INSTAND EQA SCHEMES MANUAL. January Gesellschaft zur Förderung der Qualitätssicherung. in medizinischen Laboratorien e. V.

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1 2 INSTAND EQA SCHEMES MANUAL January 2014 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. The samples are non reactive to antibodies against HIV (human-immuno-deficiencyvirus (HTLV III/LAV)) and HBs-Ag (hepatitis B surface antigen). The products must be handled like patient samples!

2 Alternatively the results can be entered online: 100 Clinical chemistry 300 Pancreas/gastrointestinal tract 102 CZE 301 Ca-metabolism/special thyroid 110 Neonatal bilirubin 302 Hormones 111 Glucose 303 Estradiol 118 Dry chemistry I: ammonia 304 Aldosterone 120 Dry chemistry I: Reflotron systems 305 Fertility - 1. trimester screening 121 Dry chemistry I: Vitros systems 306 Fertility - 2. trimester screening fecal diagnostics Fertility analytes 141 Serum proteins/electroph. 308 hcg Glycated proteins I-IV 309 Virilization 151 Lipids/lipoproteins 320, 321, 323 Infection serology Blood gas analysis 322 CRP 172 Urine chemistry I - sediment (pictures) 398 hgh Urine chemistry II 464 CSF V 175 Urine chemistry III Haemostasis Narcotic drugs in human urine 601 Immunsuppressive drugs Urine chemistry IV 602 Antimykotika/Immunsuppressives 179 Urine chemistry V 612/912 Haematology - Differential blood count (automatic) 181 Photometer controls 620 Arteriosclerosis 185 Biogene amine in plasm 630 ACE TDM I-XV 700 Ethanol Trace elements I-IV 720 Allergy diagnostic 211 Haematology - Blood cell count Molekulargenetik I 213 Haematology 10 - Immunophenotyping Molekulargenetik II 215 Haematology 05 - Reticulocyte analysis 750 CDT 216 Haematology 04 - Reticulocyte analysis 760 Myocardial markers 217 Haematology 11 - Stem/ Progenitor cells 761 BNP Haemostaseology Neonatal screening Immunohaematology Molekulargenetik II Immunohaematology 800 POCT-Glucose 236 Free haemoglobin 802 POCT-Lactate 240 hs CRP 850 Antiretrovirals I 241 Immunology-Plasmaproteins Psychotherapeutic drugs I-V Cystatin Gammopathies Autoimmune diseases Haemostasis Vitamins (serum) Vtamins (whole blood) Tumor markers PSA Thyroid hormones Thyroid gland antibodies Fertility analytes (general) Adrenal gland/pituitary 1/15

3 TABLE OF CONTENTS Key of manufacturers / for reagents 3-7 Important comments for No.: Clinical Chemistry Blood smear analysis (incl. anamnesis of the special sample) Allergy diseases Glycated proteins (HbA1, HbA1c) Haemostasis Important comments 12 New key code NEW! The method codes are now available on the protocol sheet! If your coding doesn`t fit the specifications of the current manuel, you will only receive a confirmation of participation. For any further queries, don`t hesitate to contact Mrs. Kutsch kutsch@instand-ev.de You are kindly asked to use this list for coding and registration your results from the EQA-survey. INSTAND e.v. Postfach D Düsseldorf Tel.: +49 (0) Fax: +49 (0) instand@instand-ev.de 2/15

