Human Immunodeficiency Virus (HIV)
Clinical Specimen Submission Guidance
Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM
STI & Arbovirus Laboratory 401-222-5591
Human Immunodeficiency Virus/AIDS (HIV/AIDS)
Human Immunodeficiency Virus/AIDS (HIV/AIDS)
HIV screening is performed using the FDA cleared assay ALINITY HIV Ag/Ab Combo Assay (Abbott Diagnostics).
The Geenius HIV 1/2 Supplemental Assay (Bio-Rad) for confirmation and the HIV-1 RNA Qualitative Assay (Hologic) for confirmation.
The performance characteristics of these assays were verified by the RISHL.
The RISHL testing algorithm is https://health.ri.gov/publications/guidleines/AlgorithmForHIVConfirmatoryTesting.pdf
The CDC's HIV laboratory testing algorithm https://www.cdc.gov/hivpartners/php/guidelines/?CDC_AAref_Val is utilized to interpret the combined laboratory results and should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis.
HEALTH CARE WORKER EXPOSURES WILL BE EXPEDITED: Contact the STD & Arbovirus Laboratory for additional instructions at (401) 222-5591
Screening:
Collect minimum 2.5 mL serum or plasma or 5 mL whole blood in EDTA or heparin tube. Store at room temperature no more than 3 days (15-25°C), or 7 days refrigerated at 2 ° - 8°C.
Specimens must be received at the laboratory and tested within 7 days of collection.
Confirmation:
IF SUBMITTING FOR CONFIRMATION TESTING: ORIGINAL SPECIMEN TUBE MUST BE SENT TO RISHL
If specimen is not received in original tube the following comment will be added to the report "Specimen received was not in its original tube as is required for HIV Confirmatory testing".
Specimen stability is affected by elevated temperature. Whole Blood, plasma or serum may be stored for up to 72 hours from time of draw at <= 25°C; temperatures not to exceed 30°C are acceptable for no more than 24 hours. Specimens may be stored for up to 5 days at 2 ° - 8°C following centrifugation. Plasma separated from the cells may be stored for longer periods of time at <= -20°C before testing.
Patients Receiving Long-acting PrEP:
Submitters should include a request for an HIV RNA test if patients are on injectable pre-exposure prophylaxis (PrEP) for HIV prevention in people who have not been diagnosed with HIV, per current recommendations.
CLIA regulations require specimens be labeled with at least two patient identifiers. Examples of identifiers are first and last name, date of birth, chart/medical record number. The specimen container must be labeled to match the test requisition or the electronic order.
Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf
HIV
For patients receiving injectable PrEP treatment: write "HIV RNA" under Comments/Other Test Requests
Refrigerated: Transport and deliver to the laboratory within 24 hours of collection at 2-8°C in a cooler able to maintain specimen temperature. A plug-in electric cooler is recommended, however, a cooler packed with excess frozen gel packs is acceptable as long as the transport temperature is maintained at 2-8°C.
Specimens must be packaged & transported in accordance with current federal shipping regulations.
Non-hemolyzed
Negative
Providers must report patient information on Human Immunodeficiency Virus/AIDS within 4 days using the RIDOH reportable disease form.
Screen: 3 business days
Confirmation: 5 business days
Containers specifically labeled for transport of specimens to the RISHL STI & Arbovirus Laboratory are available in all Serology Laboratories and Laboratory Sendout Departments.