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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

Lab

STI & Arbovirus Laboratory 401-222-5591

Analyte Name

STI & Arbovirus Laboratory 401-222-5591

Disease

Human Immunodeficiency Virus/AIDS (HIV/AIDS)

Test Description

HIV testing is performed using FDA cleared assays, namely the ALINITY HIV Ag/Ab Combo Assay (Abbott Diagnostics) for screening, 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/hiv/guidelines/testing.html 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.

Special Instructions

HEALTH CARE WORKER EXPOSURES WILL BE EXPEDITED: Contact the STD & Arbovirus Laboratory for additional instructions at (401) 222-5591

Specimen

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 two patient identifiers on the specimen container and the test requisition (e.g., patient first & last name, DOB, unique patient identifier such as medical record number)

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form.

https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

HIV

For patients receiving injectable PrEP treatment, also write HIV RNA in the comments section of the RISHL requisition.

Transport

Transport as soon as possible at 2 ° - 8°C on cold pack.

Specimens must be packaged & transported in accordance with current federal shipping regulations.

Containers specifically labeled for transport of specimens to the RISHL STI & Arbovirus Laboratory are available in all Serology Laboratories and Laboratory Sendout Departments.

Integrity

Non-hemolyzed

Normal Value

Negative

Reporting Requirement

Providers must report patient information on Human Immunodeficiency Virus/AIDS within 4 days using the RIDOH reportable disease form.

Turnaround Time

Screen: 3 business days

Confirmation: 5 business days