Neo-Sensitabs Susceptibility Testing

Transcription

1 Neo-Sensitabs Susceptibility Testing Potencies according to EUCAST and CLSI Product list 2014 Unique characteristics ensure that NEO-SENSITABS are ideal for use in the laboratory Susceptibility testing with NEO-SENSITABS practice is performed according CLSI and EUCAST guidelines. Rosco Diagnostica is the leader in the field of phenotypic methods for detection of Neo-SensitabsTM Susceptibility Rosco Diagnostica A/S Product list 2014

2 Neo-Sensitabs - Products in Alphabetical Order Packaging Neo-Sensitabs are packed in cartridges containing 1 x tablets Minimum sale: 1 package containing 5 cartridges (2 tablets) Please order per package on your order sheets REF No. Antibiotic Code A Potency µg 2-8 EUCAST CLSI Amikacin AMI30 30 x x 70112N Amoxycillin AMOXY 30 x Amoxycillin + Clavulanate AMC n x Amoxycillin + Clavulanate AMC n x x Ampicillin AMP.2 2 x Ampicillin AMP10 10 x x Ampicillin + Sulbactam SAM x Azithromycin AZI15 15 x x Aztreonam AZT30 30 x x B 70812N Bacitracin BACIT 40 C 612 Cefaclor CCL30 30 x x Cefazolin CFZ30 30 x Cefepime FEP30 30 n x x Cefepime + Clavulanate FEP+C n Cefixime CFM.5 5 x x Ceftolozane + Tazobactam C / T x Cefotaxime CTX05 5 x Cefotaxime CTX30 30 x Cefotaxime + Clavulanate CTX+C n Cefotaxime + Boronic Acid CTXBO Ceftazidime + Boronic Acid CAZBO N Cefoxitin CFCID Cefoxitin CFO30 30 x x Cefpodoxime CPD10 10 n x x Cefpodoxime + Clavulanate CPD+C 10+1 n Ceftaroline CPT30 30 x Ceftaroline CPT. 5 5 x Ceftazidime CAZ10 10 x Ceftazidime CAZ30 30 x Ceftazidime + Clavulanate CZ+CL n Ceftibuten CBT30 30 x Ceftizoxime ZOX30 30 x Ceftobiprole CFBIP 30 n x Ceftriaxone CTR30 30 x x Cefuroxime CXM30 30 x x 72812N Cephalexin CFLEX 30 x Cephalothin CEP30 30 x 73012N Cephradine CFRAD 60 x Chloramphenicol CLR30 30 x x Ciprofloxacin CIPR Ciprofloxacin CIRP5 5 x x Clarithromycin CLA15 15 x x Clindamycin CLI.2 2 x x Colistin CO x x D 80312N Daptomycin DAPCa 30 (+100) Doxycycline DOX30 30 x x Doripenem DOR10 10 x x Neo-SensitabsTM Susceptibility Rosco Diagnostica A/S Product list 2014

3 REF No. Antibiotic Code E Potency µg 2-8 EUCAST CLSI Ertapenem ETP10 10 n x x Erythromycin ERY15 15 x x F Fosfomycin FO n x Fucidin FUC10 10 x x 74312N Fucidin FUCID 100 x 74412N Furazolidone FURAZ x G Gentamicin GEN10 10 x x Gentamicin GEN30 30 x 43012N Gentamicin GN2 2 x x I Imipenem IMI10 10 x x Imipenem + EDTA IM10E K Kanamycin KAN30 30 x 43112N Kanamycin KA0 0 x L 74812N Levofloxacin LEVOF 5 x x Linezolid LIZ10 10 x 75112N Linezolid LINEZ 30 x M Mecillinam MEC10 10 x x Meropenem MRP10 10 x x Metronidazole MTR.5 5 x x 75512N Metronidazole MTR Minocycline MIN30 30 x x 79812N Moxifloxacin MOXIF 5 x x 75712N Mupirocin MUPIR Mupirocin MP x x N Nalidixan NAL30 30 x x 75912N Neomycin NEOMY Netilmicin NET10 10 x Netilmicin NET30 30 x Nitrofurantoin NI x Nitrofurantoin NI Nitrofurantoin NI x 76212N Norfloxacin NORFX 10 x x 76312N Novobiocin NOVO5 5 x O Ofloxacin OFL.5 5 x x Oxacillin OXA.1 1 x x P 76912N Pefloxacin (stop production) PEFLX 10 x 77012N Pefloxacin PEF.5 5 x Penicillin (Penicillin G) PENG1 1 x x Penicillin (Penicillin G) PEN10 10 x 77212N Pipemicid Acid PIPEM 30 x Piperacillin PIP30 30 x 77312N Piperacillin PIPRA 100 x Piperacillin + Tazobactam PTZ x 77412N Piperacillin + Tazobactam PI+TZ x 77512N Polymyxins (Colistin) CO1 1 Q 80012N Quinupristin - Dalfopristin SYN15 15 x x Neo-SensitabsTM Susceptibility Rosco Diagnostica A/S Product list 2014

