.01_2018 A FIRENZE 2018_DEPL.1000 REV

Transcription

1 diagnostica senese CATALOGUE 2018

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3 CATALOGUE 2018 DIESSE DIAGNOSTICA SENESE SPA Sales Office Via del Pozzo, 5 Loc. S. Martino Monteriggioni (SI) ITALY T / 61/ 50 F salesoffice@diesse.it Quality Management System Certificate UNI EN ISO 9001:2008 N EN ISO 13485:2012 Q1N ISO 13485:2003 QS

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5 INTRODUCTION DIESSE Diagnostica Senese SpA is an Italian manufacturer of innovative in vitro diagnostics systems. DIESSE was founded in 1980, DIESSE has focused its efforts on developing a solid position in the IVD market segments of hematology, seroimmunology and bacteriology. A mainstay of DIESSE strategy is the in-house production of most of the basic biologic components of the diagnostic kits (polyclonal and monoclonal antibodies, native and recombinant antigens), along with the capacity of designing instruments and dedicated plastic devices in order to develop close automated systems.

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7 CATALOGUE 2018 CUBE NEXT 6 LINE VES-MATIC CUBE 8 LINE VES-MATIC ORIGINAL 10 LINE CHORUS 14 LINE ELISA ENZY-WELL 34 LINE AUTO DAT 38 LINE RAPID TEST 40 LINE

8 CUBE NEXT LINE instruments CUBE 30 touch Automatic continuous loading instrument for the determination of the ESR on 30 samples simultaneously directly on the hematocrit tube. Automatic barcode reading, internal mixing and internal printer. MINI-CUBE Automatic continuous loading instrument for the determination of the ESR on 4 samples simultaneously directly on the hematocrit tube. USB and Bluetooth connector for personal computer, smart-phone and tablet. External bar-code reader and printer (optional). 6

9 7 accessories BLUETOOTH MINI-CUBE PRINTER Customized Bluetooth thermal printer for MINI-CUBE for automatic printing of results. ESR CONTROL CUBE NEXT 12X3 ml Control blood for the ESR test, for use with the MINI-CUBE and CUBE 30 touch instruments. It contains 6 tubes labeled with control with normal values and 6 tubes labeled for control with pathological values. EXTERNAL BARCODE READER External bar-code reader for all instruments of VES-MATIC ORIGINAL, VES-MATIC CUBE line, MINI-CUBE and CUBE 30 touch. MINI-CUBE THERMAL PAPER Thermal paper for Bluetooth Printer MINI-CUBE MINI CUBE USB TO SERIAL ADAPTER USB-serial adapter for serial connection to Host PC through the USB port of MINI- CUBE THERMAL PAPER Paper rolls for thermal printer in VES-MATIC CUBE, VES-MATIC ORIGINAL and CUBE 30 touch instruments. TEST DEVICE NEXT tests TEST DEVICE NEXT 1K tests TEST DEVICE NEXT 5K tests TEST DEVICE NEXT 10K tests Dedicated tube with transponder RF. To be used only once to charge the MINI-CUBE and CUBE 30 touch systems with the exact number of tests (not compatible with the VES-MATIC CUBE instrument)

10 VES-MATIC CUBE LINE instruments VES-MATIC CUBE Automatic instrument for the determination of the ESR directly on the hematocrit tube (190 samples/hour), using racks from the main cell counters. The first result is performed after 24 minutes. Host query interface. VES-MATIC CUBE Automatic instrument for the determination of the ESR directly on the hematocrit tube (95 samples/hour), using dedicated racks. The first result is performed after 26 minutes. Host query interface. VES-MATIC CUBE TRACK Automatic instrument for the determination of the ESR directly on the hematocrit tube (95 samples/hour), to be connected to clinical laboratory total automation tracks. 8

11 9 accessories EXTERNAL BARCODE READER External bar-code reader for all instruments of VES-MATIC ORIGINAL, VES-MATIC CUBE line, MINI-CUBE and CUBE 30 touch. TEST DEVICE 1K tests TEST DEVICE 5K tests TEST DEVICE 10K tests Dedicated tube with transponder RF. To be used only once to charge the VES-MATIC CUBE systems with the exact number of tests (not compatible with the MINI-CUBE and CUBE 30 touch instrument). ESR CONTROL CUBE 4x9 ml Control blood for the ESR tests to be used with the VES-MATIC CUBE 2x9 ml systems. Contains two normal and two pathological level vials and dedicated barcode labels. THERMAL PAPER Paper rolls for thermal printer in VES-MATIC CUBE, VES-MATIC ORIGINAL and CUBE 30 touch instruments.

