HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes

Cleveland Heartlab H, Test

NEW YORK DOH APPROVED: YES

CPT Code:

HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes: 87389
HIV-1/2 Antibody Differentiation (Reflex Only): 86701, 86702 (if reflexed)
HIV-1 RNA, Qualitative, Real-Time PCR: 87535 (if reflexed)

Order Code:

HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes: 91431
HIV-1/2 Antibody Differentiation: 901698
HIV-1 RNA, Qualitative, Real-Time PCR: 16185

Includes:

HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes: HIV Ag/Ab, 4th Generation
If HIV Antigen and Antibody, 4th Generation Screen is Repeatedly Reactive, HIV-1/2 Antibody Differentiation will be performed at an additional charge (CPT codes: 86701, 86702).
HIV-1/2 Antibody Differentiation: HIV 1 Antibody, HIV 2 Antibody
If HIV-1/2 Antibody Differentiation is Indeterminate or Negative, HIV-1 RNA, Qualitative, Real-Time PCR will be performed at an additional charge (CPT code 87535).
HIV-1 RNA, Qualitative, Real-Time PCR: HIV-1 RNA, Qualitative Real-Time PCR

HIV Testing Pathway Algorithm: https://www.questdiagnostics.com/hcp/intguide/InfectDis/HIV/TS_HIV4thGenScreen_Figure.pdf

ABN Requirement: No
Specimen:
Preferred:
Serum
Alternative:
EDTA Plasma
Volume: 
3.0 mL
Minimum Volume: 
2.0 mL
Container:
Preferred:
Gel-barrier tube (SST)
Alternative:
EDTA (Lavender Top) tube

Collection:

Serum:

  1. Collect and label sample according to standard protocols.
  2. Gently invert tube 5 times immediately after draw.
  3. Allow blood to clot 30 minutes.
  4. Centrifuge for 10 minutes.

EDTA Plasma:

  1. Draw and gently invert 8 to 10 times.
  2. Centrifuge for 10 minutes.
    EDTA plasma must be separated from cells within 2 hours of collection.
  3. Pre-squeeze transfer pipet bulb and draw off approximately 2/3 of the upper plasma layer.  Note: This ensures that the buffy coat and red cells remain undisturbed.
  4. Aliquot plasma into labeled transport tube as “EDTA plasma” and cap tightly.

Discard original tube.

Special Specimen Collection Instructions: Tube must be labeled with patient identifiers and submitted only for HIV testing. SST tube should be spun after clotting and remain unopened.

Transport: Store serum or EDTA plasma at 2°C to 8°C after collection and ship the same day per packaging instructions included with the provided shipping box.

Stability:

Ambient (15-25°C): 72 hours
Refrigerated (2-8°C): 
5 days
Frozen (-20°C): 
30 days

Causes for Rejection: Specimens other than serum or EDTA plasma; improper labeling; samples not stored properly; samples older than stability limits; frozen SST tube

Methodology: Immunoassay (IA)

Turn Around Time:  2 to 3 days

Reference Range:

 Reference Range
HIV Ag/Ab, 4th GenerationNon-Reactive

Clinical Significance: This 4th generation HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV1/HIV2 infection, including acute or primary HIV-1 infection.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.