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Test Order
Test Order
HIV-1 Rapid Recency Assay CDC-10541
Synonym(s)
Recent Infection, Rapid Point-of-Care Assay, Immunoassay, Lateral Flow, Incidence, International only
CDC Pre-Approval Needed
Supplemental Information Required
Supplemental forms will be provided upon Pre-Approval. Following fields are required: Requestor (Sender POC), Address, E-Mail, Phone, Date of shipment, Number of specimens, Specimen type, Tests requested. All submitted specimens must include two unique specimen identifiers and collection date.
Supplemental Form
ILB-160-F08B HIV Serology Requisition Form
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
Plasma, Serum
Minimum Volume Required
Plasma: 0.5 mL (2 mL preferred)
Serum: 0.5 mL (2 mL preferred)
Collection, Storage, and Preservation of Specimen Prior to Shipping
Whole blood should be processed into plasma or serum within 24 hours. Specimens can be kept refrigerated at 2-8°C if shipped within 72 hours of collection; otherwise specimen should be kept frozen at -20°C or colder.
For plasma whole blood collection, blood can be collected in EDTA anticoagulant tubes.
Transport Medium
Specimens can be kept refrigerated at 2-8°C if shipped within 72 hours of collection; otherwise specimen should be kept frozen at -20°C or colder.
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 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 100
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
Lateral flow rapid test
Turnaround Time
8 Weeks
Interferences & Limitations
Determination of HIV-1 incidence for surveillance purposes only.
Persons with diagnosis of AIDS or low CD4+ T cell counts (<200 cells per µl), recipients of anti-retroviral therapy, and known elite controllers should be excluded from the study populations to reduce the likelihood of misclassification of recency of infection.
The Rapid Test for Recent Infection (RTRI) does not distinguish between HIV-1 and HIV-2.
HIV-2 positive specimens should be excluded from recency analysis.
Persons with diagnosis of AIDS or low CD4+ T cell counts (<200 cells per µl), recipients of anti-retroviral therapy, and known elite controllers should be excluded from the study populations to reduce the likelihood of misclassification of recency of infection.
The Rapid Test for Recent Infection (RTRI) does not distinguish between HIV-1 and HIV-2.
HIV-2 positive specimens should be excluded from recency analysis.
Additional Information
Determination of HIV-1 incidence for surveillance purposes only. Specimen will be rejected for any of the following reasons: improperly labeled, unlabeled, discrepant documentation, no documentation, insufficient quantity, and/or evidence of contamination.
CDC Points of Contact
Version
1.1
Content Credential