HTLV

6 Results Found

HTLV Blot 2.4 (RUO)

The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for the detection of antibodies to HTLV-I and HTLV-II in human serum or plasma samples. It is intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using screening procedures like the Enzyme-Linked Immunosorbent Assays (ELISA). This test kit is supplied for Investigational Use Only: The performance characteristics of this product have not been established.

HTLV I/II ELISA 4.0 (RUO)

The MPD HTLV-I/II ELISA 4.0 is a direct sandwich immunoassay that utilizes a combination of recombinant proteins and a tri-fusion recombinant protein labeled with horseradish peroxidase. The MPD HTLV-I/II ELISA 4.0 is intended as a semi-qualitative enzyme-linked immunosorbent assay for the detection of antibodies to both HTLV-I and HTLV-II found in human serum or plasma.

HTLV Blot 2.4 (CE)

The MP Diagnostics HTLV BLOT 2.4 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to HTLV-I and HTLV-II in human serum or plasma. It is intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using screening procedures like the Enzyme-Linked Immunosorbent Assays (ELISA).

HTLV I/II ELISA 4.0 (CE)

The MP Diagnostics HTLV I/II ELISA 4.0 is an enzyme-linked immunosorbent assay intended for the detection of antibodies to Human T-cell Lymphotropic Virus type 1 (HTLV-I) and type 2 (HTLV-II) in human serum or plasma. It is intended as a screening test, requiring repeat testing of initially reactive specimens.

HTLV I/II ELISA 4.1

The MP Diagnostics (MPD) HTLV-I/II ELISA 4.1 SYSTEM is an enzyme-linked immunosorbent assay intended for the detection of antibodies to Human T-cell Lymphotropic Virus type 1 (HTLV-I) and type 2 (HTLV-II) in human serum or plasma. It is intended as a screening test, requiring repeat testing of initially reactive specimens. The MP Diagnostics HTLV-I/II ELISA 4.1 System is intended to screen individual 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 preasystole and in testing blood specimens from donors when specimens are obtained post-asystole.

HTLV I/II Blot 2.4 (FDA)

The MP Diagnostics HTLV Blot 2.4 is intended as a supplemental (additional more specific), test to confirm the presence of anti-HTLV-I/II antibodies in blood donor specimens repeatedly reactive on an FDA licensed screening test and to differentiate between HTLV type-I and HTLV type-II infections for donor notification and counseling. The possible serological profiles defined by the HTLV Blot 2.4 include the following: HTLV-I Seropositive, HTLV-II Seropositive, HTLV-I/II Seropositive, Seronegative and Indeterminate. The MP Diagnostics HTLV Blot 2.4 uses a combination of HTLV-I/II genetically engineered proteins (i.e., recombinant antigens) and HTLV-I viral proteins derived from native, inactivated viral particles (i.e., viral lysate). The differentiation between HTLV-I and HTLV-II is accomplished through the use of rgp46-I, a unique HTLV-I envelope recombinant protein, and rgp46-II, a unique HTLV-II envelope recombinant protein. Both proteins are derived from the central region of the external glycoprotein, gp46, of HTLV-I and HTLV-II respectively. GD21, a common yet specific HTLV-I and HTLV-II epitope envelope recombinant protein derived from a truncated region of p21e (rgp21), is also used to enhance the specificity of envelope antibody detection: GD21 has demonstrated better specificity over p21e73, an earlier version of the recombinant antigen. The antigenicity exhibited by these recombinant proteins is either common to HTLV-I and HTLV-II antibodies or type specific to one of the two viral types to allow confirmation and differentiation in a single assay. Additional differentiation between HTLV viral types is effected using gag proteins p19 and p24; if p19 is greater than or equal to p24, HTLV-I infection is suggested, and if p24 is greater than p19, HTLV-II infection is suggested.

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