4 INSTAND - Codes (also for haemostaseology!) AB-Analitica ABBOTT ABX DIAGNOSTICS ACCURI Acris ADALTIS AESKU DIAGNOSTICS AID ALBIO ALERE (INVERNESS MEDICAL) Alexis altona Diagnostic AMPLISENS ANALYTICON ANALYTIK JENA ANDIATEC APPLIED BIOSYSTEMS Aptec ARGENE (BIOMERIEUX) ARTUS ASTRA DIAGNOSTICS ATTONOL AUTOIMMUN DIAGN. AVL AXIS-SHIELD AG AXON LAB BAG Health Care BAYER HEALTH (Siemens) BAYER VITAL BDL LABORDIAGNOSTIK GmbH BECKMAN (OLYMPUS) BECKMAN COULTER BECTON DICKINSON BEHNK ELEKTRONIK BINAX BINDING SITE,THE BIOCHROM BIOCON BioCytex BIOKIT BIOLABO BioLegend biolytical BIOMED BIOMERIEUX BIONIME BIOPHARM BIORAD BIOS Biosens BIOSENS BIOSERV Diagn. BIOSITE Biosource BIOSTAR BIOTEC-FISCHER BIOTEST BIOTRIN BodiTech BOSKAMP BRAHMS BRAUN BST Bio Sensor Technology BUEHLMANN AU AB AD AC ACR SO AE AA AO VV ALX AK AM AN AJ AQ AP APT AG AR AS AT AI AV AH AY BA BG BY LM OL BE BN EB BI BS BH BC BIC BB BIL BIG B2 BD AX BM BZ BR BQ B1 BV BX BO BIS BU BF BT BL BOD BP HN BJ BST BK CARE DIAGNOSTICA Cederlane ceeramtools Cell Sciences CENTRONIC CEPHEID Chemagen CHEMICON CHIPRON CHIRON CHROMOGENIX CHROMSYSTEMS CIS (ISOTOPEN-DIAGN.) CLEARVIEW CLINICAL ASSAYS Coachrom COAMATIC CORGENICS CORIS BIOCONCEPT COULTER DADE BEHRING (Siemens) DAKO DDV DEMEDITEC DEUKA SEIKEN Diaclone DIAGAST DIAGLOBAL Diagon Diagonal DIAMED DIAPRO DIASORIN DIASYS Diatron DIAZYME DIESSE DIAGNOSTICA DIGENE DLD DIAGNOSTIKA DPC BIERMANN (Siemens) DR.KOCH-DR.MERK DRG INSTRUMENTS DSL DUPONT DYTREX (INFOPIA) ebiosciences EKF Diagnostics ELECTRO NUCLEONICS EPPENDORF EURO IMMUN Eurolyser Exbio FAST-TRACK DIAGNOSTICS FEINCHEMIE SEBNITZ FOCUS FOOKE FRESENIUS FROST FUJIZOKI (Fujirebio) FUMOUZE gabmed GmbH GEN ID Gen-Probe GENBIO 3/15 CD CED CT CL CN CI CG CC CP CO CX CR IW CW CS COA CM CE CB CU BW DA DV DT DK DC DJ DH DIG DB DM DR DO DS DIA DZ DE DN DX DG KM DI DL DP DY EBI EK EN EP ER EL EX FT FS FC FO FR FX FU FM GM GI GX GB GENELAB GeneProof GENERIC ASSAYS GENES-4U Genetex Genomica GENTRA SYSTEMS GenWay Biotech Inc. GENZYME GmbH Gerbion GFE BLUT mbh GOEDECKE GONOTEC GRADIPORE GREINER GREINER SCHWEIZ GRIFOLS GULL HAEMOCHROM HAIN HAL HELENA DIAGNOSTIKA HEMAGEN HEMOCUE HISS DIAGNOSTICS Hitachi HITADO/Nobis HUMAN HYCOR HYPHEN IBL ICN BIOMEDICALS IIM IME-DC IMMUCHROM IMMUCOR IMMUNDIAGNOSTIK IMMUNO IMMUNODIAG. SYSTEMS IMMUNOLAB IMTEC Ingenetix INNOGENETICS INNOTRAIN INSTRUMENTATION LAB. INTEX INVICON INVITEK Invitrogen IQ Products IRIS International KABE LABORTECHNIK KELLER MEDICAL KNAUER KONELAB (Siemens) Lab21 LabiTec LABOR DIAGNOSTIKA LABOR+TECHNIK LANGE LDBIO DIAGNOSTICS LIFESCAN LifeSpan BioSciences LINCO GE GP GA GN GT GC GS GW GD GH GF GO GQ GG GR GZ GL GU HO HA HL HD HG HM HI HH HT HU HC HY IB IE IP IME IC IU IK IM ID IN IT IG IS IO IL IX IV II INV IQ IR KL KE KA KN LZ LE LD LT LA LO LS LB LI

5 INSTAND - Codes (also for haemostaseology!) LOXO LRE MEDIZINTECHNIK Luminex MACHEREY-NAGEL MALINCKRODT MARDX MAST DIAGNOSTICA MATRITECH MBL International MEDAC MEDIAGNOST Medical & Biological Laboratories MEDIGNOST MEDIPAN MediRox MEDIX BIOCHEMICA Medtronic MENARINI MERCK MERIDIAN BIOSCIENCE MERLIN MEDICAL LEMGO MICROGEN BIOPRODUCTS MICROGENICS Microimmune Micropoint MIKROGEN MILENIA BIOTEC MILLIPORE Milteny MILTENYI BIOTEC Mitsubishi MÖLAB MOLTER MP Biomedicals MP Diagnostics MUREX NAL VON MINDEN NANOGEN NICHOLS INSTITUTE NOVA BIOMEDICAL NOVAGNOST (Siemens) Novartis NOVATEC Novus Biomedical OMEGA OMEGA DIAGNOSTICS (ALLERGO ONE LAMBDA (Thermo Fisher Scie OraSure Technology ORGANON TEKNIKA ORGENICS ORGENTEC ORION ORTHO CLIN.DIAGN. OSMETECH / Opti Medical OTHER MANUFACTURES OWN MANUFACTURE Oxford Biotechnology OXOID PANBIO Partec PathoFinder PENTAPHARM PERKIN ELMER PFAFF MEDICAL GmbH LX LR LU MG MN MY MA MH MBL MC MT MEL MD MP MED MM MET MB ME MR MML MF MI MU MPT MK MZ ML MIL MQ MIT MOE MO MJ MS MX MV NN NI NV NX NT NO NB OA AL OB OU OT OG OC ON OR OS ZY ZX OX OD PB PA PT PN PE PF PHADIA (THERMO FISHER SCIENT PRODESSE PROGEN Promega Protox QIAGEN Qualpro Diagnostics QUIDEL R&D Systems R-BIOPHARM RADIM RADIOMETER RANDOX RAVO DIAGNOSTICA Raybiotech Inc. Reagen RECIPE Remel RISA ROBOSCREEN ROCHE DIAGNOSTICS ROTEM RPC Diagnostic Systems SACACE BIOTECHNOLOGIE SAMSUNG SANOFI PASTEUR Santa Cruz Biotechnology Inc. SARSTEDT SARTORIUS SAVAYON SCHEBO BIOTECH AG SCIL DIAGNOSTICS SCIMEDX SEBIA Seegene Sekisui Virotech SERAMUN Servoprax SIEMENS MED.SOLUT.DIAG SIFIN SIGMA DIAGNOSTICS STAGO Stago / Tcoag (Trinity Biotech) Standard Diagnostics Syco Med SYSMEX Taidoc Technology Corp TECAN TECHNICON TECHNOCLONE TECO MEDICAL GROUP Tem International TEST-LINE Thermo Scientific TIB MOLBIOL TOSOH BIOSCIENCE United States Biological VECTOR BEST VIDIA VIENNA LAB VIRAMED VIRCELL VIRIMMUN VIRION DEUTSCHLAND 4/15 PH PO PR PM PRO QG QP QI RD RB RM RA RX RV RAY RG RE RL RI RS RO RT RP SG SM PS SCB SA SR SV SH SC SX SB SE VT SU SP SI SF SD ST TB S1 SYC SY QU TN TE TC TO TI TT TS TM TH USB VB VZ VL VM VC VI VD VIRION/SERION VIRO-IMMUN LAB.DIAGN. VITA VIVA ( see Inverness Medical) WAKO WALLAC VR VO VA VV WA WL

