Test Information

This assay qualitatively detects HIV-1 p24 antigen and antibodies to HIV-1 (group M and group O) and HIV-2 in human serum or plasma. 

If patient is under 2 years of age, please see HIV1 RNA Detection/Quantification PCR

Collect


Blood, Gold

Preferred Draw Volume

3.5 mL

Minimum Draw Volume

1.2 mL

Other Acceptable Containers

Red

Pediatric Collection

2 microtainers

Unacceptable Conditions

Gross hemolysis

Collection Comments

Allow Gold tube to sit for 30 minutes to form clot. Spin for 10 minutes at 1100-1300 g in a swing bucket unit or 15 minutes in a fixed angle to separate cells from serum. Send spun tube room temp. Refrigerated is acceptable. Remember to properly label tube with patient name, DOB, test and collect date. Indicate 'serum' or 'plasma' on label.

Storage/Transport Temperature

Refrigerated serum/plasma

Stability (from collection to initiation)

Spun samples: Room Temp: 3 days; Refrigerated: 7 days; Frozen: > 7 days

Ordering Recommendations

HIV-1/-2 Ab/HIV Ag QL test is a qualitative test for the presence of antibodies to human immunodeficiency virus 1 and human immunodeficiency virus 2. Professional organizations have different recommendations for HIV antibody testing, however, testing for HIV antibody is ordered for patients in high risk group or individuals with a history of possible exposure to HIV 1 or 2. This test also detects the HIV 1 Ag as well as the HIV 1 and 2 Ab. Positives reflex to HIV 1/2 Ab Confirmation as appropriate.

Performed

Monday - Friday;Days, Evenings, Nights

Methodology

Chemiluminescent Microparticle Immunoassay (CMIA)

Reported

2-3 days

Performing Lab

Chemistry

Synonyms

  • 4500
  • HIV 1/2 Ab HIV Ag QL
  • HIV 1/HIV 2 Ab HIV Ag QL
  • HIV-1/-2 Ab/HIV Ag QL GP
  • HIVAgAb
  • HIV -1/-2 Ab
  • HIV Screen
  • HIV 4th Generation
  • p24 Antigen

Reference Interval

Negative or Non-reactive

Clinical Interpretation

HIV Algorithm Recommendations:
HIVAgAb: If negative or nonreactive, no further testing needed.
            If positive or reactive, reflex to HIV ½ Ab Confirmation.
HIVCONFM: If HIV AB Negative, or Indeterminate (HIV-1 Indtrmnt, HIV-2 Indtrmnt, HIV Indtrmnt) further testing is needed. Followup with HIV-1 RNA, Qualitative, TMA testing. Send EDTA (lavender) tube for sendout testing for HIV1TMA.
            If HIV-1 Positive, the sample is positive for HIV 1 antibodies. If HIV 1 Pos*, the sample is positive for HIV 1 antibodies and indeterminate for HIV 2 antibodies. Further testing may be recommended if clinically necessary.
            If HIV-2 Positive, the sample is positive for HIV 2 antibodies. If HIV 2 Pos*, the sample is positive for HIV 2 antibodies and indeterminate for HIV 1 antibodies. Further testing may be recommended if clinically necessary.
            If HIV-2 + wHIV-1, the sample is positive for HIV-2 antibodies with HIV-1 cross-reactivity. Further testing may be recommended if clinically necessary.
            If HIV POS Untype, the sample is positive for HIV antibodies, but is untypable. Further confirmatory HIV-1 and HIV-2 nucleic acid testing (NAT) is recommended.
HIV1TMA: If positive, it confirms HIV-1 infection in persons who may have an acute HIV-1 infection or repeatedly test positive for HIV-1 infection using the HIVAgAb.
            If negative, it helps to resolve indeterminate or inconclusive HIV results. Further or repeat testing may be needed if suspicion is still present.

CPT Codes

87389; reflex 86701 and 86702

LOINC Codes

  NAME LOINC
Order HIV-1/-2 Antibody/HIV Antigen QL 56888-1
     
Result HIV-1/-2 Ab/HIV Ag QL 56888-1
  HIVAgAb Interp 13499-9

Test Code (Outreach Synonym)

4500

Catalog Code

768938821
Collection

Test Information

This assay qualitatively detects HIV-1 p24 antigen and antibodies to HIV-1 (group M and group O) and HIV-2 in human serum or plasma. 