4 REF No. Antibiotic Code R Retapamulin RETA.2 2 Potency µg 2-8 EUCAST CLSI Rifampicin RIF.5 5 x x S 77812N Spectinomycin SPECT 200 x Streptomycin STR10 10 x 44712N Streptomycin ST0 0 x 78112N Sulphonamides SULFA 240 x T Teicoplanin TPN30 30 x x 80112N Telithromycin TEL15 15 x x 78312N Temocillin TEMOC 30 n x x Tetracyclines (Oxytetracycline) TET30 30 x x Ticarcillin TIC75 75 n x x Ticarcillin + Clavulanate TIM n x x 80412N Tigecycline TIG15 15 x x Tobramycin TOB10 10 x x Trimethoprim TRIM5 5 x x Trimethoprim + Sulfamethoxazole SxT x x Trimethoprim 2,5 V Vancomycin VAN.5 5 x Vancomycin VAN30 30 x n= Store at 2 8 C Our product have 2 years to 5 years of expire date. For more product information When cartridges are opened and placed in a dispenser: Cartridges to be kept at room temperature: To be used within the next 12 months. ncartridges to be kept at 2-8 degrees: To be used within 2 months. Accessories REF No Product Dispenser 1 cartridge single dispenser Dispenser 7 cartridges round Petri dishes of 9 cm diameter Dispenser 12 cartridges round Petri dishes of cm diameter Dispenser 16 cartridges square Petri dishes of 12 x 12 cm ID Plate - Zone readings 901 Zone Measuring stick Neo-SensitabsTM Susceptibility Rosco Diagnostica A/S Product list 2014

5 Diatabs Identification of Bacteria and Fungi Product list Diatabs TM Rosco Diagnostica A/S Product list

6 Diatabs - Products in Alphabetical Order REF Tablets Product Diatabs 2-8 Code No. per vial A Tablet in mm Adonitol ADO Alkaline Phosphatase n Alk P Alpha-Galactosidase α-gal Alpha-Glucosidase α-glu l-arabinose n ARA Arginine Dihydrolase ADH 6 B Bacitracin Low 0.4 U BaL 6** 511 Beta-Glucosidase β-glu Beta-Glucuronidase PGUA Beta-Lactamase n ACIDO Beta-Xylosidase β-xyl Bile Esculin BE Boronic Acid BORON 25 9** Brilliant Green 100 µg BrG 6** C C µg C * Cloxacillin n CLOXA 25 9** Cycloheximide CYC 9** D Deferoxamine 2 µg DEFRX 9** Dipicolinic Acid D.P.A. 25 9** d-xylose n XYL 25 6 E Esculin Hydrolysis ESC 6 F Factor V n 6** Factor X n 6** Factor X + V n 6** G Gamma-Glutamyl Aminopeptidase g-glu Glucose GLU 6 H Hippurate Hydrolysis HIP 6 I 591 Indoxyl Acetate n IAC Inulin INU 6 L Lactose LAC LDC/Indole (Lysine Decarboxylase/Indole) LDC/IND Leucine Aminopeptidase LAP Lysine Decarboxylase LDC Diatabs TM Rosco Diagnostica A/S Product list

7 REF Tablets Product Diatabs 2-8 Code No. per vial M Tablet in mm Maltose MAL Mannitol MAN Mannose MSE Metronidazole 5 µg MTR.5 9** Metronidazole µg MTR 9** N Nitrate Reduction NO3 6 O O/129 (Vibriostaticum) 1 µg O/ ** 311 ONPG (Beta-Galactosidase) ONPG Optochin 10 µg OPT 6** Ornithine Decarboxylase ODC Oxgall 1000 µg OXG 6** Oxidase OXI 6 P PGUA/Indole (Beta-Glucuronidase/Indole) PGUA/IND Porphyrin (d-ala) ALA Proline Aminopeptidase n PRO Ps. aeruginosa Screen 80 µg PSAER 9** Pyrazinamidase PZA Pyrrolidonyl Aminopeptidase PYR 6 R l-rhamnose RHAM 6 S S.P.S µg SPS 6** Sorbitol SOR Sucrose SUC 6 T TDA or Indole (Tryptophan Deaminase or Indole) TDA or IND Tellur 0 µg TEL 6** Trehalose TRE Tributyrin n TRIB Trypsin TRYP 6 U Urease URE Urease/Indole URE/IND Urease/TDA URE/TDA 6 V Voges-Proskauer VP 6 n = Store at 2 8 C ** Diatabs tablets to be used on agar media for more information: (Diatabs User s Guide) Diatabs TM Rosco Diagnostica A/S Product list

