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HIV-1/HIV-2 Diagnostic Testing

The Bloodborne Viruses Laboratory (BVL) provides a variety of referral testing services, including confirmation of reactive rapid tests, detection of suspected acute infections, and resolution of discrepant results. Contact the laboratory for more information and to request approval to submit specimens. After receiving approval to submit specimens, follow the collection and shipping guidelines for the test requested, complete the DOH-49 test requisition form in full, and choose the appropriate test from the HIV testing menu:

  • Choose HIV diagnostic testing for primary HIV screening
     
  • Choose HIV diagnostic testing and HIV rapid test confirmation for confirming reactive HIV rapid tests
     
  • Choose HIV-1 qualitative RNA testing for specimens with a reactive HIV screening test and negative or indeterminate supplemental antibody test
     
  • Choose HIV-defendant testing for court-ordered defendant testing

The BVL follows the CDC's Recommended Laboratory HIV Testing Algorithm for Serum or Plasma Specimens. The BVL also offers HIV rapid test confirmation for dried blood spot (DBS) specimens using an alternative algorithm. HIV rapid testing sites must be enrolled for DBS confirmation testing by the NYSDOH. Sites must complete training on DBS collection and shipping prior to submitting DBS to the BVL. For information on enrolling your site for HIV DBS testing contact RTPAI@health.ny.gov.

HIV Diagnostic Tests Available

HIV Ag/Ab Testing: BVL uses an FDA-approved chemiluminescent microparticle immunoassay that detects HIV-1 p24 antigen and IgM/IgG antibodies to HIV-1 (groups M and O) and HIV-2 in human serum and plasma.  A reactive result does not distinguish between the detection of HIV-1 p24 antigen, HIV-1 antibody, or HIV-2 antibody.  As with all immunoassays, there may be nonspecific reactions due to a variety of causes.  A repeatedly reactive result is considered preliminary and supplemental testing of the specimen is required to produce a final interpretation. This test is for plasma and serum only. 

HIV-1/2 Supplemental Antibody Testing: The BVL performs supplemental testing to confirm the presence of HIV-1 and HIV-2 antibodies in plasma and serum using an FDA-approved single-use, immunochromatographic assay. The BVL has also validated and received NYSDOH Clinical Laboratory Evaluation Program (CLEP) approval to conduct this supplemental HIV-1/2 antibody test on dried blood spots using a modified protocol. Supplemental HIV-1/2 antibody testing is intended only for specimens that are reactive on an HIV screening assay.

HIV-1 RNA Testing: The BVL conducts qualitative HIV-1 RNA testing by real-time transcription-mediated amplification (TMA) using a modified FDA-approved method. The BVL has conducted validation studies and has received NYSDOH CLEP approval to perform TMA for qualitative detection of HIV-1 RNA on plasma, serum and dried blood spots (DBS). The BVL has determined the limit of detection for plasma (20 copies/mL), serum (8 copies/mL) and DBS (2500 copies/mL). HIV-1 qualitative RNA results are reported as detected or not detected.

HIV-2 Nucleic Acid Testing: The BVL uses a NYSDOH CLEP-approved real-time PCR assay to detect and quantify HIV-2 RNA.