6 INSTAND - Codes (also for haemostaseology!) Abbott I-Stat Abbott TDx, FLx Abbott Cell-Dyn 1200 Abbott Cell-Dyn 1300 Abbott Cell-Dyn 1600/1700 Abbott Cell-Dyn 1800 Abbott Cell-Dyn 3000 Abbott Cell-Dyn 3500/3700 Abbott Cell-Dyn 3200 Abbott Cell-Dyn 4000 Abbott AxSym Abbott Architect Abbott Cell-Dyn Ruby Abbott Cell-Dyn Sapphire Abbott Cell-Dyn Emerald Abbott Precision Xtra Abbott Precision Xtra plus Abbott Precision Xceed pro Abbott Freestyle Precision H Abbott Freestyle Precision Abbott Freestyle Abbott: other devices Accuri: all devices Axis-Shield - Afinion System Axis-Shield - NycoCard System Axis-Shield: other devices applied biosystems - TaqMan applied biosystems - API masss spectrometry Applied Biosystems - SCIEX QTRAP 5500 Applied biosystems: other devices BioMérieux Vidas BioMérieux Hemolab BioMérieux: other devices Axon Lab Hitachi S40/M40 Axon Lab: other devices Beckman: PK 7300 Beckman Paragon Systeme Beckman Paragon CZE 2000 Beckman Array-Systeme Beckman Immage-Systeme Beckman Synchron CX-Systeme Beckman Synchron LX-Systeme Beckman Unicel DX-System Beckman Access Beckman: other devices Siemens (Bayer Healthcare) Advia Siemens (Bayer Healthcare) ACS 180 Siemens (Bayer Healthcare) Centaur Siemens (Bayer Healthcare) Rapidpoint 400, 405, 500 Siemens (Bayer Healthcare) Rapidlab 1200 Siemens (Bayer Healthcare) Rapidlab 800 Siemens (Bayer Healthcare) Rapidlab 248 Siemens (Bayer Healthcare) Rapidlab 348 Siemens (Bayer Healthcare) DCA 2000 Siemens (Bayer Healthcare) Clinitek Atlas Siemens (Bayer Healthcare) Clinitkek, other devices Siemens (Bayer Healthcare) Advia 120 Siemens (Bayer Healthcare) Advia2120 Siemens (Bayer Healthcare) Advia 2120i Siemens (Bayer Healthcare) H-Series Siemens (Bayer Healthcare): other devices Braun Omnitest plus Braun Omnitest 3 Braun oter devices Bionime Righttest GM300 Bionime oter devices Becton Dickinson Biosciences FACScan Becton Dickinson Biosciences FACSCalibur Becton Dickinson Biosciences FACS Canto I Becton Dickinson Biosciences FACS Canto II Becton Dickinson Biosciences LSR II Becton Dickinson Biosciences LSR Fortessa Becton Dickinson Biosciences FACS DIVA AB01 AB07 AB10 AB11 AB12 AB13 AB14 AB15 AB16 AB17 AB18 AB20 AB30 AB31 AB32 AB40 AB41 AB43 AB44 AB45 AB46 AB99 AC99 AH01 AH02 AH99 AP01 AP02 AP03 AP99 AX01 AX03 AX99 AY01 AY99 BE01 BE15 BE16 BE32 BE51 BE80 BE81 BE82 BE85 BE99 BG07 BG16 BG17 BG20 BG21 BG22 BG23 BG24 BG25 BG50 BG51 BG52 BG53 BG54 BG55 BG99 BJ01 BJ03 BJ99 BM01 BM99 BN01 BN02 BN03 BN04 BN05 BN06 BN07 Becton Dickinson Biosciences Accuri C6 Becton Dickinson: other devices Biosite Triage System Biosite: other devices BodiTech i-chroma Bio-Rad Variant II BioRad: Tango BioRad: HemOS BioRad: IH-1000 Bio-Rad: other devices Binding Site: SPA plus Binding Site: other devices BST Glukometer 3000 BST Glukometer pro BST: other devices Siemens (Dade-Behring) BEP III Siemens (Dade-Behring) Nephelometer Siemens (Dade Behring) Turbitimer Siemens (Dade-Behring) BN Prospect Siemens (Dade-Behring) Dimension Siemens (Dade-Behring) Dimension Vista Siemens (Dade-Behring) BCT Siemens (Dade-Behring) BCS / BCS XP Siemens (Dade-Behring) CA-systems Siemens (Dade-Behring) BFT II Siemens (Dade-Behring) CS-2000i / CS-2100i Siemens (Dade-Behring) CS-5100 Siemens (Dade-Behring): other devices Bayer Vital Contour Bayer Vital Breeze2 Bayer Vital Contour XT Bayer Vital oter devices Care Diagnostica EcoSolo Care Diagnostica EcoSolo II Care Diagnostica oter devices Beckman Coulter MD-series Beckman Coulter MAX M/AL Beckman Coulter ONYX, ONYX / AL Beckman Coulter HmX Beckman Coulter STKR/STKS Beckman Coulter AC*T-series Beckman Coulter GEN*S Beckman Coulter AC.T5 Diff-series Beckman Coulter LH 500 Beckman Coulter LH 750/780 Beckman Coulter UniCel DxH 800 Beckman Coulter Epics Beckman Coulter FC500 Beckman Coulter Gallios Beckman Coulter Navios Beckman Coulter Cyan Beckman Coulter Cellios Beckman Coulter Astrios Beckman Coulter: other devices Siemens (DPC Biermann) Immulite Siemens (DPC Biermann) Immulite 2000 Siemens (DPC Biermann) Immulite Turbo Siemens (DPC Biermann) Immulite 2500 Siemens (DPC Biermann): other devices Diatron Abacus 5 Diatron Abacus Junior / 30 Diatron: other devices Diagast: Qwalys Diamed CD-X Diamed: other devices Diasorin Liaison Diasorin Liaison XL Diasorin: other devices Dytrex (Infopia) Easy Gluco Dytrex (Infopia) Finetest Dytrex (Infopia) oter devices Behnk Elektronik Coagulator CM 2,-4,-8 Behnk Elektronik Thrombotimer 1,-2,-4 BN08 BN99 BO01 BO99 BOD01 BR01 BR02 BR03 BR04 BR99 BS01 BS99 BST01 BST02 BST99 BW03 BW04 BW07 BW08 BW09 BW13 BW14 BW15 BW16 BW17 BW18 BW19 BW99 BY01 BY02 BY03 BY99 CD01 CD02 CD99 CU12 CU13 CU14 CU15 CU33 CU34 CU35 CU36 CU37 CU38 CU39 CU40 CU41 CU42 CU43 CU44 CU45 CU46 CU99 DG01 DG02 DG03 DG04 DG99 DIA01 DIA02 DIA99 DJ01 DM01 DM99 DO01 DO02 DO99 DY01 DY02 DY99 EB01 EB02 5/15

