At the forefront of multiplex PCR

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1 Prodesse At the forefront of multiplex PCR 2005 PRODUCT CATALOG Distributed by

2 Standard Format Assays Real Time Format Assays Available Now Hexaplex Influenza A Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 RSV A RSV B Hexaplex Plus 7 Hexaplex detections and Human metapneumovirus Pneumoplex Bordetella pertussis Chlamydophila pneumoniae Legionella micdadei Legionella pneumophila Mycoplasma pneumoniae Adenoplex Subtype A Subtype B Subtype C Subtype D Subtype E Subtype F West Nile Virus Herpes Mplex Herpes Simplex 1 Herpes Simplex 2 Cytomegalovirus* Epstein-Barr virus Varicella zoster virus HHV-6 SARS/Coronaplex SARS virus Coronavirus OC43 Coronavirus 229E Available Now Pneumoplex Chlamydophila pneumoniae Legionella pneumophila/micdadei Mycoplasma pneumoniae West Nile Virus Bordetella pertussis RSV In Development ProFlu-1 Influenza A Influenza B RSV A/B Hexaplex Influenza A/B Parainfluenza 1/2/3 RSV A/B ProEnterovirus ProGastro Series Pro hmpv (Human Metapneumovirus) ProAdenovirus In Development Gastroplex * - Not CE Marked P Rev 3.0 All assays include internal control.

3 W229 N1870 Westwood Drive Waukesha, WI Tel: (888) Fax: (262) Web: This catalog for use in CE countries MULTIPLEX PCR PRODUCTS for the simultaneous detection of pathogens CE Marked Kits for Standard Platform PCR Kits contain: Supermix, RT Mix (RNA Assays Only), RNase/DNase Free Water, Positive Controls, Probes, Internal Control, Internal Probe, Hybridization Buffer, Wash Solution, TMB Substrate (A and B), Stop Solution, NeutrAvidin Strip Plates Reportable Results: Number of samples processed per kit will vary based upon run size and control strategy. For a run size of 12 samples plus controls, a 48 Reaction Kit will yield 40 reportable results and a 96 Reaction Kit will yield 80 reportable results. HEXAPLEX Detects Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Influenza A, Influenza B, RSV A, RSV B H01SK48 H01SK96 Hexaplex Kit for 48 Reactions Hexaplex Kit for 96 Reactions HEXAPLEX PLUS Detects Parainfluenza (1, 2 and 3), Influenza (A and B), RSV (A and B), Human Metapneumovirus Discriminator Probes (available separately) allow discrimination of individual viruses H02SK48 H02SK96 H02PB80 Hexaplex Plus Kit for 48 Reactions Hexaplex Plus Kit for 96 Reactions Set of Discriminator Probes for Hexaplex Plus for 48 Reactions PNEUMOPLEX Detects B. pertussis, C. pneumoniae, L. micdadei, L. pneumophila, M. pneumoniae P01SK48 P01SK96 Pneumoplex Kit for 48 Reactions Pneumoplex Kit for 96 Reactions Page 1 of 10

4 HERPES MPLEX Detects Herpes Simplex Virus-1, Herpes Simplex Virus-2, Epstein-Barr Virus, Varicella Zoster Virus, HHV-6 N02SK48 N02SK96 Herpes Mplex Kit for 48 Reactions Herpes Mplex Kit for 96 Reactions ADENOPLEX Detects Adenovirus Subtype A, Subtype B, Subtype C, Subtype D, Subtype E, Subtype F A01SK48 A01SK96 Adenoplex Kit for 48 Reactions Adenoplex Kit for 96 Reactions SARS/CORONAPLEX Detects SARS, Coronavirus OC43, Coronavirus 229E K01SK48 K01SK96 SARS/Coronaplex Kit for 48 Reactions SARS/Coronaplex Kit for 96 Reactions WEST NILE VIRUS Detects West Nile Virus K15SK48 K15SK96 West Nile Virus Kit for 48 Reactions West Nile Virus Kit for 96 Reactions Not Included in Kits: Taq polymerase RNase Inhibitor Reverse Transcriptase MgCl 2 Please see last page of catalog for: Nucleic Acid Isolation Kits and PCR Product Purification Kits Page 2 of 10

