PMID- 28201761
OWN - NLM
STAT- MEDLINE
DCOM- 20170721
LR  - 20191210
IS  - 1945-2403 (Electronic)
IS  - 0146-4760 (Linking)
VI  - 41
IP  - 5
DP  - 2017 Jun 1
TI  - Evaluation of an Automated Reader and Color Interpretation-Based Immunoassays for 
      Multiplexed Drug-of-Abuse Testing in Urine.
PG  - 412-420
LID - 10.1093/jat/bkx014 [doi]
AB  - On-site drugs of abuse testing devices have undergone continuous improvement. We 
      evaluated three devices with different designs: an automated reader, the 
      Multi-Drug Screen Test Device with DxLINK (DxLINK; Innovacon, Alere, San Diego, 
      USA) and two colorimetric immunoassays, the One Step Multi-Line Screen Panel with 
      Integrated E-Z Split Key Cup II (E-Z Cup; Innovacon, Alere) and the One Step 
      Multi-Drug Screen Panel card (Multi4 card; Alere, Abon Biopharm, Hangzhou, 
      China). Eleven drugs [amphetamine, secobarbital, oxazepam, buprenorphine, 
      benzoylecgonine, methylenedioxymethamphetamine (MDMA), 
      11-nor-9-carboxy-Delta9-tetrahydrocannabinol (THC), methamphetamine, methadone, 
      morphine and nortriptyline] were tested using the DxLINK and E-Z Cup. Four drugs 
      (benzoylecgonine, THC, methamphetamine and morphine) were tested using the Multi4 
      card using control materials (Detectabuse Stat-Skreen; Biochemical Diagnostics, 
      Edgewood, NY, USA). The concentrations (-50%, -25%, +25%, +50% and 3x cut-off 
      values) of the control materials were confirmed by mass spectrometry. Concordance 
      rates were calculated around cut-offs. All devices showed high overall agreement 
      rates of >90% with a few exceptions: the DxLINK exhibited lower sensitivity for 
      benzoylecgonine, methadone and nortriptyline (60% and 30%, 92% and 40%, and 96% 
      and 60% sensitivity at +50% and +25% cut-off levels, respectively). The E-Z Cup 
      exhibited lower sensitivity for oxazepam and nortriptyline (97% and 50%, and 97% 
      and 40% sensitivity at +50% and +25% cut-off levels, respectively). We 
      additionally evaluated test-band color by visual inspection using a standard 
      color-scale card. When detailed color criteria for determination of positivity 
      were applied for the E-Z Cup, using slightly less stringent criteria, oxazepam, 
      buprenorphine, MDMA and nortriptyline showed increases in sensitivity from 70-80% 
      to 90-100%, all with a specificity above 98%. Overall, all devices exhibited 
      satisfactory performance at +/-50% cut-off levels for commonly used drugs, with the 
      exception of lower sensitivity for cocaine testing for DxLINK. Careful evaluation 
      of devices and elaborate calibration of visual interpretation for determining 
      positivity may help improve the performance of these devices.
CI  - (c) The Author 2017. Published by Oxford University Press. All rights reserved. For 
      Permissions, please email: journals.permissions@oup.com.
FAU - Kim, Seon Young
AU  - Kim SY
AD  - Department of Laboratory Medicine, Chungnam National University School of 
      Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
FAU - Kim, Hyunjin
AU  - Kim H
AD  - Department of Laboratory Medicine, Chungnam National University School of 
      Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
FAU - Park, Yeongchun
AU  - Park Y
AD  - Department of Laboratory Medicine, Chungnam National University School of 
      Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
FAU - Lim, Jinsook
AU  - Lim J
AD  - Department of Laboratory Medicine, Chungnam National University School of 
      Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
FAU - Kim, Jimyung
AU  - Kim J
AD  - Department of Laboratory Medicine, Chungnam National University School of 
      Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
FAU - Koo, Sun Hoe
AU  - Koo SH
AD  - Department of Laboratory Medicine, Chungnam National University School of 
      Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
FAU - Kwon, Gye Cheol
AU  - Kwon GC
AD  - Department of Laboratory Medicine, Chungnam National University School of 
      Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PL  - England
TA  - J Anal Toxicol
JT  - Journal of analytical toxicology
JID - 7705085
RN  - 0 (Illicit Drugs)
RN  - 40D3SCR4GZ (Buprenorphine)
RN  - 44RAL3456C (Methamphetamine)
RN  - 5353I8I6YS (benzoylecgonine)
RN  - 76I7G6D29C (Morphine)
RN  - 7J8897W37S (Dronabinol)
RN  - CK833KGX7E (Amphetamine)
RN  - I5Y540LHVR (Cocaine)
RN  - UC6VBE7V1Z (Methadone)
SB  - IM
MH  - Amphetamine/urine
MH  - Automation
MH  - Buprenorphine/urine
MH  - China
MH  - Cocaine/analogs & derivatives
MH  - Dronabinol/analysis
MH  - Gas Chromatography-Mass Spectrometry
MH  - Illicit Drugs/*urine
MH  - Immunoassay/*methods
MH  - Mass Spectrometry
MH  - Methadone/urine
MH  - Methamphetamine/urine
MH  - Morphine/urine
MH  - Sensitivity and Specificity
MH  - Substance Abuse Detection/*methods
EDAT- 2017/02/16 06:00
MHDA- 2017/07/22 06:00
CRDT- 2017/02/16 06:00
PHST- 2016/09/05 00:00 [received]
PHST- 2017/02/16 06:00 [pubmed]
PHST- 2017/07/22 06:00 [medline]
PHST- 2017/02/16 06:00 [entrez]
AID - 2991449 [pii]
AID - 10.1093/jat/bkx014 [doi]
PST - ppublish
SO  - J Anal Toxicol. 2017 Jun 1;41(5):412-420. doi: 10.1093/jat/bkx014.