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The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyser intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.

The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut offs:

The Evidence MultiSTAT DOA Urine Multiplex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) and the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For In Vitro Diagnostic use only.

FOR PRESCRIPTION USE ONLY

The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilized antibodies specific to different Drugs of Abuse (DOA) compound classes. A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.

The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.

Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.

The Evidence MultiSTAT DOA Urine MultiPlex (EV4393) will be supplied as a test kit comprising:

• 12 x Urine Test Cartridges
• 6 x 1 ml Urine Cut Off Material (lyophilized)
• 4 x 1 ml Urine Positive Control Material (lyophilized)
• 2 x 10 ml Reconstitution Buffer
• 1 x Batch Barcodes

Each kit is supplied with the Evidence MultiSTAT Accessory kit (EV4116) which contains:

• 12 x MultiSTAT Tip Cartridges
  • 1 x Tip/Waste Cartridge
  • 6 x 1000 µl Pipette Tip
  • 1 x Liquid Absorber

Reagent Composition
MultiSTAT DOA Urine MultiPlex Assay Diluent
20 mM phosphate buffer, pH 7.0 containing protein, detergents, and preservatives. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Conjugate
20 mM Tris based buffer, pH 7.0 containing protein, preservatives, and horseradish peroxidase - labelled drug derivatives. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Biochip
Solid substrate containing immobilized antibody discrete test regions. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Wash Buffer
20 mM Tris buffered saline, pH 7.4, containing surfactant and preservatives. This is contained within the cartridge.

LUM-EV934/PX
Luminol-EV934 and Peroxide are contained within the cartridge and are mixed in a ratio of 1:1 by the analyser to give the working signal reagent

MultiSTAT DOA Urine MultiPlex Cut Off
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives and drug concentrations at the assay cut off values (detailed in Table 3 above).

MultiSTAT DOA Urine MultiPlex Positive Control
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives, and drug concentrations.

MultiSTAT Reconstitution Buffer
A solution at a neutral pH containing preservatives.

N/A

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