Plasma

Separate plasma from cells within 6 hours.

Preferred Minimum: 3.0 mL plasma in pink EDTA top tube
Absolute Minimum: 2.5 mL plasma in pink EDTA top tube

Serum. Heparinized specimens.

Sunday-Saturday

4-10 days upon receipt at reference laboratory

By report

This assay predicts HIV-1 resistance to protease inhibitors, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and integrase inhibitors. The protease gene, integrase gene and the reverse transcriptase gene of the viral genome are sequenced using Next Generation Sequencing. Drug resistance is assigned using the Stanford hivdb database.

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 adherence, percentage of resistant virus population, dosing, and drug pharmacology issues.

This test detects populations down to 10 percent of the total population which may account for resistance interpretation differences between methods. Some insertions or deletions may be difficult to detect using this software.

This test was developed, and its performance characteristics determined by the reference laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Note: This test may be unsuccessful if the plasma HIV-1 RNA viral load is less than 500 copies per mL of plasma.

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 #3724. 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:

Consent for HIV-Related Testing in Minors

HIV Pre-Test Education

Massively Parallel Sequencing

87900, 87901, 87906

See also:
HIV Phenotyping & Genotyping, Plasma

See Additional Information:
Specimens Requiring Immediate Delivery