If patient is under 2 years of age, please see HIV1 RNA Detection/Quantification PCR

Collect


Blood, Gold

Preferred Draw Volume

3.5 mL

Minimum Draw Volume

1.2 mL

Other Acceptable Containers

Red

Pediatric Collection

2 microtainers

Unacceptable Conditions

Gross hemolysis

Collection Comments

Allow Gold tube to sit for 30 minutes to form clot. Spin for 10 minutes at 1100-1300 g in a swing bucket unit or 15 minutes in a fixed angle to separate cells from serum. Send spun tube room temp. Refrigerated is acceptable. Remember to properly label tube with patient name, DOB, test and collect date. Indicate 'serum' or 'plasma' on label.

Storage/Transport Temperature

Refrigerated serum/plasma

Stability (from collection to initiation)

Spun samples: Room Temp: 3 days; Refrigerated: 7 days; Frozen: > 7 days
Ordering

Ordering Recommendations

HIV-1/-2 Ab/HIV Ag QL test is a qualitative test for the presence of antibodies to human immunodeficiency virus 1 and human immunodeficiency virus 2. Professional organizations have different recommendations for HIV antibody testing, however, testing for HIV antibody is ordered for patients in high risk group or individuals with a history of possible exposure to HIV 1 or 2. This test also detects the HIV 1 Ag as well as the HIV 1 and 2 Ab. Positives reflex to HIV 1/2 Ab Confirmation as appropriate.

Performed

Monday - Friday;Days, Evenings, Nights

Methodology

Chemiluminescent Microparticle Immunoassay (CMIA)

Reported

2-3 days

Performing Lab

Chemistry

Synonyms

  • 4500
  • HIV 1/2 Ab HIV Ag QL
  • HIV 1/HIV 2 Ab HIV Ag QL
  • HIV-1/-2 Ab/HIV Ag QL GP
  • HIVAgAb
  • HIV -1/-2 Ab
  • HIV Screen
  • HIV 4th Generation
  • p24 Antigen
Result Interpretation

Reference Interval

Negative or Non-reactive

Clinical Interpretation

HIV Algorithm Recommendations:
HIVAgAb: If negative or nonreactive, no further testing needed.
            If positive or reactive, reflex to HIV ½ Ab Confirmation.
HIVCONFM: If HIV AB Negative, or Indeterminate (HIV-1 Indtrmnt, HIV-2 Indtrmnt, HIV Indtrmnt) further testing is needed. Followup with HIV-1 RNA, Qualitative, TMA testing. Send EDTA (lavender) tube for sendout testing for HIV1TMA.
            If HIV-1 Positive, the sample is positive for HIV 1 antibodies. If HIV 1 Pos*, the sample is positive for HIV 1 antibodies and indeterminate for HIV 2 antibodies. Further testing may be recommended if clinically necessary.
            If HIV-2 Positive, the sample is positive for HIV 2 antibodies. If HIV 2 Pos*, the sample is positive for HIV 2 antibodies and indeterminate for HIV 1 antibodies. Further testing may be recommended if clinically necessary.
            If HIV-2 + wHIV-1, the sample is positive for HIV-2 antibodies with HIV-1 cross-reactivity. Further testing may be recommended if clinically necessary.
            If HIV POS Untype, the sample is positive for HIV antibodies, but is untypable. Further confirmatory HIV-1 and HIV-2 nucleic acid testing (NAT) is recommended.
HIV1TMA: If positive, it confirms HIV-1 infection in persons who may have an acute HIV-1 infection or repeatedly test positive for HIV-1 infection using the HIVAgAb.
            If negative, it helps to resolve indeterminate or inconclusive HIV results. Further or repeat testing may be needed if suspicion is still present.
Additional Information

CPT Codes

87389; reflex 86701 and 86702

LOINC Codes

  NAME LOINC
Order HIV-1/-2 Antibody/HIV Antigen QL 56888-1
     
Result HIV-1/-2 Ab/HIV Ag QL 56888-1
  HIVAgAb Interp 13499-9

Test Code (Outreach Synonym)

4500

Catalog Code

768938821