Florida Bureau of Public Health laboratories
HIV-1 OraSure Diagnostic Algorithm
As an alternative to blood testing, this FDA approved specimen type for HIV-1 Ab only detection. The algorithm consists of up to two serial tests (HIV-1 Ab Enzyme Immunoassay (EIA) and HIV-1/HIV-2 Ab Supplemental DPP). This algorithm is traditionally used in outreach settings; however, it does not differentiate acute from established HIV infections.
Analyte(s)
HIV-1
Test Code
0520
Testing Location
Jacksonville Laboratory
Testing Department
Retrovirology (HIV)
Pre-approval Required?
No
Required Forms
BPHL Test Requisition, DH1847
(not needed if orders are placed via electronic order)
Supply Ordering
Supplies may be requested from your servicing laboratory. Supplies ordered from BPHL should only be used for specimen sent to the BPHL for testing.
Turn Around time
2-3 business days after receipt at the laboratory.
Minimum Volume
Device preset. Do not pour out media.
Collection Media
OraSure Collection Devices® manufactured by Orasure Technologies, Inc (OTI)
Specimen Sources
Oral swab
Specimen Labeling
Specimen must be labeled with at least two unique patient identifiers, ex: Name and DOB, and the date of collection.
Information on the specimen must match the requisition and/or test order.
Special SPecimen Preparation
OraSure Collection Devices® manufactured by Orasure Technologies, Inc (OTI). Each OraSure Collection Device has an expiration date, displayed as “year (20xx)/month (xx)”. Please make sure the device has NOT expired prior to use. Expired devices cannot be tested at the BPHL.
Storage Conditions
Collected OraSure specimens may be stored at 2°– 37°C for a maximum of 21 days (including time for shipping and testing).
Packaging and Shipping
OraSure specimens may be shipped overnight, 2-day delivery or hand delivered Monday-Friday at 2-37°C, using cold packs as needed. Specimen needs to be received at the lab within 21 days of collection.
unsatisfactory specimen
1) Expired collection device used for specimen collection
2) No ID on specimen
3) Information on specimen does not match requisition/test order
4) Grossly hemolyzed
5) Leaked in transit
7) No specimen received with test order
8) Bloods received greater than 6 days post-collection
9) Specimen not centrifuged
10) Quantity not sufficient (QNS)
11) Patient age is not appropriate for testing
Interferences and Limitations
OraSure Collection Device is intended for person >13 years of age.
This specimen collection device is NOT suggested for suspect HIV-2
infections.
Reference Range
HIV-1 Negative
Result Indicator
HIV-1 Positive
HIV-1 Negative
Inconclusive
Reference lab
None
Reflex testing
Recollect a blood specimen if the OraSure result is Inconclusive