Test ID: RHIV
HIV Antibody Rapid Test Confirmatory Profile, 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
Follow-up serologic testing of patients with reactive rapid HIV antibody screening test results
Confirmatory testing by Western blot is recommended on serum specimens that are reactive by the rapid HIV antibody tests, even if the chemiluminescence immunoassay results are non-reactive in these patients
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CTHIV | HIV-1/-2 Ab Screen, S | No | Yes |
| WBAR | HIV-1/-2 Ab Confirm Eval, S | Yes | Yes |
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 |
| 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.
When this test is ordered, both HIV-1/-2 antibody screen and HIV-1/-2 antibody confirmatory testing will always be performed.
If HIV-1/-2 antibody confirmatory evaluation is negative, then HIV-2 antibody evaluation is performed at an additional charge.
If HIV-1/-2 antibody confirmatory evaluation is indeterminate or uninterpretable, then HIV-1 antibody confirmation by immunofluorescence and HIV-2 antibody evaluation are performed at an additional charge.
If HIV-2 antibody evaluation is reactive, then HIV-2 antibody confirmation will be performed at an additional charge.
The following algorithms are available in Special Instructions:
-HIV Rapid Serologic Testing Follow-up Algorithm
-HIV Treatment Monitoring 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
CTHIV/26312: Chemiluminescence Assay
WBAR/23878: Western Blot
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
Human Immunodeficiency Virus (HIV)
Rapid HIV Antibody Confirmation
Rapid Human Immunodeficiency Virus-1 (HIV-1) Confirmation
Western Blot Assay
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: 2 mL
Collection Instructions: Spin down and remove serum from clot within 24 hours.
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
AIDS is caused by at least 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, exposure to infected blood or blood products, or from an infected mother to her fetus or infant. HIV type 2 (HIV-2) was 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 into 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 should only be performed on specimens that are repeatedly reactive by EIA or CIA.
In testing algorithms that begin with rapid HIV antibody tests, confirmatory antibody testing should be performed regardless of the result of the EIA or CIA tests. Since individuals at risk for HIV infection may have negative HIV antibody screening test results by EIA or CIA with indeterminate Western blot (WB) results (especially during early stage of infection), such individuals may be interpreted erroneously not to have HIV infection despite having reactive rapid HIV antibody test results. The positive predictive values of rapid HIV antibody tests are low (<50%) in populations with low prevalence rates (<1%) of HIV infection. To rule-out HIV infection in high-risk, rapid test-positive patients, the appropriate follow-up serologic tests should include HIV-1 antibody by WB assay (see WBAR/23878 HIV-1/-2 Antibody Confirmatory Evaluation, Serum) with or without HIV-1/-2 antibody screening by EIA or CIA. HIV-1 antibody by WB assay should be done regardless of the anti-HIV-1 screening test result. The WB testing contains sequential reflexive testing for HIV-2 antibody by EIA (see HIV2/86702 HIV-2 Antibody Evaluation, Serum), HIV-1 antibody confirmation by IFA (see HIVFA/81758 HIV-1 Antibody Confirmation by Immunofluorescence, Serum), and HIV-2 antibody confirmation by immunoblot assay when necessary.
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. 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 (IFA) is necessary to verify the presence of HIV-1 infection. Presence of HIV-2 infection is confirmed by the HIV-2 antibody-specific immunoblot assay.
A negative HIV-1/-2 antibody screening test result indicates the absence of HIV-1 or HIV-2 infection. However, confirmatory HIV-1 antibody testing by WB (WBAR/23878 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.
Result of the confirmatory HIV-1 antibody WB assay is interpreted as positive when at least 2 of the 3 following bands are present: p24, gp41, and gp120/160. A positive HIV-1 antibody WB result with a reactive rapid HIV antibody test result indicates presence of HIV-1 infection, regardless of the HIV-1/-2 antibody screening test result, but it does not indicate the stage of the HIV-1 infection. 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.
For asymptomatic individuals with reactive rapid HIV test results, negative HIV-1 antibody WB results with either reactive or negative HIV-1/-2 antibody screening test results most likely indicate false-reactive rapid HIV antibody test results. However, a negative HIV-1 antibody WB result does not exclude the possibility of early HIV-1 or HIV-2 infection. If the HIV-1 antibody WB test result is negative, the HIV-2 antibody test by EIA will be performed automatically (at an additional charge).
