HIV Antigen/Antibody Combo (HIV-1 & HIV-2)
| Label Mnemonic: | HIV |
| Epic code: | LAB7444 |
| Downtime form: | Doctor/Provider Orders - Pathology Core and Specialty Care Nursery |
Chemistry
6240 RCP
356-3527
6240 RCP
356-3527
Specimen(s):
Plasma
Collection Medium:
 |
| Plasma Separator Tube 4.5 mL |
Minimum:
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:
Negative
Comments:
Methodology for HIV screening changed on 1/18/22 to the Roche Diagnostics Elecsys HIV Duo assay for the cobas 8000 analyzer which detects the following:
• HIV p24 antigen
• HIV-1 antibodies (including groups M and O)
• 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:
Below are hyperlinks to the education and minor informed consent forms:
Consent for HIV-Related Testing in Minors
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:
Consent for HIV-Related Testing in Minors – Due to a Healthcare Worker Exposure
• HIV p24 antigen
• HIV-1 antibodies (including groups M and O)
• 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:
Consent for HIV-Related Testing in Minors
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:
Consent for HIV-Related Testing in Minors – Due to a Healthcare Worker Exposure
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.
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.
Methodology:
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
See also:
HIV-1/HIV2 Antibody Differentiation by Geenius Assay, Plasma
HIV-1/HIV2 Antibody Differentiation by Geenius Assay, Plasma