The new generation of preanalyticals

Transcription

1 The new generation of preanayticas

2 Transwab was the first commerciay produced ge transport swab, and for many years has ed the fied for reiabe microbioogica specimen coection and transport. A programme of continous deveopment has kept Transwab ahead of changes in aboratory science and reguatory requirements, so that it remains a trusted partner in the diagnosis of infectious disease 1-8. Sigma-Transwab combines a of this experience in an a-new format and technoogy for the new era of iquid preanaytica microbioogy, whie remaining competey suitabe for conventiona methodoogies. The specimen is coected by swab into the tube containing 1 m of Liquid Amies Transport Medium. The microorganisms from the initia specimen are dispersed throughout the medium, producing a uniform suspension ready for use, whether for direct inocuation onto pates or into broth, or with an automatic samping and inocuation system, or with any of the rapid moecuar tests currenty avaiabe. The process is enhanced by the incorporation of an open-ceed foam-tipped swab which aows compete fow through of the iquid medium, reagents, and microorganism. This increases the sensitivity of any diagnostic procedures. The via, made from shatterproof poypropyene, has a conica base, and can be centrifuged if required. The base is skirted, so the tube is free standing for convenience of use at the bench, whie the new screw cap ensures secure containment of iquids. The cap aso incorporates an ingenious swab capture mechanism. Thus when the swab is paced in the tube, snapped at its break point and broken, and the cap screwed home, the swab is captured securey, so that when the cap is removed, whether manuay or mechanicay, the swab is automaticay removed with the cap. Sigma-Transwab is aso avaiabe in two further formats with coour coded caps. Dua & tripe formats for swabbing at mutipe sites. Format features one standard white shaft Sigma swab, and one or two standard Sigma swabs with red shafts. The white shaft swab is captured by the cap. Sigma-Transwab (mini-tip format) uses a narrow fine-tip shaft, aso with a foam tip, and is particuary suited for nasopharyngea and urethra specimens. This does not use the swab capture mechanism. A variants of Sigma-Transwab are M40-A compiant, suitabe for aerobic, anaerobic and fastidious microorganisms, and can be transported at ambient or refrigerator temperatures. The iquid medium is based on the origina formuation of Amies, but without charcoa. It can be used immediatey for Gram stains at the time of coecting the specimen, and transported securey whether by externa courier or interna pneumatic system. A Sigma-Transwabs are CE-marked, and conform to the requirements of the European Medica Devices Directive and In Vitro Medica Devices Directives 31,32. The transport system for microbioogy

3 New coection via Screw cap for sampe integrity and security Compatibe with most automatic decapping Integra swab capture no further manua handing of swab shaft required Coour coded caps according to format and appication Sef-standing for convenience Inner conica base can be centrifuged Shatterproof poypropyene New -swab Soft poyurethane foam bud preferred by patients High absorbency for optimum sampe uptake Open ce for compete fow through of medium and reagents Maximum reease of microorganism Entire specimen is reeased into iquid phase Breakpoint for easy handing, ensures exact fit of swab in tube and swab capture Fine-tip option avaiabe for urethra and nasopharyngea specimens New transport medium Liquid Amies for automated and conventiona processing Liquid Amies provides suspension for quick Gram stain and mutipe cutures Liquid Amies maintains viabiity of Aerobes, Anaerobes, and Fastidious bacteria for up to 48 hours at ambient and refrigerated temperatures (as required for M40 compiance) 1,3,29 Rapid eution of specimen aows accurate and quantitative diutions Stabe at room temperature for 24 months Swab Capture As cap is repaced, swab is captured and becomes attached to cap.

