HIV-1/2 rapid antibody test - plasma specimen

Collect

PREFERRED: Plasma is the preferred specimen. Blood can be collected in plastic tubes containing dipotassium EDTA with or without gel separator (either a lavender top tube or a pearl top plasma preparation tube[PPT]). Other anticoagulants have not been tested and should not be used.

REMARK: Serum IS NOT an acceptable alternative specimen for the HIV-1/2 antibody test.

Volume Required

4 ml of blood

Minimum Required

2 ml of blood

Transport

For the CHOP enterprise, submit blood specimens as soon as possible at room temperature to Central Laboratory Services.

For outside clients, it is recommended that plasma specimens be removed from the red blood cells or separator gel as soon as possible after collection and before shipping specimens. When shipping plasma specimens, package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. Specimens may be shipped at 2-8C (wet ice) or frozen (dry ice). Do not exceed the storage time limitations listed under the heading of Stability.

Stability

Plasma specimens should be stored for no longer than 3 days at room temperature or 7 days at 2-8C following specimen collection and separation from red blood cells or separator gel. If a storage period greater than 7 days is anticipated, plasma should be stored frozen at -20C or colder. No more than 3 freeze-thaw cycles should be performed on any sample prior to testing, and specimens should not be stored in frost-free freezers.


Unacceptable conditions

Do not use serum or plasma specimens that are heat-inactivated, pooled, grossly hemolyzed, or contain obvious microbial contamination.

Specimen Handling

Unprocessed blood specimens should routinely be refrigerated at 4C upon arrival in the laboratory. One should remove the plasma from red blood cells or separator gel as soon as possible to avoid hemolysis. The best results are generally observed for serum or plasma specimens that are clear and nonhemolyzed. Lipemic, icteric, or hemolyzed specimens should be avoided when possible, and specimens with obvious microbial contamination should not be used. Specimens containing unremoved clots, red blood cells, or particulate matter may give inconsistent results and should be clarified by centrifugation before testing.

Days Performed

Daily (Mon thru Su) on Day Shift; Mon thru Fri on Evening Shift

Reported

Same shift

Reflex Testing

All positive rapid HIV-1/2 test results require additional testing for confirmation. A conventional laboratory-based screening immunoassay and Western blot as well as an HIV-1 RNA qualitative test will be ordered and performed by the laboratory to confirm the initially reactive rapid test results.

CPT

86701

Methodology

Rapid Immunochromatographic Assay

Disease Information

Utility:

The Rapid HIV-1/2 Antibody Test is ued by the laboratory to test source patients that have been involved in accidental exposures of healthcare workers to blood and body fluids and to test mothers receiving care at the Center for Fetal Diagnosis and Treatment and delivering their babies in the Special Delivery Unit. Employees involved in an accidental exposure to blood or body fluids from a source patient must contact Occupational Health and get prior authorization to order the test. The test can then be ordered as part of the Occupational Health Order Set in EPIC.

Interpretation

A positive result using the Rapid HIV-1/2 Antibody Test is presumptive and suggests the presence of HIV-1 and/or HIV-2 antibodies in the specimen. Additional testing is necessary to the confirm the result. A conventional laboratory-based screening immunoassay and Western blot as well as an HIV-1 RNA qualitative test should be ordered.

A negative result using the Rapid HIV-1/2 Antibody Test does not preclude the possibility of exposure to HIV or infection with HIV. An antibody response to recent exposure to HIV may take weeks to months to reach detectable levels. Consider ordering the HIV antigen antibody combo screening assay and/or the HIV RNA qualitative test if acute primary HIV infection is possible.

Reference Values

Negative for HIV-1 and HIV-2 antibodies by rapid test

Remarks

As of 15 May 2012, written informed consent for HIV testing is no longer required; documentation of verbal consent is adequate. Our hospital policies have been modified to conform with the revised Pennsylvania Act 148 (state statute that governs HIV testing) and the emphasis of the Commonwealth of Pennsylvania and Centers for Diseases Control and Prevention to provide routine HIV testing of individuals 13-65 years of age. This policy change applies to CHOP affiliated inpatient and outpatient care sites in Pennsylvania, New Jersey and Delaware. The new HIV-related policies can be found in the online Patient Care Manual. The patient or person consenting to the test must still be notified of the intent to test and be provided with HIV-related information. Two handouts are available in the Patient-Family Education Manual to provide information about HIV and HIV testing: "Understanding HIV: Testing and Prevention" and "HIV Testing is for Everyone". A competent minor, regardless of age, is permitted under Pennsylvania state law to consent to HIV testing and/or treatment services. Parental consent is not required. Otherwise, verbal consent can be obtained only from a biologic parent, an adoptive parent, legal guardian, or by a court order. Documentation in the medical record must show that verbal consent was obtained. Documentation of verbal consent for an HIV-related test can be accomplished through the Epic hospital computer system by selecting one of two certifications; either "I certify that the patient and/or personal representative have been given information about HIV testing and have verbally consented to the test" OR "I certify that HIV testing is required because of a life threatening medical condition or occupational exposure, and obtaining consent is not possible at this time".