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Test Code HVPPS HIV-1 and HIV-2 Antibody Confirmation and Differentiation Prenatal, Serum


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 HVPRS / HIV Antigen and Antibody Prenatal Routine Screen, Serum or 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: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 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.


Forms

If not ordering electronically, complete, print, and send an Infectious Disease Serology Test Request (T916) with the specimen.

Useful For

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in serum 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

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HPS12 HIV-1/HIV-2 RNA Detect Prenatal, S Yes No

Testing Algorithm

This test is for confirmation and differentiation of HIV-1/2 antibodies (Ab). If the following result types are obtained, HIV-1/HIV-1 RNA detection will be performed at an additional charge:

-Negative for both HIV-1 Ab and HIV-2 Ab

-Indeterminate for HIV-1 Ab but negative for HIV-2 Ab

-Negative for HIV-1 Ab but indeterminate for HIV-2 Ab

-Indeterminate for both HIV-1 Ab and HIV-2 Ab

-Positive for both HIV-1 Ab and HIV-2 Ab

 

For more information see HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results

Reporting Name

HIV Ab Differentiation Prenatal, S

Specimen Type

Serum

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 30 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

Negative

Method Description

The Geenius HIV 1/2 Supplemental Assay cassette contains antibody-binding protein A, which is conjugated to colloidal gold dye particles, and HIV-1 and HIV-2 antigens, which are bound to the membrane solid phase. The sample is applied to the sample and buffer well. After the sample and buffer have migrated onto the test strip, additional buffer is added to the buffer well. The buffer causes the specimens and reagents to flow laterally and facilitates the binding of antibodies to the antigens. In a reactive sample, the antibodies are captured by the antigens immobilized in the test area.

 

The protein A-colloidal gold binds to the captured antibodies, causing development of pink or purple lines. When there are no HIV antibodies, there are no pink or purple lines in the test area. The sample continues to migrate through the membrane, and a pink or purple line develops in the control area, which contains protein A. This built-in procedural control provides evidence that the test was performed properly and that the sample and reagents have migrated through the cassette.(Package insert: Geenius HIV 1/2 Supplemental Assay. Bio-Rad Laboratories; 07/2019)

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86701

86702

87535 (if appropriate)

87538 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HVPPS HIV Ab Differentiation Prenatal, S 89365-1

 

Result ID Test Result Name Result LOINC Value
618221 HIV-1 Ab Differentiation Prenatal, S 68961-2
618222 HIV-2 Ab Differentiation Prenatal, S 81641-3