Preferred LOINCS (Logical Observation Identifiers Names and Codes)

FDA-Approved Test Methods Applicable to the HIV Diagnostic Testing Algorithm

Clinical laboratories must adhere to the manufacturer's specifications for all tests that have been approved by the FDA. Any modification to the manufacturer's package insert must be validated, and validation data for the modification must be submitted to the NYSDOH Clinical Laboratory Evaluation Program (CLEP) for approval prior to use on clinical specimens.

As of May 16, 2013, the following test kits have been approved by the FDA to aid in the diagnosis of HIV infection and meet the criteria specified for each step of the HIV Diagnostic Testing Algorithm. The Department's preferred LOINC codes for reporting test results in the Electronic Clinical Laboratory Reporting System (ECLRS) are listed. Updates to this table will be posted as they are updated.

Test Kit Name Test Manufacturer Preferred LOINC
Step 1. HIV-1/HIV-2 AG/Ab combo immunoassay (4th Generation)
  • Abbot Architect HIV Ag/Ab Combo Assay
  • GS HIV Ag/Ab Combo EIA
  • Abbot Laboratories
  • Bio-Rad Laboratories
  • 56888-1
  • 56888-1
Step 1. HIV-1/HIV-2 immunoassay (3rd Generation)
  • Abbott PRISM HIV O Plus Assay
  • ADVIA Centaur HIV 1/O/2 Enhanced Assay
  • GS HIV-1/HIV-2 + O EIA
  • Ortho Vitros Anti HIV 1+2
  • Abbott Laboratories
  • Siemens Healthcare Diagnostics
  • Bio-Rad Laboratories
  • Ortho-Clinical Diagnostics
  • 48345-3, 579-5
  • 48345-3, 579-5
  • 48345-3, 579-5
  • 31201-7
Step 2. HIV-1/HIV-2 antibody differentiation immunoassay
  • Multispot HIV-1/HIV-2 Rapid Immunoassay1
  • Bio-Rad Laboratories
  • 69668-2
Step 3. HIV-1 RNA assay2
  • Aptima HIV-1 RNA Qualitative Assay
  • Hologic Gen-Probe
  • 5018-7, 5017-9, 25835-0

1The Multispot test was originally approved by the FDA in 2004 as a laboratory rapid test to detect and differentiate antibodies to HIV-1 and HIV-2. The manufacturer has received approval from the FDA for a modification to the package insert that includes instructions for use of the Multispot test in the HIV Diagnostic Testing Algorithm. Consult the package insert for detailed instructions on use of the test.

2The currently available FDA-approved quantitative HIV-1 RNA tests (i.e. viral load tests) are not labled for diagnostic use.

Note: There are no FDA-approved HIV-2 RNA or DNA tests currently available. A laboratory-developed HIV-2 RNA test that has been approved for diagnostic use is available at the NYSDOH Wadsworth Center. If HIV-2 RNA testing is warrented, contact the Wadsworth Center at (518) 474-2163.