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Test Code HVDSP HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Prenatal, Plasma


Ordering Guidance


This test is not suitable for follow-up testing of patients with reactive results from any rapid HIV tests, except for pregnant patients who were reactive by the Determine HIV-1/-2 Ag/Ab Combo rapid point-of-care test on serum or plasma (but not whole blood). Per the latest CDC recommended HIV testing algorithm patients with reactive results from any rapid HIV tests should be tested subsequently with laboratory-based HIV antigen and antibody combination immunoassays, such as HIVSP / HIV Antigen and Antibody Prenatal Routine Screen, Plasma.

 

If specimens are autopsy or cadaver blood sources, the proper US Food and Drug Administration licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.

 

New York State clients: This test should not be requested for maternal/newborn HIV screening on specimens originating in New York State, due to state regulatory requirements for expedited result reporting.



Necessary Information


Date of collection is required.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot plasma into plastic vial.


Useful For

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in plasma specimens from prenatal patients who show reactive results with 3rd- (HIV-1/-2 antibody only) and 4th-generation (HIV antigen and antibody) HIV serologic assays

 

This test is not useful as a screening test for HIV infection in symptomatic or asymptomatic individuals.

 

This test should not be used as a screening or confirmatory test for blood donor specimens.

Disease States

  • HIV-2 infection
  • HIV infection

Method Name

Rapid Immunochromatographic Assay

Reporting Name

HIV Ab Differentiation Prenatal, P

Specimen Type

Plasma

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma Frozen (preferred) 30 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

AIDS is caused by 2 known types of HIV. HIV type 1 (HIV-1) is found in patients with AIDS or AIDS-related complex and in asymptomatic infected individuals at high risk for AIDS. The virus is transmitted by sexual contact, by exposure to infected blood or blood products, or from an infected mother to her fetus or infant. HIV type 2 (HIV-2) infection is endemic only in West Africa, and it has been identified in individuals who had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in viral morphology, overall genomic structure, and its ability to cause AIDS.

 

Antibodies against HIV-1 and HIV-2 are usually not detectable until 6 to 12 weeks following exposure and are almost always detectable by 12 months. They may fall to undetectable levels (ie, seroreversion) in the terminal stage of AIDS when the patient's immune system is severely depressed.

 

Routine serologic screening of patients at risk for HIV-1 or HIV-2 infection usually begins with an HIV-1/-2 antigen and/or antibody screening test, which may be performed by various US Food and Drug Administration approved assay methods, including rapid HIV antibody tests, enzyme immunoassays, and chemiluminescent immunoassays. In testing algorithms that begin with these methods, supplemental or confirmatory testing should be requested only for specimens that are repeatedly reactive by these methods according to assay manufacturers' instructions for use.

Reference Values

Negative

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86701

86702

87535 (if appropriate)

87538 (if appropriate)

87536 (if appropriate)

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HPP12 HIV-1/HIV-2 RNA Detect Prenatal, P Yes No
HIQNP HIV-1 RNA Detect/Quant Prenatal, P Yes No