HIV Combo (HIV 1/2 and p24)

CPT: 86703

Synonyms

HIV Ag/Ab Combo (CHIV)

Expected Turnaround Time

24 Hours

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements

Specimen

Serum, Plasma

Volume

5 ml

Minimum Volume

100 ul

Container

SST (Serum), Lithium Heparin (Plasma), EDTA (Plasma), Sodium Heparin (Plasma)

Collection

Collect Serum sample in the serum separator tube (SST), once the serum tube is clotted, spin the sample in the centrifuge to separate serum. Store the sample in the refrigerator.

Storage Instructions

Room Temp., Refrigerated (2-8 C)

Stability Requirements

Room temp. 7 days, Refrigerated 7 days

Causes for Rejection

Incorrect labeling, frozen gel-barrier tube, mislabeled samples, QNS

Test Details

Use

HIV Ag/Ab Combo (CHIV) assay is for in vitro diagnostic use in the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2, in serum and plasma (potassium EDTA, lithium heparin, sodium heparin) .

Methodology

sandwich immunoassay

Reference Interval

Non reactive

Additional Information

HIV-1/2 Antigen and Antibody Combination (HIV Combo), also known as a 4th-generation HIV test, is a screening assay that detects both HIV-1 and HIV-2 antibodies as well as the p24 antigen, a viral protein that appears early in HIV-1 infection. This test improves early detection by reducing the diagnostic window period to approximately 2–3 weeks post-exposure, compared to earlier-generation antibody-only tests. The p24 antigen is typically detectable before seroconversion, allowing for identification of acute HIV infection.  A reactive result requires confirmatory testing, typically with an HIV-1/HIV-2 antibody differentiation assay and, if needed, nucleic acid amplification testing (NAAT) for HIV RNA. This test is recommended by the CDC as the preferred initial screening method for HIV due to its enhanced sensitivity and ability to detect early infection.

References

Centers for Disease Control and Prevention (CDC). (2014). Laboratory testing for the diagnosis of HIV infection: Updated recommendations. Retrieved from https://stacks.cdc.gov/view/cdc/23447

Branson, B. M., Owen, S. M., Wesolowski, L. G., Bennett, B., Werner, B. G., Wroblewski, K. E., & Pentella, M. A. (2011). Laboratory testing for the diagnosis of HIV infection: Updated recommendations. Clinical Infectious Diseases, 52(6), 685–689. https://doi.org/10.1093/cid/ciq112

Delaney, K. P., Hanson, D. L., Masciotra, S., Ethridge, S. F., Wesolowski, L. G., & Owen, S. M. (2017). Time until emergence of HIV test reactivity following infection with HIV-1: Implications for interpreting test results and retesting after exposure. Clinical Infectious Diseases, 64(1), 53–59. https://doi.org/10.1093/cid/ciw666

Footnotes

Statement on Medical Necessity
All ordered tests should be medically necessary for the diagnosis or detection of disease, illness, impairment, symptom, syndrome, or disorder and the results should be used in the medical management and treatment decisions for the patient. Solaris requires ICD-10 codes with each order for lab testing and both the tests ordered and the diagnosis should be documented in the provider’s medical record for the patient. The United States Department of Health and Human Services, Office of Inspector General, takes the position that a provider who orders medically unnecessary tests may be subject to civil penalties.

Panels and Profiles
Solaris offers Providers the convenience of ordering test combinations in a group at times with the flexibility to choose appropriate test(s) for individual patients. Providers should only order those tests that he or she believes are medically necessary for each patient, and a lesser inclusive profile or individual tests should be ordered if not all tests in the test combination/profile are medically necessary. All tests offered in a test combination/profile may be ordered separately as individual tests. Solaris encourages clients to contact their Solaris representative if the testing configurations shown do not meet individual needs for any reason, or if some other combination of procedures is needed.

CPT Codes
CPT Codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are the responsibility of the billing party and are listed here for informational purposes. Correct coding may vary from one carrier to another. Solaris may bill specific carriers using codes other than what is shown.

Questions?

For questions or inquiries related to testing please reach out to
customerservice@solarisdx.com or contact us by phone at (844) 550-0308.