12 VES-MATIC ORIGINAL LINE instruments VES-MATIC EASY Automatic instrument for the determination of the ESR on 10 samples simultaneously and random access. Complete with printer. USB connector and external bar code reader (optional) connector. VES-MATIC Automatic instrument for the determination of the ESR on 20 samples simultaneously. The ESR reading at the first hour is performed in 24 minutes including the mixing of samples. VES-MATIC Automatic instrument for the determination of the ESR on 30 samples simultaneously. The ESR reading at the first hour is performed in 26 minutes or in 10 minutes (fast method) including the mixing of samples. 10

13 VES-MATIC 30 PLUS Automatic instrument for the determination of the ESR on 30 samples simultaneously using the Vacu-Code tubes (bar code label tubes). The ESR reading at the first hour is performed in 26 minutes or in 10 minutes (fast method) including the mixing of samples. Internal bar code reader. VES-RACK II Manual system for the determination of the ESR on 20 samples simultaneously, using both Vacu-Code tubes and all the other kind of tubes. VES-RACK SMART Manual system for the determination of the ESR in 30 minutes. The package contains 12 graduated devices.

14 VES-MATIC ORIGINAL LINE accessories EXTERNAL BARCODE READER External bar-code reader for all instruments of VES-MATIC ORIGINAL, VES-MATIC CUBE line, MINI-CUBE and CUBE 30 touch. CHIP CARD /B Card to charge test number on VES-MATIC 20/30 and 30 PLUS CONNECTING CABLE Cable to be used for the connection of more than one VES-MATIC 30/20 module to a personal computer. ESR CONTROL 4x9 ml Control blood for the ESR tests to be used with the VES-MATIC system. 2x9 ml Contains two normal and two pathological level vials. LATEX CUVETTES FOR VES-MATIC (for technical service only) Latex cuvettes for sensor calibration: Nr. 2 cuvettes for VM 20/VM 20 new model/vm 30/VM EASY (Triton concentration: 2 ml and 3 ml) THERMAL PAPER Paper rolls for thermal printer in VES-MATIC CUBE, VES-MATIC ORIGINAL and CUBE 30 touch instruments. VES-MATIC SERIAL ADAPTOR Serial adaptor kit to connect one VES-MATIC 30/20 module to a personal computer. It is possible to connect up to 32 modules. 12

15 13 blood drawing and analysis system VACU-TEC 100 tests Vacuum tubes for blood drawing, with outertubes, 100 sterile tests containing sodium citrate solution for direct determination of the ESR. Sample volume: 1 ml. VACU-CODE 100 tests Vacuum tubes for blood drawing, without outertubes, containing sodium citrate solution for direct determination of the ESR. Suitable for bar code label on primary tube. To be used with VES-MATIC PLUS. Sample volume: 1 ml. VACU-TEC DOUBLE LABEL 100 tests 10200/W Vacuum tubes for blood drawing, with outertubes, 100 sterile tests 10202/W containing sodium citrate solution for direct determination of the ESR and for a positive identification of the sample. Sample volume: 1 ml. VACU-TEC FLAG 100 tests Vacuum tubes for blood drawing, without outertubes, containing 200 tests sodium citrate solution for direct determinationof the ESR. Complete with identification label. Labels for bar code support included in the package. Sample volume: 1 ml. VACU-TEC S.C. 100 tests Vacuum tubes for blood drawing, with outertubes, joined 100 sterile tests to a safety collar where a double label is applied, containing sodium citrate solution for direct determination of the ESR. Sample volume: 1 ml. VACU-TEC CUVETTE-L 200 tests Vacuum tubes for blood drawing, without outertubes, 6x250 tests containing sodium citrate solution for direct determination 100 sterile tests of the ESR. Complete with identification label. Sample volume: 1 ml. VES-TEC 100 tests 10201/A Tubes for blood drawing, with outertubes, containing sodium citrate solution for direct determination of the ESR. Sample volume: 1 ml. VES-TEC CUVETTE-L 200 tests Tubes for blood drawing, without outertubes, containing sodium citrate solution for direct determination of the ESR. Complete with identification label. Sample volume: 1 ml.

