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The HSV 1+2 IgG ELISA TEST is to be used manually or in conjunction with the Duet™ instrument in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus associated disease.

The HSV 1+2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus (HSV) in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The HSV 1+2 IgG ELISA Test is comprised of the following items: Antigen-Coated ELISA Plate, IgG Specimen Diluent, Conjugate, Substrate Buffer, p-NPP Tablets, Stopping Reagent, Positive Control and Negative Control, Reference Serum, 20X Wash Solution, ELISA Plate Sealer, Resealable Storage Bag, and ELISA Worksheet. When the HSV 1+2 IgG ELISA Test is employed, diluted patient serum is incubated with partially purified HSV antigen bound to the ELISA plate wells. If antibodies to herpes simplex virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to herpes simplex virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.

The MUMPS IgG ELISA TEST is to be used in the testing of human serum specimens from asymptomatic and symptomatic children and adults for whom quantitation of the presence or the qualitative presence or absence of detectable IgG antibody to mumps virus is warranted in the determination of immunological experience pertaining to infection with mumps virus and as an aid in the diagnosis of mumps infection.

The Mumps IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative and semi-quantitative detection of IgG antibody to the mumps virus in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The Mumps IgG ELISA Test is comprised of the following items: Mumps Antigen-Coated ELISA Plate; IgG Specimen Diluent; Conjugate; Substrate Buffer; p-NPP Tablets; Stopping Reagent; Calibrator 1 and 2; Positive Control and Negative Control; Reference Serum; 20X Wash Solution; ELISA Plate Sealer; Resealable Storage Bag; ELISA Worksheet; Activity Units Graph Paper. When the Mumps IgG ELISA Test is employed, diluted patient serum is incubated with purified mumps virus antigen bound to the ELISA plate wells. If antibodies to the mumps virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the mumps virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.