Harmonisering av narkotikaanalyser i urinprov Equalis expertgrupp Läkemedel / Toxikologi Therese Hansson Användarmöte 23 april 2015
Expertgruppsarbete HARMONISERINGAR Nationell harmonisering av metoder inom alkohol- och drogtestningsområdet, med målet att förbättra rättssäkerheten. Therese Hansson
2009 2010 2011 2012 2013 2014 2015 U-Kreatinin Nedre gränsvärde Jan 2012 Kvalitetssäkringsprogram PEth PEth Mätkomponent Namn Mätmetod Beslutsgränser Sept 2013 Narkotikaanalyser i urin Gränsvärden (screening och verifiering) Amfetaminer, Bensodiazepiner, Cannabis, Kokain, Opiater Svarsrutiner
Confirmation cut-off Therese Hansson
Testing performed at 3 different laboratories in Sweden. 66 Urine Samples Benzodiazepines Lab 1 29 Positive 37 Negative Lab 2 45 Positive 21 Negative 37 True Positive 29 True Negative Lab 3 37 Positive 29 Negative
SWEDEN Lab A <-> 120 km Lab B Driving licens SCREENING KIMS Cannabinoids II Lab A: cut-off 20 µg/l Positive Lab B: cut-off 50 µg/l Negative CONFIRMATION Lab B: cut-off 6 µg/l THC-COOH 6,2 µg/l
MÅL - Nationell enhetlighet GRÄNSVÄRDEN (cut-off) 1 Harmonisera gränsvärden (cut-off värden) på de fem (5) vanligaste missbruksmedlen på både screening och verifikation - Amfetamin - Bensodiazepiner - Cannabis - Kokain - Opiater 2 SVARSRUTINER Öka rättsäkerheten på drogtestområdet Therese Hansson
Hur har arbetsprocessen sett ut?
WORKING PROCESS - Basis for a national recommendation 1 The situation in SWEDEN International guidelines Occuring cut-offs on immunoassays on the market. Lab Data from four national laboratories Literature Therese Hansson
Adapt to the world outside Sweden USA: SAMHSA UK SCDAT (Switzerland) EUROPE EWDTS AUSTRALIA / NEW ZEALAND: AS / NZS Most commercially screening immunoassays which can be purchased in SWEDEN are developed in view of the american market. SAMHSA s cut-off concentrations have received international impact. Therese Hansson
Guidelines *) Target analyte must be d-methamphetamine and the test must significantly cross-react with MDMA, MDA, and MDEA REFERENSER SAMHSA* [5] EWDTS** [6] UK *** [10] AS/NZS**** [11] (USA) (Europa) (Storbritannien) (Australien, Nya Zeeland) Screening Verifikation Screening Verifikation Screening Verifikation Screening Verifikation (µg/l) (µg/l) (µg/l) (µg/l) (µg/l) (µg/l) (µg/l) (µg/l) Amfetaminer 500 (Amf/Metamf) 500 300 300 (Amf) 500 (MDMA,Ecstasy) 300 (Metamf) Amfetamin 250 200 200 150 Metamfetamin 250 + Amf 100 200 200 150 MDMA 250 200 200 150 MDA 250 200 200 150 Bensodiazepiner 200 200 200 Temazepam 100 100 200 Oxazepam 100 100 200 Demetyldiazepam 100 100 200 7-aminoklonazepam 100 7-aminoflunitrazepam 100 7-aminonitrazepam 100 Cannabis 50 50 50 50 THC-COOH 15 15 15 15 Kokain 150 300 300 300 Bensoylekgonin 100 150 150 150 Opiater (total) 2000 300 300 300 Morfin (total) 2000 300 300 300 Kodein (total) 2000 300 300 300 6-AM 10 10 10 10 10 * SAMHSA = Substance Abuse and Mental Health Service Administration ** EWDTS = European Workplace Drug Testing Society *** UK = United Kingdom **** AS/NZS= Australien New Zealand Standard 1) SAMHSA (USA) - Substance Abuse and Mental Health Services Administration (Department of Health and Human Services, HHS) Mandatory Guidelines for Federal Workplace Drug testing Programs, November 25, 2008, 2) EWDTS (Europa) - European Workplace Drug testing Society. European Laboratory Guidelines for Legally Defensible Workplace Drug Testing Urine Drug Testing (version 1.0, 2002) (http://www.ewdts.org/guidelines/ewdtsguidelines.pdf) 3) UK (Storbritannien) - United Kingdom Laboratory Guidelines for Legally Defensible Workplace Drug Testing Urine Drug Testing (version 1.0, 2001) 4) AUS (Australien, Nya Zeeland) - Joint Technical Committee CH-036. Analysis of Body Fluids and Wastes (2001) (Australien /New Zealand Standard) Therese Hansson
