Screening for HIV-1 and/or HIV-2 infection in nonsymptomatic pregnant patients
This test should not be used as a screening or confirmatory test for blood donor specimens.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HVPPS | HIV Ab Differentiation Prenatal, S | Yes | No |
| HPS12 | HIV-1/HIV-2 RNA Detect Prenatal, S | Yes | No |
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.
If the following result types are obtained from the HIV-1/-2 confirmation/differentiation test, HIV-1/HIV-2 RNA detection will be 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
For more information, see HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results
Chemiluminescent Microparticle Immunoassay
Acquired Immune Deficiency Syndrome (AIDS)
Anti-HIV
Anti-HIV-1/-2
HIV combo
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
Human Immunodeficiency Virus (HIV)
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.
If the following result types are obtained from the HIV-1/-2 confirmation/differentiation test, HIV-1/HIV-2 RNA detection will be 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
For more information, see HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results
Serum
If specimen is from either autopsy or cadaver blood sources, the proper US Food and Drug Administration-licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.
This test should not be used to screen or test asymptomatic, nonpregnant individuals. For testing such patients, order HIVSS / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Serum.
New York State clients: This test should not be requested for maternal/newborn HIV screening on specimens originating in New York State, due to state regulatory requirements for expedited result reporting.
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2 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 serum into a plastic vial.
If not ordering electronically, complete, print, and send an Infectious Disease Serology Test Request (T916) with the specimen.
1.2 mL
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 6 days | |
| Frozen | 30 days |
Screening for HIV-1 and/or HIV-2 infection in nonsymptomatic pregnant patients
This test should not be used as a screening or confirmatory test for blood donor specimens.
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.
If the following result types are obtained from the HIV-1/-2 confirmation/differentiation test, HIV-1/HIV-2 RNA detection will be 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
For more information, see HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results
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 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.
Negative
Negative HIV-1/-2 antigen and antibody screening test results usually indicate absence of HIV-1 and HIV-2 infection. However, such negative results do not rule-out acute HIV infection. If acute HIV-1 or HIV-2 infection is suspected, detection of HIV RNA (HPS12 / HIV-1/HIV-2 RNA Detection, Prenatal, Serum) 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, see HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results
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 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
1. Chavez P, Wesolowski L, Patel P, Delaney K, Owen SM: Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab Combo assay. J Clin Virol. 2011 Dec;52(Suppl 1):S51-S55. doi: 10.1016/j.jcv.2011.09.010
2. Branson BM, Owen SM, Wesolowski LG, et al: Laboratory testing for the diagnosis of HIV infection: Updated recommendations. Centers for Disease Control and Prevention; June 27, 2014. Accessed May 3, 2021. Available at http://stacks.cdc.gov/view/cdc/23447
3. Centers for Disease Control and Prevention: 2018 Quick reference guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens. CDC; January 2018. Accessed May 3, 2021. Available at https://stacks.cdc.gov/view/cdc/50872
4. Centers for Disease Control and Prevention. Technical update: Use of the Determine HIV 1/2 Ag/Ab combo test with serum or plasma in the laboratory algorithm for HIV diagnosis. CDC; October 4, 2017. Accessed May 3, 2021. Available at https://stacks.cdc.gov/view/cdc/48472
5. Duncan D, Duncan J, Kramer B, et al: An HIV diagnostic testing algorithm using the cobas HIV-1/HIV-2 qualitative assay for HIV type differentiation and confirmation. J Clin Microbiol. 2021;59(7):e03030-20. doi: 10.1128/JCM.03030-20
The Abbott Architect HIV Ag/Ab Combo assay for use on the Architect i System is a 2-step immunoassay to determine the presence of HIV-1 p24 antigen, antibodies to HIV-1 (groups M and O), and antibodies to HIV-2 in human serum or plasma using chemiluminescent microparticle immunoassay technology. First, patient specimen, Architect i wash buffer, assay diluent, and paramagnetic microparticles are combined in a single reaction well. HIV-1 p24 antigen and HIV-1/HIV-2 antibodies present in the patient specimen bind to the HIV-1 antigen, HIV-2 antigen, and HIV-1 p24 monoclonal (mouse) antibody-coated microparticles. After washing, the bound HIV-1 p24 antigen and HIV-1/HIV-2 antibodies bind to the acridinium-labeled conjugates. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). The amount of HIV antigen and antibodies present in the patient specimen is directly proportionate to the RLU detected by the Architect i System optics. The presence or absence of HIV-1 p24 antigen or HIV-1/HIV-2 antibodies in the specimen is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined periodically by assay calibration. Patient specimens with signal-to-cutoff (S/CO) values greater than or equal to 1.00 are considered reactive for HIV-1 p24 antigen or HIV-1/HIV-2 antibodies. Specimens with S/CO values less than 1.00 are considered nonreactive or negative.(Package insert: HIV Ag/Ab Combo. Abbott Laboratories; 04/2020)
Monday through Saturday
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.
87389
G0475 (if appropriate)
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HVPRS | HIV-1/-2 Ag and Ab Prenatal Scrn, S | 56888-1 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| HIVS5 | HIV-1/-2 Ag and Ab Prenatal, S | 56888-1 |