8 Reagents REF NO Product Reagents Stored at 2 8 C ML per sales Unit Ninhydrin 3,5% solution n 20 ml Kovac s Reagent n 20 ml Aminopeptidase reagent n 20 ml N-N-Dimethyl-a-naphtyl. n 20 ml Sulfalinic Acid n 20 ml CE Marking All products are CE marked according to the European Directive 98/79/EC for In Vitro Diagnostic Medical Devices. Instructions For Use The relevant Instructions for use of each product are made freely available on our Website: in 7 12 different European languages. Diatabs User s Guide The latest version of the Diatabs User s Guide is downloadable from our website Diatabs TM Rosco Diagnostica A/S Product list

9 Neo-Sensitabs Antifungal Agents Product list 2014 Unique characteristics ensure that NEO-SENSITABS are ideal for use in the clinic Susceptibility testing with NEO-SENSITABS practice is performed according CLSI and EUCAST guidelines. Rosco Diagnostica is the leader in the field of phenotypic methods for detection of Neo-Sensitabs Antifungal Agents Rosco Diagnostica A/S Product list 2014

10 Neo-Sensitabs Antifungal Agents- Products in Alphabetical Order Packaging Neo-Sensitabs Antifungals are packed in cartridges containing 1 x tablets Minimum sale: 1 package containing 5 cartridges (2 tablets) Please order per package on order sheets REF No. Product Code Potency N Amphotericin B AMPHO 10 n 82412N Caspofungin CASP5 5 n 81112N Ciclopirox CICLO 81212N Clotrimazole CTRIM N Econazole ECONZ N Fluconazole FLUCZ N Fluorocytosine FLU N Itraconazole ITRAC N Ketoconazole KETOC N Miconazole MICOZ N Nystatin NYSTA 82612N Posaconazole POSAC N Terbinafine TERBI N Voriconazole VOR.1 1 n = Store at 2 8 C Instructions for Use Neo-Sensitabs The Instructions for Use are made freely available on our web site It can be downloaded in PDF format in different European languages. CE Marking All products - except the Veterinary Antimicrobials - are CE marked according to The European Directive 98 /79/ EC for In Vitro Diagnostic Medical Devices. For more product information go to Rosco website Neo-Sensitabs Antifungal Agents Rosco Diagnostica A/S Product list 2014

11 Kits for Detection of Resistance Mechanisms Product list 2014 Unique characteristics ensure that NEO-SENSITABS are ideal for use in the laboratory Susceptibility testing with NEO-SENSITABS practice is performed according CLSI and EUCAST guidelines. Minimum orders for kits are 1 package. Rosco Diagnostica is the leader in the field of phenotypic methods for detection of Kits Product list Rosco Diagnostica A/S

12 Screening and Confirmation of ESBL s REF no. Product Tests pr. kit Detection of: Total ESBL Confirm Kit (EUCAST) Cefotaxime Cefotaxime + Clavulanate Ceftazidime Ceftazidime + Clavulanate Cefepime Cefepime + Clavulanate ESBL ESBL Confirm (acc. to CLSI) Kit Cefotaxime Cefotaxime + Clavulanate Ceftazidime Ceftazidime + Clavulanate ESBL ESBL Confirm (Chrom. AmpC) Kit (EUCAST) Cefepime Cefepime + Clavulanate 100 ESBL New Rapid ESBL Screen Kit Cefotaxime + tazobactam + Indicator Cefotaxime + Indicator ESBL Screening and Confirmation of ESBL+AmpC REF no. Product Tests pr. kit Detection of: ESBL + AmpC Screen Kit Cefotaxime Cefotaxime + Clavulanate Cefotaxime + Cloxacillin Cefotaxime + Clavulanate + Cloxacilin ESBL + AmpC Total ESBL + AmpC Confirm Kit Cefotaxime + Cloxacillin Cefotaxime + Clavulanate Ceftazidime + Cloxacillin Ceftazidime + Clavulanate Cefotaxime + Cloxacillin + Clavulanate Ceftazidime + Cloxacillin + Clavulanate ESBL + AmpC Kits Product list Rosco Diagnostica A/S