7 INSTAND - Codes (also for haemostaseology!) Behnk Elektronik Coagulometer CL 4,-8 Behnk Elektronik Thrombolyzer Systeme Behnk Elektronik Thrombostat 1/2 Behnk Elektronik: other devices EKF Biosen EKF: other devices Eurolyser Smart 700/340 Eurolyser Smart 540 Eppendorf: all devices Euroimmun: Euroscan Euroimmun: other devices Eschweiler System 2000 Eschweiler: other devices Grifols: Erythra Gonotec Osmomat 030 / 3000 Gonotec Osmomat 050 Gonotec: other devices Greiner: other devices HemoCue Glucose 201+ HemoCue B-Glucose-Analyzer HemoCue B-Hemoglobin HemoCue Hb 201 DM HemoCue Donor Hb Checker HemoCue Donor Hb 301 HemoCue 201+ HemoCue: other devices Brahms Kryptor Brahms: other devices Horiba ABX/AXON-Lab (Roche) Micros 45/60 OT/CT Horiba ABX/AXON-Lab (Roche) Micros CRP 100/200 Horiba ABX/AXON-Lab (Roche) Pentra 120 Horiba ABX/AXON-Lab (Roche) Pentra DF/DX 120 Horiba ABX/AXON-Lab (Roche) Pentra 60/60C+ Horiba ABX/AXON-Lab (Roche) Pentra 80/80XL Horiba Microsemi CRP Horiba ABX/AXON-Lab (Roche): other devices Hitado Super GL Hitado Super GL easy Hitado Super GL ambulance Hitado Dimex junior Hitado other devices Human: other devices IDS-iSYS Immunidiag. Systems: other devices Instrumentation Laboratory Electra Instrumentation Laboratory ACL Instrumentation Laboratory ACL-Futura / Advances /Top Instrumentation Laboratory GEM PCL Plus Instrumentation Laboratory: other devices IME-DC IME-DC Fidelity IME-DC idia IME-DC: other devices In Vitrogen IRIS ichem 100 IRIS ichem Velocity IRIS: other devices Immucor: Echo Immucor: Galileo Immucor: Neo Johnson & Johnson: Vitros 5.1 FS Johnson & Johnson: Vitros ECQ Johnson & Johnson: Vitros 250 Johnson & Johnson: Vitros 350 Johnson & Johnson: Vitros 750 Johnson & Johnson: Vitros 950 Johnson & Johnson: Vitros DT60 Johnson & Johnson: Vitros DT60 II Johnson & Johnson: Vitros 5600 Johnson & Johnson: Vitros andere Geräte Knauer Osmometer automatic Knauer: other devices Keller Medical Hemochron Jr. Signature Keller Medical Hemochron Jr. Signature+ EB03 EB04 EB05 EB99 EK01 EK99 EL01 EL02 EP99 ER01 ER99 ES01 ES99 GL01 GQ01 GQ02 GQ99 GR99 HM01 HM02 HM03 HM04 HM05 HM06 HM07 HM99 HN01 HN99 HO01 HO02 HO03 HO04 HO05 HO06 HO07 HO99 HT01 HT02 HT03 HT04 HT99 HU99 ID01 ID99 IL01 IL02 IL03 IL04 IL99 IME01 IME02 IME03 IME99 INV IR01 IR02 IR99 IU01 IU02 IU03 JJ01 JJ02 JJ03 JJ04 JJ05 JJ06 JJ07 JJ08 JJ09 JJ99 KA01 KA99 KE01 KE02 Keller Medical Hemochron Elite Keller Medical Hemochron: other devices Siemens (Kone) AC920 Siemens (Kone) AC970 Siemens (Kone): other devices Lange Miniphotometer LP20 Lange LP 700 Lange LP 400 Lange: other devices LabiTec Coa Data 4004 LabiTec: other devices Lifescan One Touch Basic Lifescan One Touch Vita Lifescan One Touch Ultra Easy Lifescan One Touch Ultra 2 Lifescan One Touch Ultra Smart Lifescan One Touch Profile Lifescan One Touch Hospital Lifescan One Touch other devices Menarini Aution Max Menarini Aution Jet Menarini Aution Micro Menarini HA-8160 Menarini HB-9210 Menarini GlucoMen LX Menarini GlucoMen Visio Menarini: other devices Medtronic ACT Plus Milteny MACSQuant Milteny: other devices Mitsubishi Pathfast (POCT) Mikrogen: Profiblot Mikrogen Dynex DSX Mikrogen: other devices Merlin Medical Lemgo Ball-Coagulometer MC-devices Merlin Medical Lemgo: other devices Micropoint qlabs Miltenyi Biotec: MACSQuant Nihon Kohden MEK 6108G Nihon Kohden: other devices Nova STAT-Profile 1-10 Nova STAT-Profile Ultra Nova STAT-Profile M Nova phox, phox-plus, phox-plus L Nova CCX (Critical Care Express) Nova Xpress Nova StatStrip Nova: other devices BECKMAN (OLYMPUS) AU-Systeme BECKMAN (OLYMPUS): other devices Orion Quikread Orion Quikread 101 Orion Quikread go Orion: other devices Ortho Diagnostics Cytoron absolute Ortho: AutoVue Ortho Diagnostics: other devices Opti Medical / Osmetech Opti CCA Opti Medical / Osmetech Opti CCA TS Opti Medical / Osmetech Opti 1 Opti Medical / Osmetech Opti R Opti Medical / Osmetech: other devices Partec CyFlow SL Partec PAS Partec CyFlow ML Partec CyFlow Space Partec: other devices Phadia: all devices QBC+ QBC II QBC II plus QBC Reference QBC Autoread QBC Automated Reader with Accutube Software 6/15 KE03 KE99 KN02 KN03 KN99 LA01 LA02 LA12 LA99 LE01 LE99 LS01 LS02 LS03 LS04 LS05 LS06 LS07 LS99 MB01 MB02 MB03 MB04 MB05 MB10 MB11 MB99 MET01 MIL01 MIL99 MIT01 MK01 MK02 MK99 MM01 MM99 MPT01 MQ01 NK02 NK99 NV01 NV02 NV03 NV04 NV05 NV10 NV11 NV99 OL01 OL99 ON01 ON02 ON03 ON99 OR01 OR02 OR99 OS01 OS02 OS03 OS04 OS99 PA01 PA02 PA03 PA04 PA99 PH99 QB01 QB02 QB03 QB04 QB05 QB06

