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Evaluation of the diagnostic performance of an oral fluid screening test device for substance abuse at traffic controls.
Clin Biochem. 2021 Jul; 93:112-118.CB

Abstract

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 (Δ9-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.

Authors+Show Affiliations

Department of Medical Biochemistry, Karadeniz Ereğli State Hospital, Zonguldak, Turkey. Electronic address: drgamzeavcioglu@gmail.com.Department of Medical Biochemistry, Ankara Yıldırım Beyazıt University Faculty of Medicine, Ankara, Turkey.Department of Psychiatry, Ankara Training and Research Hospital, Ankara, Turkey.Department of Medical Biochemistry, Ankara Yıldırım Beyazıt University Faculty of Medicine, Ankara, Turkey.Department of Medical Biochemistry, Ankara Yıldırım Beyazıt University Faculty of Medicine, Ankara, Turkey.Department of Medical Biochemistry, Ankara Yıldırım Beyazıt University Faculty of Medicine, Ankara, Turkey.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

33882283

Citation

Avcioglu, Gamze, et al. "Evaluation of the Diagnostic Performance of an Oral Fluid Screening Test Device for Substance Abuse at Traffic Controls." Clinical Biochemistry, vol. 93, 2021, pp. 112-118.
Avcioglu G, Yilmaz G, Yalcin Sahiner S, et al. Evaluation of the diagnostic performance of an oral fluid screening test device for substance abuse at traffic controls. Clin Biochem. 2021;93:112-118.
Avcioglu, G., Yilmaz, G., Yalcin Sahiner, S., Kozaci, L. D., Bal, C., & Yilmaz, F. M. (2021). Evaluation of the diagnostic performance of an oral fluid screening test device for substance abuse at traffic controls. Clinical Biochemistry, 93, 112-118. https://doi.org/10.1016/j.clinbiochem.2021.04.009
Avcioglu G, et al. Evaluation of the Diagnostic Performance of an Oral Fluid Screening Test Device for Substance Abuse at Traffic Controls. Clin Biochem. 2021;93:112-118. PubMed PMID: 33882283.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the diagnostic performance of an oral fluid screening test device for substance abuse at traffic controls. AU - Avcioglu,Gamze, AU - Yilmaz,Gulsen, AU - Yalcin Sahiner,Safak, AU - Kozaci,L Didem, AU - Bal,Ceylan, AU - Yilmaz,Fatma Meric, Y1 - 2021/04/18/ PY - 2020/06/28/received PY - 2021/03/22/revised PY - 2021/04/03/accepted PY - 2021/4/22/pubmed PY - 2021/8/7/medline PY - 2021/4/21/entrez KW - Cut-off KW - LC-MS/MS KW - Oral fluid KW - Oral fluid screening test device KW - Plasma KW - Substance abuse SP - 112 EP - 118 JF - Clinical biochemistry JO - Clin Biochem VL - 93 N2 - 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 (Δ9-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. SN - 1873-2933 UR - https://www.unboundmedicine.com/medline/citation/33882283/Evaluation_of_the_diagnostic_performance_of_an_oral_fluid_screening_test_device_for_substance_abuse_at_traffic_controls_ DB - PRIME DP - Unbound Medicine ER -