Be lieve in Inno vat ion

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* Sidecar, Alfred 60AST and HB& 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 fl agged 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 samples can then be tested with a 8 CEFOTAXIME SI 959-CTX 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 results within few hours. 11 CEFTAZIDIME ENTEROBACTERIACEAE SI 949-CAZ 11 CEFTAZIDIME PSEUDOMONAS SI 812-CAZ The results are expressed in percentage 12 CEFTAZIDIME PSEUDOMONAS SI 950-CAZ 12 CEFTRIAXONE ENTEROBACTERIACEAE SI 813-CRO 13 CEFTRIAXONE SI 951-CRO 13 CEFUROXIME ENTEROBACTERIACEAE SI 815-FUR of resistance to the antibiotic and 14 CEFUROXIME SI 960-FUR 14 CIPROFLOXACIN SI 817-CIP classifi ed as Resistant, Intermediate or 15 CIPROFLOXACIN SI 963-CIP 15 CLINDAMYCIN STAPHYLOCOCCI SI 818-CLI Sensitive. 16 CLINDAMYCIN STAPHYLOCOCCI SI 964-CLI 16 COTRIMOXAZOLE SI 820-SXT 17 COLISTIN PSEUDOMONAS SI 983-CST 17 FOSFOMYCIN SI 821-FOS Alifax AST is applicable on positive 18 COTRIMOXAZOLE ENTEROBACTERIACEAE SI 965-SXT 18 GENTAMICIN SI 822-GEN cultures obtained using the Uro-Quick 19 COTRIMOXAZOLE STAPHYLOCOCCI SI 982 - SXT 19 LEVOFLOXACIN SI 823-LEV Screening Kit (Code SI 390.900), 20 GENTAMICIN SI 967-GEN 20 LINEZOLID SI 824-LZD HB&L™ Culture Kit (Code SI 405.901), 21 GENTAMICIN HLAR SI 999-GEN 21 MEROPENEM ENTEROBACTERIACEAE SI 825- 22 GENTAMICIN STAPHYLOCOCCI SI 968-GEN 22 MEROPENEM PSEUDOMONAS SI 826-MEM bacterial suspensions from isolated 23 LEVOFLOXACIN SI 969-LEV 23 NORFLOXACIN SI 828-NOR colonies and now also on positive 24 LINEZOLID SI 970-LZD 24 OXACILLIN STAPH. AUREUS SI 829-OXA hemoculture. 25 MEROPENEM ENTEROBACTERIACEAE SI 971-MEM 25 PIPERACILLIN-TAZOBACTAM ENTEROBACTERIAEAE SI 830-TZP 26 MEROPENEM PSEUDOMONAS SI 979-MEM 26 PIPERACILLIN-TAZOBACTAM PSEUDOMONAS SI 831-TZP Comparative studies vs the Kirby Bauer 27 PIPERACILLIN-TAZOBACTAM ENTEROBACTERIACEAE SI 953-TZP 27 TEICOPLANIN STAPHYLOCOCCI SI 832-TEI reference system(1,2) and other automated 28 PIPERACILLIN-TAZOBACTAM PSEUDOMONAS SI 952-TZP 28 TEICOPLANIN ENTEROCOCCI SI 833-TEI 29 RIFAMPICIN SI 996-RIF 29 VANCOMYCIN STAPH. AUREUS SI 834-VAN systems(3,4,5) show high correlations. 30 TEICOPLANIN CNS SI 976-TEI 30 VANCOMYCIN CNS AND ENTEROCOCCI SI 835-VAN Results are available in 3 hours. 31 TEICOPLANIN . AUREUS AND ENTEROCOCCI SI 975-TEI 32 VANCOMYCIN CNS AND ENTEROCOCCI SI 974-VAN 33 VANCOMYCIN S. AUREUS SI 973-VAN * MARKED on Urine and isolated colonies

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 1DAYRESULT

FULL INTEGRATED TECHNOLOGIES

Mc FARLAND BACTERIAL MONITOR CULTURE

MASS SPECTROMETRY SUSCEPTIBILITY IDENTIFICATION TESTING

ALIFAX SUSCEPTIBILITY TESTING ON POSITIVE HEMOCULTURE SAMPLES Ref. 6

NEW 1. POSITIVE SAMPLE SELECTION AND MICROSCOPE EVALUATION

Thanks to the unique application positive blood cultures can 2. 10 µl BACTERIAL SUSPENSION IN A HB<M be tested with Alifax AST ENRICHMENT VIAL + DEB SUPPLEMENT UNTIL THE 0.5 MCFARLAND kits dramatically reducing the analytical turnaround time and giving results in few hours(4,5,6). 3. ALIFAX AST WITH A CUSTOMIZED ANTIBIOTIC PANEL Alifax AST gives results about FOLLOWING: antibiotics effectiveness 24-48 - GRAM INDICATION hours sooner than traditional - ADMINISTERED DRUG INFORMATION - THERAPEUTIC PROTOCOL DATA AND GUIDE LINE methods. BACTERIAL YEALD FROM ENRICHMENT VIAL CAN BE USED FOR MASS SPECTROMETRY IDENTIFICATION 0.5 Mc Farland Antibiotic 4 Reference Antibiotic 1 Antibiotic 2 Antibiotic 3 Antibiotic 5

4. RESULTS IN 3 HOURS

60 TEST KIT Each Alifax AST antibiotic kit contains: SHELF LIFE • 10 vials of lyophilized antibiotic From production: 12 months at +4÷8 ° • 1 Regenerating Solution From reconstitution: 4-7 days at +4 °C • 60 blue cap disposable vials with broth STORAGE CONDITIONS Refrigerated temperature (+4÷8 °C) RELATED KIT AST Mc Farland Kit Code SI 912 SVR

30 TEST KIT SHELF LIFE Each Alifax AST antibiotic kit contains: From production: 12 months at +4÷8 °C • 5 vials of lyophilized antibiotic From reconstitution: 4-7 days at +4 °C STORAGE CONDITIONS • 2 Regenerating Solution Refrigerated temperature (+4÷8 °C) RELATED KIT Empty vials for automation Code SI AST-EV Automation kit Code SI 1201.900 -NF AST Broth kit Code SI 1201.905

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", Chemother. 2006 Feb;18(1): 12-9 2- . 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- . 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, ° 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. 08.01.15 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) Microbiologia Medica, 2010, Vol. 25, N°4, 238-243

ALIFAX S..l. Via . 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 € 6.000.000 entirely deposited Company with single partner