8 INSTAND - Codes (also for haemostaseology!) QBC Star QBC: other devices Qiagen: RotorGene Quo-Test Monometer Advance Medpro Maxi/mini Taidoc Technology Corp: other devices Radiometer ABL 5, BPH 5 Radiometer ABL 505 / 555 Radiometer ABL , ,EML 100 / 105 Radiometer ABL , Radiometer ABL 77 / 80 Radiometer OSM 2/3 Radiometer ABL 90 Radiometer NPT 7 Radiometer AQT 90 Radiometer: other devices Roche (AVL) 900er series Roche (AVL) Compact 1-3 Roche (AVL) Omni 1-9 Roche (AVL) Cobas b 121 (Omni C) Roche (AVL) Cobas b 221 (Omni S) Roche Coasys Roche Coasys plus C Roche Cobas h 232 (Cardiac Reader) Roche/Stago STA /STA-Compact Roche/Stago STA-R / STA-R Evolution Roche Hitachi-Systeme Roche Accu-Chek Compact plus Roche Accu-Chek Mobile Roche Accu-Chek Aviva Roche Accu-Chek Aviva nano Roche Accu-Chek Active Roche Accu-Chek Go Roche Accu-Chek Performa Roche Accu-Chek Inform Roche Accu-Chek Inform II Roche Accu-Chek Sensor Roche Accutrend plus Roche CoaguChek XS Roche CoaguChek S Roche Integra-Systeme Roche Elecsys-Systeme Roche Modular-systems Roche Cobas-System (6000) Roche ES devices Roche Cardiac reader Roche: Light Cycler Roche: TaqMan Roche Miditron Roche Cobas-System (8000) Roche (AVL) Cobas b 123 Roche Cobas-System (8000) Roche Urisys 1100 Roche Urisys 1800 Roche Urisys 2400 Roche Cobas U 411 Roche: other devices Rotem: alle devices Sarstedt: ElphoScan (mini) Sarstedt: Elphor system Sarstedt: other devices Sebia: Hydrasys Sebia: Capillarys Sebia: Minicap Sebia: other devices Samsung: LABGEO PT10 Samsung: LABGEO IB10 Samsung: LABGEO HC10 Sysmex CC130, 150, 170,180, F300, 500, 520, 800, 820 Sysmex M2000,K800, 1000, 4500 Sysmex SE9000, 9500 Sysmex XE2100 Sysmex SF3000 QB07 QB99 QG01 QU01 QU02 QU03 QU99 RA01 RA02 RA03 RA04 RA05 RA06 RA07 RA08 RA09 RA99 RO01 RO02 RO03 RO04 RO05 RO07 RO08 RO09 RO10 RO11 RO24 RO30 RO31 RO32 RO33 RO34 RO35 RO36 RO37 RO38 RO39 RO40 RO41 RO42 RO46 RO50 RO55 RO56 RO57 RO58 RO59 RO60 RO70 RO71 RO72 RO73 RO80 RO81 RO82 RO83 RO99 RT99 SA01 SA02 SA99 SB01 SB02 SB03 SB99 SM01 SM02 SM03 SY02 SY06 SY07 SY08 SY13 Sysmex KX21 SY14 Sysmex PocH-100i SY15 Sysmex XT1800i, 2000i SY16 Sysmex XS800i SY20 Sysmex XS1000i SY21 Sysmex XE5000 SY22 Sysmex K1000 SY27 Sysmex K4500 SY28 Sysmex XT4000i SY29 Sysmex XN9000 SY30 Sysmex XN2000 SY31 Sysmex XN1000 SY32 Sysmex Urisys 308 SY40 Sysmex: other devices SY99 Stago/Tcoag (Trinity Biotech) KC4 TB01 Stago/Tcoag (Trinity Biotech) KC4A TB02 Stago/Tcoag (Trinity Biotech) AMAX 190/200/400 mechanical testb03 Stago/Tcoag (Trinity Biotech) AMAX 190/200/400 optical testingtb04 Stago/Tcoag (Trinity Biotech) Destiny Plus/Destiny MAX optical TB05 t Stago/Tcoag (Trinity Biotech) Destiny Plus/Destiny MAX mechantb06 Stago/Tcoag (Trinity Biotech) KC - 10 TB07 Stago/Tcoag (Trinity Biotech) KC - 40 TB08 Stago/Tcoag (Trinity Biotech) Option-devices TB09 Stago/Tcoag (Trinity Biotech) Thrombolyzer-devices TB10 Stago/Tcoag (Trinity Biotech) Coagulometer Schnitger-Gross TB11 Trinity Biotech: other devices TB99 Technoclone Thrombotrack 1,-4,-8 TC01 Technoclone: other devices TC99 Tosoh G7 TH01 Tosoh G8 TH02 Tosoh AIA600-II TH03 Tosoh: other devices TH99 Tecan Sunrise TN01 Tecan: other devices TN99 TECO Coatron-M/A-Series TO01 TECO Dimex junior TO02 TECO: other devices TO99 Sekisui Virotech: other devices VT01 Sekisui Virotech Coapresta2000 VT99 Epocal EPOC VV01 Other devices ZY99 7/15

