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HelpTest ID HVCOP HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Plasma
Ordering Guidance
If specimen is from either autopsy or cadaver blood sources, the proper FDA-licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.
Screening, supplemental or confirmatory serologic tests for HIV-1 or HIV-2 antibodies cannot distinguish between active neonatal HIV infection and passive transfer of maternal HIV antibodies in infants during the postnatal period (up to 2 years old). Diagnosis of HIV infection in newborns and infants up to 2 years old should be made by virologic tests, such as detection of HIV RNA (HIP12 / HIV-1/HIV-2 RNA Detection, Plasma).
New York State clients: This test should not be requested for maternal or newborn HIV screening on specimens originating in New York State, due to state regulatory requirements for expedited result reporting.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 4 mL
Collection 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.
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916)
Secondary ID
48341Useful For
Screening for HIV-1 and HIV-2 infection in nonsymptomatic, nonpregnant individuals older than 2 years
This test should not be used as a screening or confirmatory test for blood donor specimens.
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HVDIP | HIV Ab Confirm / Differentiation, P | Yes | No |
| HIP12 | HIV-1/HIV-2 RNA Detect, P | Yes | No |
| HIVQN | HIV-1 RNA Detect/Quant, P | Yes | No |
Testing Algorithm
This test begins with HIV-1/-2 antigen and antibody (Ab) 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.
-Negative for both HIV-1 Ab and HIV-2 Ab
- Indeterminate for HIV-1 Ab but negative for HIV-2 Ab
- Negative for HIV-1 Ab but indeterminate for HIV-2 Ab
- Indeterminate for both HIV-1 Ab and HIV-2 Ab
- Positive for both HIV-1 Ab and HIV-2 Ab
If the following result types are obtained from the HIV-1/-2 confirmation/differentiation, HIV-1 RNA detection and quantification will be performed at an additional charge:
-Positive for HIV-1 Ab and negative for HIV-2 Ab
-Positive for HIV-1 Ab and indeterminate for HIV-2 Ab
For more information, see HIV Testing Algorithm (Fourth Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results
Special Instructions
Method Name
Chemiluminescent Microparticle Immunoassay
Reporting Name
HIV-1/-2 Ag and Ab Screen, PSpecimen Type
PlasmaSpecimen Minimum Volume
1.2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Plasma | Refrigerated (preferred) | 6 days |
| Frozen | 30 days |
Clinical Information
AIDS is caused by 2 known types of HIV. HIV type 1 (HIV-1) is found in patients with AIDS or AIDS-related complex and in asymptomatic infected individuals at high risk for AIDS. The virus is transmitted by sexual contact, by exposure to infected blood or blood products, or from an infected mother to her fetus or infant. HIV type 2 (HIV-2) infection is endemic only in West Africa, and it has been identified in individuals who had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in viral morphology, overall genomic structure, and its ability to cause AIDS.
Antibodies against HIV-1 and HIV-2 are usually not detectable until 6 to 12 weeks following exposure and are almost always detectable by 12 months. They may fall to undetectable levels (ie, seroreversion) in the terminal stage of AIDS when the patient's immune system is severely depressed.
Routine serologic screening of patients at risk for HIV-1 or HIV-2 infection usually begins with an HIV-1/-2 antigen and/or antibody screening test, which may be performed by various US Food and Drug Administration-approved assay methods, including rapid HIV antibody tests, enzyme immunoassays, and chemiluminescent immunoassays. In testing algorithms that begin with these methods, supplemental or confirmatory testing should be requested only for specimens that are repeatedly reactive by these methods.
Reference Values
Negative
Cautions
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 >1,250 mg/dL)
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Heat-inactivated specimens
-Cadaveric specimens
-Presence of particulate matter
Day(s) Performed
Monday through Saturday
Report Available
1 to 2 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
87389
G0475