Antimicrobial Susceptibility Testing

Believe in In nova tion

ANTIMICROBIAL SUSCEPTIBILITY TESTING

Alifax clinical susceptibility testing is the unique test that gives results in only 3 hours

In cases of serious bacterial infections the timely administration of an effective antibiotic therapy is associated with an increase in disease resolution and subsequent patient survival. For this reason, the microbiology laboratory has to provide "clinically useful results" in order to guide the clinician to choose the most appropriate antibiotic therapy as soon as possible. Rapid Antimicrobial Susceptibility Test (AST) results facilitate effective treatment, reduce the number of laboratory tests ordered, days of hospitalization and Public Health costs. In addition, they are useful to monitor the evolution of resistant bacteria.

LIGHT SCATTERING TECHNOLOGY APPLIED TO SUSCEPTIBILITY TESTING EACH ANTIBIOTIC IS INDIVIDUALLY MARKED AST Sidecar, Alfred 60 and HB&L are EUCAST LYOPHILISED ANTIBIOTICS Code CLSI LYOPHILISED ANTIBIOTICS Code conceived in order to properly monitor 1 AMIKACIN ENTEROBACTERIACEAE SI 956-AMK 1 AMIKACIN SI 801-AMK the turbidity levels of the samples 2 AMIKACIN PSEUDOMONAS NN) SI 978-AMK 2 AMOXICILLIN-CLAVULANATE STAPHYLOCOCCI SI 802-AMC simultaneously to the culture test. 3 AMIKACIN STAPHYLOCOCCI SI 981-AMK 3 AMPICILLIN ENTEROBACTERIACEAE SI 803-AMP 4 AMPICILLIN ENTEROBACTERIACEAE SI 954-AMP 4 AMPICILLIN ENTEROCOCCI SI 804-AMP Positive samples are flagged when the 5 AMPICILLIN ENTEROCOCCI SI 955-AMP 5 AZTREONAM ENTEROBACTERIACEAE SI 805-ATM turbidity reaches the 0.5 McFarland by 6 AMPICILLIN-SULBACTAM ENTEROBACTERIACEAE SI 997-AMS 6 AZTREONAM PSEUDOMONAS SI 806-ATM McFarland Monitor. Monomicrobial 7 AZTREONAM ENTEROBACTERIACEAE SI 957-ATM 7 CEFOTAXIME ENTEROBACTERIACEAE SI 807-CTX 8 CEFOTAXIME SI 959-CTX samples can then be tested with a 8 CEFOXITIN STAPH. AUREUS SI 809-FOX 9 CEFOXITIN CNS SI 962-FOX 9 CEFOXITIN CNS SI 810-FOX customized antibiotic panel providing 10 CEFOXITIN STAPH. AUREUS SI 961-FOX 10 CEFTAZIDIME ENTEROBACTERIACEAE SI 811-CAZ 11 CEFTAZIDIME ENTEROBACTERIACEAE SI 949-CAZ results within few hours. 11 CEFTAZIDIME PSEUDOMONAS SI 812-CAZ 12 CEFTAZIDIME PSEUDOMONAS SI 950-CAZ 12 CEFTRIAXONE ENTEROBACTERIACEAE SI 813-CRO 13 CEFTRIAXONE SI 951-CRO The results are expressed in percentage 13 CEFUROXIME ENTEROBACTERIACEAE SI 815-FUR 14 CEFUROXIME SI 960-FUR of resistance to the antibiotic and 14 CIPROFLOXACIN SI 817-CIP 15 CIPROFLOXACIN SI 963-CIP 15 CLINDAMYCIN STAPHYLOCOCCI SI 818-CLI classified asResistant, Intermediate 16 CLINDAMYCIN STAPHYLOCOCCI SI 964-CLI 16 COTRIMOXAZOLE SI 820-SXT or Sensitive. 17 COLISTIN PSEUDOMONAS SI 983-CST 17 DAPTOMYCIN STAPHYLOCOCCI SI 837-DAP 18 COLISTIN ENTEROBACTERIACEAE SI 984-CST 18 FOSFOMYCIN SI 821-FOS Alifax AST is applicable on positive 19 COTRIMOXAZOLE ENTEROBACTERIACEAE SI 965-SXT 19 GENTAMICIN SI 822-GEN cultures obtained using the Uro-Quick 20 COTRIMOXAZOLE STAPHYLOCOCCI SI 982 - SXT 20 LEVOFLOXACIN SI 823-LEV 21 DAPTOMYCIN STAPHYLOCOCCI SI 986-DAP Screening Kit (Code SI 390.900), 21 LINEZOLID SI 824-LZD 22 GENTAMICIN SI 967-GEN Automation kit (Code SI 1201.900), 23 GENTAMICIN HLAR SI 999-GEN 22 MEROPENEM ENTEROBACTERIACEAE SI 825-MEM HB&L™ Culture Kit (Code SI 405.901), 24 GENTAMICIN STAPHYLOCOCCI SI 968-GEN 23 MEROPENEM PSEUDOMONAS SI 826-MEM bacterial suspensions from isolated 25 LEVOFLOXACIN SI 969-LEV 24 NORFLOXACIN SI 828-NOR 26 LINEZOLID SI 970-LZD 25 OXACILLIN STAPH. AUREUS SI 829-OXA colonies and now also on positive 27 MEROPENEM ENTEROBACTERIACEAE SI 971-MEM 26 PIPERACILLIN-TAZOBACTAM ENTEROBACTERIAEAE SI 830-TZP hemoculture. 28 MEROPENEM PSEUDOMONAS SI 979-MEM 27 PIPERACILLIN-TAZOBACTAM PSEUDOMONAS SI 831-TZP Comparative studies vs the Kirby Bauer 29 PIPERACILLIN-TAZOBACTAM ENTEROBACTERIACEAE SI 953-TZP 28 TEICOPLANIN STAPHYLOCOCCI SI 832-TEI 30 PIPERACILLIN-TAZOBACTAM PSEUDOMONAS SI 952-TZP 29 TEICOPLANIN ENTEROCOCCI SI 833-TEI reference system(1,2) and other automated 31 RIFAMPICIN SI 996-RIF 30 VANCOMYCIN STAPH. AUREUS SI 834-VAN 32 TEICOPLANIN CNS SI 976-TEI 31 VANCOMYCIN CNS AND ENTEROCOCCI SI 835-VAN systems(3,4,5) show high correlations. 33 TEICOPLANIN S. AUREUS AND ENTEROCOCCI SI 975-TEI Results are available in 3 hours. 34 VANCOMYCIN CNS AND ENTEROCOCCI SI 974-VAN 35 VANCOMYCIN S. AUREUS SI 973-VAN