Indeterminate HIV-1 antibody WB results occur when bands are present but the patterns do not meet the criteria for a positive result. Indeterminate results may indicate a) early, late, or incomplete HIV-1 antibody reactivity, b) presence of HIV-2 antibodies, or c) presence of nonspecific cross-reactive antibodies. For specimens with indeterminate WB results, confirmatory HIV-1 antibody testing by IFA) and HIV-2 antibody testing by EIA will be performed automatically (at additional charges).
Indeterminate WB patterns can be found in up to 15% of persons without evidence of HIV infection. Individuals with persistent, stable, indeterminate HIV-1 antibody WB results but without risk factors should be monitored for 6 months. If no additional WB bands develop during that time, the patient is determined not to be HIV-infected.
An uninterpretable HIV-1 antibody WB result indicates the presence of smear or blotches obscuring proper reading of the WB strip, in the absence of discrete bands. Such findings indicate probable nonspecific binding of antibodies in the patient's serum to the WB strip. For specimens with such uninterpretable WB results, confirmatory HIV-1 antibody test by IFA and HIV-2 antibody testing by EIA will be performed automatically (at additional charges).
See HIV Rapid Serologic Testing Follow-up Algorithm and HIV Treatment Monitoring Algorithm in Special Instructions.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The US Association of Public Health Laboratories recommends verification of all positive confirmatory HIV antibody test results prior to the clinical diagnosis of HIV infection. A second serum specimen should be obtained from the patient and submitted for repeat testing to verify all positive confirmatory test results.
Although repeatedly positive confirmatory HIV antibody test results indicates HIV infection, a diagnosis of AIDS can only be made based on the case definition of AIDS established by the CDC.
High-risk individuals with reactive rapid HIV-1 antibody test results but negative HIV-1/-2 antibody screening test results and indeterminate or negative HIV-1 antibody Western blot (WB) results should be retested 1 to 3 months. Repeat testing may be done by a combination of either rapid HIV antibody test with HIV-1 antibody WB or routine HIV-1/-2 antibody screening test with HIV-1 antibody WB.
Positive HIV antibody WB results in infants of < or =18 months of age and born to HIV-infected mothers may indicate passive transfer of maternal HIV antibodies. 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 of age). Diagnosis of HIV infection in newborns and infants should be made by virologic tests such as detection of HIV RNA (HIVQU/81958 HIV-1 RNA Quantification, Plasma) or HIV proviral DNA (PHIV/88635 HIV-1 Proviral DNA Qualitative Detection by PCR, Blood).
Assay performance characteristics have not been established for the following specimen characteristics:
-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
-Individuals of <2 years of age
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Center for Disease Control and Prevention: Protocols for confirmation of reactive rapid HIV tests. MMWR Morb Mortal Wkly Rep 2004;53:221-222
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. 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
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
HIV 1 and 2 Antibody Screen
HIV-1/-2 screening chemiluminescent immunoassay: 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 on the VITROS ECi/ECiQ Immunodiagnostic System. 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)
HIV 1 and 2 Antibody Confirmatory Evaluation
Samples are diluted and applied to the nitrocellulose strip containing specific protein bands derived from purified, inactivated HIV-1 strain lymphadenopathy associated virus (LAV) grown in the CEM cell line. If specific HIV-1 antibodies are present, they bind to these proteins resolved on the strip. Unbound sample is removed by washing. The phosphatase-labeled conjugate is then added to the strip and allowed to incubate. The conjugate attaches to antibody already bound to viral proteins on the strip. Excess conjugate is removed by washing. Color development reagent is then added to the strip. Reaction sites, where enzyme-labeled antibody is bound, are identified by dark bands. The position and intensity of the bands are compared to reference strips developed using positive control sera. All specimens yielding indeterminate or uninterpretable results are retested, and results are reported based on the best 2 out of 3 replicate testing.(Package insert: Genetic Systems HIV-1 Western blot. 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.
HIV-1/-2 antibody screen: Monday through Saturday
HIV-1/-2 antibody confirmatory evaluation: Monday through Friday
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.
86689-HIV-1 antibody
86703-HIV-1 and HIV-2
86689 x 2-HIV-1 and HIV-2 (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 |
|---|---|---|
| HIV1 | HIV-1/-2 Ab Evaluation, S | 7918-6 |
| 9190 | HIV-1 Ab Confirm Western Blot, S | 5221-7 |
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