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HIV 1/2 Ag/Ab. Screen
Test CodeLAB6701
Alias/See Also
HIV1/2 Antibody Antigen
CPT Codes
87806
Minimum Volume
Must submit 2 unopened tubes for possible reflex testing
Instructions
"Routine venipuncture Collect two 5ml Red/gold top serum separator tubes"
Specimen Stability
Serum specimens may be stored at room temperature (15- 30°C) for up to two days before testing. If testing will not be performed within two days of sample collection, serum should be stored at 2- 8°C if the test is to be run within 7 days of collection.
Methodology
Alere Determine™ HIV–1/2 Ag/Ab Combo is an immunochromatographic test for the simultaneous and separate qualitative
detection of free HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2.
Setup Schedule
Daily/STAT
Report Available
Within 24 hours
Limitations
Test has not been evaluated for patients less than 12 years old. If testing is needed on a patient under 12 years old, please order send out test: Quest 91431, HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes.
Specimens from individuals infected with HIV-1 and/or HIV-2 who are receiving antiretroviral (ART) therapy may
produce false negative test results.
Specimens from individuals with Toxoplasma IgG, human anti-mouse antibodies, rheumatoid factor, elevated
triglycerides (above 600 mg/dL), herpes simplex virus infection, hospitalized and cancer patients may give false
positive test results.
Specimens from individuals infected with HIV-1 and/or HIV-2 who are receiving antiretroviral (ART) therapy may
produce false negative test results.
Specimens from individuals with Toxoplasma IgG, human anti-mouse antibodies, rheumatoid factor, elevated
triglycerides (above 600 mg/dL), herpes simplex virus infection, hospitalized and cancer patients may give false
positive test results.
Reference Range
HIV-1 P24 Antigen not detected.
HIV-1 and/or HIV-2 Antibodies not detected.
Clinical Significance
Tests reported as POSITIVE are PRELIMINARY POSITIVE and will be sent out to a reference lab for confirmatory testing.
A test that is POSITIVE for HIV-1 and/or HIV-2 Antibodies in the absence of reactivity for HIV-1 P24 Antigen is interpreted as PRELIMINARY POSITIVE for HIV-1 and/or HIV-2 antibodies.
A test that is PRELIMINARY POSITIVE for HIV-1 P24 Antigen in the absence of reactivity for HIV-1 or HIV-2 Antibodies may indicate an acute HIV-1 infection.
A test that is POSITIVE for HIV-1 and/or HIV-2 Antibodies in the absence of reactivity for HIV-1 P24 Antigen is interpreted as PRELIMINARY POSITIVE for HIV-1 and/or HIV-2 antibodies.
A test that is PRELIMINARY POSITIVE for HIV-1 P24 Antigen in the absence of reactivity for HIV-1 or HIV-2 Antibodies may indicate an acute HIV-1 infection.
Additional Information
HIV_Ab-Ag_Screening_CMs_2016
CDC_Recommendations_For_HIV_Testing_Algorithm
NCD HIV Testing (Prognosis Including Monitoring)
NCD HIV Testing (Diagnosis)
