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.

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

ANTIMICROBIALSUSCEPTIBILITY TESTING

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

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.

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LIGHT SCATTERING TECHNOLOGY APPLIED TO SUSCEPTIBILITY TESTING

Sidecar, Alfred 60AST and HB&L are conceived in order to properly monitor the turbidity levels of the samples simultaneously to the culture test. Positive samples are flagged when the turbidity reaches the 0.5 McFarland by McFarland Monitor. Monomicrobial samples can then be tested with a customized antibiotic panel providing results within few hours.

The results are expressed in percentage of resistance to the antibiotic and classified as Resistant, Intermediate or Sensitive.

Alifax AST is applicable on positive cultures obtained using the Uro-Quick Screening Kit (Code SI 390.900), Automation kit (Code SI 1201.900), HB&L™ Culture Kit (Code SI 405.901), bacterial suspensions from isolated colonies and now also on positive hemoculture.

Comparative studies vs the Kirby Bauer reference system(1,2)

and other automated systems

(3,4,5) show high correlations.

Results are available in 3 hours.

EACH ANTIBIOTIC IS INDIVIDUALLY MARKED

1 AMIKACIN ENTEROBACTERIACEAE SI 956-AMK

2 AMIKACIN PSEUDOMONAS NN) SI 978-AMK

3 AMIKACIN STAPHYLOCOCCI SI 981-AMK

4 AMPICILLIN ENTEROBACTERIACEAE SI 954-AMP

5 AMPICILLIN ENTEROCOCCI SI 955-AMP

6 AMPICILLIN-SULBACTAM ENTEROBACTERIACEAE SI 997-AMS

7 AZTREONAM ENTEROBACTERIACEAE SI 957-ATM

8 CEFOTAXIME SI 959-CTX

9 CEFOXITIN CNS SI 962-FOX

10 CEFOXITIN STAPH. AUREUS SI 961-FOX

11 CEFTAZIDIME ENTEROBACTERIACEAE SI 949-CAZ

12 CEFTAZIDIME PSEUDOMONAS SI 950-CAZ

13 CEFTRIAXONE SI 951-CRO

14 CEFUROXIME SI 960-FUR

15 CIPROFLOXACIN SI 963-CIP

16 CLINDAMYCIN STAPHYLOCOCCI SI 964-CLI

17 COLISTIN PSEUDOMONAS SI 983-CST

18 COLISTIN ENTEROBACTERIACEAE SI 984-CST

19 COTRIMOXAZOLE ENTEROBACTERIACEAE SI 965-SXT

20 COTRIMOXAZOLE STAPHYLOCOCCI SI 982 - SXT

21 DAPTOMYCIN STAPHYLOCOCCI SI 986-DAP

22 GENTAMICIN SI 967-GEN

23 GENTAMICIN HLAR SI 999-GEN

24 GENTAMICIN STAPHYLOCOCCI SI 968-GEN

25 LEVOFLOXACIN SI 969-LEV

26 LINEZOLID SI 970-LZD

27 MEROPENEM ENTEROBACTERIACEAE SI 971-MEM

28 MEROPENEM PSEUDOMONAS SI 979-MEM

29 PIPERACILLIN-TAZOBACTAM ENTEROBACTERIACEAE SI 953-TZP

30 PIPERACILLIN-TAZOBACTAM PSEUDOMONAS SI 952-TZP

31 RIFAMPICIN SI 996-RIF

32 TEICOPLANIN CNS SI 976-TEI

33 TEICOPLANIN S. AUREUS AND ENTEROCOCCI SI 975-TEI

34 VANCOMYCIN CNS AND ENTEROCOCCI SI 974-VAN

35 VANCOMYCIN S. AUREUS SI 973-VAN

EUCAST LYOPHILISED ANTIBIOTICS Code

1 AMIKACIN SI 801-AMK

2 AMOXICILLIN-CLAVULANATE STAPHYLOCOCCI SI 802-AMC

3 AMPICILLIN ENTEROBACTERIACEAE SI 803-AMP

4 AMPICILLIN ENTEROCOCCI SI 804-AMP

5 AZTREONAM ENTEROBACTERIACEAE SI 805-ATM

6 AZTREONAM PSEUDOMONAS SI 806-ATM

7 CEFOTAXIME ENTEROBACTERIACEAE SI 807-CTX

8 CEFOXITIN STAPH. AUREUS SI 809-FOX

9 CEFOXITIN CNS SI 810-FOX

10 CEFTAZIDIME ENTEROBACTERIACEAE SI 811-CAZ

11 CEFTAZIDIME PSEUDOMONAS SI 812-CAZ

12 CEFTRIAXONE ENTEROBACTERIACEAE SI 813-CRO

13 CEFUROXIME ENTEROBACTERIACEAE SI 815-FUR

14 CIPROFLOXACIN SI 817-CIP

15 CLINDAMYCIN STAPHYLOCOCCI SI 818-CLI

16 COTRIMOXAZOLE SI 820-SXT

17 DAPTOMYCIN STAPHYLOCOCCI SI 837-DAP

18 FOSFOMYCIN SI 821-FOS

19 GENTAMICIN SI 822-GEN

20 LEVOFLOXACIN SI 823-LEV

21 LINEZOLID SI 824-LZD

22 MEROPENEM ENTEROBACTERIACEAE SI 825-MEM

23 MEROPENEM PSEUDOMONAS SI 826-MEM

24 NORFLOXACIN SI 828-NOR

25 OXACILLIN STAPH. AUREUS SI 829-OXA

26 PIPERACILLIN-TAZOBACTAM ENTEROBACTERIAEAE SI 830-TZP

27 PIPERACILLIN-TAZOBACTAM PSEUDOMONAS SI 831-TZP

28 TEICOPLANIN STAPHYLOCOCCI SI 832-TEI

29 TEICOPLANIN ENTEROCOCCI SI 833-TEI

30 VANCOMYCIN STAPH. AUREUS SI 834-VAN

31 VANCOMYCIN CNS AND ENTEROCOCCI SI 835-VAN

CLSI LYOPHILISED ANTIBIOTICS Code

Thanks to the unique application positive blood cultures can be tested with Alifax AST kits dramatically reducing the analytical turnaround time and giving results in few hours(4,5,6).