16 CHORUS LINE instrument CHORUS TRIO Easy-to-use single test multiparametric system for immunometric assay. accessories Chorus AUTOSAMPLER Integrated automated pipettor instrument for dispensing of the samples in diagnostic devices. TANK FOR CLEANING SOLUTION 2L /C 2L plastic tank for Cleaning Solution for the Chorus instrument. TANK FOR CLEANING SOLUTION 1L /S 1L plastic tank for Sanitizing Solution for the Chorus instrument. 14

17 TANK FOR WASHING BUFFER 1L /I 1L plastic tank for Washing Buffer for the Chorus instrument. TANK FOR WASHING BUFFER AUTOIMMUNITY 1L /A 1L plastic tank for Buffer Autoimmunity for the Chorus instrument. THERMAL PAPER 4 pcs Paper rolls for thermal printer. TIPS FOR CHORUS AUTOSAMPLER 10X96 pcs Tips for automation in Autosampler.

18 CHORUS LINE common reagents CHORUS NEGATIVE CONTROL/SAMPLE DILUENT 1x5 ml Solution to be used as negative control sample and as diluent for highly reactive samples. CLEANING SOLUTION x20 ml Cleaning solution for washing tubing system and sampling needles X concentrated. SANITIZING SOLUTION 4x20 ml Sanitizing solution for sanitizing tubing system and sampling needles. 1x20 ml X concentrated. WASHING BUFFER 4x100 ml Cleaning solution for washing of reaction wells. 10 X concentrated. WASHING BUFFER AUTOIMMUNITY 12x20 ml Cleaning solution for washing of reaction wells. 50 X concentrated. 16

19 17 infectious diseases ToRCH Chorus CYTOMEGALOVIRUS IgG 36 tests For the determination of anti-cytomegalovirus IgG antibodies in human serum. Contains calibrator and positive control. Chorus CYTOMEGALOVIRUS IgG AVIDITY 12 tests For the determination of anti-cytomegalovirus IgG antibodies avidity in human serum. Contains avidity controls. Chorus CYTOMEGALOVIRUS IgM 36 tests For the determination of anti-cytomegalovirus IgM antibodies in human serum. Contains calibrator and positive control. Chorus HERPES SIMPLEX 1+2 IgG 36 tests For the determination of anti-herpes simplex (type 1 and 2) IgG antibodies in human serum. Contains calibrator and positive control. Chorus HERPES SIMPLEX 1+2 IgM 36 tests For the determination of anti-herpes simplex (type 1 and 2) IgM antibodies in human serum. Contains calibrator and positive control. Chorus HERPES SIMPLEX 1 IgG Recombinant 36 tests For the determination of anti-herpes simplex type 1 IgG antibodies in human serum, using recombinant antigens. Contains calibrator and positive control. Chorus HERPES SIMPLEX 2 IgG Recombinant 36 tests For the determination of anti-herpes simplex type 2 IgG antibodies in human serum, using recombinant antigens. Contains calibrator and positive control. Chorus HSV 1 SCREEN 36 tests For the determination of anti-herpes simplex type 1 immunoglobulins in human serum. Immunoenzymatic competitive method. Contains calibrator and positive control. Chorus HSV 2 SCREEN 36 tests For the determination of anti-herpes simplex type 2 immunoglobulins in human serum. Immunoenzymatic competitive method. Contains calibrator and positive control. Chorus RUBELLA IgG 36 tests For the determination of anti-rubella IgG antibodies in human serum. Contains calibrator and positive control. Chorus RUBELLA IgG AVIDITY 12 tests For the determination of anti-rubella IgG antibodies avidity in human serum. Contains avidity controls.

20 CHORUS LINE infectious diseases Chorus RUBELLA IgM 36 tests For the determination of anti-rubella IgM antibodies in human serum. Contains calibrator and positive control. Chorus TOXOPLASMA IgA 36 tests For the determination of anti-toxoplasma gondii IgA 12 tests 81043/12 antibodies in human serum. Contains calibrator and positive control. Chorus TOXOPLASMA IgG 36 tests For the determination of anti-toxoplasma gondii IgG antibodies in human serum. Contains calibrator and positive control. Chorus TOXOPLASMA IgG AVIDITY 12 tests For the determination of anti-toxoplasma gondii IgG antibodies avidity in human serum. Contains avidity controls. Chorus TOXOPLASMA IgM 36 tests For the determination of anti-toxoplasma gondii IgM antibodies in human serum. Contains calibrator and positive control. CHILDHOOD DISEASES Chorus MEASLES IgG 36 tests For the determination of anti-measles IgG antibodies in human serum. Contains calibrator and positive control. Chorus MEASLES IgM 36 tests For the determination of anti-measles IgM antibodies in human 12 tests 81073/12 serum. Contains calibrator and positive control. Chorus MUMPS IgG 36 tests For the determination of anti-mumps IgG antibodies in human serum. Contains calibrator and positive control. Chorus MUMPS IgM 36 tests For the determination of anti-mumps IgM antibodies in human 12 tests 81076/12 serum. Contains calibrator and positive control. Chorus PARVOVIRUS B19 IgG 36 tests For the determination of anti- Parvovirus B19 IgG antibodies in human serum. Contains calibrator and positive control. 18