13 Screening and Confirmation of Carbapenemases REF no. Product Tests pr. kit Detection of: Rapid CARB Screen Kit Imipenem + Indicator (CARB) Diatabs CARB Negative Control Diatabs Carbapenemases Enterobacteriaceæ P. aeruginosa KPC and MBL Confirm Kit (EUCAST) Meropenem Meropenem + Dipicolinic Acid Meropenem + Phenylboronic Acid Meropenem + Cloxacillin Carbapenemases Enterobacteriaceae Triple disk, for detection of KPC + MBL Meropenem + Phenylboronic + Dipicolinic acid Carbapenemases KPC, MBL and OXA-48 Confirm Kit Meropenem Meropenem + Dipicolinic acid Meropenem + Cloxacillin Meropenem + Phenylboronic acid Temocillin Carbapenemases Enterobacteriaceae KPC/MBL in P. aeruginosa/acinetobacter Confirm Kit Meropenem Meropenem + Phenylboronic acid Meropenem + Cloxacillin High Imipenem Dipicolinic acid Carbapenemases P. aeruginosa/acinetobacter Total MBL Confirm kit Imipenem Imipenem + EDTA Imipenem + Dipicolinic acid Meropenem Dipicolinic acid MBL all species New OXA-48+CARB Screen kit (30-60 min) Imipenem + Brthymol Blue Ertapenem + Brthymol Blue Negative Control Blue Carbapenemases All species Lysis buffer Not needed Confirmation of AmpC s Kits Product list Rosco Diagnostica A/S

14 REF no. Product Tests pr. kit Detection of: AmpC Confirm Kit Cefotaxime Cefotaxime + Cloxacillin Ceftazidime Ceftazidime + Cloxacillin AmpC Other Kits REF no. Product Tests pr. kit Detection of: Detection of hgisa,gisa,vre,daptomycin resistance Vancomycin Teicoplanin Daptomycin Staphylococci Enterococci Detection of COLISTIN resistance in Enterobacteriaceae, P. aeruginosa and Acinetobacter COLISTIN Prediffusion 100 MDR Gram negatives Urin Kit Privat Praksis Ampicillin Ciprofloxacin Mecillinam Nitrofurantoin Sulphonamide Trimethoprim Beta-Glucuronidase Susceptibility testing urines All products are CE marked according to the European Directive 98/79/EC for In Vitro Diagnostic Medical Devices. Detection of resistance mechanisms User s Guide The latest version of detection of resistance mechanisms User s Guide is downloadable from our website. Minimum orders for kits are 1 package Kits Product list Rosco Diagnostica A/S

15 AmpC Confirm Kit Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. Content and formulation 4 cartridges, formulated for maximum stability, each containing approximately tablets: Cefotaxime 30 µg, coded CTX30 Cefotaxime 30 µg + Cloxacillin, coded CTXCX Ceftazidime 30 µg, coded CAZ30 Ceftazidime 30 µg + Cloxacillin, coded CAZCX Quality Control As positive Q. C. stains the following may be used: Enterobacter cloacae NCTC 13406, AmpC positive Enterobacter cloacae ATCC BAA 1143, Amp C positive E. coli ATCC is a negative Q. C. stain All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. References Hansen F et al: Evaluation of Rosco Neo-Sensitabs for phenotypic detection and subgrouping of ESBL,AmpC and carbapenemase-producing Enterobacteriaceae. APMIS 120, , Edquist P et al : Phenotypic detection of plasmid-acquired AmpC in E. coli- evaluation of screening criteria and performance of 2 commercial methods for the phenotypic confirmation of AmpC production Eur J Clin Microbiol Infect Dis 32, , AmpC Cefotaxime 30 µg Ceftazidime30 µg CTX30 CAZ30 CTXCX 5mm - AmpC CAZCX - 5mm AmpC Confirm Kit Ref Okt. 2013

16 Susceptibility testing of Antifungals REF NO. PRODUCT Mueller Hinton agar BBL - II ANTIFUNGAL AGENTS REF NO. PRODUCT CODE POTENCY STORE N Amphotericin B AMPHO 10 n 82412N Caspofungin CASP5 5 n 81112N Ciclopirox CICLO 81212N Clotrimazole CTRIM N Econazole ECONZ N Fluconazole FLUCZ N Fluorocytosine FLU N Itraconazole ITRAC N Ketoconazole KETOC N Miconazole MICOZ N Nystatin NYSTA 82612N Posaconazole POSAC N Terbinafine TERBI N Voriconazole VOR.1 1 PACKAGING The cartridges contain tablets. Packed in boxes containing 1 x 5 cartridges = 2 tablets. STORAGE Our product have 2 years to 5 years of expire date. When cartridge are opened and placed in a dispenser: Cartridges to be kept at room temperature: To be used within the next 12 months. Cartridges to be kept at 2-8 : To be used within 2 months. Product list 2013 Neo-Sensitabs Susceptibility Testing Potencies according to EUCAST and CLSI Okt. 2013

17 Detection of COLISTIN resistance in Enterobacteriaceae, P. aeruginosa and Acinetobacter Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for qualitative in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. The prediffusion method is very useful for testing high molecular antimicrobials. Content and formulation 2 cartridges of COLISTIN Prediffusion Neo-Sensitabs, formulated for maximum stability, each containing tablets. Totaling 100 tests Quality Control As Q. C. strains the following may be used: E. coli ATCC Ps. aeruginosa ATCC All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. References Boyen F et al: Disk prediffusion is a reliable method for testing Colistin susceptibility in porcine E. coli strains. Vet Microbiol 144, , Nastro M et al Evaluation of the prediffusion method for Colistin in K. pneumonia. Rev Argent Microbiol 44, supl1, P40, 2012 (Spanish) COLISTIN Prediffusion Sensitive Intermediate Resistant Enterobacteriaceae 16 mm mm < 12 mm Ps aeruginosa 16 mm mm < 12 mm Acinetobacter spp. 20 mm mm < 14 mm Detection of COLISTIN resistance in Enterobacteriaceae, P. aeruginosa and Acinetobacter Ref Okt. 2013