The Alifax systems detect if a bacteria is sensitive or resistant to selected antibiotics by comparing growth curves of the same bacterial suspension inoculated in vials with and without (reference vial) drugs. REFERENCE RESISTANT SENSITIVE

Not for sale in U.S. Due to regulatory requirements, the products listed herein are available for sale in any relevant Country territory provided that they have been registered according to the applicable domestic law. The products listed herein may have incurred changes with respect to the last available edition. ALIFAX ANTIMICROBIAL SUSCEPTIBILITY TESTING The Alifax systems determine if a bacteria is sensitive or resistant to selected antibiotics by comparing growth curves of the same bacterial suspension inoculated in vials with and without 1DAYRESULT (reference vial) drugs. FULL INTEGRATED TECHNOLOGIES

Mc FARLAND BACTERIAL REFERENCE RESISTANTMONITOR SENSITIVE CULTURE ALIFAX SUSCEPTIBILITY TESTING ON POSITIVE HEMOCULTURE SAMPLES

MASS Ref. 6 SPECTROMETRY SUSCEPTIBILITY IDENTIFICATION TESTING NEW 1. POSITIVE SAMPLE SELECTION AND MICROSCOPE EVALUATION ALIFAX SUSCEPTIBILITY TESTING ON POSITIVE HEMOCULTURE SAMPLES Ref. 6

Thanks to the new revolutionary 1:10 1.2. DILUTIONPOSITIVE SAMPLE1:10 OF SELECTIONPOSITIVE BLOOD AND MICROSCOPE CULTURE BROTH EVALUATION application on HB&L and Alfred IN SALINE SOLUTION 60, positive blood cultures can be tested with Alifax AST kits dramatically reducing the The Clinical AST is a robust and analytical turnaround time and TMTM " valid AST, that introduced in 2.3. 50010 µl µl BACTERIAL SUSPENSION SUSPENSION DILUTION IN IN A A HB&L HB&L giving results in few hours(4,5,6). ENRICHMENTCULTURE VIAL VIAL + DEB + DEB SUPPLEMENT SUPPLEMENT routine for critically ill patients UNTIL THE 0.50.5 MCF MCFARLANDARLAND has allowed the clinician to Alifax AST gives results about set/correct promptly antibiotic antibiotics effectiveness 24-48 therapy improving the chances hours sooner than traditional of successful treatment 3. ALIFAX AST WITH A CUSTOMIZED ANTIBIOTIC PANEL methods. FOLLOWING: and also impacting on the 4. ALIFAX AST with a customized antibiotic panel following: - GRAM INDICATION antimicrobial stewardship - Gram indication - ADMINISTERED DRUG INFORMATION - Administered drug information through a calibrated use of - THERAPEUTIC PROTOCOL DATA AND GUIDE LINE antibiotics. - Therapeutic protocols data and guide line BACTERIAL YEALD FROM ENRICHMENT VIAL CAN BE (Carla Fontana ECCMID 2016) USED FOR MASS SPECTROMETRY IDENTIFICATION 0.5 Mc Farland Antibiotic 4 Reference Antibiotic 1 Antibiotic 2 Antibiotic 3 Antibiotic 5 0.5 Mc Farland Antibiotic 4 " Reference Antibiotic 1 Antibiotic 2 Antibiotic 3 Antibiotic 5

