Donor HIV‑1/2 plus O Antibody Screen with Reflex to Differentiation
Use
This test is used to screen blood and HCT/P (human cells, tissues, and products) donors for HIV‑1, HIV‑2, and group O antibodies using an assay kit that is FDA approved or cleared for donor testing. Reactive results are reflexed to HIV‑1 and HIV‑2 antibody differentiation, per CDC algorithm for fourth‑generation HIV screening to confirm infection status, with follow‑up HIV‑1 RNA testing if differentiation is negative or indeterminate.
Special Instructions
Not provided.
Limitations
This screen is intended solely for donor screening and should not be used for general diagnostic purposes. Reflexes may incur additional charges. Differentiation may not resolve infection status in early acute infection, requiring RNA testing. Laboratory modifications to FDA‑approved tests are prohibited for donor use.
FDA Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
Group O antibodies
AnalyteHIV‑1 antibodies
AnalyteHIV‑2 antibodies
Analyte
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
Not provided
Minimum Volume
Not provided
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