| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
HIV Ag/Ab, 4th Gen, Reflex
MessageChemistry
Test Code
LAB5210361
Alias/See Also
HIV-1/2 Rapid Antibody, HIV P24 Antigen w/ reflex
CPT Codes
87389
Includes
Human Immunodeficiency Virus Antigen + Antibody
Preferred Specimen
Gold top (serum separator tube)
Minimum Volume
Whole blood: 800 uL (TWO full red-top microtainers).
Serum/plasma: 400 uL
Serum/plasma: 400 uL
Other Acceptable Specimens
Red Top tube acceptable
Instructions
This test is for the simultaneous qualitative detection of antibodies to Human Immunodeficiency Virus types 1, including group M and O, and/or 2 (anti-HIV-1 and anti-HIV-2) and HIV p24 antigen in human serum in adults, pregnant women, adolescents and children (as young as 2 years of age). A reactive test result with this test does not distinguish between the detection of HIV-1 p24 antigen, antibodies to HIV-1 and antibodies to HIV-2. The results of the test, in conjunction with other serological evidence and clinical information, may be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2.
It is not intended for newborn screening or for use with cord blood specimens or specimens from individuals less than 2 years of age.
Reflex Testing: all specimens "reactive" for HIV-1/2 antibodies or p24 antigen will be sent for confirmatory testing at Quest Diagnostics at an additional charge to the patient. When so indicated, Lab will automatically reflex order "HIV 1/2 Antigen and Antibodies, Fourth Generation [LAB5210553]" Confirmatory testing at Quest Diagnostics which may include: HIV-1/2 Ab/Ag 4th Gen Screen HIV-1/2 Ab Differentiation, HIV-1 Qualitative RNA, and TMA.
Patients <2 years of age instead order HIV RNA QUAL [LAB5210299]. Draw 3-4 red microtainers. Minimum volume= 0.6 mL. Quest test code:16185
NOTE: Initial orders for "Needlestick, Source Patient" will use label code, Source Patient Exposure Panel. Results of "Reactive" must be phone to EHS, and will automatically reflex confirmatory testing to Quest.
REFERENCE DEPT: If reflex testing to Quest from a reactive HIV is indicated, see"HIV 1/2 Antigen and Antibodies, Fourth Generation [LAB5210553]" Confirmation for processing. For newborns and patients <2 years, alternate testing is HIV 1 RNA Qual. Credit the HIV; Process samples as above.
Transport Temperature
Refrigerated
Specimen Stability
Room Temperature: <1 day
Refrigerated: 7 days
Frozen: Indefinite.
Refrigerated: 7 days
Frozen: Indefinite.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolyzed specimens
Methodology
Chemiluminescence
FDA Status
Approved
Setup Schedule
Daily
Report Available
Same Day
Limitations
This test may not give reactive test results in all infected individuals, therefore, a negative test result does not exclude the possibility of exposure or infection with HIV. HIV antibodies and/or p24 antigen may be undetectable in some stages of the infection and in some clinical conditions.
Reference Range
Negative
Clinical Significance
Acquired Immunodeficiency Syndrome (AIDS) is caused by two types of human immunodeficiency viruses designated HIV-1 and HIV-2. The HIV Combo test uses 3 recombinant antigens derived from HIV-1 envelope (env13), HIV-1 group O envelope (env70-3) and HIV-2 envelope (env31). These antigens detect antibodies to HIV-1 and antibodies to HIV-2 in the same test. The use of these recombinant antigens improves test specificity by avoiding non-specific reactions due to cross-reaction with human cell proteins which are present in cell lysates. The HIV Combo test also uses antibodies to HIV p24 antigen to enable detection of HIV p24 antigen that may be present prior to the onset of antibody response enabling earlier diagnosis of HIV-1 infection.
Performing Laboratory
Hoag Newport/ Hoag Irvine
Additional Information
HIV 1/2 and AB Confirmation