5 CE Marked Kits for Real Time PCR Prodesse s Real Time products have been designed using TaqMan technology and are compatible for use on: Bio-Rad Kits contain: icycler iq Cepheid Applied Biosystems Corbett Research Supermix, RT Mix (RNA Assays Smart Only), Cycler RNase/DNase Free Water, Positive 7500 Controls, Internal Control Rotor-Gene 3000 Reportable Results: Number of samples processed per kit will vary based upon assay, run size and control strategy. For a run size of 12 samples plus controls, a 48 Reaction Kit will yield 43 to 45 reportable results and a 96 Reaction Kit will yield 86 to 91 reportable results. ProFlu-1 REAL TIME Detects Influenza A, Influenza B, RSV H55SK48 ProFlu-1 Real Time Kit for 48 Reactions H55SK96 ProFlu-1 Real Time Kit for 96 Reactions NEW!! PNEUMOPLEX REAL TIME Detects C. pneumoniae, L. micdadei/pneumophila, M. pneumoniae P50SK48 Pneumoplex Real Time Kit for 48 Reactions P50SK96 Pneumoplex Real Time Kit for 96 Reactions BORDETELLA PERTUSSIS REAL TIME Detects Bordetella Pertussis P65SK48 Bordetella Pertussis Real Time Kit for 48 Reactions P65SK96 Bordetella Pertussis Real Time Kit for 96 Reactions Page 3 of 10

6 WEST NILE VIRUS REAL TIME Detects West Nile Virus K50SK48 West Nile Virus Real Time Kit for 48 Reactions K50SK96 West Nile Virus Real Time Kit for 96 Reactions RSV REAL TIME Detects RSV H65SK48 RSV Real Time Kit for 48 Reactions H65SK96 RSV Real Time Kit for 96 Reactions Not Included in Kits: Taq polymerase RNase Inhibitor Reverse Transcriptase MgCl 2 Please see last page of catalog for: Nucleic Acid Isolation Kits Page 4 of 10

7 CE Marked Reagents for Standard Platform PCR Supermixes (Each vial contains enough reagent for approximately 26 reactions) HSM01 Supermix for Hexaplex multiplex PCR (Primers) 1.05 ml HSM02 Supermix for Hexaplex Plus multiplex PCR (Primers) 1.05 ml PSM01 Supermix for Pneumoplex multiplex PCR (Primers) 1.05 ml NSM02 Supermix for Herpes Mplex multiplex PCR (Primers) 1.05 ml ASM01 Supermix for Adenoplex multiplex PCR (Primers) 1.05 ml KSM01 Supermix for SARS/Coronaplex multiplex PCR (Primers) 1.05 ml KSM15 Supermix for West Nile Virus multiplex PCR (Primers) 1.05 ml HPB88 HPB89 HPB80 HEXAPLEX FAMILY Probes (Each vial contains enough reagent for approximately 52 probes) Set of Hexaplex Probes: 1 Vial of Each Probe HPB01-HPB07 plus Hexaplex Internal Probe (1x8 Vials) Each Set of Hexaplex Plus Probes: 1 Vial of Each Probe HPB08, HPB61-63 plus Hexaplex Plus Internal Probe (1x5 Vials) Each Set of Hexaplex Plus Discriminator Probes: 1 Vial of Each Probe HPB01-HPB07 (1x7 Vials) Each HPB01 HPIV-1 Probe 35 µl HPB02 HPIV-2 Probe 35 µl HPB03 HPIV-3 Probe 35 µl HPB04 Influenza A Probe 35 µl HPB05 Influenza B Probe 35 µl HPB06 RSV A Probe 35 µl HPB07 RSV B Probe 35 µl HPB08 Human metapneumovirus Probe 175 µl HPB61 Pooled Probe for HPIV-1, 2 and µl HPB62 Pooled Probe for Influenza A and B 175 µl HPB63 Pooled Probe for RSV A and B 175 µl HPB98 Hexaplex Plus Internal Probe 175 µl HPB99 Hexaplex Internal Probe 35 µl PNEUMOPLEX Probes (Each vial contains enough reagent for approximately 52 probes) PPB88 Set of Probes: 1 Vial of Each Probe plus Internal Probe (1 x 6 Vials) Each PPB01 Bordetella pertussis Probe 35 µl PPB02 Chlamydophila pneumoniae Probe 35 µl PPB03 Legionella micdadei Probe 35 µl PPB04 Legionella pneumophila Probe 35 µl PPB05 Mycoplasma pneumoniae Probe 35 µl PPB99 Pneumoplex Internal Probe 35 µl HERPES MPLEX Probes (Each vial contains enough reagent for approximately 52 probes) NPB89 Set of Probes: 1 Vial of Each Probe plus Internal Probe (1 x 6 Vials) Each NPB21 Herpes Simplex 1 Probe 35 µl NPB22 Herpes Simplex 2 Probe 35 µl NPB24 Epstein-Barr Virus Probe 35 µl NPB25 Varicella Zoster Virus Probe 35 µl NPB26 HHV-6 Probe 35 µl NPB98 Herpes Mplex Internal Probe 35 µl Page 5 of 10 Probes

