For In Vitro Diagnostic Use Only
CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory.
For complete assay information, see the assay specific package insert.
ARCHITECT Anti-HBc
Intended Use: The ARCHITECT CORE assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti HBc) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information.
WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT CORE for use in screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established when the ARCHITECT CORE assay is used in conjunction with other manufacturers’ assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. Users are responsible for establishing their own assay performance characteristics in these populations.
Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.
ARCHITECT HBsAg Qualitative
Intended Use: The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. Not intended for use in screening blood, plasma, or tissue donors.
Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
ARCHITECT HBsAg Qualitative Confirmatory
Intended Use: The ARCHITECT HBsAg Qualitative Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum by means of specific antibody neutralization. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. Not intended for use in screening blood, plasma, or tissue donors.
Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
ARCHTECT Anti-HBs (AUSAB)
Intended Use: The ARCHITECT AUSAB assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. It is intended for quantitative measurement of antibody response following hepatitis B virus (HBV) vaccination, determination of HBV immune status, and for the laboratory diagnosis of HBV disease associated with HBV infection when used in conjunction with other laboratory results and clinical information.
WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT AUSAB for use in screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.
Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.
ARCHITECT Anti-HCV
Intended Use: The ARCHITECT Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to hepatitis C virus (anti-HCV) in human adult serum and plasma (potassium EDTA, lithium heparin, and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection.
WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT Anti-HCV for use in screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established for newborns, infants, children, or populations of immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.
Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
ARCHITECT Anti-HBc IgM
Intended Use: The ARCHITECT CORE-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human adult and pediatric serum or plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HBc is indicated as an aid in the diagnosis of acute or recent hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information.
WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT CORE-M for use in screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established when the ARCHITECT CORE-M assay is used in conjunction with other manufacturers’ assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.
Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.
ARCITECT HIV Ag/Ab Combo
Intended Use: The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV 1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin). The ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women.
An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV-1 p24 antigen, HIV-1 antibody, or HIV-2 antibody.
The ARCHITECT HIV Ag/Ab Combo assay is not intended for use in screening blood or plasma donors. The effectiveness of ARCHITECT HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.
Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.
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