Instruments & Systems, Human T-lymphotropic virus (HTLV)

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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 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 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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