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Hepatitis C Antibody and HIV-1/2, Screen and Diagnostic Panel with Reflexes
Test Code36646
CPT Codes
86803, 87389
Includes
If Hepatitis C Antibody is reactive or borderline, then Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87522).
If Hepatitis C Viral RNA, Quantitative, Real-Time PCR is ≥300 IU/mL, then Hepatitis C Viral RNA Genotype, LiPA will be performed at an additional charge (CPT code(s): 87902).
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 Indeterminate or Negative, then HIV-1 RNA, Qualitative, TMA will be performed at an additional charge (CPT code(s): 87535).
If Hepatitis C Viral RNA, Quantitative, Real-Time PCR is ≥300 IU/mL, then Hepatitis C Viral RNA Genotype, LiPA will be performed at an additional charge (CPT code(s): 87902).
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 Indeterminate or Negative, then HIV-1 RNA, Qualitative, TMA will be performed at an additional charge (CPT code(s): 87535).
Preferred Specimen
HCV: 2.5 mL serum collected in each of two separate Serum Separator Tubes (SST®) and
HIV: 3 mL serum collected in a third separate Serum Separator Tube (SST®)
HIV: 3 mL serum collected in a third separate Serum Separator Tube (SST®)
Minimum Volume
2 mL per SST®
Instructions
HIV Serum: Collect in a serum separator tube. 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.
Tubes submitted for HIV testing must be labeled with patient identifier and submitted only for HIV testing.
Transport Temperature
Refrigerated (cold packs)
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 serum separator tubes
Methodology
Immunoassay (IA)
Setup Schedule
See Individual Assays
Clinical Significance
HCV: Hepatitis C Virus (HCV) is a major cause of hepatitis. Making positive HCV Ab tests reflex to confirmatory molecular testing is necessary to confirm active HCV infection. Providing a second reflex to perform genotyping on HCV isolates when RNA is detected is also a necessary step before starting therapy. This double reflex will reduce the percentage of antibody-positive patients who lack appropriate confirmatory RNA testing and who do not have genotype testing performed.
HIV: This 4th generation HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV1/HIV2 infection, including acute or primary HIV-1 infection.
HIV: This 4th generation HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV1/HIV2 infection, including acute or primary HIV-1 infection.