18 Detection of hgisa, GISA, VRE and Daptomycin susceptibility Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for qualitative in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. The prediffusion method is very useful for testing high molecular antimicrobials. Content and formulation 3 cartridges of tablets, formulated for maximum stability, each containing approximately tablets: Vancomycin 30 µg, coded VAN30 Teicoplanin 30 µg, coded TEI30 Daptomycin 30 µg, coded DAP30 All products from Rosco Diagnostica A/S are Quality Control marked in compliance As Q. C. strains the following may be used: with the European Union Staph aureus ATCC ; hvisa and Daptomycin susceptible directive 98/79/EC for Staph aureus AST 403, GISA and Daptomycin susceptible In Vitro Diagnostic Medical Enterococcus faecalis ATCC 51299, Van B. Staph aureus AST 408, GISA and Daptomycin resistant Devices. References Nielsen SV,Casals JB: Detection of decreased susceptibility to glycopeptides in S. aureus using tablet(disc) prediffusion.presented at ECCMID Koeth L et al: Multisite evaluation of the Daptomycin Neo-Sensitab prediffusion method against 20 S. aureus.presentation P-1065, ECCMID Vancomycin 30 ug Teicoplanin 30 ug Daptomycin 30 ug hgisa < 20 mm or < 20 mm GISA < 20 mm and < 20 mm < 5mm VRE Van A no Zone No zone Van B < 16mm(hazy) > 20 mm Van C < 12 mm (sharp) > 20 mm Daptomycin resistance Staphylococci < 20 mm Enterococci no zone Detection of hgisa, GISA, VRE and Daptomycin susceptibility Ref Okt. 2013

19 ESBL + AmpC Screen Kit Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. Content and formulation 4 cartridges, each containing approximately tablets, formulated for maximum stability: Cefotaxime 30 µg, coded CTX30 Cefotaxime 30 µg + Clavulanate, coded CTX+C Cefotaxime 30 µg + Cloxacillin, coded CTXCX Cefotaxime 30 µg + Clavulanate + Cloxacillin, coded CTXCC Quality Control As positive Q. C strains the following may be used: Enterobacter cloacae NCTC 13406, Amp C positive Enterobacter cloacae ATCC BAA 1143, Amp C positive Klebs. pneumoniae ATCC ESBL positive All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. References Hansen F et al: Evaluation of Rosco Neo-Sensitabs for phenotypic detection and subgrouping of ESBL,AmpC and carbapenemase-producing Enterobacteriaceae. APMIS 120, , Edquist P et al : Phenotypic detection of plasmid-acquired AmpC in E. coli- evaluation of screening criteria and performance of 2 commercial methods for the phenotypic confirmation of AmpC production Eur J Clin Microbiol Infect Dis 32, , ESβL AmpC ESβL + AmpC CTX+C or B CTXCC D CTXCX or C CTXCC D CTX+C and B CTXCC D Cefotaxime CTX30 A 5 mm - 5 mm - <5 mm (AmpC) - Cefotaxime + Clavulanate CTX+C B - <5 mm - 5 mm - 5 mm (AmpC) Cefotaxime + Cloxacillin CTXCX C - 5 mm - <5 mm - 5 mm (ESBL) ESBL + AmpC Screen Kit Ref Okt. 2013

20 Total ESBL + AmpC Confirm Kit Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Content and formulation 6 cartridges of tablets, formulated for maximum stability, each containing tablets: Cefotaxime + Cloxacillin, coded CTXCX Cefotaxime + Clavulanate, coded CTX+C Ceftazidime + Cloxacillin, coded CAZCX Ceftazidime + Clavulanate, coded CAZ+C Cefotaxime + Cloxacillin + Clavulanate, coded CTXCC Ceftazidime + Cloxacillin + Clavulanate, coded CAZCC Quality Control As positive Q. C. stains the following may be used: Enterobacter cloacae NCTC 13406, AmpC positive Klebs. pneumoniae ATCC , ESBL positive Enterobacter cloacae ATCC BAA-1143 AmpC positive All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. References Hansen F et al: Evaluation of Rosco Neo-Sensitabs for phenotypic detection and subgrouping of ESB, AmpC and carbapenemase-producing Enterobacteriaceae. APMIS 120, , Edquist P et al: Phenotypic detection of plasmid-acquired AmpC in E. coli- evaluation of screening criteria and performance of 2 commercial methods for the phenotypic confirmation of AmpC production Eur J Clin Microbiol Infect Dis 32, , Enterobacteriaceae Cefotaxime + Cloxacillin + Clavulanate CTXCC Ceftazidime + Cloxacillin + Clavulanate CAZCC Cefotaxime + Cloxacillin >= 5 mm and/or - ESBL Ceftazidime + Cloxacillin >= 5 mm AmpC Cefotaxime + Clavulanate >= 5 mm and/or - Ceftazidime + Clavulanate >= 5 mm- Cefotaxime + Cloxacillin >= 5 mm and ESBL + AmpC Cefotaxime + Clav Ceftazidime + Cloxacillin >= 5 mm >= 5 mm and Ceftazidime + Clav >= 5 mm Total ESBL + AmpC Confirm Kit Ref Okt. 2013

