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HIV Supplemental Assay - Geenius

Laboratory Fee Schedule
Procedure #:  MBP0231A 
CPT:  86701, 86702 

Synonym(s):  HIV Supplemental Assay, HIV-1/HIV-2 Antibody Differentiation, HIV-1/2 Antibody, Anti-HIV
Requisition Form N/A

Test Description

The Geenius™ HIV 1/2 Supplemental Assay is an immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2).

Pre-Approval

Needed

N/A

Supplemental Information Required

N/A
Supplemental Form(s) N/A
Performed on Specimens from (sources) Human
Sample/Specimen Type for Testing Serum collected in serum separator tube (SST) or red top tubes.
Minimum Volume/Size Required 50 µL
Storage/Preservation Prior to Shipping
  • Store at 2-8° C for up to 5 days.
  • For long term storage, store frozen at -20°C or below.
Transport Medium N/A
Specimen Labeling
  • Two patient-specific identifiers required on specimen (e.g., patient full name, date of birth, medical record number). 
  • Three patient identifiers are preferred. 
  • Patient identifiers on specimen label must exactly match identifiers on submission form (e.g., abbreviated name on label and full name on form is not acceptable).  
  • Additional DSHS Laboratory specimen labeling guidelines available online here. 
Shipping and Specimen Handling Requirements
  • Ship according to Dangerous Goods Regulations, IATA, and/or CFR 49.
  • Category B Biological Substance, UN3373 shipping requirements apply.  
  • Handle as infectious agent using universal precautions. 
  • Triple contained in accordance with federal shipping regulations for infectious agents.  
  • Submitters are responsible for packaging and shipping specimens according to regulatory requirements.  
  • Additional DSHS Laboratory specimen shipping guidelines online here.  
Method Immunochromatography
Turn-around Time 2 working days 
Interferences/Limitations
  • The homology between HIV-1 and HIV-2 viruses can lead to cross-reactivity between anti-HIV-1 and anti-HIV-2 antibodies. 
  • False negative results may occur in individuals infected with HIV-1 and/or HIV-2 who are receiving antiretroviral therapy (ART), post-exposure prophylaxis (PEP), or pre-exposure prophylaxis (PrEP).
Common Causes for Rejection
  • Insufficient specimen quantity.
  • Unacceptable specimen type or source.
  • Improper shipping conditions.
  • Expired media or collection container.
  • Expired reagents/media/collection container. 
  • Discrepancies between G-2A submission form and specimen label. 
  • Missing/incomplete/illegible submission form or label.
Additional Information  The HIV Supplemental Assay is a reflex test only and cannot be requested as a stand-alone test.