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Uni-Gold™ Recombigen® HIV
Technology : Rapid Tests ~ HIV Brand : Uni-Gold ™ ~ HIV Analyte : Sexually Transmitted Diseases ~ HIV Intended UseUni-Gold™ Recombigen® HIV is a single use rapid immunoassay, for the qualitative detection of antibodies to HIV-1 in serum, plasma and whole blood(venipuncture and fingerstick). Uni-Gold™ Recombigen® HIV is intended for use in point of care settings as an aid in diagnosis of infection with HIV-1.This test is suitable for use in appropriate multi-test algorithms designed for the statistical validation of rapid HIV test results. PrincipleUni-Gold™ Recombigen® HIV was designed as a rapid immunoassay and is intended to detect antibodies to HIV-1 in human serum, plasma and whole blood (venipuncture and fingerstick).Uni-Gold™ Recombigen® HIV uses proteins representing regions of the HIV virus. If antibodies to HIV-1 are present in the sample, they combine with these proteins and a color reagent and this complex binds to the proteins in the test forming a visible pink/red band in the test region of the device adjacent to the word ‘Test’. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly. A reactive result is indicated by a pink/red band in the test region of the device. A non-reactive result occurs in the absence of detectable levels of antibodies to HIV-1 in the specimen; consequently no visually detectable band develops in the test region of the device. DescriptionCLIA COMPLEXITY;WAIVED FOR WHOLE BLOOD FINGERSTICK AND VENIPUNCTURE SAMPLES MODERATE COMPLEXITY FOR SERUM AND PLASMA SAMPLES Product Code : 1206506 Format : Uni-Gold™ 20 test Test/Kit : 20 Test FDA : Cleared Additional Information : Insert Version : 045-146 09/04 - See addendum instructions for use, attached as Additional Information
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