8 ADENOPLEX Probes (Each vial contains enough reagent for approximately 52 probes) APB88 Set of Probes: 1 Vial of Each Probe plus Internal Probe (1 x 7 Vials) Each APB01 Adenoplex Subtype A Probe 35 µl Probes APB02 Adenoplex Subtype B Probe 35 µl APB03 Adenoplex Subtype C Probe 35 µl APB04 Adenoplex Subtype D Probe 35 µl APB05 Adenoplex Subtype E Probe 35 µl APB06 Adenoplex Subtype F Probe 35 µl APB99 Adenoplex Internal Probe 35 µl SARS/CORONAPLEX Probes (Each vial contains enough reagent for approximately 52 probes) KPB011 SARS Probe 35 µl KPB012 Coronavirus OC43 Probe 35 µl KPB013 Coronavirus 229E Probe 35 µl KPB019 SARS/Coronaplex Internal Probe 35 µl WEST NILE VIRUS Probes (Each vial contains enough reagent for approximately 52 probes) KPB151 West Nile Virus Probe 35 µl KPB159 West Nile Virus Internal Probe 35 µl Page 6 of 10

9 CE Marked Reagents for Real Time PCR (designed for Taqman instruments) Supermixes (Each item contains enough reagent for approximately 26 reactions) HSM55 Supermix for ProFlu-1 Real Time (Primers/Probes) 1.05 ml HSM65 Supermix for RSV Real Time (Primers/Probes) 1.05 ml KSM65 Supermix for West Nile Virus Real Time (Primers/Probes) 1.05 ml PSM50 Supermix for Pneumoplex Real Time (Primers/Probes) 1.05 ml PSM65 Supermix for Bordetella pertussis Real Time (Primers/Probes) 1.05 ml Prodesse s Real Time products have been designed using TaqMan technology and are compatible for use on: Bio-Rad icycler iq Cepheid Smart Cycler Applied Biosystems 7500 Corbett Research Rotor-Gene 3000 Page 7 of 10

