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The FasTraQ Automated Analyzer in coniunction with the PrePaQ Total hCG Cartridge is intended for use as an aid in the early detection of pregnancy where rapid, quantitative results in the emergency department or where other rapid diagnostics are required. The assay is to be used with patient whole blood samples. The Quantech PrePaQ Total hCG Test Cartridge is intended for use with the FasTraQ Automated Analyzer to provide rapid, quantitative measurement of human chorionic gonadotropin (hCG) in whole blood for the determination of pregnancy. The Analyzer and hCG Cartridge combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. The FasTraQ System is designed for use by non-laboratory medical professionals in emergency departments, STAT or central laboratories.

The PrePaQ Cartridge in coniunction with the FasTraQ Automated Analyer is use to quantitate hCG in whole blood using surface plasmon resonance (SPR). The Quantech PrePaQ Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with SPR surface mass measurement. Each PrePaQ cartridge contains a solid phase ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-alpha hCG polyclonal antibody conjugated to alkaline phosphatase is attached to the antigen to form the sandwich. An enhancing solution is used to further increase the mass on the surface.

The Quantech Total β-hCG Assay is intended to be used, as aid in the early detection of pregnancy. The Quantech Total β-hCG Assay is intended to be used for the quantitative determination of human chorionic gonadotropin in EDTA-stabilized plasma, for the early detection of pregnancy.

The Quantech Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with surface plasmon resonance (SPR) surface mass measurement. Each test module contains a solid phase anti-ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-hCG polyclonal antibody, used to enhance the specific detection by SPR is introduced sequentially.

The Quantech CK-MB Assay is intended to be used as an aid in diagnosing myocardial infarction in patients exhibiting chest pain. It is intended to be used in conjunction with EKG, and physician examination, as well as possibly other biochemical blood tests to rule in or out origin of the chest pain. The Quantech CK-MB Assay is intended to be used for the quantitative determination of the cardiac isoenzyme CK-MB, in order to assist in the diagnosis of acute myocardial infarction.

The Quantech CK-MB assay is based on the principle of two site, or sandwich immunoassav in combination with SPR surface mass measurement. Each test module contains a solid phase anti-CK-MB monoclonal antibody immobilized onto a gold surface. An anti-CK-MB polyclonal antibody, used to enhance the specific detection of the isoenzyme is introduced sequentially. The Quantech assay utilizes CK-MB-specific antibody to capture the CK-MB in the sample. This is followed by a quantitation of the surface mass increase using surface plasmon resonance (SPR), to measure the CK-MB in plasma.