Alifax AST gives results about antibiotics effectiveness 24-48 hours sooner than traditional methods.

ALIFAX SUSCEPTIBILITY TESTING ON POSITIVE HEMOCULTURE SAMPLES

Each Alifax AST antibiotic kit contains: • 5 vials of lyophilized antibiotic• 2 Regenerating Solution• 1 Mic CARD

30 TEST KIT

RELATED KITS

FOR AUTOMATION ON ALFRED 60AST AND SIDECAR1. AUTOMATION KIT Code SI 1201.9002. G-NF AST BROTH KIT Code SI 1201.9053. EMPTY VIALS Code SI AST-EV

FOR MANUAL EXECUTION ON HB&L1. AUTOMATION KIT Code SI 1201.9102. G-NF AST BROTH KIT Code SI 1201.905

SHELF LIFEFrom production: 8-12 monthsFrom reconstitution: 4-7 days

STORAGE CONDITIONSRefrigerated temperature (+4÷8 °C)

1. POSITIVE SAMPLE SELECTION AND MICROSCOPE EVALUATION

Ref. 6

2. 10 µl BACTERIAL SUSPENSION IN A HB&LTM ENRICHMENT VIAL + DEB SUPPLEMENT

UNTIL THE 0.5 MCFARLAND

3. ALIFAX AST WITH A CUSTOMIZED ANTIBIOTIC PANEL FOLLOWING:

- GRAM INDICATION - ADMINISTERED DRUG INFORMATION - THERAPEUTIC PROTOCOL DATA AND GUIDE LINE

BACTERIAL YEALD FROM ENRICHMENT VIAL CAN BE USED FOR MASS SPECTROMETRY IDENTIFICATION

4. RESULTS IN 3 HOURSR

efer

ence

0.5

Mc

Farl

and

Anti

bio

tic

1

Anti

bio

tic

2

Anti

bio

tic

3

Anti

bio

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4

Anti

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NEW

Bibliography1- 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): 12-92- 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):179-1833- 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, 24-265- 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, 60-636- 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

Mc FARLANDMONITOR

BACTERIALCULTURE

MASSSPECTROMETRYIDENTIFICATION

SUSCEPTIBILITYTESTING

FULL INTEGRATED TECHNOLOGIES

1DAYRESULT

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 (reference vial) drugs.

Thanks to the new revolutionary application on HB&L and Alfred 60, positive blood cultures can be tested with Alifax AST kits dramatically reducing the analytical turnaround time and giving results in few hours(4,5,6).

Alifax AST gives results about antibiotics effectiveness 24-48 hours sooner than traditionalmethods.

ALIFAX ANTIMICROBIAL SUSCEPTIBILITY TESTING

ALIFAX SUSCEPTIBILITY TESTING ON POSITIVE HEMOCULTURE SAMPLES

Each Alifax AST antibiotic kit contains: • 10 vials of lyophilized antibiotic• Regenerative Solution• 60 blue cap disposable vials with coloured glass

SHELF LIFEFrom production: 8 months at +2÷8 °C.From reconstitution: 7 days at +4 °CSTORAGE CONDITIONSRefrigerated temperature (+2÷8 °C)RELATED KITAST Mc Farland Kit Code SI 912 SVR

1. POSITIVE SAMPLE SELECTION AND MICROSCOPE EVALUATION

Ref. 6

REFERENCE RESISTANT SENSITIVE

2. DILUTION 1:10 OF POSITIVE BLOOD CULTURE BROTH IN SALINE SOLUTION

3. 500 µl SUSPENSION DILUTION IN A HB&LTM CULTURE VIAL + DEB SUPPLEMENT

UNTIL THE 0.5 MCFARLAND

4. ALIFAX AST with a customized antibiotic panel following:

- Gram indication - Administered drug information - Therapeutic protocols data and guide line

5. RESULTS IN 3 HOURSR

efer

ence

1:10

0.5

Mc

Far

land

Ant

ibio

tic 1

Ant

ibio

tic 2

Ant

ibio

tic 3

Ant

ibio

tic 4

Ant

ibio

tic 5

NEW

Bibliography1- 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): 12-92- 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):179-1833- 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 hour in positive blood cultures” Microbiologia Medica, Anno 2010, Vol. 25, N° 1, 24-265- 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, 60-636- 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

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ALIFAX S.p.A. Via F. Petrarca, 2/1 35020 Polverara - Padova, ITALY Tel. +39 049 0992000 Fax +39 049 5855434 info@alifax.com www.alifax.comEntered in Padova companies register at the n. 04337640280. Company stock € 6.000.000 entirely deposited Company with single partner

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ALIFAX S.r.l. Via F. Petrarca, 2/1 - 35020 Polverara - Padova, ITALY - Tel. +39 049 0992000 - Fax +39 049 5855434 - info@alifax.com - www.alifax.comEntered in Padova companies register at the n. 04337640280. Company stock E 10.000.000 entirely deposited Company with single partner

SI 1201.900 SI 1201.905 SI 1201.910