Multispot HIV-1/HIV-2 Rapid Test

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Overview

Multispot HIV-1/HIV-2 Rapid Test

Multispot HIV-1/HIV-2 Rapid Test: Test Result Appearance and Interpretation

Refer to the Package Insert for detailed procedure instructions.

HIV Serological Profile

HIV Serological Profile

NAME AND INTENDED USE

The Multispot HIV-1/HIV-2 Rapid Test is a single use qualitative immunoassay to detect and differentiate circulating antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1, HIV-2) in fresh or frozen human serum and plasma. This rapid HIV-1/HIV-2 test kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in fresh or frozen human serum or plasma. This test is suitable for use in multi- test algorithms designed for statistical validation of an HIV screening test result or as part of an HIV-1/HIV-2 diagnostic testing algorithm that includes differentiation of HIV-1 and HIV-2 antibodies.

RESTRICTIONS

  • Sale of the Multispot HIV-1/HIV-2 Rapid Test is restricted to clinical laboratories that have an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional materials.
  • The Multispot HIV-1/HIV-2 Rapid Test is approved for use only by an agent of a clinical laboratory.
  • Test subjects must receive the “Subject Information Notice” prior to specimen collection, and appropriate information when test results are provided, unless this test is used as part of a multi-test diagnostic algorithm.
  • The Multispot HIV-1/HIV-2 Rapid Test is not approved for use to screen blood, plasma, cell, or tissue donors.

PRODUCT DESCRIPTION

The Multispot HIV-1/HIV-2 Rapid Test is a single use qualitative immunoassay to detect and differentiate circulating antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1, HIV-2) in fresh or frozen human serum and plasma. This rapid HIV-1/HIV-2 test kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in fresh or frozen human serum or plasma. This test is suitable for use in multi-test algorithms designed for statistical validation of an HIV screening test result or as part of an HIV-1/HIV-2 diagnostic testing algorithm that includes differentiation of HIV-1 and HIV-2 antibodies.

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Multispot HIV-1/HIV-2 Rapid Test
Multispot HIV-1/HIV-2 Rapid Test

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HIV rapid test for detection and differentiation of human immunodeficiency virus (HIV-1 and HIV-2) antibodies in human serum or plasma

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