21 ESBL Confirm Kits Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. Content and formulation ESBL Confirm (acc. to CLSI/EUCAST) Kit (98011) Comprises one cartridge ( tests) each of the following Cefotaxime 30 µg Cefotaxime 30 µg + Clavulanate Ceftazidime 30 µg Ceftazidime 30 µg + Clavulanate Testing of Enterobacteriaceae Group 1 (without chromosomal AmpC) according to CLSI/EUCAST. ESBL Confirm (Chrom. AmpC) Kit (98012) It comprises two cartridges (100 tests) each of the following: Cefepime 30 µg Cefepime 30 µg + Clavulanate Testing of Enterobacteriaceae Group 2 (possessing chromosomal AmpC) according to EUCAST. Total ESBL Confirm Kit (98014) Comprises one cartridge ( tests) each of the following: Cefotaxime 30 µg Cefotaxime 30 µg + Clavulanate Ceftazidime 30 µg Ceftazidime 30 µg + Clavulanate Cefepime 30 µg Cefepime 30 µg + Clavulanate Testing of any kind of Enterobacteriaceae, including chromosomal AmpC producers. All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. Quality Control As positive Q.C. strains the following may be used: Klebsiella pneumoniae ATCC ,ESBL positive,(except cefepime) Enterobacter cloacae NCTC 13464, ESBL positive (use Cefepime and FEP+C) References Hansen F et al: Evaluation of Rosco Neo-Sensitabs for phenotypic detection and subgrouping of ESBL, AmpC and carbapenemase-producing Enterobacteriaceae. APMIS 120, , Reuland E.A.et al: High prevalence of ESBL-producing Enterobacteriaceae carriage in Dutch community patients with gastrointestinal complaints Clin Microbiol Infect 19, , ESBL Confirm kits Ref Okt. 2013

22 KPC/MBL in P. aeruginosa/acinetobacter Confirm Kit Tablets are used for qualitative in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. The kit is intended for detection of the carbapenemases; KPC and MBL in Pseudomonas aeruginosa and MBL in Acinetobacter spp. Content and formulation 5 cartridges of tablets, formulated for maximum stability, each containing approximately tablets: Meropenem 10 µg, coded MRP10 Meropenem 10 µg + Phenylboronic Acid (KPC and AmpC inhibitor), coded MRPBO Meropenem 10 µg + Cloxacillin High (AmpC inhibitor), coded MPCXH All products from Rosco Imipenem 10 µg, coded IMI10 Diagnostica A/S are Dipicolinic acid (DPA) marked in compliance Quality Control As positive Q. C. strains the following may be used: P. aeruginosa ATTC 10145/CCUG 59626, MBL positive K. pneumoniae CCUG 58547, MBL positive K. pneumoniae NCTC 13439, MBL positive K. pneumoniae CCUG 56233, KPC positive K. pneumoniae NCTC 13438, KPC positive References Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. Dongeun Yong et al: Evaluation of double-disk potentiation tests using Dipicolinic acid for detection of MBL-producing Pseudomonas spp and Acinetobacter spp. J. Clin. Microbiol, , Miriagou V et al: Detecting VIM-1 production in P. mirabilis by an Imipenem-Dipicolinic acid double disk synergy test: J. Clin Microbiol 48, , 2010 KPC MβL Mc Conkey agar Meropenem + Phenylboronic MRPBO Meropenem + Cloxacillin High MPCXH Meropenem 10 µg 4mm and < 3 mm P. aeruginosa MRP10 Meropenem + Cloxacillin High 4 mm MPCXH P. aeruginosa Imipenem - - Synergism Acinetobacter 10 µg IMI Synergism DPA KPC/MBL in P. aeruginosa/acinetobacter Confirm Kit Ref Okt. 2013

