CDIA™ Mononucleosis Test Cassette - Creative Diagnostics

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CDIATM Mononucleosis Test Cassette (DTS353)

Intended Use

The Mononucleosis Serum Rapid Test (Cassette) is a rapid, convenient method for detecting infectious mononucleosis heterophile antibodies at the early stage of infection. With the combination of a mononucleosis antigen isolated from bovine red cell membranes and a mouse antibody against human IgM(
  • Serum, plasma
  • Cassette
  • Mononucleosis Serum Rapid Test (Cassette) demonstrated a sensitivity of 96.3% (55-2/55) and a specificity of96.6% (90-3/90).

Product Introduction

General Description

Infectious mononucleosis(IM) is an acute,benign,communicable disease most commonly caused by the Epstein-Barr virus EBV) and characterized

by lymphadenopathy,pharyngitis,fever,atypical lymphocytosis,and splenomegaly. The diagnosis of IM is usually based on evaluation of characteristic clinical,hematologic,and serologic changes.Serologic diagnosis of IM is demonstrated by the presence of heterophile and EBV antibodies in the sera of patients.The heterophile antibodies belong to the immunoglobulin M(IgM) class. The Mononucleosis Serum Rapid Test(Cassette) is an immunochromatographic assay which utilizes the heterophile antigen isolated from bovine red cell membranes,and a mouse monoclonal antibody,to selectively identify the IM heterophile antibodies in serum with a high degree of sensitivity.

Principle Of The Test
Mononucleosis Serum Rapid Test (Cassette) includes an immunochromatographic device in which a dye-conjugated monoclonal antibody against human IgM, and a heterophile antigen immobilized on the membrane are used to produce a distinctive visual pattern registering the presence of IM heterophile antibodies in the test sample. In the test procedure, patient serum or plasma is pretreated with an extraction buffer and then added to the sample well "S"of the test device with the aid of a transfer pipette.Labeled antibody-dye conjugate binds to the IM heterophile antibodies (if the latter are present in the specimen) forming a colored dye complex.This complex is captured by the heterophile antigen immobilized in the test zone "T" of the membrane, and is visible as a pink-rose color test band.A colored conjugate is captured in the control zone "C" of the membrane by an immobilized reagent, where it is visible as a pink-rose control band. A pink-rose band in the test zone with the control band visible is considered a positive result,and indicates that the patient specimen contains IM antibodies.The presence of the control band indicates that the test device is functioning correctly,and that the test reagents and sample specimen have properly mixed and migrated through the test membrane.

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