10.0 mL blood pearl-top tube (PTT) preferred. Also acceptable gold-top tube, red-top tube, and EDTA lavender-top tube.
Specimen Required
2.0 mL plasma
Specimen Min Vol
1.0 mL plasma
Specimen Preparation
Spin down and separate plasma
Storage/Transport Temperature
Refer to Specimen stability criteria as shown below
Stability (from collection to initiation)
After Separation from cells:
Ambient
3 days
Refrigerated
7 days
Frozen
1 year
Unacceptable Conditions
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers
Special Instructions
Available ONLY to the following patient groups: •Women in labor or women who have delivered without previous prenatal care •Newborns of mothers who decline testing •Patients in the emergency department •Referral clients when the patient requires immediate medical intervention •Samples submitted through Occupational Health for employees exposed to body fluids
CPT Codes
87389 86701 if reflexed 86702 if reflexed
Synonyms
STAT HIV Antibody
Methodology
Chemiluminescence Immunoassay
Performing Location
Microbiology
Reported STAT
3 hours
Reported Routine
Not available, refer to routine HIV testing, test code VISHAA
Additional Information
This is a 4th generation test that screens for HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. A repeatedly Reactive result will be reflexed to an HIV-1/HIV-2 antibody differentiation assay. Per CDC guidelines, Negative or Indeterminate test results by the HIV-1/HIV-2 differentiation assay should be tested with an FDA approved HIV-1 NAT. A nonreactive test result does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. HIV antibodies and HIV-1 p24 antigen may be undetectable in some stages of the infection and in some conditions. In specimens from people at risks for HIV infection, a reactive result is highly predictive of the presence of HIV-1/HIV-2 antibodies and/or HIV-1 p24 antigen and should be followed-up with appropriate FDA-approved supplemental tests for HIV-1 and/or HIV-2 antibody differentiation before making the diagnosis of HIV infection. An individual who has antibodies to HIV and/or HIV-1 p24 antigen is presumed to be infected with the virus; however, an individual who has participated in an HIV vaccine study may develop antibodies to the vaccine, and may or may not be infected with HIV. Clinical correlation is indicated with appropriate counseling, medical evaluation, and possibly additional testing to decide whether a diagnosis of HIV infection is accurate. California State Law prohibits disclosure of HIV test results to a third party without prior patient consent.
Test set up frequency
Daily
Reference Interval
Nonreactive: No HIV-1 or HIV-2 antibodies detected; No HIV-1 p24 antigen detected Reactive: HIV-1 antibodies, HIV-2 antibodies detected and/or HIV p24 antigen detected.
Additional Information
This is a 4th generation test that screens for HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. A repeatedly Reactive result will be reflexed to an HIV-1/HIV-2 antibody differentiation assay. Per CDC guidelines, Negative or Indeterminate test results by the HIV-1/HIV-2 differentiation assay should be tested with an FDA approved HIV-1 NAT. A nonreactive test result does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. HIV antibodies and HIV-1 p24 antigen may be undetectable in some stages of the infection and in some conditions. In specimens from people at risks for HIV infection, a reactive result is highly predictive of the presence of HIV-1/HIV-2 antibodies and/or HIV-1 p24 antigen and should be followed-up with appropriate FDA-approved supplemental tests for HIV-1 and/or HIV-2 antibody differentiation before making the diagnosis of HIV infection. An individual who has antibodies to HIV and/or HIV-1 p24 antigen is presumed to be infected with the virus; however, an individual who has participated in an HIV vaccine study may develop antibodies to the vaccine, and may or may not be infected with HIV. Clinical correlation is indicated with appropriate counseling, medical evaluation, and possibly additional testing to decide whether a diagnosis of HIV infection is accurate. California State Law prohibits disclosure of HIV test results to a third party without prior patient consent.
NICU/Peds Minimum Specimen Requirements
Collect 2 full - 0.5 mL gold or red top Microtainer® tubes
Collection
Collect
10.0 mL blood pearl-top tube (PTT) preferred. Also acceptable gold-top tube, red-top tube, and EDTA lavender-top tube.
