HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosis of HIV-1 and/or HIV-2 infection in cadaveric or hemolyzed serum specimens from symptomatic patients with or without risk factors for HIV infection (assay kit is FDA-approved for testing cadaveric or hemolyzed blood specimens)
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
|Test ID||Reporting Name||Available Separately||Always Performed|
|HIVFA||HIV-1 Ab Confirm by IFA, S||Yes||No|
|HIV2||HIV-2 Ab Eval, S||Yes||No|
|WBAR||HIV-1/-2 Ab Confirm Eval, S||Yes||No|
|HIV2L||HIV-2 Ab Confirmation, S||Yes||No|
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
This test begins with HIV-1/-2 antibody EIA. If HIV-1/-2 antibody EIA is reactive, then HIV-1/-2 antibody confirmatory evaluation is performed at an additional charge.
HIV-1/-2 antibody confirmatory evaluation is a reflex test that includes HIV-1 Western blot (WB) assay and, when appropriate and at an additional charge, HIV-2 EIA, HIV-1 immunofluorescence, and HIV-2 antibody confirmation.
The following algorithms are available in Special Instructions:
-HIV Testing Algorithm (excludes HIV rapid testing)
-HIV Rapid Serologic Testing Follow-up Algorithm
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Enzyme Immunoassay (EIA)-Screening Procedure
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HIV-1/-2 Cadaver/Hemolyzed, S
Acquired Immune Deficiency Syndrome (AIDS)
AIDS (Acquired Immune Deficiency Syndrome)
HIV (Human Immunodeficiency Virus)
Human Immunodeficiency Virus (HIV)
AIDS (Acquired Immune Deficiency Syndrome)
HIV (Human Immunodeficiency Virus)
Human Immunodeficiency Virus (HIV)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 mL
Collection Instructions: Spin down and remove serum from clot within 24 hours.
1. If this test is ordered as a follow-up evaluation of a specimen with a reactive rapid HIV antibody test result, clients must call Mayo Medical Laboratories at 800-533-1710 or 507-266-5700 to add supplemental testing by Western blot if the initial EIA result is negative.
2. Indicate if specimens are from autopsy/cadaver sources so that the proper FDA-licensed assay can be performed.
3. To screen for HIV antibodies in hemolyzed specimens from nonsymptomatic individuals with or without risk factors for HIV infection, order HV1CM/60357 HIV-1 and HIV-2 Antibody Screen for Hemolyzed Specimens, Serum.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross OK
Mild OK; Gross reject
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum SST||Frozen (preferred)|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Epidemiological data indicate that AIDS is caused by at least 2 types of HIV. The first virus, HIV-1, has been isolated from patients with AIDS, AIDS-related complex, and asymptomatic infected individuals at high risk for AIDS. HIV-1 is transmitted by sexual contact, exposure to infected blood or blood products, or from an infected mother to her fetus or infant. A second HIV virus, HIV-2, was isolated from patients in West Africa in 1986. HIV-2 appears to be endemic only in West Africa, but it also has been identified in individuals who have lived in West Africa or had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in its morphology, overall genomic structure, and its ability to cause AIDS.
Antibodies against HIV-1 and HIV-2 are usually not detected until 6 to 12 weeks following exposure and are almost always detected by 12 months. They may fall into undetectable levels in the terminal stage of AIDS.
See HIV Testing Algorithm (excludes HIV rapid testing) and HIV Rapid Serologic Testing Follow-up Algorithm in Special Instructions.
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.
See HIV Serologic Interpretive Guide in Special Instructions for further interpretive information.
A reactive HIV-1/-2 antibody screen result obtained by EIA suggests the presence of HIV-1 and/or HIV-2 infection. However, it does not differentiate between HIV-1 and HIV-2 antibody reactivity. Confirmatory testing by HIV-1 antibody-specific Western blot (WB) or immunofluorescence assay is necessary to verify the presence of HIV-1 infection. The presence of HIV-2 infection is screened by HIV-2 antibody-specific EIA with confirmation by HIV-2 antibody-specific immunoblot assay.
All EIA-reactive specimens tested will automatically be tested by WBAR/23878 HIV-1/-2 Antibody Confirmatory Evaluation, Serum at an additional charge. Please see the individual unit code for interpretation of these subsequent test results. All confirmed antibody-positive test results should be verified by submitting a second serum specimen for retesting.