23 KPC/Metallo-β-Lactamase Confirm Kit KPC/MBL and OXA-48 Confirm Kit Meropenem+Boronic Acid+Dipicolinic Acid Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for qualitative in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. The kit is intended for detection of the carbapenemases; KPC, MBL and OXA-48 in Enterobacteriaceae Content and formulation 4 or 5 cartridges of tablets, formulated for maximum stability, each containing approximately tablets: Meropenem 10 µg, coded MRP10 Meropenem 10 µg + Phenylboronic Acid (KPC and AmpC inhibitor), coded MRPBO Meropenem 10 µg + Cloxacillin (AmpC inhibitor), coded MRPCX Meropenem 10 µg + Dipicolinic acid (Metallo-β-Lactamase inhibitor), coded MRPDP Temocillin 30 ug (only in the OXA-48 Confirm kit 98015) Quality Control As positive Q. C. strains the following may be used: Klebs. pneumoniae NCTC 13438, KPC positive Klebs. pneumoniae NCTC 13439, MBL positive Klebs. pneumoniae ATCC BAA-1705, KPC positive Klebs. pneumoniae ATCC BAA-2146, MBL positive As negative Q.C strain the following may be used: Klebs. pneumoniae ATCC All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. References Giske CG et al: A sensitive and specific phenotypic assay for detection of MBL and KPC in K. pneumoniae with the use of meropenem disks supplemented with phenylboronic acid,dipicolinic acid and cloxacillin.clin Microbiol Infect 17, ,2011. Ambrettii S et al: Evaluation of phenotypic and genotypic approaches for the detection of Class A and Class B carbapenemases in Enterobacteriaceae.Microbial Drug Res 19, , Miriagou V et al: Combined disk methods for the detection of KPC and/or VIM positive K. pneumoniae: improving reliability for the double carbapenemase producers.clin Microbiol Infect E412-E415,2013 Giakkoupi P et al: Evaluation of the modified KPC+MBL Confirm kit for the phenotypic detection of Class A and B carbapenemases in K. pneumoniae isolates. Presented at the ECCMID KPC/Metallo-β-Lactamase Confirm Kit Ref KPC/MBL and OXA-48 Confirm Kit Ref Meropenem+Boronic Acid+Dipicolinic Acid Ref Oct. 2013

24 AmpC + porin loss ESBL + porin loss (a) KPC MβL OXA-48 and similars OXA-48 + ESBL (a) Meropenem 10 µg MRP10 Meropenem 10 µg MRP10 Meropenem 10 µg MRP10 Meropenem + Cloxacillin (MRPCX) Meropenem 10 µg MRP10 Meropenem 10 ug MRP10 Meropenem 10 ug MRP10 Meropenem + Phenylboronic MRPBO 4mm and Meropenem + DPA MRPDP Meropenem + Cloxacillin MRPCX Temocilin 30 µg 3 mm 5mm 12mm 3 mm 3 mm 3 mm 12mm 4mm 3 mm 3 mm Variable 4mm < 4mm 5mm 3 mm Variable 3 mm 3 mm 3 mm 3 mm 3 mm 3 mm No zone of inhibition No zone of inhibition Triple Disk MER + DPA + BO double inhibitor KPC MRPDP 4 mm MBL MRPBO 4 mm KPC + MBL MRPDP MRPBO 4 mm and 4 mm KPC/Metallo-β-Lactamase Confirm Kit Ref KPC/MBL and OXA-48 Confirm Kit Ref Meropenem+Boronic Acid+Dipicolinic Acid Ref Oct. 2013

25 Rapid CARB Screen Kit Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for in vitro screening of carbapenemase producing bacteria. The method is valid for Enterobacteriaceae and Pseudomonas aeruginosa. Content and formulation Two vials with 6 mm tablets; Imipenem + Indicator (CARB), formulated for maximum stability, each containing 25 tablets equivalent to a total of tests: One vial with 6 mm. tablets: CARB Negative Control Diatabs, tablets. Interpretation of results A change of color from red to yellow indicates a positive reaction, indicating that the test strain possesses a carbapenemase. If the reaction is positive after 30 minutes or 1 hour, it is not necessary to incubate further. In most cases, a carbapenemase is detected in 30 min. Please notice: Some Enterobacteriaceae producing OXA 48 (or similar), showing MIC s for Imipenem <= 0.5 µg / ml may show a negative result with Rapid CARB Screen Kit. These isolates should be reported as susceptible to Imipenem/meropenem according to CLSI and EUCAST recommendations. Quality Control DIATABS POSITIVE NEGATIVE Imipenem + Indicator (CARB) Klebsiella pneumoniae BAA 1705 E. coli ATCC References Nordmann P et al. Rapid detection of carbapenemase producing Enterobacteriaceae. Emerg. Infect. Dis. 18, 13-17, Nordmann P et al. Rapid detection of carbapenemase production in Pseudomonas. Presentation CI-078, ICAAC, Tijet N et al:" Evaluation of the Carba NP Test for rapid detection of carbapenemase-producing Enterobacteriaceae and Ps aeruginosa." Antimicr Ag. Chemother 57, , All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. Rapid CARB Ref Okt. 2013