Specimen Required
2.0 mL plasma
Specimen Min Vol
1.0 mL plasma
Specimen Preparation
Spin down and separate plasma
Storage/Transport Temperature
Refer to Specimen stability criteria as shown below
Stability (from collection to initiation)
After Separation from cells:
Ambient
3 days
Refrigerated
7 days
Frozen
1 year
Unacceptable Conditions
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers
Special Instructions
Available ONLY to the following patient groups: •Women in labor or women who have delivered without previous prenatal care •Newborns of mothers who decline testing •Patients in the emergency department •Referral clients when the patient requires immediate medical intervention •Samples submitted through Occupational Health for employees exposed to body fluids
Test Info
CPT Codes
87389 86701 if reflexed 86702 if reflexed
Synonyms
STAT HIV Antibody
Methodology
Chemiluminescence Immunoassay
Performing Location
Microbiology
Reported STAT
3 hours
Reported Routine
Not available, refer to routine HIV testing, test code VISHAA
Additional Information
This is a 4th generation test that screens for HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. A repeatedly Reactive result will be reflexed to an HIV-1/HIV-2 antibody differentiation assay. Per CDC guidelines, Negative or Indeterminate test results by the HIV-1/HIV-2 differentiation assay should be tested with an FDA approved HIV-1 NAT. A nonreactive test result does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. HIV antibodies and HIV-1 p24 antigen may be undetectable in some stages of the infection and in some conditions. In specimens from people at risks for HIV infection, a reactive result is highly predictive of the presence of HIV-1/HIV-2 antibodies and/or HIV-1 p24 antigen and should be followed-up with appropriate FDA-approved supplemental tests for HIV-1 and/or HIV-2 antibody differentiation before making the diagnosis of HIV infection. An individual who has antibodies to HIV and/or HIV-1 p24 antigen is presumed to be infected with the virus; however, an individual who has participated in an HIV vaccine study may develop antibodies to the vaccine, and may or may not be infected with HIV. Clinical correlation is indicated with appropriate counseling, medical evaluation, and possibly additional testing to decide whether a diagnosis of HIV infection is accurate. California State Law prohibits disclosure of HIV test results to a third party without prior patient consent.
Test set up frequency
Daily
Result Interpretation
Reference Interval
Nonreactive: No HIV-1 or HIV-2 antibodies detected; No HIV-1 p24 antigen detected Reactive: HIV-1 antibodies, HIV-2 antibodies detected and/or HIV p24 antigen detected.
Additional Information
This is a 4th generation test that screens for HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2. A repeatedly Reactive result will be reflexed to an HIV-1/HIV-2 antibody differentiation assay. Per CDC guidelines, Negative or Indeterminate test results by the HIV-1/HIV-2 differentiation assay should be tested with an FDA approved HIV-1 NAT. A nonreactive test result does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. HIV antibodies and HIV-1 p24 antigen may be undetectable in some stages of the infection and in some conditions. In specimens from people at risks for HIV infection, a reactive result is highly predictive of the presence of HIV-1/HIV-2 antibodies and/or HIV-1 p24 antigen and should be followed-up with appropriate FDA-approved supplemental tests for HIV-1 and/or HIV-2 antibody differentiation before making the diagnosis of HIV infection. An individual who has antibodies to HIV and/or HIV-1 p24 antigen is presumed to be infected with the virus; however, an individual who has participated in an HIV vaccine study may develop antibodies to the vaccine, and may or may not be infected with HIV. Clinical correlation is indicated with appropriate counseling, medical evaluation, and possibly additional testing to decide whether a diagnosis of HIV infection is accurate. California State Law prohibits disclosure of HIV test results to a third party without prior patient consent.
NICU/Pediatric Info
NICU/Peds Minimum Specimen Requirements
Collect 2 full - 0.5 mL gold or red top Microtainer® tubes
