HIVVL

Viral Load (HIV RNA), Quantitative method

Blood/ K3 EDTA (Lavender Top) 3 mL, 2 tubes

Plasma EDTA, minimum volume 1.5 mL - Separate plasma within 24 hours of collection.

Plastic tube

Hemolysis: N/A
Lipemia: N/A
Icterus: N/A
Other: Heparin, anticoagulant blood

Specimen Type	Temperature	Time
Whole blood	At temperature, 2oC to 25oC	24 hours
Plasma	At temperature, 25oC to 30oC	1 day
	Refrigerated, 2oC to 8oC	6 days
	Frozen, -20oC to -80oC	6 weeks

HIVVL

Viral Load (HIV RNA), Quantitative method

Real-Time Reverse Transcription polymerase chain reaction (RT-PCR) assay

Tuesday, Thursday, Friday and Saturday at 10:00 a.m.
Sunday, at 07:00 p.m.

Received specimen to reported within 3 days.

Molecular biology & Genetics, Laboratory Department Tel.14168

2 months

HIVVL

Viral Load (HIV RNA), Quantitative method

Human Immunodeficiency Virus (HIV) is the etiologic agent of Acquired Immunodeficiency Syndrome (AIDS). HIV infection can be transmitted by sexual contact, exposure to infected blood or blood products, or by an infected mother to the fetus. Within three to six weeks of exposure to HIV, infected individuals generally develop a brief, acute syndrome characterized by flu-like symptoms and associated with high levels of viremia in the peripheral blood. In most infected individuals this is followed by an HIV-specific immune response and a decline of plasma viremia, usually within four to six weeks of the onset of symptoms. After seroconversion, infected individuals typically enter a clinically stable, asymptomatic phase that can last for years. Quantitative measurements of HIV viremia in the peripheral blood have shown that higher virus levels may be correlated with increased risk of clinical progression of HIV disease, and that reductions in plasma virus levels may be associated with decreased risk of clinical progression.

Test	Reference Value
HIV Viral Load	Not detected
HIV Viral Load Log equivalent	Not detected

This assay has a plasma HIV-1 RNA quantification result range of 20 to 10,000,000 copies/mL (1.30-7.00 log copies/mL).
An "Not detected" result indicates that the assay was unable to detect HIV-1 RNA in the plasma specimen tested.
A result of "<20 copies/mL" indicates that HIV-1 RNA is detected, but the level present is less than the lower quantification limit of this assay. Due to the increased sensitivity of this assay, patients with previously low or undetectable HIV-1 viral load may show increased or detectable viral load with this assay. However, the clinical implications of a viral load below 20 copies/mL remain unclear.
A result of ">10,000,000 copies/mL" cannot accurately quantify HIV-1 RNA above this level" indicates that HIV-1 RNA is detected, but the level present is above the upper quantification limit of this assay. For the purpose of monitoring patient's response to antiretroviral therapy, the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents defines virologic failure as a confirmed viral load above 200 copies/mL, which eliminates most cases of viremia resulting from isolated blips or assay variability. Confirmed viral load rebound (ie, >200 copies/mL) on 2 separate tests obtained at least 2 to 4 weeks apart should prompt a careful evaluation of patient's tolerance of current drug therapy, drug-drug interactions, and patient adherence.

Manufacturer’s package insert, COBAS^®AmpliPrep/COBAS^® TaqMan^® HIV-1Test, version 2.0, September 2019, Roche Molecular Systems, NJ 08876 Branchburg, USA.