4 -VCM Universa Transport for Viruses, Chamydia, Mycopasma & Ureapasmas Incuded in Medica Wire s new range of preanayticas is Sigma-VCM for the coection and transportation of key pathogens, incuding nove H1N1 infuenza virus (swine fu). Retaining the we documented quaities of Virocut medium, VCM has been deveoped to make it suitabe not ony for viruses, but aso for chamydia, mycopasma, ureapasmas, and even certain important fastidious bacteria such as Neisseria gonorrhoeae 10,11. The base medium aows surviva and recovery of the target organisms, whie a new cocktai of antimicrobias prevents the growth of most contaminating bacteria and fungi in the specimen. Target organisms can be identified by cuture or moecuar techniques. -VCM is avaiabe in a range of formats, refecting the many appications for which it can be used. It is suppied as a sterie device comprising a sef-standing conica based via with 1m or 3m of VCM medium, and a choice of 1 or 2 Sigma-swabs, 1 or 2 mini-tip Sigmaswabs, or one of each. A standard versions come with gass beads in the Medium, but it is aso possibe to have Sigma- VCM without beads, or to have tubes containing 1m or 3m of VCM medium (with beads). Sigma-VCM is suppied with Sigma-swabs, the open ce foam tipped swabs which aow optimum uptake and reease of target microorganisms, and compete fow-through of reagents for optimum sensitivity for moecuar test protocos. Standard Sigma-swab is suitabe for genera swab appications such as skin esions, nose and throat. Mini-tip Sigma-swabs are suitabe for nasopharyngea and urethra samping. Sigma-VCM is compiant with CLSI s M40-A standard for the recovery of viruses, and has been tested in the same way* for chamydia and mycopasmas (incuding ureapasmas). Sigma-VCM wi aso meets the requirements of M40-A for the recovery of Neisseria gonorrhoeae, making it the compete swab device for STD cinics. * M40-A does not specify requirements for chamydia or mycopasma ive recoveries, but the criteria for bacteria and viruses were adapted to show better than acceptabe performance for chamydia and mycopasma. -VCM, the truy universa transport device Both independent and interna studies show that Sigma- VCM wi recover viruses, chamydia, mycopasmas and ureapasmas so that they can be identified, either by god standard ce cuture methods, or by the new moecuar techniques such as RT-PCR that are now routine in many aboratories. Transport for Viruses, Chamydia, Mycopasmas & Ureapa

5 -Swab Open-ceed foam bud Optimum absorption and reease Optimum performance with moecuar test VCM medium Optimum recovery of target organisms Optimum compatibiity with moecuar test Antibiotics inhibit contaminating bacteria and fungi Choice of fi voume -Swab features unique open ce structure for optimum absorbance and reease of microorganisms and reagents. Swab Capture smas

6 -Virocut Virocut medium for virus isoation and identification -Swab Open-ceed foam bud Optimum absorption and reease Optimum performance with moecuar test Standard shaft or ENT/urethra Virocut medium Optimum recovery of target organisms Optimum compatibiity with moecuar test Antibiotics inhibit bacteria and fungi Recovers wide range of respiratory, genita and enteric viruses Transport specimens at ambient temperatures Choice of fi voume Sigma-Virocut combines Medica Wire s open ce bud Sigma-Swab with Virocut medium 12-28, for ong the eading transport medium for virus specimens. Virocut medium can be used with traditiona ce cuture techniques, or the many current moecuar techniques. Virocut has ong been recognised as one of the best transport devices for viruses, demonstrating surviva of many types of virus at ambient temperatures, incuding Herpes Simpex Virus, Varicea-Zoster Virus, Infuenza Type A (incuding Nove H1N1, H5N1, and H3N2), Infuenza Type B, respiratory syncytia virus, mumps virus, adenovirus, rhinovirus, and various enterovirus. Virocut medium stabiises the virus partices aowing ong surviva, and aso contains antimicrobias to prevent the growth of any bacteria Swab Capture The transport system for viruses

