Collect

Serum separator tube (SST), lavender (EDTA), or pink (K2EDTA).

Specimen Preparation

Separate from cells within 24 hours of collection. Transfer 3 mL serum or plasma into an ARUP standard transport tube. (Min: 2.3 mL) Remove particulate material. This test requires a dedicated transport tube submitted only for the HIV PANEL assay.

Unacceptable Conditions

Heparinized or citrated plasma specimens. Specimens containing particulate material. Severely hemolyzed or heat-inactivated specimens.

Storage/Transport Temperature

Frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 24 hours (CRITICAL: SHIP FROZEN); Refrigerated: 5 days; Frozen: 6 weeks (avoid repeated freeze/thaw cycles)

Performed

Sun-Sat

Notes

The fourth-generation screen test is for the simultaneous qualitative detection of human iImmunodeficiency virus type 1 (HIV-1) p24 antigen and antibodies to HIV type 1 (HIV-1 groups M and O) and HIV type 2 (HIV-2). Results of the screen cannot be used to distinguish between the presence of HIV-1 p24 antigen, HIV-1 antibody (Ab), or HIV-2 Ab.

If the HIV-1,2 combo antigen/Ab screen is repeatedly reactive, then the HIV-1/2 Ab differentiation immunoassay will be performed. Additional charges apply. The HIV-1/2 Ab differentiation immunoassay confirms and discriminates between HIV-1 and HIV-2 Abs. Results for each type are reported.

If the HIV-1/2 Ab differentiation immunoassay is Negative or Indeterminate, then the Human Immunodeficiency Virus 1 and 2 (HIV-1/HIV-2) by Qualitative NAAT will be added. Additional charges apply.

This multitest algorithm is recommended by the Centers for Disease Control and Prevention (CDC) and was adopted by the Clinical Laboratory Standards Institute (CLSI) for the diagnosis of HIV (refer to http://arupconsult.com/content/human-immunodeficiency-virus).

Refer to the following tests for additional information regarding Performed or Reported times, Interpretive Data, and Notes for the reflex tests of this panel:
Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) Antibody Differentiation, Supplemental with Reflex to HIV-1/HIV-2 Qualitative NAAT (ARUP test code 2012669); Human Immunodeficiency Virus 1 and 2 (HIV-1/HIV-2) by Qualitative NAAT (ARUP test code 3017779).

Ordering Recommendations

In accordance with the recommended HIV laboratory testing algorithm, this antigen/antibody combination test (fourth generation) detects p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. Repeatedly reactive HIV-1/HIV-2 antigen/antibody screening results are tested with an HIV-1/HIV-2 antibody differentiation assay. Negative or indeterminate results for the HIV-1/HIV-2 antibody differentiation assay are reflexed to a qualitative nucleic acid amplification test [Human Immunodeficiency Virus 1 and 2 (HIV-1/HIV-2) by Qualitative NAAT].

Performed

Sun-Sat

Methodology

Qualitative Chemiluminescent Immunoassay (CLIA)/Qualitative Immunoassay/Qualitative Polymerase Chain Reaction (PCR)

Reported

1-2 days

Synonyms

  • HIV 1,2 Combo Antigen/Antibody
  • Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antigen/Antibody (Fourth Generation) Preliminary Test
  • Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antibodies, Preliminary Test With Confirmation
  • HIV-1/2 Antigen and Antibodies
  • Fourth generation HIV
  • HIV Diagnosis
  • 4th generation, Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody

ARUP Test Code

2012674

Reference Interval

Effective November 12, 2018
Components
Reference Interval
HIV 1,2 Combo Antigen/AntibodyNegative

Interpretive Data

This test should not be used for blood donor screening, associated reentry protocols, or for screening human cells, tissues, and cellular- and tissue-based products (HCT/P).

CPT Codes

87389; if reflexed, add 86701; 86702; 87535; 87538

LOINC

  • 56888-1

ARUP Test Code

2012674

Performing Lab

ARUP Laboratories

Test Build Information

Order CodeOrderNameResultCodeResultNameRESULT LOINCCPT
HIVPNHIV AG/AB PANELHIVAAHIV AG-AB56888-187389
REFLEX if Repeatively Reactive    
Order CodeOrderNameResultCodeResultNameRESULT LOINCCPT
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIVDIFHIV-1/2 AB DIFF IMMUNOASSAY77202-087535, 87538
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIV1AHIV-1 Antibody68961-2 
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIV2AHIV-2 ANTIBODY81641-3 
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIVINTHIV SEROLOGIC INTERPRETATION80203-3 
      
REFLEX if Negative or Indeterminate    
Order CodeOrderNameResultCodeResultNameRESULT LOINCCPT
12QUALHIV 1/2 BY QUALITATIVE NAAT1NAATHIV-1 QUALITATIVE BY NAAT5017-986701, 86702
12QUALHIV 1/2 BY QUALITATIVE NAAT2NAATHIV-2 QUALITATIVE BY NAAT69353-1 

 

Collection

Collect

Serum separator tube (SST), lavender (EDTA), or pink (K2EDTA).

