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Rapid HIV Reporting and Algorithm Changes - New Test Bulletin

Thursday, January 3, 2019

Laboratory Alliance of Central New York uses the Alere Determine™ HIV–1/2 Ag/Ab Combo test for rapid HIV screens with expedited reporting of preliminary reactive results prior to completion of confirmatory testing.  This test was recently approved to be the first step in the CDC HIV diagnostic algorithm and as such, reactive results must be reported to the New York State Department of Health Bureau of HIV/AIDS Epidemiology.  Although specimen requirements and availability of testing are unchanged, reporting of results and confirmatory testing will be updated, effective January 8, 2019. 

Currently, results of HIV1 p24 antigen and results of HIV1/2 antibody (undifferentiated) are reported as two individual tests within the rapid screen test code.  Effective January 8, 2019, results will be reported under one test code.  Although the ordering code and test name are unchanged, components of the test battery corresponding to individual antigen and antibody tests will be replaced with a new component representing the rapid screen preliminary results and entitled HIV RAPID SCR PRELIM.  Possible results for the screen will be as follows:

NEGATIVE

ANTIBODY REACTIVE

ANTIGEN REACTIVE

ANTIBODY REACTIVE AND ANTIGEN REACTIVE

Negative screens will be appended with a comment indicating that the result is final.  Screens reactive for antibody and/or antigen will reflexively order the antibody differentiation test (2nd step in the algorithm).  If results of the differentiation test do not confirm the screen result, qualitative HIV-1 RNA by TMA (Transcription Mediated Amplification) will be reflexively ordered to complete the 3rd step in the algorithm.

These reporting changes are pertinent to the rapid HIV screen only, which is intended to be used in situations where results are desired to be reported immediately, without concurrent reporting of required confirmatory testing.  Examples include, but are not limited to:

  • Emergency room patients
  • Labor and Delivery patients
  • Source patient in employee exposure to blood-borne pathogens
  • Patients at high risk of infection

The automated HIV1/2 4th gen screen should be used for most routine screening situations.

Please see the entire test bulletin here for complete information.

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