7 -Swab The medium free transport system and fungi present in the specimen. These features make it suitabe for ce cuture based anaysis, but many studies in recent years have shown Virocut to be competey compatibe with many of the newer moecuar techniques such as DFA, ELISA and PCR 18, Virocut & Sigma-Virocut have been vaidated according to CLSI s M40-A standard for vira cuture transport devices, which requires surviva of reference strains for at east 96 hours at ambient or refrigerated temperatures. Sigma-Virocut is suppied with Sigma-Swab, the open ce foam tipped swabs which aows optimum uptake and reease of target microorganisms, and compete fow-through of reagents for optimum sensitivity for moecuar test protocos. Standard Sigma-Swab is suitabe for genera swab appications such as skin esions, nose and throat. Sigma-Swab ENT /urethra is suitabe for nasopharyngea and urethra samping. Sigma-Virocut is suppied as a sterie device comprising a sef-standing conica based via with either 1m or 2m of Virocut medium, and a choice of 1or 2 standard Sigma-Swab, 1 fine-tip Sigma- Swab ENT/urethra, or one of each. It is stored at room temperature, with a shef ife of 1 year. Specimens, once coected, can be transported under ambient or refrigerator temperature conditions. Sigma-Virocut is CE-marked, and conforms to the requirements of the European Medica Devices Directive and In Vitro Medica Devices Directives. No diution of sampe No overgrowth No non-viabes Suitabe for bacteria, fungi, viruses Open-ceed, inert structure aows free access to reagents for direct testing Sigma-Swabs. Medica Wire s Sigma-Swab features a specia poyurethane foam tip (standard or ENT finetip). Studies have shown that a dry poyurethane foam-tipped swab can be used for the transport of many micro-organisms. The soft-foam bud is more comfortabe for patients, and has significant advantages for both conventiona and moecuar methods In-house and pubished studies show that Sigma- Swab maintains many casses of organisms in stabe numbers, incuding bacteria 29-33, fungi, viruses 23, and mycopasma. It is particuary usefu for MRSA screening, with good recovery and no overgrowth. Absorbent foam-tipped swabs have been shown to be superior to focked swabs when used with a rapid antigen test for infuenza 29. Sigma-Swab is avaiabe with two bud types. The standard version has a norma sized bud suitabe for genera purpose swabbing such as wounds, incuding surgica wounds, skin, mouth, nose and throat. The fine-tip version (Mini Sigma-Swab ) has a narrow shaft and is especiay suited for urethra and nasopharyngea samping. Sigma-Swab and Mini Sigma-Swab are suppied sterie in pee pouch, tubed and tubed-duo formats.

