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HIV-1 RNA, Qualitative, TMA

Test Summary

HIV-1 Qualitative is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA in human serum and plasma by PCR. The test is intended to be used as an aid in diagnosis of HIV-1 infection. Detection of HIV-1 nucleic acid is indicative of HIV-1 infection. 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 HIV-1 infection. The HIV-1 Qualitative PCR may also be used as an additional test to confirm the presence of HIV-1 infection in an individual with specimens reactive for HIV-1 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 in pediatric subjects and pregnant women. This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1.6 mL serum

Minimum Volume

0.8 mL

Instructions

Separate plasma or serum from the cells by centrifugation within 24 hours after
collection.  Transfer the plasma or serum to a plastic screw-cap vial and ship frozen.

Patient Preparation

N/A

Storage

Plastic screw-cap vial

Transport Temperature

Frozen

Specimen Stability

  • Room temperature: 72 hours
  • Refrigerated: 5 days
  • Frozen: 42 days

Limitations

N/A

Other Acceptable Specimens

Plasma collected in a PPT potassium EDTA (white-top) tube, or EDTA (lavender-top) tube

Unacceptable Specimens

⁠⁠⁠⁠⁠⁠⁠Whole blood • Unspun PPT • Frozen Plasma received in plasma preparation tube (in situ) • Frozen serum received in serum separator tube (in situ)

Order Code

HIV1QL

EPIC (Premier) Code

LAB5484

Includes

N/A

CPT Code

  • 87535

Billing Code

  • 670049

CPT Statement

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

FDA Status

FDA Approved

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Department

Reference Testing

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Tuesday, Thursday, Saturday; Report available: 1 - 5 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1.6 mL serum

Minimum Volume

0.8 mL

Instructions

Separate plasma or serum from the cells by centrifugation within 24 hours after
collection.  Transfer the plasma or serum to a plastic screw-cap vial and ship frozen.

Patient Preparation

N/A

Storage

Plastic screw-cap vial

Transport Temperature

Frozen

Specimen Stability

  • Room temperature: 72 hours
  • Refrigerated: 5 days
  • Frozen: 42 days

Limitations

N/A

Other Acceptable Specimens

Plasma collected in a PPT potassium EDTA (white-top) tube, or EDTA (lavender-top) tube

Unacceptable Specimens

⁠⁠⁠⁠⁠⁠⁠Whole blood • Unspun PPT • Frozen Plasma received in plasma preparation tube (in situ) • Frozen serum received in serum separator tube (in situ)

Billing

CPT Code

  • 87535

Billing Code

  • 670049

CPT Statement

Result Information

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

Testing Laboratory

N/A

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Tuesday, Thursday, Saturday; Report available: 1 - 5 days