Test ID: HIV2M
HIV-2 Antibody Screen, Serum
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Screening for and detection of HIV-2 antibodies in asymptomatic individuals
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 |
|---|---|---|---|
| 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.
If HIV-2 antibody by EIA is repeatedly reactive, then HIV-2 antibody confirmation for confirmatory/supplemental testing will be added at an additional charge.
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
Method Name A short description of the method used to perform the test
Enzyme Immunoassay (EIA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
AIDS (Acquired Immune Deficiency Syndrome)
HIV (Human Immunodeficiency Virus)
HIV 2 Ab
HIV-2 Ab
HIV2 Antibody
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: 1.2 mL
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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Refrigerated | 7 days | |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Epidemiologic data suggest that AIDS is caused by at least 2 types of HIV, HIV-1 and HIV-2. HIV-1 has been isolated from patients with AIDS and asymptomatic infected individuals. The closely related HIV-2 was first isolated from patients in West Africa in 1986, and the first case of AIDS due to HIV-2 in a patient was reported in the United States in 1988. HIV-2 appears to be endemic only in West Africa, but HIV-2 also has been identified in individuals who have lived in West Africa or had sexual relations with individuals from that region. HIV-2 infection is rare in the United States (<100 cases reported to date); most of the reported cases are from the northeastern states and involve persons from West Africa.
Both HIV-1 and HIV-2 are transmitted by sexual contact, sharing contaminated needles, exposure to infected blood or blood products, or from an infected mother to her fetus or infant. During the course of HIV-2 infection, antibodies are formed against the viral proteins p26 and gp34. Immunosuppressed patients may fail to develop these antibodies. Patients with positive results on HIVE/9333 HIV-1/-2 Antibody Evaluation, Serum and indeterminate or negative results on HIV-1 Western blot, especially those that react only with core (p18, p24, or p55) and polymerase (p31, p51, or p66) proteins should be investigated for the presence of HIV-2 antibodies.
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
See HIV Serologic Interpretive Guide in Special Instructions for further interpretive information.
Interpretation Provides information to assist in interpretation of the test results
Reactive screening test results suggest the presence of HIV-2 antibodies. All repeatedly reactive serum specimens are automatically confirmed by an HIV-2 antibody immunoblot assay with an additional charge. HIV-2 antibody immunoblot results are reported as either "Positive," "Negative," or "Indeterminate."
Negative screen results indicate the absence of HIV-2 antibodies. These results should be interpreted with caution in patients who are at high risk or have symptoms or signs of HIV infection.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test should be ordered only to screen or HIV-2 antibodies in asymptomatic individuals with or without risk factors for this infection.
For testing symptomatic patients (ie, diagnostic purposes) with or without risk factors for HIV-2 infection, order HIV2/86702 HIV-2 Antibody Evaluation, Serum.
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.
All results that are reactive by HIV-2 antibody screening test and positive by confirmatory test should be verified by testing second serum specimens. Positive confirmatory HIV-2 antibody test results are required by statute in most states to be reported to the state departments of health for surveillance of communicable diseases.
False-reactive HIV-2 antibody screening test results may occur in patients with HIV-1 infection due to cross-reactivity of HIV-1 antibodies with the viral core and polymerase proteins used in the HIV-2 antibody screening tests.
Patients at risk for HIV-2 infection and suspected to have acute HIV-2 infection may have a) negative HIV-2 antibody screen results, or b) repeatedly reactive HIV-2 antibody screen results but negative or indeterminate confirmatory test results. For such patients, testing for HIV-2 RNA or proviral DNA (FHV2Q/91490 HIV-2 DNA/RNA Qualitative Real-Time PCR) is recommended.
Assay performance characteristics have not been established for the following types of serum specimen:
-Grossly icteric
-Grossly lipemic
-Grossly hemolyzed
-Cadaveric specimens
-Presence of particulate matter
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Constantine N: HIV antibody assays-May 2006. HIV InSite Knowledge Base (online textbook); Available from URL: http://hivinsite.ucsf.edu/InSite?page=kb-00&doc=kb-02-02-01
2. Branson BM, Handsfield HH, Lampe MA, et al: 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 Bio-Rad GS HIV-2 EIA is manufactured from virus that was isolated from the peripheral blood lymphocytes of a West African man. The virus, which is designated HIV-2, is propagated in a CEM cell line. The infected cell line is cultured and the virus is purified by centrifugation. The viral concentrate is disrupted and inactivated using a chaotropic agent and heat before being absorbed onto wells of a microwell plate. Specimens to be tested are diluted in specimen diluent and added to each well, incubated with the absorbed antigen, and washed. If antibodies to the virus are present, they bind to antigen and are not removed by washing. The conjugate reagent, peroxidase-labeled goat antihuman immunoglobulin, is then added to the wells and will bind to the antibody-antigen complex, if present. Unbound conjugate is removed by a wash step. Next, chromogen buffered substrate reagent is added to the plate and allowed to incubate. A blue or blue-green color develops in proportion to the amount of antibody that has been bound to the antigen-coated plate. The enzyme reaction is stopped by the addition of acid. This will result in a color change to yellow. The optical absorbance of controls and specimens is determined with a spectrophotometer with wavelength set at 450 nm. (Package insert: Human Immunodeficiency Virus Type 2 GS HIV-2 EIA: Bio-Rad Laboratories, Redmond, 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 through 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.
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.
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.
G0432-HIV-2 antibody screen
86689-HIV-2 line immunoassay (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 |
|---|---|---|
| 60356 | HIV-2 Ab Screen, S | 30361-0 |
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