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PrEP HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes
Test Code13670
CPT Codes
87389
Includes
If HIV Antigen and Antibody, 4th Generation Screen is repeatedly Reactive, then HIV-1/2 Antibody Differentiation will be performed at an additional charge (CPT code(s): 86701, 86702).
If HIV-1/2 Antibody Differentiation is Negative or Indeterminate, then HIV-1 RNA, Qualitative Real-Time PCR will be performed at an additional charge (CPT code(s): 87535).
If HIV-1/2 Antibody Differentiation is Negative or Indeterminate, then HIV-1 RNA, Qualitative Real-Time PCR will be performed at an additional charge (CPT code(s): 87535).
Preferred Specimen
3 mL serum
Minimum Volume
2 mL
Other Acceptable Specimens
Plasma collected in: EDTA (lavender-top) tube
Instructions
Serum: Collect in a serum separator tube or red-top tube (no gel). The tube should be centrifuged after clotting. Spun serum separator tubes may be submitted at room temperature or refrigerated unopened without transfer to a plastic, screw-cap vial. Red-top tube (no gel) serum should be transferred to a plastic, screw-cap vial and submitted for testing.
Plasma: Collect in an EDTA (lavender-top) tube and centrifuge tube within 24 hours of collection. Transfer plasma to a plastic, screw-cap vial, label as plasma, and submit for testing.
Submitted tubes must be labeled with patient identifier and submitted only for HIV testing.
Transport Container
Transport tube
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 72 hours
Refrigerated: 5 days
Frozen: 30 days
Refrigerated: 5 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Frozen specimens submitted in original collection container
Methodology
Immunoassay (IA)
Setup Schedule
Set up: Mon-Sat; Report available: 2-3 days
Reference Range
PREP HIV Ag/Ab, 4TH GEN | Non-Reactive |
PrEP HIV 1 Ab | Negative |
PrEP HIV 2 Ab | Negative |
PrEP HIV 1 RNA, QL REAL TIME PCR | Not Detected |
Clinical Significance
This test is used to diagnose HIV-1 and HIV-2 infection, including acute infection, and to differentiate HIV-1 from HIV-2. It is consistent with the HIV diagnostic algorithm recommended by the Centers for Disease Control and Prevention. This diagnostic algorithm is NOT intended for patients currently on PrEP as these patients require concurrent HIV Antigen/Antibody and HIV-1 RNA tests.
If the HIV-1/HIV-2 Antigen/Antibody test is positive, an antibody-based HIV-1/HIV-2 test is performed (at additional charge) to confirm infection and differentiate between HIV-1 and HIV-2. If the antibody-based HIV-1/HIV-2 test is Negative or Indeterminate, an HIV-1 RNA test will be performed (at additional charge) to identify patients with acute, early HIV-1 infection.
For determination of HIV status for patients who have taken oral PrEP within 3 months, or injectable PrEP within 12 months, please order PrEP HIV-1/2 Antigen and Antibodies, Fourth Generation, Screen and HIV-1 RNA.
If the HIV-1/HIV-2 Antigen/Antibody test is positive, an antibody-based HIV-1/HIV-2 test is performed (at additional charge) to confirm infection and differentiate between HIV-1 and HIV-2. If the antibody-based HIV-1/HIV-2 test is Negative or Indeterminate, an HIV-1 RNA test will be performed (at additional charge) to identify patients with acute, early HIV-1 infection.
For determination of HIV status for patients who have taken oral PrEP within 3 months, or injectable PrEP within 12 months, please order PrEP HIV-1/2 Antigen and Antibodies, Fourth Generation, Screen and HIV-1 RNA.