HIV-1 Antibody Confirmation by Immunofluorescence, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Confirmatory detection of HIV-1 antibodies in human serum specimens that are repeatedly reactive by antibody screening assays or showed indeterminate or uninterpretable results by HIV-1 antibody Western blot
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
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
Indirect Immunofluorescence Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HIV-1 Ab Confirm by IFA, S
HIV-1 AB, IFA
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
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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 reject
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
HIV type 1 (HIV-1) is the major etiologic agent of AIDS. The virus is transmitted through sexual contact, by exposure to blood (including sharing contaminated needles and syringes) or certain blood products, or from an infected mother to her fetus or child during the perinatal period. HIV-1 has been isolated from patients with AIDS or AIDS-related complex and from healthy persons at high risk for AIDS. Although there are 2 types of AIDS-causing viruses, namely HIV-1 and HIV-2, infections with HIV-2 outside of West Africa are uncommon.
This assay can be used to confirm the presence of HIV-1-specific antibodies when the initial screening assay is repeatedly reactive.
See HIV Serologic Screening Algorithm (excludes HIV rapid testing), and HIV Rapid Serology 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 negative result indicates the absence of HIV-1 specific antibodies.
A positive result indicates the presence of HIV-1 specific antibodies.
An indeterminate result does not imply that HIV-1 antibodies are present or absent in the serum specimen. Rather, it indicates that HIV-1 antibody status of the specimen cannot be resolved through the use of this assay. The correct approach in such situations should be based on subsequent repeat testing and the patient's clinical findings.
See HIV Serologic Screening Algorithm (excludes HIV rapid testing) and HIV Rapid Serology Follow-up Algorithm in Special Instructions.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not offered for maternal/newborn HIV-1 antibody confirmation for specimens originating in New York.
Some individuals infected with HIV-2 may have antibodies that can bind to viral antigens present on the HIV-1 antibody immunofluorescence assay (IFA) slides.
Specimens from icteric patients may cause false-positive or indeterminate test results.
This assay is not FDA-approved for testing cadaveric or hemolyzed specimens.
Assay performance characteristics have not been established for the following types of serum specimens:
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly lipemic (triglyceride level of >500 mg/dL)
-Grossly hemolyzed (hemoglobin level of >180 mg/dL)
-Presence of particulate matter
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Sullivan MT, Mucke H, Kadey SD, et al: Evaluation of an indirect immunofluorescence assay for confirmation of human immunodeficiency virus type 1 antibody in U.S. blood donor sera. J Clin Microbiol 1992;30:2509-2510
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 Recomm Rep 2006;55;1-17
3. Hariri S, McKenna MT: Epidemiology of human immunodeficiency virus in the United States. Clini Microbiol Rev 2007;20:478-488
Method Description Describes how the test is performed and provides a method-specific reference
The assay is performed by indirect IFA, using immortalized human T cells that express HIV-1 antigen on their surface. The cells are fixed to the surface of a glass slide. Fixed, uninfected T cells are used as a control. To perform the assay, a serum sample is diluted and placed in the infected and uninfected wells of the IFA slide and incubated. When a serum sample with HIV-1 antibodies comes in contact with the HIV-1 antigens on the slide, antigen-antibody binding takes place. Unbound material is removed by aspiration and washing. Bound HIV-1-specific antibodies are detected with anti-human immunoglobulin conjugated to fluorescein isothiocyanate, which binds human antibodies and fluoresces when exposed to ultraviolet light. Unbound material is removed by aspiration and washing. A glass coverslip is mounted to the slide and the slide is viewed under a microscope with ultraviolet light. The interpretation of the degree and pattern of fluorescence of the infected cells of the IFA slide compared with the uninfected cells determines the HIV-1 status of the sample.(Package insert: Human Immunodeficiency Virus Type 1 (HIV-1) Fluorognost HIV-1 IFA. Sanochemia Pharmazeutika AG, Vienna, Austria 2007)
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; 10 a.m.
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.
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.
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|
|81758||HIV-1 Ab Confirm by IFA, S||14092-1|