تويت
COMPLEXITY: MODERATE
NAME AND INTENDED USE
The OraQuick® Rapid HIV-1 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human
Immunodeficiency Virus Type 1 (HIV-1) in fingerstick whole blood specimens. The OraQuick® Rapid HIV-1 Antibody Test
is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multitest
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® Rapid HIV-1 Antibody Test is restricted to clinical laboratories
o that have an adequate quality assurance program, including pl anned systematic activities to provide
adequate confidence that requirements for quality will be met; and
o where there is assurance that operators will receive and use the instructional materials.
• The OraQuick® Rapid HIV-1 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® Rapid HIV-1 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 ********ed 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.3 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 six 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® Rapid HIV-1 Antibody Test is a point-of-care test to aid in the diagnosis of infection with HIV-1.
Read this package insert completely before using the product. Follow the instructions carefully. Not doing so
may result in inaccurate test results.
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 fourth 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 issue by providing results during the initial visit and enabling immediate counseling.
Additionally, for pregnant women who do not know their HIV status at the time of delivery, rapid HIV testing permits
therapy to be initiated for these mothers during labor, and to their infants post partum, substantially reducing the chance that
the infants will become infected with HIV. Likewise, rapid HIV testing is instrumental in the decision to initiate treatment
for health care workers after accidental exposures to body fluids from infected individuals. In the U.S., it is estimated that
600,000 to 1,000,000 “needlestick injuries” occur each year. Critical decisions about treatment depend on the availability of
accurate, rapid HIV test results.
BIOLOGICAL PRINCIPLES OF THE TEST
The OraQuick® Rapid HIV-1 Antibody Test is a manually performed, visually read, 20 minute immunoassay for the
qualitative detection of antibodies to HIV-1 in human whole blood obtained from a finger puncture. The OraQuick® rapid
test is comprised of a single-use test device and a single-use vial containing a pre-measured amount of a buffered developer
solution. Each component is sealed in separate compartments of a single pouch to form the test. The OraQuick® rapid test
utilizes a proprietary lateral flow immunoassay procedure. The device plastic housing holds an assay test strip comprised of
several materials that provide the matrix for the immunochromatography of the specimen and the platform for indication of the test results.
The assay test strip, which can be viewed through the test device result window, contains synthetic peptides representing the
HIV envelope region and a goat anti-human IgG procedural control immobilized onto a nitrocellulose membrane in the Test
(T) zone and the Control (C) zone, respectively.
A fingerstick whole blood specimen is collected and transferred into the vial of developer solution, followed by the insertion
of the test device. The developer solution facilitates the flow of the specimen into the device and onto the test strip. As the
diluted specimen flows through the device, it rehydrates the protein-A gold colorimetric reagent contained in the device. As
the specimen continues to migrate up the strip, it encounters the T zone. If the specimen contains antibodies that react with
the antigens immobilized on the nitrocellulose membrane, a reddish-purple line will appear, qualitatively indicating the
presence of antibodies to HIV-1 in the specimen. The intensity of the line color is not directly proportional to the amount of
antibody present in the specimen.
Further up the assay strip, the sample will encounter the C zone. This built-in procedural control serves to demonstrate that a
specimen was added to the vial and that the fluid has migrated adequately through the test device. A reddish-purple line will
appear in the C zone during the performance of all valid tests, whether or not the sample is positive or negative for antibodies
to HIV-1 (refer to the Interpretation of Results section below).
The test results are interpreted after 20 minutes but not more than 60 minutes after the introduction of the test device into the
developer solution containing the test specimen. No precision pipeting, predilutions, or specialized instrumentation are
required to perform the OraQuick® Rapid HIV-1 Antibody Test.
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NAME AND INTENDED USE
The OraQuick® Rapid HIV-1 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human
Immunodeficiency Virus Type 1 (HIV-1) in fingerstick whole blood specimens. The OraQuick® Rapid HIV-1 Antibody Test
is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multitest
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® Rapid HIV-1 Antibody Test is restricted to clinical laboratories
o that have an adequate quality assurance program, including pl anned systematic activities to provide
adequate confidence that requirements for quality will be met; and
o where there is assurance that operators will receive and use the instructional materials.
• The OraQuick® Rapid HIV-1 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® Rapid HIV-1 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 ********ed 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.3 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 six 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® Rapid HIV-1 Antibody Test is a point-of-care test to aid in the diagnosis of infection with HIV-1.
Read this package insert completely before using the product. Follow the instructions carefully. Not doing so
may result in inaccurate test results.
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 fourth 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 issue by providing results during the initial visit and enabling immediate counseling.
Additionally, for pregnant women who do not know their HIV status at the time of delivery, rapid HIV testing permits
therapy to be initiated for these mothers during labor, and to their infants post partum, substantially reducing the chance that
the infants will become infected with HIV. Likewise, rapid HIV testing is instrumental in the decision to initiate treatment
for health care workers after accidental exposures to body fluids from infected individuals. In the U.S., it is estimated that
600,000 to 1,000,000 “needlestick injuries” occur each year. Critical decisions about treatment depend on the availability of
accurate, rapid HIV test results.
BIOLOGICAL PRINCIPLES OF THE TEST
The OraQuick® Rapid HIV-1 Antibody Test is a manually performed, visually read, 20 minute immunoassay for the
qualitative detection of antibodies to HIV-1 in human whole blood obtained from a finger puncture. The OraQuick® rapid
test is comprised of a single-use test device and a single-use vial containing a pre-measured amount of a buffered developer
solution. Each component is sealed in separate compartments of a single pouch to form the test. The OraQuick® rapid test
utilizes a proprietary lateral flow immunoassay procedure. The device plastic housing holds an assay test strip comprised of
several materials that provide the matrix for the immunochromatography of the specimen and the platform for indication of the test results.
The assay test strip, which can be viewed through the test device result window, contains synthetic peptides representing the
HIV envelope region and a goat anti-human IgG procedural control immobilized onto a nitrocellulose membrane in the Test
(T) zone and the Control (C) zone, respectively.
A fingerstick whole blood specimen is collected and transferred into the vial of developer solution, followed by the insertion
of the test device. The developer solution facilitates the flow of the specimen into the device and onto the test strip. As the
diluted specimen flows through the device, it rehydrates the protein-A gold colorimetric reagent contained in the device. As
the specimen continues to migrate up the strip, it encounters the T zone. If the specimen contains antibodies that react with
the antigens immobilized on the nitrocellulose membrane, a reddish-purple line will appear, qualitatively indicating the
presence of antibodies to HIV-1 in the specimen. The intensity of the line color is not directly proportional to the amount of
antibody present in the specimen.
Further up the assay strip, the sample will encounter the C zone. This built-in procedural control serves to demonstrate that a
specimen was added to the vial and that the fluid has migrated adequately through the test device. A reddish-purple line will
appear in the C zone during the performance of all valid tests, whether or not the sample is positive or negative for antibodies
to HIV-1 (refer to the Interpretation of Results section below).
The test results are interpreted after 20 minutes but not more than 60 minutes after the introduction of the test device into the
developer solution containing the test specimen. No precision pipeting, predilutions, or specialized instrumentation are
required to perform the OraQuick® Rapid HIV-1 Antibody Test.
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