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Epic Test Code LAB473 HIV-1, 2 antibodies and  p24 antigen

Performing Location(s)

BMC

Specimen Type

Plasma

Preferred Container

Lav Top Tube

Blood Tube Draw Volume

Min 50% draw volume  

Minumum Volume to Submit for Testing

1.0 mL EDTA Plasma

  • Multiple test may be performed from this volume. For question please contact the lab at 547-3975.  

Transportation Needs

Deliver specimen to the laboratory within 1 hour of collection. If not possible see “storage requirements”

Storage Requirements

  • Sample tubes should be centrifuged within 24 hours of collection followed by the transfer of the plasma  to a labeled plastic, aliquot tube
  • Store spun or unspun specimens at room temp for upto 3 days. If delay in transport > 24 hours is expected refrigerate sample. 

Causes for Rejection

Mislabeled or unlabeled specimen
Less than 50% draw for Vacutainer tubes
Hemolysis ≥ (500 mg/dL HgB)
Lipemia ≥ (1200+-50 mg/dL Trig)
Bilirubin ≥ (20 mg/dL Bili)
Plasma >7 days refrigerated
Whole blood or Plasma > 3 days  room temp
Heparin, NaF, Citrate, Oxalate,Serum 
Newborn or Cord Blood
Children <2 years of age

Limitations

  • Preliminary positive results with this test will be confirmed by Antibody Differentiation. (LAB37881)  
  • It is recognized that currently available assays for the detection of antibodies to HIV-1 and/or HIV-2 may not detect all infected individuals. A negative result does not exclude the possibility of exposure to or infection with HIV. HIV antibodies and p24 antigen  may be undetectable in some stages of infection and in some clinical conditions
  • The performance of the assay has not been established for population of infants or children or cord blood.
  • An individual who has antibodies to HIV is presumed to be infected. However an individual who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV.
  • A Negative test does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV 2 as levels may be below the limit of infection.
  • Performance of this test has not be validated on children <2 years of age. These patients require LAB3788 HIV-1 RNA Detection and Quantification, Plasma.
  • Specimens from patient who have received mouse monoclonal antibodies (HAMA) for diagnosis or therapy may exhibit either falsely elevated or depressed levels.
  • Hydrophobic antibodies in human serum may interfere, and additional info may be needed for specimens from patients with Non-Hodgkin’s Lymphoma.

Reference Values

 

Population Units Reference Range
All Populations none Antibody and Antigen Non-reactive

A non-reactive result does not exclude the possibility of exposure or infection to HIV as may be below the limit of detection of the assay.

Presumptive Positive results will be reflexed to confirmatory testing.

Reflex Testing

A HIV-1 and HIV-2 Antibody Differentiation (CPT: 86701 and 86702)  will be performed and billed on all positives as required by NYSDOH.

Includes

Screen for HIV types 1, Sub group 0 and HIV2 antibodies and p24 antigen.

If positive, screen is repeated.

If repeat is positive, the specimen will be sent to referral laboratory for HIV-1 and HIV-2 Antibody Differentiation.(LAB37881)

All Positive results will be called/Tiger Texted to ordering practitioner.

Additional Information

Other Requirements::

  • The test is to determine the presence or absence of antibody or antigen to Human Immunodeficiency Virus (HIV)
  • The test for HIV antibody or antigen is voluntary.
  • This test is not diagnostic for AIDS. Though most patients with AIDS or the AIDS-Related Complex have antibody to HIV, the reverse is not necessarily true. You may have antibody and not develop AIDS.
  • Repeatedly reactive HIV screening tests may be evidence of infection and may imply risk to develop AIDS or ARC. All positive screening tests will be confirmed.

 

Additional Information:

This test detects HIV-1 HIV-2 and Group 0 peptide antibodies and p24 antigen.

 

Preliminary positive HIV Screens will  be reported to NYSDOH. 

  • Post-test counseling for people with a confirmed test HIV positive including partner notification services and prompt referral for evaluation of their clinical status and consideration for antiretroviral therapy. The NYS Department of Epidemiology and Counseling, a division of the Department of Health consider it best practice to conduct an in-person meeting to provide the results and counsel the patient. Having a face-to-face meeting is not mandated by law, but is strongly recommended.
  • Both the CDC and NYS recommend that people who test HIV negative be informed of the meaning of their test result and that high risk individuals should be referred for prevention services.  In NYS, post-test counseling for a negative HIV test can be streamlined. This does not have to be in-person. A simple one page patient handout is available from NYS Department of Health and is CDC compliant.

 

 

 

The following resource may be useful.

http://www.health.ny.gov/diseases/aids

 

 

Days of Analysis

All

Available STAT

Yes

All Positive results will be called/Tiger Texted to ordering practitioner.

Methodology

Two Step Chemilumimetric Immunoassay

CPT Code

87389

Last Updated

17-Nov-22 BHD