PMID- 33882283
OWN - NLM
STAT- MEDLINE
DCOM- 20210806
LR  - 20210806
IS  - 1873-2933 (Electronic)
IS  - 0009-9120 (Linking)
VI  - 93
DP  - 2021 Jul
TI  - Evaluation of the diagnostic performance of an oral fluid screening test device 
      for substance abuse at traffic controls.
PG  - 112-118
LID - S0009-9120(21)00112-0 [pii]
LID - 10.1016/j.clinbiochem.2021.04.009 [doi]
AB  - INTRODUCTION: The aim of this study was to evaluate the analytical performance of 
      the Kite Biotechnology Oral fluid (OF) screening test device, which is used for 
      roadside screening of cannabis, opiates, amphetamines, methamphetamine, 
      3,4-methylenedioxymethamphetamine (MDMA), cocaine and benzodiazepines by 
      comparing samples with matched plasma samples, analysed via liquid 
      chromatography-tandem mass spectrometry (LC-MS/MS) for confirmation. METHODS: OF 
      and plasma samples were obtained simultaneously from a total of 100 subjects. OF 
      samples were analysed by OF screening test based on immunochromatography. The OF 
      screening test cut-off values were 50 ng/mL for amphetamines (d-amphetamine) and 
      methamphetamine/MDMA (d-methamphetamine), 30 ng/mL for cocaine (benzoylecgonine), 
      40 ng/mL for opiates (morphine), 20 ng/mL for benzodiazepines (nordazepam), and 
      25 ng/mL for cannabis (Delta(9)-tetrahydrocannabinol). LC-MS/MS method validation was 
      performed according to the CLSI C62-A recommendations with the following 
      parameters: matrix effect, lower limit of quantification (LLOQ), linearity, 
      intra-day and inter-day precision and accuracy. RESULTS: The overall specificity, 
      accuracy and negative predictive values (NPV) were acceptable and met the DRUID 
      standard of >80%. The OF screening test device showed good sensitivity for 
      cocaine, amphetamines and opiates, whereas it indicated poor sensitivity for 
      methamphetamine/MDMA (66.7%) and failed to detect cannabis and benzodiazepines. 
      CONCLUSION: The present study is the first report to evaluate the Kite 
      Biotechnology OF screening test device. The diagnostic performance of the OF 
      screening test device was acceptable for opiates, cocaine and amphetamines, but 
      it was insufficient for methamphetamine/MDMA, benzodiazepines and cannabis 
      because of sensitivity issues.
CI  - Copyright (c) 2021 The Canadian Society of Clinical Chemists. Published by Elsevier 
      Inc. All rights reserved.
FAU - Avcioglu, Gamze
AU  - Avcioglu G
AD  - Department of Medical Biochemistry, Karadeniz Eregli State Hospital, Zonguldak, 
      Turkey. Electronic address: drgamzeavcioglu@gmail.com.
FAU - Yilmaz, Gulsen
AU  - Yilmaz G
AD  - Department of Medical Biochemistry, Ankara Yildirim Beyazit University Faculty of 
      Medicine, Ankara, Turkey.
FAU - Yalcin Sahiner, Safak
AU  - Yalcin Sahiner S
AD  - Department of Psychiatry, Ankara Training and Research Hospital, Ankara, Turkey.
FAU - Kozaci, L Didem
AU  - Kozaci LD
AD  - Department of Medical Biochemistry, Ankara Yildirim Beyazit University Faculty of 
      Medicine, Ankara, Turkey.
FAU - Bal, Ceylan
AU  - Bal C
AD  - Department of Medical Biochemistry, Ankara Yildirim Beyazit University Faculty of 
      Medicine, Ankara, Turkey.
FAU - Yilmaz, Fatma Meric
AU  - Yilmaz FM
AD  - Department of Medical Biochemistry, Ankara Yildirim Beyazit University Faculty of 
      Medicine, Ankara, Turkey.
LA  - eng
PT  - Comparative Study
PT  - Evaluation Study
PT  - Journal Article
DEP - 20210418
PL  - United States
TA  - Clin Biochem
JT  - Clinical biochemistry
JID - 0133660
RN  - 0 (Amphetamines)
RN  - 0 (Illicit Drugs)
RN  - 44RAL3456C (Methamphetamine)
RN  - 5353I8I6YS (benzoylecgonine)
RN  - 67220MCM01 (Nordazepam)
RN  - 76I7G6D29C (Morphine)
RN  - 7J8897W37S (Dronabinol)
RN  - I5Y540LHVR (Cocaine)
SB  - IM
MH  - Amphetamines/analysis
MH  - Cocaine/analogs & derivatives/analysis
MH  - Data Accuracy
MH  - Driving Under the Influence
MH  - Dronabinol/analysis
MH  - Equipment Failure Analysis
MH  - Female
MH  - Forensic Toxicology/instrumentation/methods
MH  - Humans
MH  - Illicit Drugs/analysis
MH  - Immunoassay/*instrumentation/*methods
MH  - Male
MH  - Methamphetamine/analysis
MH  - Morphine/analysis
MH  - Nordazepam/analysis
MH  - Plasma/chemistry
MH  - Predictive Value of Tests
MH  - Saliva/*chemistry
MH  - Substance Abuse Detection/*instrumentation/*methods
MH  - Tandem Mass Spectrometry
OTO - NOTNLM
OT  - Cut-off
OT  - LC-MS/MS
OT  - Oral fluid
OT  - Oral fluid screening test device
OT  - Plasma
OT  - Substance abuse
EDAT- 2021/04/22 06:00
MHDA- 2021/08/07 06:00
CRDT- 2021/04/21 20:07
PHST- 2020/06/28 00:00 [received]
PHST- 2021/03/22 00:00 [revised]
PHST- 2021/04/03 00:00 [accepted]
PHST- 2021/04/22 06:00 [pubmed]
PHST- 2021/08/07 06:00 [medline]
PHST- 2021/04/21 20:07 [entrez]
AID - S0009-9120(21)00112-0 [pii]
AID - 10.1016/j.clinbiochem.2021.04.009 [doi]
PST - ppublish
SO  - Clin Biochem. 2021 Jul;93:112-118. doi: 10.1016/j.clinbiochem.2021.04.009. Epub 
      2021 Apr 18.