21 19 Chorus PARVOVIRUS B19 IgM 36 tests For the determination of anti- Parvovirus B19 IgM antibodies in human serum. Contains calibrator and positive control. Chorus VARICELLA IgG 36 tests For the determination of anti-varicella Zoster IgG antibodies in human serum. Contains calibrator and positive control. Chorus VARICELLA IgM 36 tests For the determination of anti-varicella Zoster IgM 12 tests 81079/12 antibodies in human serum. Contains calibrator and positive control. VACCINABLES Chorus DIPHTHERIA IgG 12 tests 81266/12 For the determination of IgG class antibodies against Diphtheria toxin in human serum and plasma. Contains calibrator and positive control. Chorus POLIOVIRUS IgG 12 tests 81264/12 For determination of IgG class antibodies against Poliovirus in human serum and plasma. Contains calibrator and positive control. Chorus TETANUS IgG 36 tests Kit for determination of IgG antibodies against Tetanus toxin in human 12 tests 81270/12 serum and plasma. Contains calibrator and positive control. BACTERIAL RESPIRATORY INFECTIONS Chorus CHLAMYDOPHILA PNEUMONIAE IgA 36 tests For the determination of anti-chlamydophila Pneumoniae IgA antibodies in human serum. Contains calibrator and positive control. Chorus CHLAMYDOPHILA PNEUMONIAE IgG 36 tests For the determination of anti-chlamydophila pneumoniae IgG antibodies in human serum. Contains calibrator and positive control. Chorus CHLAMYDOPHILA PNEUMONIAE IgM 36 tests For the determination of anti-chlamydophila pneumoniae IgM antibodies in human serum. Contains calibrator and positive control. Chorus LEGIONELLA PNEUMOPHILA 1-6 IgG 36 tests For the determination of anti-legionella pneumophila serogroups 12 tests 81090/ IgG antibodies in human serum. Contains calibrator and positive control.

22 CHORUS LINE infectious diseases Chorus LEGIONELLA PNEUMOPHILA 1 IgG 36 tests For the determination of anti-legionella pneumophila serogroup 12 tests 81091/12 1 IgG antibodies in human serum. Contains calibrator and positive control. Chorus LEGIONELLA PNEUMOPHILA IgM 36 tests For the determination of anti-legionella pneumophila 12 tests 81093/12 IgM antibodies in human urine. Contains calibrator and positive control. Chorus MYCOPLASMA PNEUMONIAE IgA 36 tests For the determination of anti-mycoplasma pneumoniae 12 tests 81033/12 IgA antibodies in human serum. Contains calibrator and positive control. Chorus MYCOPLASMA PNEUMONIAE IgG 36 tests For the determination of anti-mycoplasma pneumoniae 12 tests 81034/12 IgG antibodies in human serum. Contains calibrator and positive control. Chorus MYCOPLASMA PNEUMONIAE IgM 36 tests For the determination of anti-mycoplasma pneumoniae IgM antibodies in human serum. Contains calibrator and positive control. VIRAL RESPIRATORY INFECTIONS Chorus ADENOVIRUS IgA 36 tests For the determination of anti-adenovirus IgA antibodies in human serum. Contains calibrator and positive control Chorus ADENOVIRUS IgG 36 tests For the determination of anti-adenovirus IgG antibodies in human serum. Contains calibrator and positive control. Chorus INFLUENZA A IgA 36 tests For the determination of anti-influenza A IgA antibodies 12 tests 81192/12 in human serum. Contains calibrator and positive control. Chorus INFLUENZA A IgG 36 tests For the determination of anti-influenza A IgG antibodies 12 tests 81190/12 in human serum. Contains calibrator and positive control. Chorus INFLUENZA B IgA 36 tests For the determination of anti-influenza B IgA antibodies 12 tests 81195/12 in human serum. Contains calibrator and positive control. 20