A negative HIV-1/-2 antibody EIA screen result indicates the absence of HIV-1 or HIV-2 infection. However, confirmatory testing by WB (WBAR/23878 HIV-1/-2 Antibody Confirmatory Evaluation, Serum) is recommended for specimens that are reactive by the rapid HIV antibody tests, even if the EIA results are negative.
See HIV Testing Algorithm (excludes HIV rapid testing) and HIV Rapid Serologic Follow-up Testing Algorithm in Special Instructions.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
All tests in WBAR/23878 HIV-1/-2 Antibody Confirmatory Evaluation, Serum have not been FDA-approved for testing on cadaveric specimens.
This test is not offered as a screening or confirmatory test for blood donor specimens.
This test is not offered for maternal/newborn HIV screening for specimens originating in New York.
The predictive value of a reactive (or positive) test 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 of the test.
Negative results should be evaluated cautiously if the patient has clinical symptoms and/or a history of high-risk behavior for HIV infection. The CDC recommends confirmatory testing by WB on serum specimens that are reactive by the rapid HIV antibody tests, even if the initial EIA results are negative.
Screening and confirmatory tests for HIV-1/-2 antibodies cannot distinguish between active neonatal HIV infection and passive transfer of maternal HIV antibodies in infants during the postnatal period (up to 18 months of age). Reactive and confirmed positive antibody test results in infants during this period may indicate passive transfer of maternal HIV antibodies.
A reactive screen and confirmed HIV antibody test result should be reported by the health care provider to the State Department of Health in accordance with the legislation in some states.
Assay performance characteristics have not been established for the following specimen characteristics:
-Containing particulate matter
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Constantine N: HIV antibody assays May 2006. In HIV InSite Knowledge Base (online textbook). Available at URL: http://hivinsite.ucsf.edu/InSite?page=kb-00&doc=kb-02-02-01
2. Centers for Disease Control and Prevention: Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Morb Mortal Wkly Rep 2006;55(RR14):1-17
3. Hariri S, McKenna MT: Epidemiology of human immunodeficiency virus in the United States. Clin Microbiol Rev 2007;20:478-488
4. Owen SM, Yang C, Spira T, et al: Alternative algorithms for human immunodeficiency virus infection diagnosis using tests that are licensed in the United States. J Clin Microbiol 2008;46:1588-1595
Method Description Describes how the test is performed and provides a method-specific reference
The Genetic Systems HIV-1/HIV-2 PLUS O EIA is based on the principle of direct antibody sandwich technique. Microwell-strip plates (solid-phase) are coated with purified HIV antigens: gp190 and p24 recombinant proteins derived from HIV-1, gp36 peptide representing the immunodominant region of the HIV-2 transmembrane glycoprotein, and a synthetic polypeptide mimicking an artificial (not encoded by any existing virus) HIV-1 group O-specific epitope.
Serum samples and assay controls are added to the plate with specimen diluent containing a dye that changes color from purple to blue when combined with a specimen sample or control. The wells are incubated and then washed. Following addition of a colored conjugate solution (green) that contains the peroxidase-conjugated HIV-1 and HIV-2 antigens, the wells are incubated again. If anti-HIV-1 and/or anti HIV-2 antibody is present, it will not bind to the antigen coated on the well and to the peroxidase-conjugated antigens in the conjugate solution. The antigen-antibody-antigen complexes remain bound to the well during a subsequent wash step that will remove any unbound materials. Working chromogen solution (TMP) is added to the plate wells and allowed to incubate. A blue or blue-green color develops in proportion to the amount of HIV antibody present in the sample. Color development is stopped by the addition of acid, which changes the blue-green color to yellow. The optical absorbance of specimens and controls is determined spectrophotometrically at a wavelength of 450 nm.(Package insert: Genetics Systems HIV-1/HIV-2 PLUS O EIA. Bio-Rad Laboratories, Redman, WA)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday, Wednesday, Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86703-HIV-1 and HIV-2, single assay
86689-HIV-1 confirmation by Western blot (if appropriate)
86689-HIV-1 confirmation by immunofluorescence (if appropriate)
86702-HIV-2 line immunoassay (if appropriate)
86702-HIV-2 antibody evaluation (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|83628||HIV-1/-2 Cadaver/Hemolyzed, S||31201-7|