4.5. RESULTS ININ 33 HOURS

Each Alifax AST antibiotic kit contains: SHELF LIFE SHELF LIFE 30 TEST10 vialsKIT of lyophilized antibiotic From production: 8 months at +2÷8 °C. • From production: 8-12 months Each• AlifaxRegenerative AST antibiotic Solution kit contains: From reconstitution: 7 days at +4 °C FromSTORAGE reconstitution: CONDITIONS 4-7 days • • 560 vials blue of cap lyophilized disposable antibiotic vials with coloured glass • 2 Regenerating Solution STORAGERefrigerated CONDITIONS temperature (+2÷8 °C) • 1 Mic CARD RefrigeratedRELATED KIT temperature (+4÷8 °C) AST Mc Farland Kit Code SI 912 SVR

Bibliography 1- S. Roveta et al. (Microbiology Institute, Genoa University, Italy) "Antibiotic susceptibility tests directly on urine samples by Uro-Quick, a rapid automated system", J Chemother. 2006 Feb;18(1):RELATED 12-9 KITS 2- E. Pezzati et al. (Microbiology Institute, Genoa University, Italy) " Evaluation of the Uro-Quick system for antibiotic susceptibility tests of strains collected from intensive care units" Annals of Microbiology 2006, 56(2):179-183 3- A. Tessari et al. (Mic. Dep., Padova University Hospital ,Padova, Italy) Evaluation of a new rapid method for microbial growth analysis and antimicrobial susceptibility test in human biological ﬂ uids” Abstract, 17th ECCMID, München, 31 March-3 April 2007. 4- V. Kroumova et al. (Microbiology and Virology laboratory from university mayor hospital of charity of Novara, Italy) “Preliminary indications for antibiotic susceptibility tests in less than six hourFOR in positive AUTOMATION blood cultures” Microbiologia ON Medica, ALFRED Anno 2010, 60 Vol.AST 25, N° 1, 24-26 5- S. Barocci et al. (Microbiology Unit, Clinical Pathology Laboratories ASUR 4 Senigallia (AN), Italy) “HB&L System: rapid determination of antibiotic sensitivity of bacteria isolated from blood cultures” Microbiologia Medica, Anno 2010, Vol. 25, N° 1, 60-63 Rev. 07.10.11 Rev. 6- V. Rondinelli et al.“ New method for rapid Susceptibility Testing on blood culture with HB&L system: preliminary data” (Mic. e Vir. Lab Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro) MicrobiologiaAND SIDECARMedica, 2010, Vol. 25, N°4, 238-243 1. AUTOMATION KIT Code SI 1201.900 ALIFAX S.p.A. Via F. Petrarca, 2/1 35020 Polverara - Padova, ITALY Tel. +39 049 0992000 Fax +39 0492. 5855434G-NF AST [email protected] KIT Code SI www.alifax.com1201.905 Entered in Padova companies register at the n. 04337640280. Company stock € 6.000.000 entirely deposited Company with single partner3. EMPTY VIALS Code SI AST-EV

FOR MANUAL EXECUTION ON HB&L 1. AUTOMATION KIT Code SI 1201.910 2. G-NF AST BROTH KIT Code SI 1201.905

SI 1201.900 SI 1201.905 SI 1201.910

Bibliography 1- S. Roveta et al. (Microbiology Institute, Genoa University, Italy) "Antibiotic susceptibility tests directly on urine samples by Uro-Quick, a rapid automated system", J Chemother. 2006 Feb;18(1): 12-9 2- E. Pezzati et al. (Microbiology Institute, Genoa University, Italy) " Evaluation of the Uro-Quick system for antibiotic susceptibility tests of strains collected from intensive care units" Annals of Microbiology 2006, 56(2):179-183 3- A. Tessari et al. (Mic. Dep., Padova University Hospital ,Padova, Italy) Evaluation of a new rapid method for microbial growth analysis and antimicrobial susceptibility test in human biological fluids” Abstract, 17th ECCMID, München, 31 March-3 April 2007. 4- V. Kroumova et al. (Microbiology and Virology laboratory from university mayor hospital of charity of Novara, Italy) “Preliminary indications for antibiotic susceptibility tests in less than six hour in positive blood cultures” Microbiologia Medica, Anno 2010, Vol. 25, N° 1, 24-26 5- S. Barocci et al. (Microbiology Unit, Clinical Pathology Laboratories ASUR 4 Senigallia (AN), Italy) “HB&L System: rapid determination of antibiotic sensitivity of bacteria isolated from blood cultures” Microbiologia Medica, Anno 2010, Vol. 25, N° 1, 60-63 6- V. Rondinelli et al.“ New method for rapid Susceptibility Testing on blood culture with HB&L system: preliminary data” (Mic. e Vir. Lab Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro) Microbiologia Medica, 2010, Vol. 25, N°4, 238-243

Rev. 28.06.17 Rev. 7- C. Fontana et al. Clinical antimicrobial susceptibility testing as a routine experience, ECCMID 2016 ALIFAX S.r.l. Via F. Petrarca, 2/1 - 35020 Polverara - Padova, ITALY - Tel. +39 049 0992000 - Fax +39 049 5855434 - [email protected] - www.alifax.com Entered in Padova companies register at the n. 04337640280. Company stock E 10.000.000 entirely deposited Company with single partner