For In Vitro Diagnostic Use Only
Caution: United States Federal Law restricts these devices 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. These products contain human-sourced and/or potentially infectious components and must be handled in accordance with the OSHA Standard on Bloodborne Pathogens.
For complete assay information, see the assay specific package insert.
ABBOTT PRISM CHAGAS
Intended Use: The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens. The ABBOTT PRISM Chagas assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components and other living donors, for the presence of antibodies to T cruzi. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non–heart-beating) donors. It is not intended for use on cord blood specimens.
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 the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of T cruzi infection.
ABBOTT PRISM HIV O PLUS
Intended Use: The ABBOTT PRISM HIV O Plus assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma specimens. The ABBOTT PRISM HIV O Plus assay is intended to screen individual human donors, including volunteer donors of Whole Blood and blood components and other living donors, for the presence of anti-HIV-1 Groups M and O and/or anti-HIV-2. The assay is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, in testing blood specimens to screen cadaveric (non–heart-beating) donors, and as an aid in the diagnosis of HIV-1/HIV-2 infection. It is not intended for use in testing cord blood specimens.
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 the 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.
ABBOTT PRISM HEPATITIS B VIRUS CORE ANTIGEN
Intended Use: The ABBOTT PRISM HBcore assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma specimens. The product is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors to prevent transmission of hepatitis B virus (HBV) from such donors. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.
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 the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HBV infection. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe wa.
ABBOTT PRISM HEPATITIS B SURFACE ANTIGEN
Intended Use: The ABBOTT PRISM HBsAg assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens. The ABBOTT PRISM HBsAg (ChLIA) is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of HBsAg. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.
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 the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HBV infection. 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.
ABBOTT PRISM HBSAG CONFIRMATORY
Intended Use: The ABBOTT PRISM HBsAg Confirmatory assay is an in vitro qualitative chemiluminescent immunoassay (ChLIA) used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization. The ABBOTT PRISM HBsAg Confirmatory assay is intended to be used for confirmation of samples found to be repeatedly reactive by the ABBOTT PRISM HBsAg assay.
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 the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HBV infection. 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.
ABBOTT PRISM HCV
Intended Use: The ABBOTT PRISM HCV assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to hepatitis C virus (anti‑HCV) in human serum and plasma specimens. The ABBOTT PRISM HCV (ChLIA) is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart beating) donors. It is not intended for use on cord blood specimens.
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 the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HCV infection. 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.
ABBOTT PRISM HTLV‑I/HTLV‑II
Intended Use: The ABBOTT PRISM HTLV‑I/HTLV‑II assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to human T‑lymphotropic virus Type I and/or human T‑lymphotropic virus Type II (anti‑HTLV‑I/HTLV‑II) in human serum and plasma specimens. The ABBOTT PRISM HTLV-I/HTLV-II (ChLIA) is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.
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 the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HTLV-I/HTLV-II infection. 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.