8 Ordering information Code Via Fi Swab Configuration* Cap Sigma Transwab MW167S Sma 1.0m 2 Sigma Swabs (1 white with breakpoint and 1 red without breakpoint) White MW176S Sma 1.0m 1 Sigma Swab (white) with breakpoint Purpe MW176S3 Sma 1.0m 3 Sigma Swabs (1 white with breakpoint and 2 red without breakpoint) White MW177S Sma 1.0m 1 Mini-tip Sigma Swab with breakpoint Orange Feca Transwab with Cary Bair Medium MW168S Sma 1.0m 1 Sigma Swab with red safety mark and with breakpoint Bue MW168T Sma 1.0m Medium ony, no swab Bue MW268T Sma 3.0m Medium ony, no swab Bue Detais of these products are in a separate brochure. Sigma Virocut MW950S Large 2.0m 1 Standard Sigma Swab with breakpoint Green MW950S2 Large 2.0m 2 Standard Sigma Swabs with breakpoint Green MW950S3 Large 2.0m 3 Standard Sigma Swabs with breakpoint Green MW950SENT Large 2.0m 1 Mini tip Sigma Swab with breakpoint Green MW950SE2 Large 2.0m 1 Standard, 1 Mini tip Sigma Swab with breakpoint Green MW950T Large 2.0m Medium ony, no swab Green MW951S Sma 1.0m 1 Standard Sigma Swab with breakpoint Green MW951S2ML Sma 2.0m 1 Standard Sigma Swabs with breakpoint Green MW951S2 Sma 1.0m 2 Standard Sigma Swabs with breakpoint Green MW951SENT Sma 1.0m 1 Mini tip Sigma Swab with breakpoint Green MW951SE2 Sma 1.0m 1 Standard, 1 Mini tip Sigma Swab with breakpoint Green MW951T Sma 1.0m Medium ony, no swab Green Sigma VCM MW910S Sma 1.0m 1 Standard Sigma Swab with breakpoint Red MW911S Sma 1.0m 1 Mini tip Sigma Swab with break point Red MW912S Sma 1.0m 1 Standard, 1 Mini tip Sigma Swab with breakpoint Red MW915T Sma 1.0m Medium ony, no swab Red MW916T Sma 3.0m Medium ony, no swab Red MW918S Large 3.0m 1 Standard Sigma Swab with break oint Red MW919S Large 3.0m 1 Mini tip Sigma Swab with breakpoint Red MW920S Large 3.0m 1 Standard, 1 Mini tip Sigma Swab with breakpoint Red MW921S Large 3.0m 2 Standard Sigma Swabs with breakpoint Red MW924S Large 1.5m 2 Standard Sigma Swabs with breakpoint, no gass beads Red MW925 Large 3.0m 1 Standard Rayon Swab with breakpoint Red MW926T Large 3.0m Medium ony, no swab Red Sigma Swab MW940 MW941 MW942 MW943 MW944 MW945 Sigma Swab and Pee Pouch Sigma Swab Individuay Tubed and Labeed Duo Sigma Swab in Singe Tube and Labeed Mini tip Sigma Swab and Pee Pouch 2 Sigma Swabs and Pee Pouch 1 Standard, 1 Mini Sigma Swab and Pee Pouch * The position of the breakpoint varies according to product. For variants with swab capture, the breakpoint is set to ensure that after breaking, the swab fits into the cap. For variants without swab capture, the breakpoint is set to aow the swab to sit within the via without contact with the cap. References 1 Amies CR. Canadian Journa of Pubic Heath 1967; 58: Cassity, T.R., 1982, Comparison of Swabs for the Coection of Cinica Specimens for Anaerobic Cutures, Poster, Scioto Memoria Hospita, Portsmouth, Ohio 3 Graver, M.A., and J.J. Wade, 2003, Refrigeration Does Not Impair The Recovery Of Neisseria Gonorrhoeae From Charcoa Transport Medium. Poster, 43rd Annua Interscience Conference on Antimicrobia Agents and Chemotherapy, Chicago 4 Rishmawi, N. et a, 2007, Surviva of Fastidious and Non- Fastidious Anaerobic Bacteria in Three Bacteria Transport Swab Systems. J. Cin. Micro. 45, Inverarity, D., M. Digge, G. Edwards, & T. Mitche, 2006, An Evauation of Media Suitabe for the Transportation by Air of Streptococcus pneumoniae. Federation of Infection Societies Conference, Cardiff 6 Birre, K., 2007, Comparative Study of Copan Venturi Transystem & Medica Wire & Equipment Transwab Microbioogica Swabs using the Ro-Pate Method, Poster P1153, ECCMID 2007, Munich 7 Birre, K., 2007, Investigation Of The Abiity Of Transport Swabs To Reease Coected Micro-Organisms - Using The Ro Pate Method, Poster C-369 / 076, 107th Genera Meeting of American Society for Microbioogy,Toronto 8 Lindsay, G., 2008, Evauation of the surviva and recovery of Neisseria gonorrhoeae from four commercia swab transport media and a fock type swab, Persona communication 9 Stuczen, M., F. L. Bowing, V. Edwards-Jones, 2011, Evauation of the New Sigma-Transwab for Maintaining Viabiity of Anerobic and Anaerobic Bacteria, American Society for Microbioogy 111th Genera Meeting, New Oreans 10 Hague, A. J., Rudsdae, A., Hi, C., Evauation of Sigma ( )VCM (Virus, Chamydia, Mycopasma) Transport System by Moecuar Techniques Poster P09, European Society for Cinica Viroogy, Winter Meeting, London, January Stuczen, M., F. L. Bowing, V. Edwards-Jones, 2011, The Efficacy of Medica Wire -VCM Transport System in Maintaining Viabiity of Neisseria gonorrhoeae, WAM 2011 (Wessex Appied Microbioogists), Southampton 12 Porterfied J.N., Hume R.D. Evauation of Virocut coection and transport device. American Society of Microbioogy AGM Johnson F.B., Leavitt R.W., Richards D.F., Evauation of Virocut transport tube for isoation of Herpes simpex virus from cinica specimens. J.Cin Microbio 1984: 20: Johnson F. B., 1990, Transport of Vira Specimens, p Cinica Microbioogy Reviews, 3, Arvin A.M., Prober, C.G. Herpes Simpex Viruses in Manua of Cinica Microbioogy, 7th Edition, 1999, American Society of Microbioogy. 