Oral fluid testing device | Chemistry Dissertation

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Abstract

CTLS as part of the collaborative xxxxx Trading Ltd for validating One Step Multi-Drug Oral Fluid Drug Testing Device. Also the DOA test device registered with medicines and healthcare products.

Validation study of one step multi device was performed in CTLS by two ways.

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Abbreviations

µg/L – Microgram per litre
QA – Quality Assurance
POCT – Point of Care Test
MHRA – Medicines &Healthcare products Regulatory Agency
UKNEQAS – United Kingdom National External Quality
CAP – Clinical Pathology Accreditation
CTLS – Clinical Trials Laboratory
AMP – Amphetamine
BENZO – Benzodiazepines
COC – Cocaine
THC -Marijuana
MAMP – Methamphetamine
MOR -Morphine
OF – Oral Fluid
GC – Gas Chromatography
GC/MS – Gas Chromatography Mass Spectrometry
LC – Liquid Chromatography
CE – European Conformity
DDS – Digital data storage
0C – Degree centigrade
SOP – Standard Operating Procedure
IVDMD – In-Vitro Diagnostic Medical Device


Validation method 1

Validation method (1) was conducted from June 2009 through to July 2009. Seven samples were collected from UKNEQAS, which were offered pilot surveys for drugs of abuse in oral fluid and tested using a one step multi device. Three samples were detected by the one step multi device. The one step multi drugs testing device test result was compared to UKNEQAS analyst report.

Validation method 2

Validation method (2) started July 2009 and was completed in August 2009, eighteen urine and saliva sample were collected from volunteers and tested for drugs of abuse and tested using one step multi and Dipro Drug lab Multi panel Drug Test devices. During the test, three samples were providing positive results. The test results were compared with each method, and test result would be kept confidential so that client’s information would not be disclosed for any other purpose.

Chapter: 1

1     Introduction

The goal of this project at CTLS was to validate the Drug Abuse Point of Care Testing Kit which will have immense value to the public as well as to the medical research. The validation of testing the kit will certainly in turn become a reliable resource for definitive screening tool in the future. Our aim was to establish clinical cross validation trials necessary to prove drugs of abuse point of care testing kit for human saliva.

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