OVERVIEW

Purpose: The Aptima® HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of human immunodeficiency virus type 1 (HIV-1) on the fully automated Panther system. It is intended to be used as an aid in diagnosis for HIV-1 infection using appropriate HIV testing algorithms. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary infection. The Aptima HIV-1 Quant Dx assay may also be used as a supplemental test, when it is reactive, to confirm HIV-1 infection in an individual whose plasma or serum specimen is reactive with an approved assay with an indication as an aid in the diagnosis of HIV-1 infection. The Aptima HIV-1 Quant Dx assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in monitoring the effects of antiretroviral treatment, as measured by changes in plasma HIV-1 RNA levels.

SPECIMEN COLLECTION

Specimen Requirements:

• For quantitative measurements:
  • Tubes containing EDTA or acid citrate dextrose (ACD) anticoagulants or
  • Plasma preparation tubes (PPTs)
• For qualitative determination:
  • Tubes containing EDTA or ACD anticoagulants, or
  • PPTs, or
  • Serum tubes, or
  • Serum separator tubes (SSTs)

Specimen Source: Whole blood.

Minimum Volume: The minimum volume of plasma or serum for primary collection tubes is up to 1200 µL and for secondary tubes, the minimum volume is 700 µL.

Collection Method: Refer to the appropriate specimen collection kit package insert for specific collection instructions.

TEST DETAILS

Methodology: The Aptima HIV-1 Quant Dx assay utilizes the TMA method to amplify two regions of HIV-1 RNA (pol and LTR). An independent signal is generated from amplification of each region using specific primers, which are designed to amplify HIV-1 groups M, N, and O. Detection is achieved using single-stranded nucleic acid torches that are present during the amplification of each target that hybridize specifically to the amplicons in real-time. The time taken for the fluorescent signal of each target to reach a specified threshold (“tTime”) is proportional to the starting HIV-1 concentration. Each reaction has an internal calibrator/internal control (IC) that controls for potential variations in specimen processing, amplification, and detection. The concentration of a sample is then calculated using the tTimes for both pol and LTR amplification by the Panther system software. Through its algorithm and comparison with stored calibration information, the Panther system software returns a single, clinically validated result for each sample.

Compliance Category: FDA approved test.

Reference Interval: Not Detected. (Copies /mL or Log Value)

Limitations:

• Reliable results are dependent on adequate specimen collection, transport, storage, and processing
• This assay has been validated for use as a quantitative assay with only plasma
• This assay has been validated for use as a qualitative assay with plasma and serum
• Though rare, mutations within the highly conserved regions of the viral genome covered by the primers and/or probes in the Aptima HIV-1 Quant Dx assay may result in under quantification of or failure to detect the virus
• Through probit analysis, the 95% predicted detection limit for LoD for the Aptima HIV-1 Quant Dx assay is 12 copies/mL (35 IU/mL) in plasma and 8.9 copies/mL (25 IU/mL) in serum (0.35 copies=1 IU)

Sample Stability: 7 days at 37°C and 50°C, 14 days at room temperature, as well as refrigerated and frozen temperatures.

Turnaround Time: 98% < 72 hours, 50% < 24 hours

Directorship: Cheryl Hanau, MD; Garth Ehrlich, PhD, FAAAS, FAAM; Donald Hall Jr., PhD; Yinghua Qiu, PhD, DABCC

CPT Code: 87536

Review Date: 08/28/2023

SPECIMEN PROCESSING

Specimen Transport:

• Whole blood can be stored at 2°C to 30°C and must be centrifuged within 24 hours of specimen collection
• If transferred to a secondary tube, plasma may be frozen at -20°C or -70°C and serum may be frozen at -20°C
  • Do not exceed three freeze–thaw cycles to avoid affecting the result
  • Do not freeze specimens in EDTA, ACD, or serum primary collection tubes

Specimen Storage Conditions:

• EDTA and ACD Plasma Specimens
  • In primary tubes containing centrifuged plasma may be stored at 2°C to 30°C for up to 24 hours after specimen collection
  • After 24 hours, plasma may be stored:
    • In the primary collection tube at 2°C to 8°C for up to 3 days
    • In the secondary tube at 2°C to 8°C for up to 5 days, or
    • In the secondary tube at -20°C or -70°C for up to 90 days
• PPT Specimens
  • PPTs containing centrifuged plasma may be stored at 2°C to 30°C for up to 24 hours after specimen collection
  • After 24 hours, plasma may be stored:
    • In the PPT at 2°C to 8°C for up to 3 days
    • In the secondary tube at 2°C to 8°C for up to 5 days, or
    • In the PPT or secondary tube at -20°C or -70°C for up to 90 days
• SST Specimens
  • SSTs containing centrifuged serum may be stored at 2°C to 30°C for up to 24 hours after specimen collection
  • After 24 hours, serum may be stored:
    • In the SST at 2°C to 8°C for up to 5 days
    • In the secondary tube at 2°C to 8°C for up to 5 days, or
    • In secondary tube at -20°C for up to 90 days
• Dilution of Plasma Specimens
  • If a specimen is diluted, it should be tested immediately after dilution
  • A plasma specimen may be diluted in the SAT or secondary tube for testing on the Panther system

Rejection Criteria:

• Inappropriate specimen condition:
  • Incorrect patient identification
  • Unlabeled specimen
• Inappropriate specimen transport conditions:
  • Specimen leaked in transit
  • Specimen in expired transport or incorrect transport device
• Specimen stability limits exceeded

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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