16 Chapin, K.C., & F.W. Westenfed, 2003, Reagents, Stains, Media, and Ce Lines: Viroogy, p.1250 in Murray P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaer, & R.H. Yoken, 2003, Manua of Cinica Microbioogy, 8th Edition, ASM Press, Washington D.C. 17 Rudsdae, A., 2009, Evauation Of A Viroogy Specimen Transport Device With Six Viruses Using CLSI Standard M40-A, Poster C-053 ASM 109th Genera Meeting, Phiadephia 18 Rudsdae, A., and D.J Shedden, 2009, Investigation Of The Suitabiity Of The Virocut Swab Transport Device For Infuenza A Specimens Which Are To Be Anayzed By Ce Cuture Or Moecuar Techniques, Poster M42,25th Annua Cinica Viroogy Symposium, Daytona Beach 19 Lina, B. et a, 1996, Surveiance of Community-Acquired Vira Infections Due to Respiratory Viruses in Rhone-Apes (France) during Winter 1994 to 1995, J. Cin. Microbio., 34: Lina, B., 2005, Test Evauation Report Medix Biochemica Infuenza A & B (Ref 2832ETMB) Actim Inf uenza A & B (Ref 32832ETAC), Word Heath Organization Coaborating Centre for Virus Reference and Research 21 Magnard, C., et a, 1999, Comparison of Two Nested PCR, Ce Cuture, and Antigen Detection for the Diagnosis of Upper Respiratory Tract Infections due to Infuenza Viruses, J.Medica Viro., 59: Rezza, G., et a, 2006, Respiratory Viruses and Infuenza-Like Iness: A Survey in the Area of Rome, Winter , Eurosurveiance 11 (10), 01 October Schweiger, B., et a, 2000, Appication of a Fuorogenic PCR Assay for Typing and Subtyping of Infuenza Viruses in Respiratory Sampes, J. Cin. Microbio. 38: Esposito, S.,et a, 2008, Impact of Human Bocavirus on Chidren and Their Famiies, J. Cin. Microbio. 46: Schmutzard, J., et a, 2004, Detection of Herpes Simpex Virus Type 1, Herpes Simpex Virus Type 2, and Varicea-Zoster Virus in Skin Lesions. Comparison of Rea Time PCR, Nested PCR, and Virus Isoation, J. Cin. Viro., 29: Vaette, M., & B. Lina, 2009, Miieu de Transport et Persistance du Virus Grippa. (Persona communication) 27 Vaette, M., M. Bouscambert-Duchamp, R. Fanget, S. Lambert & B.Lina, Comparison Of Virocut Swab, Σ -Swab And Σ -Virocut For Infuenza A Viabiity For Ce Cuture And Moecuar Detection, Poster S84, 26th Annua Cinica Viroogy Symposium 2010, Daytona Beach 28 Etringham G.J.A., A. Rudsdae, & C. Hi, 2011, Detection of Infuenza A (Pandemic H1N1v), RSV, Rhinovirus and other respiratory viruses in different popuations using Sigma-Virocut Poster P10, European Society for Cinica Viroogy, Winter Meeting, London. 29 Mack, K. et a, 2008, Cinica Performance of Foam vs Focked Swabs coected from the anterior nares in a rapid antigen test for infuenza A & B, Poster M8 at Pan American Society for Cinica Viroogy 24th Cinica Viroogy Symposium 30 Bea, A.R., 2003, Evauation of Six Swab Transport Systems: Recovery of cinicay reevant anaerobes. Poster C-051 at American Society for Microbioogy103rd Genera Meeting, Washington D.C. 31 Stuczen M, and V. Edwards-Jones, 2009,Comparison of Medica Wire s new Sigma-Swab With HeathLink Amies Transport System (Copan) for maintenance of microorganisms viabiity, NVvM Spring Meeting, Papenda, Netherands 32 Stuczen M, and V. Edwards-Jones,Maintaining Viabiity of Aerobic and Anaerobic Bacteria from Wounds Using the New Sigma-Swab Transport System Poster C-052 ASM 109th Genera Meeting, Phiadephia 33 Edwards-Jones V, and M. Stuczen, 2009, Efficacy of a New Sigma-Swab Transport System (Medica Wire) in Maintaining Viabiity of Wound Pathogens, Poster P37, European Wound Management Association19th Conference, Hesinki 34 Cinica and Laboratory Standards Institute (CLSI). Quaity Contro of Microbioogica Transport Systems; Approved Standard - Second Edition. CLSI document M40-A2, CLSI, 2006, Vira Cuture; Approved Guideine. CLSI Document M41A. CLSI, 940 West Vaey Road, Suite 1400, Wayne, Pennsyvania USA, European Medica Devices Directive 93/42/EEC 37 European In Vitro Diagnostic Devices Directive 98/79/EC Corsham, Witshire, SN13 9RT, U.K. Teephone: Fax: E-mai: info@mwe.co.uk