HIV Supplemental Assay - Geenius

Procedure #: MBP0231A

CPT: 86701, 86702Additional

Synonym(s):	HIV Serum Confirmation Test
Requisition Form	N/A
Test Description	The Geenius™ HIV 1/2 Supplemental Assay is a single-use 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 Specimen
Sample/Specimen Type for Testing	Serum collected in 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. Store frozen at -20° C or colder for long term storage.
Transport Medium	N/A
Specimen Labeling	At least 2 patient specific identifiers: First and last name as one identifier and a DOB or a unique patient specific identifier (e.g. Medical Record number); must match information on submission form (G-2A).
Shipping and Specimen Handling Requirements	Ship according to Dangerous Goods Regulations, IATA, and/or CFR 49. Handle as infectious agent using universal precautions. Triple contained in accordance with federal shipping regulations for infectious agents. Additional forms & resources
Method	Immunochromatography
Turn-around Time	2 working days
Interferences/Limitations	Material must be viable. Improper storage or shipping temperatures limit organism recovery.
Common Causes for Rejection	Insufficient quantity, unacceptable specimen type or source, improper shipping conditions, expired media or collection container, discrepancies between specimen label and submission form, and/or incomplete or missing submission form.
Additional Information	Supplemental assay to be completed per CDC algorithm. This is a reflex test only. Not a stand-alone assay. If not in TAC or fee schedule then cannot submit on template but add to another one.