10 CE Marked Controls HEXAPLEX FAMILY Controls (Each vial contains enough reagent for approximately 75 positive controls) HCT88 Set of Hexaplex Controls: 1 Vial of Each Control HCT01-HCT07 plus Internal RNA Control (1x8 Vials) Each HCT89 Set of Hexaplex Plus Controls: 1 Vial of Each Control HCT01-HCT08 plus Internal RNA Control (1x9 Vials) Each HCT01 HPIV-1 RNA Control 30 µl HCT02 HPIV-2 RNA Control 30 µl HCT03 HPIV-3 RNA Control 30 µl HCT04 Influenza A RNA Control 30 µl HCT05 Influenza B RNA Control 30 µl HCT06 RSV A RNA Control 30 µl HCT07 RSV B RNA Control 30 µl HCT08 Human metapneumovirus Control 30 µl HCT21 RSV Real Time RNA Control 30 µl HCT31 ProFlu-1 Influenza A RNA Control 30 µl HCT32 ProFlu-1 Influenza B RNA Control 30 µl HCT33 ProFlu-1 RSV RNA Control 30 µl HCT39 ProFlu-1 Internal RNA Control (contains enough reagent for approximately 75 uses) 30 µl HCT99 Hexaplex Internal RNA Control (contains enough reagent for over 100 uses) 30 µl (Note HCT99 is designed as an internal control for: Hexaplex, Hexaplex Plus and RSV Real Time) PNEUMOPLEX Controls (Each vial contains enough reagent for approximately 7½ positive controls) Set of Controls: 1 Vial of Each Control PCT88 plus Pneumoplex Internal DNA Control (1 x 6 Vials) Each PCT01 Bordetella pertussis Control 30 µl PCT02 Chlamydophila pneumoniae Control 30 µl PCT03 Legionella micdadei Control 30 µl PCT04 Legionella pneumophila Control 30 µl PCT05 Mycoplasma pneumoniae Control 30 µl PCT99 Pneumoplex Internal DNA Control (contains enough reagent for approximately 45 uses) 180 µl (Note PCT99 is designed as an internal control for: Pneumoplex standard format, Pneumoplex Real Time and Bordetella pertussis Real Time) HERPES MPLEX Controls (Each vial contains enough reagent for approximately 7½ positive controls) NCT89 Set of Controls: 1 Vial of Each Control plus Internal DNA Control (1 x 6 Vials) Each NCT21 Herpes Simplex 1 Control 30 µl NCT22 Herpes Simplex 2 Control 30 µl NCT24 Epstein-Barr Virus Control 30 µl NCT25 Varicella Zoster Virus Control 30 µl NCT26 HHV-6 Control 30 µl NCT98 Herpes Mplex Internal DNA Control (contains enough reagent for approximately 45 uses) 180 µl Page 8 of 10

11 ADENOPLEX Controls (Each vial contains enough reagent for approximately 7½ positive controls) ACT88 Set of Controls: 1 Vial of Each Control plus Internal DNA Control (1 x 7 Vials) Each ACT01 Subtype A DNA Control 30 µl ACT02 Subtype B DNA Control 30 µl ACT03 Subtype C DNA Control 30 µl ACT04 Subtype D DNA Control 30 µl ACT05 Subtype E DNA Control 30 µl ACT06 Subtype F DNA Control 30 µl ACT99 Adenoplex Internal DNA Control (contains enough reagent for approximately 45 uses) 180 µl *Subtypes for Adenoplex are grouped into serotypes as follows: Subtypes Serotypes A 12, 18, 31 B 3, 7, 11, 14, 16, 21, 34, 35, 50 C 1, 2, 5, 6 D 8-10, 13, 15, 17, 19, 20, 22-30, 32, 33, 36-39, 42-49, 51 E 4 F 40, 41 SARS/CORONAPLEX Controls (Each vial contains enough reagent for approximately 75 positive controls) KCT011 SARS Control 30 µl KCT012 Coronavirus OC43 Control 30 µl KCT013 Coronavirus 229E Control 30 µl KCT019 SARS/Coronaplex Internal RNA Control (contains enough reagent for over 100 uses) 30 µl WEST NILE VIRUS Controls (Each vial contains enough reagent for approximately 75 positive controls) KCT151 West Nile Virus Control 30 µl KCT159 West Nile Virus Internal RNA Control (contains enough reagent for over 100 uses) 30 µl Page 9 of 10

