Skip Ribbon Commands
Skip to main content
Sign In

26484 HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma (HIVDX)

HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma (HIVDX)
Test Code: HIVDXSO
Synonyms/Keywords

​Acquired Immune Deficiency Syndrome (AIDS), Anti-HIV, Anti-HIV-1/-2, HIV Types 1 and 2 Antibodies, HIV-1/-2, HIV-1/-2 Ab, HIV-1/-2 Ag/Ab, HIV-1/-2 Antibodies, HIV-1/-2 Antigen, HIV combo, Human Immunodeficiency Virus (HIV)

Test Components

​This test begins with HIV-1/-2 antigen and antibody screen by chemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody confirmation/differentiation test by immunochromatographic method is performed at an additional charge.

If HIV-1/-2 antibody confirmation/differentiation is negative for both HIV-1 antibody and HIV-2 antibody, or indeterminate/negative for HIV-1/HIV-2 antibody, or indeterminate/indeterminate for HIV-1/ HIV-2 antibody, then HIV-1 RNA detection and quantification is performed at an additional charge.

Useful For

​Diagnosing HIV-1 and/or HIV-2 infection in symptomatic patients more than 2 years old

Follow-up testing of individuals with reactive rapid HIV test results

This test is not offered as a screening or confirmatory test for blood donor specimens.

Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Plasma​EDTA Lavender Top Tube (LTT)​4 mL​1.2 mL
Collection Processing Instructions

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot plasma into a plastic vial.

Specimen Stability Information
Specimen TypeTemperatureTime
​Plasma ​​Refrigerated (preferred)​6 days
​Frozen​30 days
Rejection Criteria
Gross hemolysis
​Gross lipemia
​Gross icterus
Interference

​Reactive result of this assay does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody.

A reactive screening test result is not diagnostic for HIV infection and should be considered preliminary.

The positive predictive value of a reactive screening test result is highly dependent on the prevalence of HIV infection in the population tested. The lower the prevalence of HIV infection, the lower the positive predictive value and higher the false-positive rate of the test. Diagnosis of HIV infection must be based on positive results of the supplemental or confirmatory serologic or molecular tests.

Recipients of experimental HIV-1 vaccines may have false-reactive HIV antibody test results due to the presence of vaccine-induced, HIV-1-specific antibodies without actual HIV infection.

Negative serologic or molecular HIV screening test results should be evaluated with caution in patients with clinical symptoms and/or a history of high-risk behavior for HIV infection. Repeat testing in 1 to 2 months is recommended in these at-risk individuals.

Assay performance characteristics have not been established for the following specimen characteristics:

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Grossly lipemic (triolein level of >1250 mg/dL)

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Heat-inactivated specimens

-Cadaveric specimens

-Presence of particulate matter

Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Marshfield Clinic Laboratories​Monday through Saturday​1 to 2 days​Chemiluminescent Microparticle Immunoassay
Reference Lab
Reference Range Information
Performing LocationReference Values
​Mayo Clinic Laboratories​Negative
Interpretation

Negative HIV-1/-2 antigen and antibody screening test results usually indicate the absence of HIV-1 and HIV-2 infection. However, such negative results do not rule-out acute HIV infection. If acute HIV-1 infection is suspected, detection of HIV-1 RNA (HIVQN / HIV-1 RNA Detection and Quantification, Plasma) or HIV-1 DNA and RNA (HIVP / HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma) is recommended.

Reactive HIV-1/-2 antigen and antibody screening test results suggest the presence of HIV-1 and/or HIV-2 infection, but it is not diagnostic for HIV infection and should be considered preliminary. A reactive result does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody. Diagnosis of HIV infection must be based on results of supplemental tests, such as HIV antibody confirmation/differentiation test (automatically reflexed on all samples with reactive screen test results at an additional charge).

All initially positive supplemental or confirmatory HIV test results (by serologic or molecular test methods) should be verified by submitting a second plasma specimen for repeat testing. Such positive HIV test results are required under laws in many states in the United States to be reported to the departments of health of the respective states where the patients reside.

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​87389
​86701​1​HIV Ab Confirm/Differentiation​if needed
​86702​1​HIV Ab Confirm/Differentiation​if needed
​87536​1​HIV-1 RNA Detect/Quant​if needed
Synonyms/Keywords

​Acquired Immune Deficiency Syndrome (AIDS), Anti-HIV, Anti-HIV-1/-2, HIV Types 1 and 2 Antibodies, HIV-1/-2, HIV-1/-2 Ab, HIV-1/-2 Ag/Ab, HIV-1/-2 Antibodies, HIV-1/-2 Antigen, HIV combo, Human Immunodeficiency Virus (HIV)

Test Components

​This test begins with HIV-1/-2 antigen and antibody screen by chemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody confirmation/differentiation test by immunochromatographic method is performed at an additional charge.

