Test Id : HIVSP
HIV Antigen and Antibody Prenatal Routine Screen, Plasma
Useful For
Suggests clinical disorders or settings where the test may be helpful
Screening for HIV-1 and HIV-2 infection in nonsymptomatic pregnant patients
This test should not be used as a screening or confirmatory test for blood donor specimens.
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HVDSP | HIV Ab Differentiation Prenatal, P | Yes | No |
| HPP12 | HIV-1/HIV-2 RNA Detect Prenatal, P | Yes | No |
| HIQNP | HIV-1 RNA Detect/Quant Prenatal, P | Yes | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test begins with HIV-1/-2 antigen and antibody (Ab) screen by electrochemiluminescence 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
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
Method Name
A short description of the method used to perform the test
Electrochemiluminescence Immunoassay (ECLIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
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)
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test begins with HIV-1/-2 antigen and antibody (Ab) screen by electrochemiluminescence 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
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
Specimen Type
Describes the specimen type validated for testing
Plasma EDTA
Ordering Guidance
If the specimen is obtained from either autopsy or cadaver blood sources, order HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum which is the US Food and Drug Administration-approved assay for these specimen types.
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.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 mL
Collection Instructions:
1. Centrifuge blood collection tube per manufacturer’s instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Transfer plasma into a plastic vial.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
1 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
| Heat-inactivated specimen | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma EDTA | Frozen (preferred) | 30 days | |
| Refrigerated | 6 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Screening for HIV-1 and HIV-2 infection in nonsymptomatic pregnant patients
This test should not be used as a screening or confirmatory test for blood donor specimens.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test begins with HIV-1/-2 antigen and antibody (Ab) screen by electrochemiluminescence 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
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
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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, but HIV p24 antigen should be detectable and yield reactive results with the HIV antigen-antibody combination detection assays.
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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Negative
Interpretation
Provides information to assist in interpretation of the test results
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 (HPP12 / HIV-1/HIV-2 RNA Detection Prenatal, 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 added to 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.
The following algorithms are available:
-HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This assay has not been licensed by the US Food and Drug Administration for the screening of blood, plasma, cells, tissues, and cellular and tissue-based product donors.
For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.
A 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 or a history of high-risk behavior for HIV infection. Repeat testing in 1 to 2 months is recommended in these at-risk individuals.
Uninfected individuals undergoing antiretroviral therapy or taking pre-exposure prophylaxis or post-exposure prophylaxis may produce non-reactive or delayed reactive test results during early stages of infection when prophylaxis fails.
Individuals who have received mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies which may interfere in assays that employ mouse monoclonal antibodies, causing false-positive test results with this assay.
This assay has no biotin interference with serum concentrations up to 1200 ng/mL. Pharmacokinetic studies have shown that serum concentrations of biotin can reach up to 355 ng/mL within the first hour after biotin ingestion for subjects consuming supplements of 20 mg biotin per day. and up to 1160 ng/mL for subjects after a single dose of 300 mg biotin.
Assay performance characteristics have not been established for the following specimen characteristics or specimen types:
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Grossly lipemic (intralipid level of >2000 mg/dL)
-Grossly icteric (total bilirubin level of >66 mg/dL)
-Heat-inactivated specimens
-Cadaveric specimens
-Presence of particulate matter
-Specimen types other than plasma
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Centers for Disease Control and Prevention: 2018 Quick reference guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens. CDC; January 2018. Accessed October 16, 2023. Available at https://stacks.cdc.gov/view/cdc/50872
2. 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 October 16, 2023. Available at https://stacks.cdc.gov/view/cdc/48472
3. Muhlbacher A, Sauleda S, Piron M, et al. A multicentre evaluation of the Elecsys HIV Duo assay. J Clin Virol. 2019;112:45-50
4. 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
Method Description
Describes how the test is performed and provides a method-specific reference
The Elecsys HIV DUO assay is based on the sandwich principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HIV-1 p24 antigen (Ag) present in patient’s sample first reacts with biotinylated monoclonal anti-p24 antibodies and ruthenylated monoclonal anti-p24 antibodies, to form a sandwich complex. In a separate reaction vessel, HIV-1 and HIV-2 antibodies (Ab) present in the same sample react with biotinylated HIV-specific recombinant antigens/peptides and ruthenylated HIV-specific recombinant antigens/peptides, to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase) to each reaction vessel, the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixtures are then each aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode which induces chemiluminescent emissions that are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the reactions to the cutoff index (COI) values set from reagent lot-specific assay calibration for the corresponding HIV-1 p24 Ag and HIV Ab.(Package insert: Elecsys HIV DUO. Roche Diagnostics; v1.0, 12/2020)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Saturday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87389
G0475
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HIVSP | HIV-1/-2 Ag and Ab Prenatal Scrn, P | 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.
|
|---|---|---|
| HIVC5 | HIV-1/-2 Ag and Ab Prenatal Scrn, P | 56888-1 |