Product Manual

ManualsBrandsOraSure ManualsMedical Supplies & EquipmentOraquick Advance HIV-1/2 Rapid Antibody Test Kit

Read this package insert completely before using the product. Follow the instructions

carefully when performing testing. Not doing so may result in inaccurate test results. Before

performing testing, all operators MUST read and become familiar with Universal

Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B

Virus, and other Blood-borne Pathogens in Health-Care Settings.

5,9

COMPLEXITY: WAIVED

or Oral Fluid, Fingerstick Whole Blood and Venipuncture Whole Blood. Any modification by the laboratory to the test system or FDA

approved test system instructions will result in the test no longer meeting the requirements for waived category.

COMPLEXITY: MODERATE

for Plasma.

NAME AND INTENDED USE

The OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human

Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid, fingerstick whole blood, venipuncture whole blood and

plasma specimens. The

OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is intended for use as a point-of-care test to aid in the

diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of

rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms.

RESTRICTIONS

• Sale of the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is restricted to clinical laboratories

– that have an adequate quality assurance program, including planned systematic activities to provide

adequate confidence that requirements for quality will be met; and

– where there is assurance that operators will receive and use the instructional materials.

• The OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is approved for use only by an agent of a clinical

laboratory.

• Test subjects must receive the “Subject Information” pamphlet prior to specimen collection and appropriate

information when test results are provided.

• The OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is not approved for use to screen blood or tissue donors.

SUMMARY AND EXPLANATION OF THE TEST

Acquired Immune Deficiency Syndrome (AIDS), AIDS related complex (ARC) and pre-AIDS are thought to be caused by the Human

Immunodeficiency Virus (HIV). The first AIDS-related virus, HIV-1 (also known as HTLV-III, LAV-1 and ARV) has been isolated from

patients with AIDS and from healthy persons at high risk for AIDS.

1,2

Genetic analysis of HIV-1 isolates has documented the existence

of subtypes. To date, eight HIV-1 subtypes (A through H), designated as Group M, have been identified world-wide in addition to the

highly divergent HIV-1 isolates from AIDS patients in Cameroon, designated as Group O.

A closely related but distinct second type

of pathogenic human immunodeficiency retrovirus, designated HIV-2 (formerly LAV-2), has been isolated from West African patients

with AIDS. HIV-2 has been shown to share a number of conserved sequences with HIV-1, but serological cross-reactivity between

HIV-1 and HIV-2 has been shown to be highly variable from sample to sample.

HIV is known to be transmitted by sexual contact, by exposure to blood (including sharing contaminated needles and syringes) or by

contaminated blood products, or it may be transmitted from an infected mother to her fetus during the prenatal period. Individuals

infected with HIV produce antibodies against the HIV viral proteins. Testing for the presence of antibodies to HIV in bodily fluids (e.g.,

blood, oral fluid, and urine) is an accurate aid in the diagnosis of HIV infection. However, the implications of seropositivity must be

considered in a clinical context. For example, in neonates, the presence of antibodies to HIV is indicative of exposure to HIV, but not

necessarily of HIV infection, due to the acquisition of maternal antibodies that may persist for up to eighteen months. Conversely,

absence of antibody to HIV cannot be taken as absolute proof that an individual is free of HIV infection or incapable of transmitting

the virus. An antibody response to a recent exposure may take several months to reach detectable levels. HIV has been isolated from

asymptomatic, seronegative individuals presumably before seroconversion following exposure.

The standard laboratory HIV testing algorithm used in the United States consists of screening with an enzyme immunoassay (EIA)

and confirmation of repeatedly reactive EIAs using a Western blot test. Results are typically reported within 48 hours to 2 weeks,

making these standard screening and supplemental tests inadequate to meet the need for rapid HIV diagnosis. The

OraQuick

ADVANCE

Rapid HIV-1/2 Antibody Test is a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2.

Using a rapid HIV test increases the number of HIV-infected persons who may be diagnosed. The Centers for Disease Control and

Prevention (CDC) estimates that nearly one third of the estimated 900,000 HIV-infected persons in the United States do not know their

HIV status. As a result, they cannot benefit from early intervention with effective antiviral therapy. Rapid HIV testing addresses this

HIV-1/2

ADV ANCE

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