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Test ID: HIVE
HIV-1/-2 Antibody Evaluation, Serum

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Screening and confirmation of HIV-1 and/or HIV-2 infection

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 IDReporting NameAvailable SeparatelyAlways Performed
HIVFAHIV-1 Ab Confirm by IFA, SYesNo
HIV2HIV-2 Ab Eval, SYesNo
WBARHIV-1/-2 Ab Confirm Eval, SYesNo
HIV2LHIV-2 Ab Confirmation, SYesNo

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 screen by the chemiluminescence immunoassay method. If HIV-1/-2 antibody screen chemiluminescence immunoassay result 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 assay and, when appropriate and at an additional charge, HIV-2 antibody screen by EIA, HIV-1 antibody confirmation by immunofluorescence assay, and HIV-2 antibody confirmation by line immunoassay.

 

The following algorithms are available in Special Instructions:

-HIV Rapid Serologic Testing Follow-up Algorithm

-HIV Testing Algorithm (excludes HIV rapid testing)

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

Chemiluminescence Assay

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

HIV-1/-2 Ab Evaluation, S

Aliases Lists additional common names for a test, as an aid in searching

Acquired Immune Deficiency Syndrome (AIDS)
Anti-HIV
Anti-HTLV III
HIV Types 1/2 Antibody, Serum
HIV-1/-2 Ab
HIV-1/-2 Antibodies
HIV-1/-2
Human Immunodeficiency Virus (HIV)
Western Blot Assay

Specimen Type Describes the specimen type needed for testing

Serum SST

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: 3 mL

Collection Instructions: Spin down and remove serum from clot within 24 hours.

Additional Information:

1. If this test is ordered as a follow-up evaluation of a specimen with a reactive rapid HIV antibody test result, clients should change test request to RHIV / HIV Antibody Rapid Test Confirmatory Profile, Serum, so that both the initial chemiluminescence immunoassay and confirmatory testing can be done (as per CDC recommendations).

2. If specimens are autopsy or cadaver blood sources, the proper FDA-licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.

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.

0.5 mL

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 TypeTemperatureTime
Serum SSTFrozen (preferred)30 days
 Refrigerated 7 days
 Ambient 24 hours

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) was isolated from patients with AIDS, AIDS-related complex, and 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) was first isolated from patients in West Africa in 1986. It appears to be endemic only in West Africa and it also 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 in the terminal stage of AIDS.

 

Routine serologic screening of patients at risk for HIV-1 or HIV-2 infection usually begins with a HIV-1/-2 antibody screening test, which may be performed by various FDA-approved assays, including rapid HIV antibody tests, EIA, and chemiluminescent immunoassay (CIA) methods. In testing algorithms that begin with EIA or CIA methods, confirmatory antibody testing by Western blot assay should only be performed on specimens that are repeatedly reactive by EIA or CIA.

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

A reactive HIV-1/-2 antibody screening test result suggests the presence of HIV-1 and/or HIV-2 infection, but it is not diagnostic for HIV infection and should be considered preliminary. This result 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. Presence of HIV-2 infection is confirmed by supplemental testing with an HIV-2 antibody-specific line immunoassay.

 

All specimens that are reactive by HIV-1/-2 antibody screening test will be automatically tested by WBAR / HIV-1/-2 Antibody Confirmatory Evaluation, Serum at an additional charge. See the individual test IDs for interpretation of these subsequent test results. All initially positive confirmatory HIV antibody test results should be verified by submitting a second serum specimen for repeat testing. Positive confirmatory HIV antibody test results are required under laws in many states to be reported to the departments of health of the respective states where the patients reside.

 

A negative HIV-1/-2 antibody screening test result indicates the absence of HIV-1 or HIV-2 infection. However, confirmatory testing by WB (WBAR / HIV-1/-2 Antibody Confirmatory Evaluation, Serum) is necessary for specimens that are reactive by the rapid HIV antibody tests; even if the screening test results are negative.

 

The following algorithms are available in Special Instructions:

-HIV Rapid Serologic Testing Follow-up Algorithm

-HIV Testing Algorithm (excludes HIV rapid testing)

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 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.

 

This test is not indicated for screening or confirmatory testing of patients with reactive results obtained using rapid HIV antibody tests.

 

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 for the test. Diagnosis of HIV infection must be based on positive results from confirmatory or supplemental serologic or molecular tests.

 

Negative HIV-1/-2 antibody screening test results should be evaluated cautiously in patients with clinical symptoms and/or a history of high-risk behavior for HIV infection. The CDC recommends confirmatory testing by Western blot on serum specimens that are reactive by the rapid HIV antibody tests; even if the initial screening test results are negative.

 

Serologic tests (screening and confirmatory) 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). Diagnosis of HIV infection in newborns and infants should be made by virologic tests such as detection of HIV RNA (HIVQU HIV-1 RNA Quantification, Plasma) or HIV proviral DNA (PHIV / HIV-1 Proviral DNA Qualitative Detection by PCR, Blood).

 

Performance characteristics have not been established for the following specimen characteristics:

-Individuals of <2 years of age

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Grossly lipemic (triolein level of >3,000 mg/dL)

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Containing particulate matter

Supportive Data

There was 100% agreement among 50 confirmed HIV-1 antibody-positive (by Western blot) and 50 HIV-1/-2 antibody screen-negative (Bio-Rad SD HIV-1/HIV-2 Plus O EIA) clinical serum specimens tested by this VITROS Anti-HIV 1+2 assay.

 

Testing of 1 known-negative and 3 known-positive serum specimens in duplicate over 10 assay runs showed inter-assay %CV ranging from 7.2% to 12.6% for the signal-to-cutoff (S/CO) ratios, with total agreement in the interpretive results.

 

Total agreement in interpretive results was observed among single aliquots of 2 known-negative and 3 known-positive (with low to high S/CO values) serum specimens (plastic screw-capped vials) tested at each of 5 freeze-thaw cycles. For 2 known-negative and 3 known-positive serum specimens stored in plastic serum gel tubes for 7 days at 2 degrees to 8 degrees C, testing on day 1, 3 and 7 of storage showed good stability (100% agreement of interpretive results) of these specimens under such condition.

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 from URL: http://hivinsite.ucsf.edu/InSite?page=kb-00&doc=kb-02-02-01

2. Branson BM, Handsfield HH, Lampe MA: Center 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. Clin Microbiol Rev 2007;20:478-488

4. Owen SM, Yang C, Spira T: 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 VITROS Anti-HIV 1+2 assay is performed using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack and the VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator. An immunometric bridging technique is used, involving a 2-stage reaction. In the first stage, HIV antibody present in the sample binds with HIV recombinant antigen coated on the wells. Unbound sample is removed by washing. In the second stage, horseradish peroxidase (HRP)-labeled recombinant HIV antigens are added in the conjugate reagent. The conjugate binds specifically to any human anti-HIV-1 or anti-HIV-2 (IgG and IgM) captured on the well in the first stage. Unbound conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS ECi/ECiQ Immunodiagnostic System. The amount of HRP conjugate bound is indicative of the level of anti-HIV-1 or anti-HIV-2 present.(Package insert: VITROS Anti-HIV 1+2, Ortho Clinical Diagnostics Inc., Raritan, NJ; publication no. GEM1252_EN)

Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 Saturday; 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

2 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

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)

86689-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 IDReporting NameLOINC Code
HIV1HIV-1/-2 Ab Evaluation, S7918-6