Description
Description
NAME AND INTENDED USE
The GS HIV-1 Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human serum, plasma, or dried blood spots. It is intended for use with persons of unknown risk as an additional, more specific test on human serum, plasma, or dried blood spot specimens found to be repeatedly reactive using a screening procedure, such as Enzyme-Linked Immunosorbent Assay (ELISA), and as an additional, more specific test for use with serum, plasma, or dried blood spot speci- mens obtained from subjects found to be reactive using rapid HIV-1 tests.
WARNINGS
For in vitro Diagnostic Use
WARNING: FDA has licensed this test for use with serum, plasma, and dried blood spot specimens only. Use of this licensed test kit with specimens other than those specifically approved for use with this test kit may result in inaccurate test results.
PRODUCT DESCRIPTION
The GS HIV-1 Western Blot kit is an in vitro qualitative assay for the detection and identification of antibodies to human immunodeficiency virus type 1 (HIV-1) in human serum, plasma, or dried blood spots. It is intended for use with persons of unknown risk as an additional, more specific test on human serum, plasma, or dried blood spot specimens found to be repeatedly reactive using a screening procedure, such as enzyme-linked immunosorbent assay (ELISA), and as an additional, more specific test for serum, plasma, or dried blood spot specimens obtained from subjects found to be reactive using rapid HIV-1 tests.
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