Description
NAME AND INTENDED USE
The GS HBsAg EIA 3.0 is a qualitative enzyme immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma. It is indicated as a screening test for specimens from individual human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. The assay is not intended for use on cord blood specimens.
The GS HBsAg EIA 3.0 is intended for manual use and use with the ORTHO® Summit System (OSS) in the screening of blood donors.
WARNINGS FOR USERS
• For In Vitro Diagnostic Use.
• This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Handle appropriately with the requisite Good Laboratory Practices. Wear protective clothing, including lab coat, eye/face protection, and disposable gloves (synthetic, non-latex gloves are recommended) while handling kit reagents and patient samples. Wash hands thoroughly after performing the test.
• Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.
• Do not pipette by mouth.
• The following is a list of potential chemical hazards contained in some kit components (refer to Product Description chart): 0.005% Gentamicin Sulfate, a biocidal preservative, which is a known reproductive toxin, photosensitizer, and sensitizer; prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals. WARNING: Components C1, C2, R3, and R4 contain 0.5% ProClin 300
PRODUCT DESCRIPTION
EIA test for the detection of Hepatitis B Surface Antigen (HBsAg) in human serum, plasma and cadaveric serum samples. No sample predilution required. Color coded reagent labels and color changes during protocol steps.