26 Rapid ESBL Screen Kit Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for in vitro screening of ESBL producing bacteria. The method is valid for Enterobacteriaceae. Content and formulation One vial with 6 mm tablets; Cefotaxime + Indicator (ESBL) Diatabs, formulated for maximum stability, each containing tablets equivalent to a total of tests. One vial with 6 mm. tablets: Cefotaxime + Tazobactam + Indicator (ESBL) Diatabs, tablets. Interpretation of results A change of color from red to yellow indicates a positive reaction. If the reaction is positive after 30 minutes or 1 hour, it is not necessary to incubate further. The tube must be incubated for no more than 2 hours, because positive reactions may fade out. Quality Control DIATABS Positive Negative Enterobacter cloacae NCTC E. coli ATCC Cefotaxime + Indicator Yellow Red Cefotaxime + Tazo + indicator Red Red References Nordmann P et al. Rapid detection of Extended-spectrum-beta-lactamase-producing Enterobacteriaceae. J.Clin Microbiol., , All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. Rapid ESBL Ref Jan. 2014

27 Total Metallo-β-Lactamase Confirm Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Tablets are used for qualitative in vitro identification of microbial resistance mechanisms by the agar tablet/disc diffusion method, in order to confirm the mechanism by which the organism has gained resistance to specific antimicrobial agents. Content and formulation 5 cartridges of tablets, formulated for maximum stability, each containing approximately tablets: Meropenem 10 µg, coded MRP10 Dipicolinic acid, coded DPA Imipenem 10 µg, coded IMI10 All products from Rosco Imipenem 10 µg + DPA, coded IM+DP Diagnostica A/S are Imipenem 10 µg + EDTA, coded IM10E marked in compliance Quality Control As positive Q. C. stains the following may be used: Klebs. pneumoniae NCTC 13438, MBL positive Klebs. pneumoniae ATCC BAA-2146, MBL positive References with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. Dongeun Yong et al: Evaluation of double-disk potentiation tests using Dipicolinic acid for detection of MBL-producing Pseudomonas spp and Acinetobacter spp. J. Clin. Microbiol, , Miriagou V et al: Detecting VIM-1 production in P. mirabilis by an Imipenem-Dipicolinic acid double disk synergy test: J. Clin Microbiol 48, , 2010 Enterobacteriaceae MBL MBL Meropenem 10 µg MRP10 Imipenem 10 µg IMI10 DPA Imipenem + DPA IM+DP Imipenem + EDTA IM10E Synergism - - Synergism 5 mm 10 mm Pseudomonas aeruginosa. Mc Conkey agar Acinetobacter spp. Mc Conkey agar MBL MBL Imipenem 10 µg IMI10 Meropenem 10 µg MRP10 DPA Synergism Imipenem + DPA IM+DP 5 mm or Imipenem + EDTA IM10E 10 mm Synergism - - Total Metallo-β-Lactamase Confirm Ref Okt. 2013

28 Okt.2013 Neo-Sensitabs - a Unique Solution Unique characteristics ensure that NEO-SENSITABS are ideal for use in the clinic Rosco Diagnostica A/S is the leader in the field of phenotypic methods for detection of Susceptibility testing with NEO-SENSITABS practice is performed according to CLSI and EUCAST guidelines. For the Neo-Sensitabs marked 2-8 C the following applies: Unopened cartridges in stock Store in a refrigerator at 2-8 C Cartridges opened and in use Use and store at room temperature within 2 months. For all other Neo-Sensitabs: Unopened cartridges in stock Cartridges opened and in use Rosco Dispensers 7 cartridges round Petri dishes of 9 cm diameter 12 cartridges round Petri dishes of cm diameter 16 cartridges square Petri dishes of 12 x 12 cm Store at room temperature Use and store at room temperature within 12 months. REF. No All products from Rosco Diagnostica A/S are marked in compliance with the European Union directive 98/79/EC for In Vitro Diagnostic Medical Devices. For convenient and accurate dispensing of one or a few tablets at a time, use this handy single cartridge dispenser. References Justesen U.S et al:" Comparison of Rosco Neo-Sensitabs with Oxoid paper disks in EUCAST disk diffusion antimicrobial susceptibility testing on Mueller-Hinton agar".eur J Clin Microbiol Infect Dis 32, , Rosco User s Guides The User s Guide contains comprehensive data and information on several subjects. NEO-SENSITABS EUCAST-and CLSI potency NEO-SENSITABS DETECTION OF RESISTANCE MECHANISMS REGRESSION LINES NEO-SENSITABS The contents are continuously updated the latest edition is from Freely available on the Rosco website can be read or downloaded. Rosco Diagnostica A/S also produces Diatabs a range of enzymatic tests for rapid identification and differentiation of bacterial species.