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1 INTRODUCTION

The Druglizer LE5 Drug Testing System is for the rapid oral fluid screening of drugs of abuse.

The system incorporates a Druglizer LE5 Drug Tester Cartridge (Druglizer LE5 Cartridge), a

Druglizer Oral Fluid Collector and a Druglizer LE5 Drug Tester instrument (Druglizer LE5,

purchased separately). The system is intended to be used by a trained professional to provide

a first line screen. A positive result displaying 'Unconfirmed' on-screen will require

confirmation by a laboratory-based reference assay like Gas chromatography – Mass

Spectrometry (GCMS) or Liquid Chromatography Mass Spectrometry (LCMS).

This document must be read carefully before using the Druglizer LE5 Drug Testing System and

Certified Operator Training provided by Alcolizer Technology must be completed before using

the Druglizer LE5 Drug Testing System. Keep the user manual available for the life of the

instrument and ensure operators have access to the user manual at all times. You must always

hand the user manual over to the subsequent instrument owner or user.

WARNING

• Only human oral fluid should be used.

• Results on the Druglizer LE5 are preliminary qualitative analytical test results. A

result displaying 'Unconfirmed' on-screen will require confirmation by a laboratory-

based reference assay.

• The presumptive presence of drugs is not a measure of impairment.

• A negative result may not necessary indicate a drug free sample. Drugs may be

present below the stated cut off.

• Foods/medicines or preclinical errors may result in false results.

The Druglizer LE5 must be stored at a temperature between –10°C and +60°C. Conduct drug

screening tests at a temperature between +5°C and +35°C.

This User Manual is applicable to the Druglizer LE5 with main module firmware version RN-1.5.0

2 TEST PRINCIPLE

The Druglizer LE5 Drug Testing System is based on a competitive lateral flow immunoassay

technique where drug molecules that may be present in the oral fluid sample compete with

the same drug attached to the nitrocellulose wicking membrane, for limited binding sites on

tagged drug specific antibodies.

The antibodies are tagged with gold colloids to produce a conjugate with a red colour. During

testing, an oral fluid sample is absorbed onto the oral fluid collector pad. Chemicals react with

the saliva to remove sample interferences and a portion of this sample wicks onto the

REF: Druglizer LE5 Drug Tester User Manual V1

NOTE

and drug test module or later

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