WORKING PROCESS - Basis for a national recommendation 1 The situation in SWEDEN International guidelines Occuring cut-offs on immunoassays on the market. Lab Data from four national laboratories Literature
WORKING PROCESS 2 Mars 2013 Equalis user meeting First Draft presented. Discussion with National Laboratories and Suppliers. 3 4 5 Mars 2013 Mars 2014 Second Draft distributed for comments to National Laboratories and Suppliers (Siemens, Thermo Scientific, Roche, Alere, Pro Diagnostics) More labdata Mars 2014 Equalis user meeting Final recommendation was presented. The users in Equalis s program for drug of abuse testing agreed for implementation. Publication - Läkartidningen April 2015 Equalis user meeting 6 Feedback Therese Hansson
WORKING PROCESS 2 Mars 2013 Equalis user meeting First Draft presented. Discussion with National Laboratories and Suppliers. 3 4 5 Okt 2013 Second Draft distributed for comments to National Laboratories and Suppliers (Siemens, Thermo Scientific, Roche, Alere, Pro Diagnostics) More labdata Mars 2014 Equalis user meeting Final recommendation was presented. The users in Equalis s program for drug of abuse testing agreed for implementation. Publication - Läkartidningen April 2015 Equalis user meeting 6 Feedback Therese Hansson
WORKING PROCESS 2 Mars 2013 Equalis user meeting First Draft presented. Discussion with National Laboratories and Suppliers. 3 4 5 6 Okt 2013 Second Draft distributed for comments to National Laboratories and Suppliers (Siemens, Thermo Scientific, Roche, Alere, Pro Diagnostics) More labdata Mars 2014 Equalis user meeting Final recommendation was presented. The users in Equalis s program for drug of abuse testing agreed for implementation. Publication - Läkartidningen Feedback
SCREENING (Immunoassay) Equalis - Final recommendation Cut-off (µg/l) CONFIRMATION Cut-off (µg/l) U-Amphetamines 500 U-Amphetamines Amphetamine Methamphetamine MDA MDMA U-Benzodiazepines 200 U-Benzodiazepines Desmethyldiazepam Temazepam Oxazepam Lorazepam 7-amino-clonazepam 7-amino-nitrazepam 7-amino-flunitrazepam OH-alprazolam 200 200 200 200 OH-triazolam U-Cannabis 20 / 25 U-Cannabis THC-COOH 10 U-Cocaine 150 U-Cocaine Benzoylecgonine 100 U-Opiates (total) 6-AM 300 10 U-Opiates (total) Morphine Codeine Ethylmorphine 6-AM 50 50 50 50 50 50 50 50 50 300 300 50 10
Rekommendation Narkotikaanalyser i urinprov EQUALIS expertgrupp Läkemedel /Toxikologi rekommenderar laboratorierna att from 2016-01-01 använda föreslagna gemensamma svenska gränsvärden (cut-off) för de fem vanligaste drogsubstansgrupperna Rekommenderar även laboratorierna: Mäta den heroinspecifika metaboliten 6-acetylmorfin (6-AM) för att styrka heroinintag som orsak till förekomst av morfin/kodein i urinprovet. Verifikationsanalysen rekommenderas vara kvantitativ och koncentrationen av drogen eller dess metabolit bör anges i svaret vid ett positivt testresultat. Provets kreatininkoncentration bör alltid mätas och anges i svaret.
Är det slut på harmoniseringar nu? Therese Hansson
2009 2010 2011 2012 2013 2014 2015 U-Kreatinin Nedre gränsvärde Jan 2012 Kvalitetssäkringsprogram PEth PEth Mätkomponent Namn Mätmetod Beslutsgränser Sept 2013 Narkotikaanalyser i urin Jan 2016 Gränsvärden (screening och verifiering) Amfetaminer, Bensodiazepiner, Cannabis, Kokain, Opiater Pre- och post analys Svarsrutiner
Contribution to the data in the harmonization work : Liselott Schönström, Clinical Chemistry Lund Mattias Persson, Clinical Chemistry Lund Lennart Karlsson, The National Board of Forensic Medicine, Linköping Maria Lönnqvist, Clinical Chemistry, Gothenburg Tomas Villen, Karolinska, Stockholm Anette Wahlgren, Clinical Chemistry Lund Anette Hjalmarsson, Clinical Chemistry Lund