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HIV Antigen/Antibody Combo With Reflex to Confirmation

Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antigen/Antibody (Fourth Generation) Preliminary Test With Cascade Reflex to Supplementary Testing
HIV Antigen/Antibody Combo With Reflex to Confirmation
CPT: 87389. If reflex testing is performed, concomitant CPT codes/charges will apply.
Updated on 01/17/2020
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Synonyms

  • HIV Antigen/Antibody
  • HIV-1
  • HIV-2
  • Human Immunodeficiency Virus
  • p24
  • HIV-1/O/2, 4th Generation
  • HIV Antigen/Antibody
  • HIV-1
  • HIV-2
  • Human Immunodeficiency Virus
  • p24

Test Includes

HIV antigen/antibody screen for HIV-1 antibody, HIV-2 antibody, and HIV-1 p24 antigen by EIA; reflex of EIA positive specimens to an HIV-1 or HIV-2 differentiation assay; specimens positive by the screening assay but negative by the differentiation assay reflex to HIV-1 RNA testing by qualitative nucleic acid amplification (NAA).

Enzyme immunoassay (EIA) for antigen/antibody screen for HIV with reflex to supplementary differentiation assay for HIV-1 or HIV-2. The antigen/antibody assay detects antibodies to HIV-1 and HIV-2 as well as HIV-1 p24 antigen. Specimens positive by the screening assay but negative by the supplementary antibody typing assay will reflex to qualitative nucleic acid amplification (NAA).

HIV antigen/antibody screen for HIV-1 antibody, HIV-2 antibody, and HIV-1 p24 antigen by EIA; reflex of EIA positive specimens to an HIV-1 or HIV-2 differentiation assay; specimens positive by the screening assay but negative by the differentiation assay reflex to HIV-1 RNA testing by qualitative nucleic acid amplification (NAA).


Special Instructions

This test requires a dedicated, unopened, gel-barrier tube or red-top tube sent directly to the testing facility.

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.


Expected Turnaround Time

1 - 2 days


Related Documents


Specimen Requirements


Specimen

Serum


Volume

2 mL


Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier tube with red/gray-mottled top or red-top tube


Collection

Usual blood collection technique


Storage Instructions

Refrigerate. Sample may be stored for two days at room temperature. For shipping, it is recommended that serum be refrigerated.

Refrigerate. Sample may be stored for two days at room temperature. For shipping, it is recommended that serum be refrigerated. Stability: room temperature for 48 hours and refrigerated or frozen for 14 days. Freeze/thaw cycles: x5.

Refrigerate. Sample may be stored for two days at room temperature. For shipping, it is recommended that serum be refrigerated..


Stability Requirements

Temperature

Period

Room temperature

48 hours (stability provided by manufacturer or literature reference)

Refrigerated

14 days (stability provided by manufacturer or literature reference)

Frozen

14 days (stability provided by manufacturer or literature reference)

Freeze/thaw cycles

Stable x5 (stability provided by manufacturer or literature reference)

Temperature

Period

Room temperature

48 hours (stability provided by manufacturer or literature reference)

Refrigerated

14 days (stability provided by manufacturer or literature reference)

Frozen

14 days (stability provided by manufacturer or literature reference)

Freeze/thaw cycles

Stable x5 (stability provided by manufacturer or literature reference)


Causes for Rejection

Specimen aliquot; specimen grossly hemolyzed; specimen in container other than those listed; received outside of specimen and/or storage and/or labeling requirements


Test Details


Use

CDC-recommended algorithm for laboratory diagnosis of HIV infection, including acute and primary infection.

The fourth-generation HIV antigen-antibody assay is acknowledged to detect acute HIV infection 4 to 12 days earlier than third-generation assays. Coupled with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection. According to the CLSI guideline, anyone testing positive by a fourth-generation screening assay and supplemental tests (either antibody or RNA detection) should initiate care and follow-up tests for clinical staging.1

CDC-recommended algorithm for laboratory diagnosis of HIV infection, including acute and primary infection.


Limitations

Reactive (repeatedly) specimens must be investigated by additional supplemental tests. A negative test for an individual does not preclude exposure to or infection with HIV-1 and/or HIV-2. Negative results can occur if the quantity of the marker present in the sample is too low for detection by the assay or if the marker is not present during the stage of disease in which a sample is collected.


Methodology

(1) HIV antigen/antibody enzyme immunoassay (EIA) screen for antibodies to HIV-1 and HIV-2 and HIV-1 p24 antigen: Reflex to supplementary differentiation assay; (2) Screen positive with negative antibody typing: Reflex to qualitative nucleic acid amplification (NAA)


References

Association of Public Health Laboratories. Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm. APHL 2019. APHL Web site. https://www.aphl.org/aboutAPHL/publications/Documents/ID-2019Jan-HIV-Lab-Test-Suggested-Reporting-Language.pdf. Accessed November 2019.
Centers for Disease Control and Prevention. Laboratory testing for the diagnosis of HIV infection : updated recommendations. CDC Stacks Web site. https://stacks.cdc.gov/view/cdc/23447. Accessed November 2019.
Clinical and Laboratory Standards Institute. Criteria for Laboratory Testing and Diagnosis of the Human Immunodeficiency Virus Infection, Approved Guideline. M53-A. Wayne, Pa: CLSI; 2011.
García T, Tormo N, Gimeno C, et al. Performance of an automated human immunodeficiency virus (HIV) antigen/antibody combined assay for prenatal screening for HIV infection in pregnant women. J Med Microbiol. 2009 Nov; 58(Pt 11):1529-1530. 19589899
Pandori MW, Branson BM. 2010 HIV Diagnostics Conference. Expert Rev Anti Infect Ther. 2010 Jun; 8(6):631-633. 20521890
Association of Public Health Laboratories. Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm. APHL 2019. APHL Web site. https://www.aphl.org/aboutAPHL/publications/Documents/ID-2019Jan-HIV-Lab-Test-Suggested-Reporting-Language.pdf. Accessed November 2019.
Centers for Disease Control and Prevention. Laboratory testing for the diagnosis of HIV infection : updated recommendations. CDC Stacks Web site. https://stacks.cdc.gov/view/cdc/23447. Accessed November 2019.
Clinical and Laboratory Standards Institute. Criteria for Laboratory Testing and Diagnosis of the Human Immunodeficiency Virus Infection, Approved Guideline. M53-A. Wayne, Pa: CLSI; 2011.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
083935 Human immunodeficiency virus; 56888-1 083936 HIV Screen 4th Generation wRfx 56888-1
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083941 HIV 1 Ab 68961-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083942 HIV 2 Ab 81641-3
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083952 RNA Qualitative 083951 HIV 1 RNA Qualitative 25835-0
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083952 RNA Qualitative 083960 Final Interpretation 62365-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083952 RNA Qualitative 083944 HIV 1/2 Supplemental Ab Test N/A
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083953 RNA Qualitative 083951 HIV 1 RNA Qualitative 25835-0
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083953 RNA Qualitative 083961 Final Interpretation 62365-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083953 RNA Qualitative 083944 HIV 1/2 Supplemental Ab Test N/A
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083950 RNA Qualitative 083951 HIV 1 RNA Qualitative 25835-0
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083950 RNA Qualitative 083959 Final Interpretation 62365-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083950 RNA Qualitative 083944 HIV 1/2 Supplemental Ab Test N/A

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