12 Nucleic Acid Isolation/PCR Product Purification (These kits are not CE Marked) Nucleic Acid Isolation for all assays: SCI96 Total Nucleic Acid Isolation Kit Each Contains: 1 Total Nucleic Acid Isolation Kit (100 Columns) PCR Product Purification for standard format assays: SCP48 PCR Product Purification Kit [Qiagen] Each Contains: 1 PCR Product Purification Kit (50 Columns) SDP48 PCR Product Purification Kit [Clontech] Each Contains: 1 Nucleospin Extraction Kit (50 Columns) CE Marked Additional Items GLS01 RT Mix for Reverse Transcription 0.30 ml GLS02 RNase/DNase Free Water 1.50 ml GLS03 NeutrAvidin Strip Plate (12 strips/plate) Each GLS04 Hybridization Buffer 30 ml GLS05 10X Wash Solution 110 ml GLS06 TMB Substrate (A&B) 50 ml (each) GLS07 Stop Solution 30 ml Our Friendly Customer Service Representatives are Available Weekdays from 8 a.m. to 5 p.m. (Central Time) To order: Please have these ready when ordering: Technical support and questions: Telephone: * Name and Telephone # * Product #/Description Our knowledgeable Technical Assistance Fax: * Ship to and Bill to address * Quantity staff is available weekdays from sales@prodesse.com * Purchase Order # (PO) 8 a.m. to 5 p.m. (Central Time) by phone MasterCard and Visa accepted or send a fax/ to us at anytime. NeutrAvidin is a registered Trademark of Pierce Chemical Company (Rockford, Illinois). *No license to use the polymerase chain reaction PCR covered under patents owned by Hoffman La-Roche is conveyed expressly or by implication to the purchaser of this product. Page 10 of 10 P Rev 5.0

13 Publications Laham, FR, Israele V, Casellas JM, Garcia AM, Lac Prugent CM, Hoffman SJ, Hauer D, Thumar B, Name MI, Pascual A, Taratutto N, Ishida MT, Balduzzi M, Maccarone M, Jackli S, Passarino R, Gaivironsky RA, Karron RA, Polack NR, Polack FP. Differential Production of Inflammatory Cytokines in Primary Infection with Human Metapneumovirus and with Other Common Respiratory Viruses of Infancy. The Journal of Infectious Diseases. 2004; 189: Weinberg GA, Erdman DD, Edwards KM, Hall CB, Walker FJ, Griffin MR, Schwartz B, New Vaccine Surveillance Network Study Group. Superiority of Reverse-Transcription Polymerase Chain Reaction to Conventional Viral Culture in the Diagnosis of Acute Respiratory Tract Infections in Children. The Journal of Infectious Diseases. 2004; 189: Henrickson KJ. Advances in the Laboratory Diagnosis of Viral Respiratory Disease. Pediatric Infectious Disease Journal. 2004; 23:S9-13. Henrickson KJ, Hoover S, Kehl KS, Hua W. National Disease Burden of Respiratory Viruses Detected in Children by Polymerase Chain Reaction. Pediatric Infectious Disease Journal. 2004; 23:S1-8. Henrickson KJ. Parainfluenza Viruses. Clinical Microbiology Reviews. 2003; 16: Kehl SC, Henrickson KJ, Hua W, Fan J. Evaluation of the Hexaplex Assay for Detection of Respiratory Viruses in Children. Journal of Clinical Microbiology. 2001; 39: Liolios L, Jenney A, Spelman D, Kotsimbos T, Catton M, Wesselingh S. Comparison of a Multiplex Reverse Transcription- PCR-Enzyme Hybridization Assay with Conventional Viral Culture and Immunofluorescence Techniques for the Detection of Seven Viral Respiratory Pathogens. Journal of Clinical Microbiology. 2001; 39(8): Hindiyeh M, Hillyard D, Carroll K. Evaluation of the Prodesse Hexaplex Multiplex PCR Assay for Direct Detection of Seven Respiratory Viruses in Clinical Specimens. American Journal of Clinical Pathology. 2001; 116(2): Barenfanger J, Drake C, Leon N, Mueller T, Troutt, T. Clinical and Financial Benefits of Rapid Detection of Respiratory Viruses: An Outcomes Study. Journal of Clinical Microbiology. 2000; 38(8): Chonmaitree T, Henrickson KJ. Detection of Respiratory Viruses in the Middle Ear Fluids of Children with Acute Otitis Media by Multiplex Reverse Transcription: Polymerase Chain Reaction Assay. The Pediatric Infectious Disease Journal. 2000; 19(3): Covalciuc KA, Webb KH, Carlson CA. Comparison of Four Clinical Specimen Types for Detection of Influenza A and B Viruses by Optical Immunoassay (FLU OIA Test) and Cell Culture Methods. Journal of Clinical Microbiology. 1999; 37 (12): Henrickson KJ. Viral Pneumonia in Children. Seminars in Pediatric Infectious Diseases. 1998; 9(3): Fan J, Henrickson KJ, Savatski LL. Rapid Simultaneous Diagnosis of Infections with Respiratory Syncytial Viruses A and B, Influenza Viruses A and B, and Human Parainfluenza Virus Types 1, 2, and 3 by Multiplex Quantitative Reverse Transcription- Polymerase Chain Reaction-Enzyme Hybridization Assay (Hexaplex). Clinical Infectious Diseases. 1998; 26: Woo PC, Chiu SS, Seto WH, Peiris M. Cost-Effectiveness of Rapid Diagnosis of Viral Respiratory Tract Infections in Pediatric Patients. Journal of Clinical Microbiology. 1997; 35(6): Fan J, Henrickson KJ. Rapid Diagnosis of Human Parainfluenza Virus Type 1 Infection by Quantitative Reverse Transcription- PCR-Enzyme Hybridization Assay. Journal of Clinical Microbiology. 1996; 34(8):

