping company, shipped date and package tracking number.
Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 77
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]
All samples must be shipped in accordance with all applicable local, state and federal regulations. Upon shipment, submitter should send an email to the CDC POC providing shipping company, shipped date and package tracking number.
Methodology
Enzyme immunoassay (EIA), immunochromatographic assay, nucleic acid amplification (NAT)
Turnaround Time
3 Weeks
Interferences & Limitations
Extensive hemolysis may affect test performance. Do not exceed 48 hours storage at 18°C to 30°C to preserve p24 antigen reactivity.
Additional Information
HIV-1/2 antigen/antibody immunoassay is followed by an HIV-1/2 differentiation supplemental assay, which may be followed by an HIV-1 RNA amplification (qualitative - CDC-10275).
If testing results are inconclusive, additional plasma or serum may be required for subsequent testing.
If testing results are inconclusive, additional plasma or serum may be required for subsequent testing.
CDC Points of Contact
Version
3.7
Content Credential