9 Important comments for the implementation of the EQA schemes. Preparation of lyophilized material The bottle must be opened carefully without loss of material. Add exactly the volume of distilled water indicated on the label to each vial. Replace stopper and hold it firmly in place. Rotate the vial gently. DO NOT SHAKE. Reconstitution time is up to 30 minutes at C. The reconstituted sample must be handled like patient samples. We recommend specifying the decimal places appropriate to the following procedure: Value < 1 3 decimal places (e.g ) Value >/= 1 and < 10 2 decimal places (e.g. 1.23) Value >/= 10 and < decimal place (e.g. 12.3) Value >/= decimal place (e.g. 123) Deviations are possible, if it is medically necessary (eg when specifying the ph). No. 100 Clinical Chemistry Recommendation - Clinical Chemistry (alk. Phosphatase). Keep the reconstituted sample for one hour at +25 C before measurement of alkaline phosphatase. Recommendation - Clinical Chemistry, estimation of Creatine Kinase. We recommended to analyse Creatine Kinase as soon as possible after reconstitution! Stability Typical stability of constituents in reconstituted serum: at +25 C at least 8 hours; at +4 C at least 3 days; at -20 C at least 1 month (to be frozen only once). Stability of bilirubin in serum stored in the dark: at +25 C at least 2 hours; at +4 C at least 6 hours; at -20 C at least 2 weeks (to be frozen only once). ATTENTION: Bilirubin is light sensitive! No. 212 Blood smear analysis Preliminary note: For the round robin test 212 a blood smear from peripheral EDTA-blood is made, stained and sent to you. According to the requirements of the German Medical Association it is only allowed to use remaining material for round robin tests; taking extra blood is not allowed. As a consequence the available material is restricted, therefore the quantity of material per each blood smear is limited, which leads to "short" blood smears. We have controlled these "short" blood smears and they are sufficient for diagnostics. From October 2012 the new protocol sheet must be used. The certificate is divided in 3 parts: a) correct counting of cells b) morphological comments c) most probable diagnosis - required for the medical evaluation of this survey. Registration of the results Please enter the method, reagent and device you use in the appropriate columns. We have already filled in the information from previous EQAS. Please check this keys if they are up to date. This also applies to the Unit column. The valid key can be found in this booklet or on the protocol sheets. These details are important to ensure a correct assignment to one of the rating groups formed. If other methods, reagents and equipment as set out in the key are used, you will be asked to indicate in clear text. The codes can be taken from the following guide. Additional Samples for the special case In addition to the two preparations, you usually receive an extra and difficult preparation (free of charge) which is not part of the EQA scheme, but is only intended for educational purposes.the diagnosis will follow together with the results of the EQA scheme. With best regards Dr. H. Diem Special case January 2014 After a three-week holiday in Thailand a 23-year-old woman develops fever and goes to the tropical institute. 8/15 Small blood count special case January 2014 Leukocytes: 2,3 /nl, Hemoglobin: 144 g/l, MCV: 88 fl, Thrombocytes: 90 /nl.