If HIV-1/-2 antibody confirmation/differentiation is negative for both HIV-1 antibody and HIV-2 antibody, or indeterminate/negative for HIV-1/HIV-2 antibody, or indeterminate/indeterminate for HIV-1/ HIV-2 antibody, then HIV-1 RNA detection and quantification is performed at an additional charge.

Ordering Applications
Ordering ApplicationDescription
​COM​HIV-1/-2 Ag and Ab Diagnostic (HIVDX)
​Cerner​HIV-1/-2 Ag and Ab Diagnostic (HIVDX)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Plasma​EDTA Lavender Top Tube (LTT)​4 mL​1.2 mL
Collection Processing

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot plasma into a plastic vial.

Specimen Stability Information
Specimen TypeTemperatureTime
​Plasma ​​Refrigerated (preferred)​6 days
​Frozen​30 days
Rejection Criteria
Gross hemolysis
​Gross lipemia
​Gross icterus
Interference

​Reactive result of this assay does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody.

A reactive screening test result is not diagnostic for HIV infection and should be considered preliminary.

The positive predictive value of a reactive screening test result is highly dependent on the prevalence of HIV infection in the population tested. The lower the prevalence of HIV infection, the lower the positive predictive value and higher the false-positive rate of the test. Diagnosis of HIV infection must be based on positive results of the supplemental or confirmatory serologic or molecular tests.

Recipients of experimental HIV-1 vaccines may have false-reactive HIV antibody test results due to the presence of vaccine-induced, HIV-1-specific antibodies without actual HIV infection.

Negative serologic or molecular HIV screening test results should be evaluated with caution in patients with clinical symptoms and/or a history of high-risk behavior for HIV infection. Repeat testing in 1 to 2 months is recommended in these at-risk individuals.

Assay performance characteristics have not been established for the following specimen characteristics:

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Grossly lipemic (triolein level of >1250 mg/dL)

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Heat-inactivated specimens

-Cadaveric specimens

-Presence of particulate matter

Useful For

​Diagnosing HIV-1 and/or HIV-2 infection in symptomatic patients more than 2 years old

Follow-up testing of individuals with reactive rapid HIV test results

This test is not offered as a screening or confirmatory test for blood donor specimens.

Test Components

​This test begins with HIV-1/-2 antigen and antibody screen by chemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody confirmation/differentiation test by immunochromatographic method is performed at an additional charge.

If HIV-1/-2 antibody confirmation/differentiation is negative for both HIV-1 antibody and HIV-2 antibody, or indeterminate/negative for HIV-1/HIV-2 antibody, or indeterminate/indeterminate for HIV-1/ HIV-2 antibody, then HIV-1 RNA detection and quantification is performed at an additional charge.

Reference Range Information
Performing LocationReference Values
​Mayo Clinic Laboratories​Negative
Interpretation

Negative HIV-1/-2 antigen and antibody screening test results usually indicate the absence of HIV-1 and HIV-2 infection. However, such negative results do not rule-out acute HIV infection. If acute HIV-1 infection is suspected, detection of HIV-1 RNA (HIVQN / HIV-1 RNA Detection and Quantification, Plasma) or HIV-1 DNA and RNA (HIVP / HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma) is recommended.

Reactive HIV-1/-2 antigen and antibody screening test results suggest the presence of HIV-1 and/or HIV-2 infection, but it is not diagnostic for HIV infection and should be considered preliminary. A reactive result does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody. Diagnosis of HIV infection must be based on results of supplemental tests, such as HIV antibody confirmation/differentiation test (automatically reflexed on all samples with reactive screen test results at an additional charge).

All initially positive supplemental or confirmatory HIV test results (by serologic or molecular test methods) should be verified by submitting a second plasma specimen for repeat testing. Such positive HIV test results are required under laws in many states in the United States to be reported to the departments of health of the respective states where the patients reside.

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Marshfield Clinic Laboratories​Monday through Saturday​1 to 2 days​Chemiluminescent Microparticle Immunoassay
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​87389
​86701​1​HIV Ab Confirm/Differentiation​if needed
​86702​1​HIV Ab Confirm/Differentiation​if needed
​87536​1​HIV-1 RNA Detect/Quant​if needed
For most current information refer to the Marshfield Laboratory online reference manual.