Harmonisering av narkotikaanalyser i urinprov

Transkript

1 Harmonisering av narkotikaanalyser i urinprov Equalis expertgrupp Läkemedel / Toxikologi Therese Hansson Användarmöte 23 april 2015

2 Expertgruppsarbete HARMONISERINGAR Nationell harmonisering av metoder inom alkohol- och drogtestningsområdet, med målet att förbättra rättssäkerheten. Therese Hansson

3 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

4

5

6

7 Confirmation cut-off Therese Hansson

8 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

9 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

10 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

11

12 Hur har arbetsprocessen sett ut?

13 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

14

15 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

16 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) (Amf) 500 (MDMA,Ecstasy) 300 (Metamf) Amfetamin Metamfetamin Amf MDMA MDA Bensodiazepiner Temazepam Oxazepam Demetyldiazepam aminoklonazepam aminoflunitrazepam aminonitrazepam 100 Cannabis THC-COOH Kokain Bensoylekgonin Opiater (total) Morfin (total) Kodein (total) AM * 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) ( 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

17 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

18 WORKING PROCESS 2 Mars 2013 Equalis user meeting First Draft presented. Discussion with National Laboratories and Suppliers 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

19 WORKING PROCESS 2 Mars 2013 Equalis user meeting First Draft presented. Discussion with National Laboratories and Suppliers 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

20 WORKING PROCESS 2 Mars 2013 Equalis user meeting First Draft presented. Discussion with National Laboratories and Suppliers 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

21 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 OH-triazolam U-Cannabis 20 / 25 U-Cannabis THC-COOH 10 U-Cocaine 150 U-Cocaine Benzoylecgonine 100 U-Opiates (total) 6-AM U-Opiates (total) Morphine Codeine Ethylmorphine 6-AM

22 Rekommendation Narkotikaanalyser i urinprov EQUALIS expertgrupp Läkemedel /Toxikologi rekommenderar laboratorierna att from 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.

23 Är det slut på harmoniseringar nu? Therese Hansson

24 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

25 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