10 Code of diagnosis for differential blood cell count (adults) - No. 212 Code-No. 1 Without any pathological signs ("normal 76 Lymphoma 78 Chronic lymphatic leukemia (B-CLL) 9940/3 Hairy cell leukemia no code no. yet Splenic B-cell lymphoma: not classifiable(=hzl-v) 9671/3 Lymphoplasmocytic lymphoma (=Immunocytom) 9689/3 Splenic marginal zone lymphoma (SMZL) 9690/3 Follicular lymphoma 9673/3 Mantle cell lymphoma 79 Prolymphocytic leukemia 9701/3 Sezary syndrome 9831/3 LGL leukemia 82 Lymphoblastic lymphoma (diffuse large cell lymphoma) 3 Virus infection special diagnosis 80 Plasma cell myeloma 82 Plasma cell leukemia 71 Acute leukemia 73 Acute myeloic leukemia (AML) 9866/3 Acute myeloic leukemia with t(15;17) 74 MDS 9982/3 Refractory anemia with ringed sideroblasts and thrombocytosis (RARS-T) 9986/3 5 q minus syndrome 2 Reactive change 13 Eosinophilia 75 Myeloproliferative neoplasia (MPN) 9875/3 Chronic myeloic leukemia (CML) 9950/3 Polycythaemia vera (PV) 9961/3 Primary myelofibrosis (PMF) 9962/3 Essential thrombocythaemia (ET) 9963/3 Chronic neutrophilic leukemia 9964/3 Chronic eosinophilic leukemia, NOS Myelodysplastic / myeloproliferative neoplasia (MDS / MPN) 9945/3 Chronic myelomonocytic leukemia (CMML) 14 Malaria not code-no. yet Microfilariae not code-no. yet Bacteria 66 Tumor infiltration of the bone marrow 66 Tumor cells in peripheral blood 9/15

11 Anemia 22 Iron deficiency anemia 26 Vit B12 or folic acid deficiency 23 Haemolytic anemia 52 Hyperfragmentation syndrome (HUS, TTP, HELLP ) 30 Hereditary spherocytosis not code-no. yet Autoimmune hemolytic anemia (AIHA) 27 Sickle cell anemia 29 Thalassemia not code-no. yet Anemia in chronic diseases not code-no. yet Cold agglutinin disease Thrombocytopenia 51 Idiopathic thrombocytopenia (ITP) 42 MyH9 associated disease (e.g. May Hegglin) not code-no. yet Macrothrombocytopenia 53 Pseudothrombocytopenia (platelet agglutinates) 61 Aplastic anemia (AA and SAA) 4 Splenectomy state not code-no. yet Persistant polyclonal B-lymphocytosis (PPBL) 10/15

12 No. 720 Allergy testing Preparation of lyophilised material Samples 11A, 12A (reconstitution with 1 ml aqua dest.) The bottle must be opened carefully without loss of material. Add exactly 1 ml of distilled water. Rotate the vial gently. DO NOT SHAKE! Reconstitution time is 30 minutes. Samples 11B, 12B (reconstitution with 0.5 ml aqua dest.) You will find the actual allergens on the protocol sheet. total IgE: Sample 11 (reconstitution with 0.5 ml aqua dest.) No. 145 Glycated Proteins The samples consist lyophilised hemolysate which includes 0,01% potassium cyanid (CAS ). A contamination with acid will produce (HCN). The material must be handled with the same precaution like a patient sample, an infectivity was not detected. Please follow the description on the protocol sheet to reconstitued the content of the vial. The reconstituted samples must be handled like a patient sample on the basis of the manufacturer (see subsequent dilution ). Rotate the samples gently. DO NOT SHAKE! The reconstitution time is 15 min. at room temperature. Because of stabilization the samples must be hemolyzed and measured not later than 4 hours after reconstitution. The standard temperature for the mikrocolumn analysis is 23 C (for HbA1c on mikrocolumn 24 C). Conversions to this temperature will be expected. Volume indicated: see protocol sheet! The bottle must be opened carefully without loss of material. Add exactly 0,5 ml of distilled water. Rotate the vial gently. DO NOT SHAKE! Reconstitution time is 30 minutes. This product is prepared from human serum. Each donor unit used in preparation of the product was non reactive to antibodies against HIV (human-immuno-deficiency-virus (HTLV III/LAV) or HBs-Ag (hepatitis B surface antigen) using FDA approved methods. Since no test can offer complete assurance and the risk of infection cannot be excluded, the products must be handled as if it were a patient sample! A meaningful analysis of the EQA-results is only possible from complete data sets. Subsequent dilution a) Bio-Rad DiaSTAT (LPLC) 20 µl of the sample µl haemolysing reagent 30 min incubation at 37 C b) Bio-Rad Diamat (HPLC) 5 µl of the sample µl haemolysing reagent 30 min incubation at 37 C c) Bio-Rad Variant I (HPLC) 5 µl of the sample µl haemolysing reagent 40 min incubation at 37 C d) Bio-Rad Variant II (HPLC) 5 µl of the sample µl wash/diluent solution no incubation necessary e) Bio-Rad D-10 (HPLC) 5 µl of the sample µl wash/diluent solution no incubation necessary f) Bio-Rad Micromat II 10 µl of the sample g) Helena HbA1c Column 50 µl of the sample µl Lyse reagent 20 min incubation at 37 C h) Helena GLYCO-Tek Affinity Column 50 µl of the sample µl haemolysing reagent to incubate at least 5 min i) Roche Tina quant 10 µl of the sample µl haemolysing reagent 11/15