14 Abstracts Harrington KP, Henrickson KJ, Khanna M, Yashina T. The SARS/Coronaplex Assay: Detection and Identification of Human Coronaviruses Including SARS by Multiplex RT-PCR. International Respiratory Virus Symposium, Ft. Myers, FL, March Khanna M, Henrickson KJ, Harrington K, Waters CR, Meece J, Reed K, Shukla S. Multiplex PCR-EHA Compared to Real Time Taqman for the Surveillance and Diagnosis of West Nile Virus. International Congress on Infectious Diseases, Cancun, March LeGoff, J, Guerot E, Matta M, Si-Mohamed A, Gutmann L, Fagon J-Y, Bélec L. Evaluation of the Hexaplex Assay for the Detection of Respiratory Viruses in Bronchoalveolar Lavages from Adults Attending at a Medical Intensive Care Unit. Réunion Interdisciplinaire de Chimiothérapie anti-infectieuse (RICAI), Paris, December Khanna M, Henrickson KJ, Fan J, Harrington K, Waters C, Kehl S. The Pneumoplex : A Multiplex PCR-EHA Based Assay Simultaneously Detects Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila and micdadei, and Bordetella pertussis Infections in a Single Test. American Society for Microbiology, Washington, DC, May Harrington KP, Henrickson KJ, Waters C, Khanna M. The Adenoplex : A Multiplex PCR-EHA Based Assay for the Detection and Identification of Adenovirus Species A-F in a Single Test. Clinical Virology Symposium, Clearwater, FL, April Peiris M, Chan KH, Maldeis NE, et al. Evaluation of the new Directigen Flu A and B Membrane Immunoassay for Rapid Diagnosis of Influenza A and B Infections. IDSA, Symposium on Molecular Diagnostics, Orlando, FL, May, Weinberg A. Incidence and Diagnosis of Viral Respiratory Tract Infections in a Lung Transplant Population. Clinical Virology Symposium, Clearwater, FL, May, Henrickson KJ, Werchau H, Rohwedder A. Comparison of Hexaplex (Multiplex-RT-PCR) and Tissue Culture (TC) to Detect Common Respiratory Viruses in Children in Germany during rd International Symposium for Influenza and Other Respiratory Viruses, December, Henrickson KJ, Fan J, Halsey J, Fratazzi C, O Connell J, Hoffmann RG. Comparison of Real Time RT-PCR (Hexaplex ) and Plaque Assay for the Quantification of Respiratory Syncytial Virus (RSV). 2 nd International Symposium for Influenza and Other Respiratory Viruses, December, Kehl S, Henrickson KJ. Cost Effective Utilization of a Multiplex RT-PCR assay (Hexaplex ) for Respiratory Virus Detection at a Children s Hospital. 2 nd International Symposium for Influenza and Other Respiratory Viruses, December, P058C 0504

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