Test Mnemonic

HIVS

Collect

Serum; Plain Red or Serum Separator Tube (SST) 

Also acceptable: Plasma; Lithium heparin, Lavender EDTA, or Sodium Citrate

Minimum Volume:  1.7 mL Serum or Plasma

Storage/Transport Temperature

Refrigerated (2-8o C).  Submit specimen in plastic transport tube.  Avoid multiple freeze/thaw cycles.

Stability (from collection to initiation)

Ambient: 3 days
Refrigerated: 7 days
Frozen: 3 months

Performed

Daily

Reported

Same day

Performing Lab

Avera McKennan Regional Laboratory

CPT Codes

87389 or HCPCS G0475; if reflexed add 86701 (HIV1) and 86702 (HIV2)

Compliance & Service Center Alerts

Reflex Tesing: All reactive results will have confirmatory HIV discriminatory antibody testing completed (HIV1 and HIV2) testing performed and will be billed. If discriminatory antibody testing is negative or undifferentiated, HIV1 RNA, Quantitative testing will be recommended. This testing will require that a new order and specimen be submitted.

Medicare Coverage Notice: Test covered under Medicare NCD or LCD. Medical necessity documentation, evaluation and appropriate Advance Beneficiary Notice (ABN) use/assessment is required for Medicare patients if this is not being requested for annual screening program coverage. If an ABN is required, it must be submitted with the test requisition.

Medicare Annual Screening Coverage Coding Guidance: CMS has authorized the coverage for one annual voluntary HIV Screening of Medicare Beneficiaries if you are age 15-65, younger than 15 or older than 65 and at increased risk, or up to three voluntary HIV screening of pregnant Medicare beneficiaries during pregnancy.
 
 

Methodology

Chemiluminescent Immunoassay

Interpretive Data

The LIAISON® XL HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum or plasma on the LIAISON® XL Analyzer. It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2-21 years) and in pregnant women.
The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies.
The LIAISON® XL HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV.
Ordering / Collection

Test Mnemonic

HIVS

Collect

Serum; Plain Red or Serum Separator Tube (SST) 

Also acceptable: Plasma; Lithium heparin, Lavender EDTA, or Sodium Citrate

Minimum Volume:  1.7 mL Serum or Plasma

Storage/Transport Temperature

Refrigerated (2-8o C).  Submit specimen in plastic transport tube.  Avoid multiple freeze/thaw cycles.

Stability (from collection to initiation)

Ambient: 3 days
Refrigerated: 7 days
Frozen: 3 months
Test Performance / Compliance

Performed

Daily

Reported

Same day

Performing Lab

Avera McKennan Regional Laboratory

CPT Codes

87389 or HCPCS G0475; if reflexed add 86701 (HIV1) and 86702 (HIV2)

Compliance & Service Center Alerts

Reflex Tesing: All reactive results will have confirmatory HIV discriminatory antibody testing completed (HIV1 and HIV2) testing performed and will be billed. If discriminatory antibody testing is negative or undifferentiated, HIV1 RNA, Quantitative testing will be recommended. This testing will require that a new order and specimen be submitted.

Medicare Coverage Notice: Test covered under Medicare NCD or LCD. Medical necessity documentation, evaluation and appropriate Advance Beneficiary Notice (ABN) use/assessment is required for Medicare patients if this is not being requested for annual screening program coverage. If an ABN is required, it must be submitted with the test requisition.

Medicare Annual Screening Coverage Coding Guidance: CMS has authorized the coverage for one annual voluntary HIV Screening of Medicare Beneficiaries if you are age 15-65, younger than 15 or older than 65 and at increased risk, or up to three voluntary HIV screening of pregnant Medicare beneficiaries during pregnancy.
 
 

Methodology

Chemiluminescent Immunoassay

Clinical Information

Interpretive Data

The LIAISON® XL HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum or plasma on the LIAISON® XL Analyzer. It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2-21 years) and in pregnant women.
The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies.
The LIAISON® XL HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV.
Internal Lab Use Only

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