HIV-1 Genotyping
Label Mnemonic: HIVGENO
Epic Lab Code: LAB5745
Downtime Form: A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
Commercial Mail-out Laboratory
5231 RCP
Collection Medium:
Pink top tube 6 mL (K2-EDTA) Pink top tube 6 mL (K2-EDTA)
Preferred Minimum: Draw TWO 6 mL pink EDTA tube
Rejection Criteria:
Serum. Heparinized specimens.
Delivery Instructions:
Deliver to laboratory immediately after collection. Separate plasma from cells within 6 hours.
Turn Around Time:
3-7 days upon receipt at reference laboratory
Reference Range:
By report
Interpretive Data:
This assay predicts HIV-1 resistance to protease and reverse transcriptase inhibitor anti-retroviral drugs. The protease gene and codons 1-335 of the reverse transcriptase gene of the viral genome are sequenced using the Viroseq™ HIV-1 Genotyping System kit. Drug resistance is assigned using ViroSeq™ software. The most current resistance algorithm and drug list is available by selecting the Drug Resistance Report above.

This test should be used in conjunction with clinical presentation and other laboratory markers. A patient's response to therapy depends on multiple factors including patient compliance, percentage of resistant virus population, dosing, and drug pharmacology issues. Resistance interpretations may vary with test method.

According to the Viroseq™ HIV-1 Genotyping System software manual, some insertions or deletions may be difficult to detect using this software. This test may not detect minor HIV-1 populations less than 20 percent of the total population.
This mailout test requires pathologist approval for orders during inpatient encounters. Mailouts staff will not process order without approval. The pathologist covering mailouts approval can be reached at pager #5379. If approval is given, the name of the pathologist can be selected in the drop-down menu to the right of the approval warning in Epic when ordering the test.

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 Health Care 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
Reverse Transcription Polymerase Chain Reaction/Nucleic Acid Sequencing
CPT Code:
See also:
HIV Phenotyping & Genotyping, Plasma
See Additional Information:
Specimens Requiring Immediate Delivery