Specimen Preparation

Separate from cells within 24 hours of collection. Transfer 3 mL serum or plasma into an ARUP standard transport tube. (Min: 2.3 mL) Remove particulate material. This test requires a dedicated transport tube submitted only for the HIV PANEL assay.

Unacceptable Conditions

Heparinized or citrated plasma specimens. Specimens containing particulate material. Severely hemolyzed or heat-inactivated specimens.

Storage/Transport Temperature

Frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 24 hours (CRITICAL: SHIP FROZEN); Refrigerated: 5 days; Frozen: 6 weeks (avoid repeated freeze/thaw cycles)

Performed

Sun-Sat

Notes

The fourth-generation screen test is for the simultaneous qualitative detection of human iImmunodeficiency virus type 1 (HIV-1) p24 antigen and antibodies to HIV type 1 (HIV-1 groups M and O) and HIV type 2 (HIV-2). Results of the screen cannot be used to distinguish between the presence of HIV-1 p24 antigen, HIV-1 antibody (Ab), or HIV-2 Ab.

If the HIV-1,2 combo antigen/Ab screen is repeatedly reactive, then the HIV-1/2 Ab differentiation immunoassay will be performed. Additional charges apply. The HIV-1/2 Ab differentiation immunoassay confirms and discriminates between HIV-1 and HIV-2 Abs. Results for each type are reported.

If the HIV-1/2 Ab differentiation immunoassay is Negative or Indeterminate, then the Human Immunodeficiency Virus 1 and 2 (HIV-1/HIV-2) by Qualitative NAAT will be added. Additional charges apply.

This multitest algorithm is recommended by the Centers for Disease Control and Prevention (CDC) and was adopted by the Clinical Laboratory Standards Institute (CLSI) for the diagnosis of HIV (refer to http://arupconsult.com/content/human-immunodeficiency-virus).

Refer to the following tests for additional information regarding Performed or Reported times, Interpretive Data, and Notes for the reflex tests of this panel:
Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) Antibody Differentiation, Supplemental with Reflex to HIV-1/HIV-2 Qualitative NAAT (ARUP test code 2012669); Human Immunodeficiency Virus 1 and 2 (HIV-1/HIV-2) by Qualitative NAAT (ARUP test code 3017779).
Ordering

Ordering Recommendations

In accordance with the recommended HIV laboratory testing algorithm, this antigen/antibody combination test (fourth generation) detects p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. Repeatedly reactive HIV-1/HIV-2 antigen/antibody screening results are tested with an HIV-1/HIV-2 antibody differentiation assay. Negative or indeterminate results for the HIV-1/HIV-2 antibody differentiation assay are reflexed to a qualitative nucleic acid amplification test [Human Immunodeficiency Virus 1 and 2 (HIV-1/HIV-2) by Qualitative NAAT].

Performed

Sun-Sat

Methodology

Qualitative Chemiluminescent Immunoassay (CLIA)/Qualitative Immunoassay/Qualitative Polymerase Chain Reaction (PCR)

Reported

1-2 days

Synonyms

  • HIV 1,2 Combo Antigen/Antibody
  • Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antigen/Antibody (Fourth Generation) Preliminary Test
  • Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antibodies, Preliminary Test With Confirmation
  • HIV-1/2 Antigen and Antibodies
  • Fourth generation HIV
  • HIV Diagnosis
  • 4th generation, Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody

ARUP Test Code

2012674
Result Interpretation

Reference Interval

Effective November 12, 2018
Components
Reference Interval
HIV 1,2 Combo Antigen/AntibodyNegative

Interpretive Data

This test should not be used for blood donor screening, associated reentry protocols, or for screening human cells, tissues, and cellular- and tissue-based products (HCT/P).

Administrative

CPT Codes

87389; if reflexed, add 86701; 86702; 87535; 87538

LOINC

  • 56888-1

ARUP Test Code

2012674

Performing Lab

ARUP Laboratories
RPS Interface Information

Test Build Information

Order CodeOrderNameResultCodeResultNameRESULT LOINCCPT
HIVPNHIV AG/AB PANELHIVAAHIV AG-AB56888-187389
REFLEX if Repeatively Reactive    
Order CodeOrderNameResultCodeResultNameRESULT LOINCCPT
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIVDIFHIV-1/2 AB DIFF IMMUNOASSAY77202-087535, 87538
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIV1AHIV-1 Antibody68961-2 
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIV2AHIV-2 ANTIBODY81641-3 
HIV12DHIV-1/2 ANTIBODY DIFF W/QUAL NAATHIVINTHIV SEROLOGIC INTERPRETATION80203-3 
      
REFLEX if Negative or Indeterminate    
Order CodeOrderNameResultCodeResultNameRESULT LOINCCPT
12QUALHIV 1/2 BY QUALITATIVE NAAT1NAATHIV-1 QUALITATIVE BY NAAT5017-986701, 86702
12QUALHIV 1/2 BY QUALITATIVE NAAT2NAATHIV-2 QUALITATIVE BY NAAT69353-1 

 

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