13 No Haemostasis Important comments Only for German laboratories concerning the According to state regulations it is mandatory to participate in proficiency testing four times a year - every three month - in Germany ( Richtlinien der Bundesärztekammer, RiliBÄK). With this black lined box you can better assess the specific performance of your reagent as it is possible with the officially accepted deviation (in Germany) shown by the grey box. Target ranges are defined for some parameters: relative deviations of the target value of 18% for APTT and 23% for PT are accepted, respectively. In your results you will find this target range as a grey box. Additionally, we show you the 2s-range of the results as a black lined box (see sample figure below). There are no state regulations for the groups 222 to 230. Therefore, only grey boxes (2s-range) are shown in these cases. If both of your results are within these grey boxes you will get the certificate. 12/15

14 1. Coding Please fill always the codes for Analyzer, Method and Testkit on the protocol sheet and never let a field uncoded, thanks a lot! Please also compare the written text for the method with your active routine method. An incomplete or wrong coding has the potential risk that your results are misinterpreted and you won t get a certificate. 2. Whole blood methods For methods using whole blood in routine use, we are sending a citrated sample for proficiency testing. This sample has to be re-calcificated with calcium chloride solution at starting of measurement, if the routine reagent contains not enough CaCl2. For example, the Thrombotest reagent has to be diluted with calcium chloride solution (3.2 mmol/l) instead of distilled water (aqua dest.). Additionally, you have to follow specific dilution steps which allows the usage of the survey sample instead of human whole blood or citrated plasma. e.g.: a) Venous citrated blood (Normotest and Thrombotest, TC): Diluted sample 1:1.67 with physiological NaCl solution (3 parts sample + 2 parts NaCl/0.9%) b) Capillary citrated blood (Hepato-Quick, Roche): Diluted sample 1:1.5 with physiological NaCl solution 20 μl of (2+1)diluted sample μl citrated buffer (or 10 μl + 50 μl (Mikro) For whole blood methods 0.2 ml of the survey sample have to be further diluted with 0.1 ml Owren's buffer (Hepatoquick) or physiological NaCL solution (Normotest, Thrombotest) to be used instead of whole blood. Thrombotest reagent has to be reconstituted with calcium chloride solution. 20 µl of the (2+1) dilution with Owren's buffer are further diluted with 100 μl (1:5 dilution with citrated buffer. For PT measurement only, the sample can be diluted with 1.5 ml distilled water (instead of 1.0 ml) with no further dilution. Dilute survey sample with 1.7 ml or 1.0 ml, alternatively, and further dilute 3:2 with NaCL 0.9% (e.g. 300 μl plasma μl NaCL) Dilute sample to be measured like the whole blood method (15 μl sample μl reagent) with the Dimex Jr. analyzer. Hepato-Quick (120 or 60 µl capillay citrated blood) CoaguQuick capillary blood TEClot PT-B Other whole blood methods For PT- and INR measurement on POCT analyzer we offer a separate survey with a whole blood method! If you are using a POCT method please register for group 286 (and not for group 221)! Please register for participation in the EQA scheme No. 286 and not in No. 221! 13/15

15 New key code for Haemostastis!! Valid from January 2013! Dear participant, Please follow this coding instructions with your next survey!!! In 2013 you will be able to report your coagulation survey results ONLINE via our homepage: We would greatly appreciate if many of you taking advantage of this new tool as time to record and analyze the data can be significantly shortened. 20 µl of the (2+1) dilution with Owren's buffer are further diluted with 100 μl (1:5 dilution with citrated buffer. For PT measurement only, the sample can be diluted with 1.5 ml distilled water (instead of 1.0 ml) with no further dilution. To realize the new online reporting system we had to rearrange the coding system. Therefore we will use a new coding from January 2013 for the coagulation surveys (Group 221, 222, 223, 224, 225, 226, 227, 229, 230, 280, 281, 282, 283, 285, 286, 288).,Each analyzer, reagent, method and producer will get a single, definite code. 14/15

16 With the first survey in January 2013 we will need your support once by giving us these information for each of your coagulation survey you are participating in. Depending on the survey group we will need the information as listed in the following table: Group Method Kit/ Producer Reagent Name (reagent) Analyzer 221 x 222-1/3 x x 224 x 225 x x x /24/ x 285-1/2/3/4/ x x You will find the new code of "Analyzer" and "Manufacturer" in this manual. All relevant codes for "Method" and "Kit" are listed on the protocol sheet. Please update your key code on the protocol sheet or with your online result report (preferable). With the online report you can choose your code from drop-down-boxes. If your method/reagent/analyzer is not available, please choose user defined and type it as free text. You will find a detailed instruction for online-reporting on our homepage: ( Just for clarification, the new coding has to be done just once. With the following surveys your codes will be pre-printed. If you have changes to your coding, please inform us in advance: kutsch@instand-ev.de or Fax +49 (89) Finally, we want to inform you that the entering of the online results contribute to a faster evaluation of the EQA schemes. For questions regarding the new coding system or online reporting please contact Ms. Mareen Kutsch: Phone +49 (89) or kutsch@instand-ev.de With best regards 15/15 Your INSTAND Team