HIV Antigen/Antibody Combo (HIV-1 & HIV-2)
Label Mnemonic: HIV
Epic Lab Code: LAB7444
Downtime Form: A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
6240 RCP
Collection Medium:
Plasma Separator Tube 4.5 mL
3.0 mL whole blood from light green top tube or THREE Microtainer® devices (allows for reflex confirmation of positive results).
Testing Schedule:
24 hrs/day, 7 days a week, including holidays.
Turn Around Time:
2 hours (upon receipt in laboratory)
Reference Range:
This assay may be significantly impacted by high-dose biotin (>5 mg dose) taken within previous 12 hours. High concentrations of biotin may lead to falsely decreased results. These concentrations may be found in patients taking over-the-counter supplements with biotin content much higher than nutritional requirements for biotin. Specimens should not be collected until at least 12 hours after the last dose.

Methodology for HIV screening changed 7/16/2018 to the Roche Diagnostics Cobas 8000 analyzer HIV Combo Ag/Ab (ECLIA) Assay detects the following:
• HIV p24 antigen
• HIV-1 antibodies
• HIV-2 antibodies

Positivity for any combination of these three components is considered a positive result that reflexes to confirmation testing. Reactive specimens are tested in duplicate.

Repeatable positive plasma will be confirmed by HIV-1/HIV-2 Antibody Differentiation by Geenius (LAB8105) following the proposed CDC guidelines.

Effective 2/21/2013, the process for consent and documentation of consent for HIV testing will be done when placing an HIV order in Epic. There is no longer a need to obtain an "HIV Pre-Test Counseling Packet".

These changes align with current state law requirements for HIV testing and UI Healthcare Policy, Policy Governing Human Immunodeficiency Virus (HIV) Education, Testing, Reporting and Confidentiality. The summary of consent requirements are as follows:

For adults (18 years or older) able to consent: verbal
  consent must be obtained prior to testing.  Written consent
  is not necessary for adult patients.

• For minors (less than 18 years old): Before undergoing
  HIV test, a minor must be informed that the legal guardian
  will be notified if the result is confirmed as positive.
  Minors must give written consent for HIV testing and treatment
  services.  The consent form must note that that the legal guardian
  will be notified of confirmed positive results.

• For adults or minors unable to consent: The individual's
  guardian may give consent.  If the legal guardian cannot be
  located or is unavailable, a health care provider may
  authorize an HIV test when the test is necessary for diagnostic
  purposes to provide appropriate urgent medical care.

HIV orders in minors will all receive retrospective audit review to 
make sure proper written consent has been obtained and is scanned into 
the patient chart in Epic.

Below are hyperlinks to the education and minor informed consent forms:

G-2d16 Consent for Human Immunodeficiency Virus (HIV)-Related Testing to be used for Minors (<18 Years of Age)

HIV Pre-Test Education

A signed patient informed consent (where required for minors) to human immunodeficiency virus (HIV)-related testing should be kept on record with the patient medical record at the ordering physician office.

No results will be given by telephone. There is also a specific consent form in the event that a minor is the source patient for a blood borne pathogen exposure and HIV testing is needed as part of the management of this exposure:

G-2d16 Consent for Human Immunodeficiency Virus (HIV)-Related Testing Due to a Healthcare Worker Exposure to Body Fluids to be used for Minors (<18 Years of Age)
Test Limitations:
This test is not approved for use in children less than two years old (similar to many other HIV screening tests). For HIV screening in children less than two years, PCR testing is often used. Consultation with pediatric infectious disease specialists is recommended if unsure about testing approaches in children less than two years old.

Negative HIV screening test results should be evaluated with caution in patients with clinical symptoms and/or a history of high-risk behavior for HIV infection. Repeat testing in 1 to 2 months is recommended in these at-risk individuals.
Electrochemiluminescence Immunoassay (ECLIA)
CPT Code:
87389 (Electrochemiluminescence Immunoassay); if reflexed, add 86701 and 86702 Human Immunodeficiency Virus Types 1 and 2 (HIV-1/HIV-2) Antibody Differentiation by Geenius