23 21 Chorus INFLUENZA B IgG 36 tests For the determination of anti-influenza B IgG antibodies 12 tests 81193/12 in human serum. Contains calibrator and positive control. Chorus RESPIRATORY SYNCYTIAL VIRUS IgA 36 tests For the determination of anti-respiratory Syncytial Virus IgA antibodies in human serum. Contains calibrator and positive control. Chorus RESPIRATORY SYNCYTIAL VIRUS IgG 36 tests For the determination of anti-respiratory Syncytial Virus IgG antibodies in human serum. Contains calibrator and positive control. SEXUALLY TRANSMITTED DISEASES Chorus CHLAMYDIA TRACHOMATIS IgG 36 tests For the determination of anti- Clamydia Trachomatis IgG antibodies in human serum. Contains calibrator and positive control. Chorus CHLAMYDIA TRACHOMATIS IgA 36 tests For the determination of anti- Clamydia Trachomatis IgA antibodies in human serum. Contains calibrator and positive control. Chorus SYPHILIS SCREEN RECOMBINANT 36 tests For the determination of anti-treponema pallidum (Nichols strain) immunoglobulins in human serum, using recombinant antigens. Immunoenzymatic method. Contains calibrator and positive control. Chorus TREPONEMA IgG 36 tests For the determination of anti-treponema pallidum (Nichols strain) IgG antibodies in human serum. Contains calibrator and positive control. Chorus TREPONEMA IgM 36 tests For the determination of anti-treponema pallidum (Nichols strain) IgM antibodies in human serum. Capture method. Contains calibrator and positive control. GASTROINTESTINAL DISEASES Chorus HELICOBACTER PYLORI IgA 36 tests For the determination of anti-helicobacter pylori IgA antibodies in human serum. Contains calibrator and positive control.

24 CHORUS LINE infectious diseases Chorus HELICOBACTER PYLORI IgG 36 tests For the determination of anti-helicobacter pylori IgG antibodies in human serum. Contains calibrator and positive control. INFECTIOUS MONOCLUEOSIS Chorus EPSTEIN-BARR EARLY ANTIGEN IgG 36 tests For the determination of IgG antibodies against Early Antigen 12 tests 81058/12 of Epstein-Barr Virus in human serum. Contains calibrator and positive control. Chorus EPSTEIN-BARR EARLY ANTIGEN IgM 36 tests For the determination of IgM antibodies against Early Antigen of 12 tests 81059/12 Epstein-Barr Virus in human serum. Contains calibrator and positive control. Chorus EPSTEIN-BARR EBNA IgG 36 tests For the determination of IgG antibodies against Nuclear Antigen of Epstein-Barr Virus in human serum. Contains calibrator and positive control. Chorus EPSTEIN-BARR VCA IgG 36 tests For the determination of IgG antibodies against Viral Capsid Antigen of Epstein-Barr Virus in human serum. Contains calibrator and positive control. Chorus EPSTEIN-BARR VCA IgM II 36 tests For the determination of IgM antibodies against Viral Capsid Antigen of Epstein-Barr Virus in human serum. Contains calibrator and positive control. VECTOR TRANSMITTED DISEASES Chorus CHIKUNGUNYA IgG 36 tests For determination of anti-chikungunya IgG antibodies in human serum. Contains calibrator and positive control. Chorus CHIKUNGUNYA IgM 36 tests For determination of anti-chikungunya IgM antibodies in human serum. Contains calibrator and positive control. Chorus DENGUE IgG 36 tests For determination of anti-dengue IgG antibodies in human serum. Contains calibrator and positive control. Chorus DENGUE IgM 36 tests For determination of anti-dengue IgM antibodies in human serum. Contains calibrator and positive control. 22

25 23 Chorus TOSCANA VIRUS IgG 36 tests For the determination of anti-toscana Virus IgG 12 tests 81067/12 antibodies in human serum. Contains calibrator and positive control. Chorus TOSCANA VIRUS IgM 36 tests For the determination of anti-toscana Virus IgM antibodies 12 tests 81068/12 in human serum. Capture method. Contains calibrator and positive control. Chorus TOXOCARA IgG 12 tests For the determination of anti-toxocara IgG antibodies in human serum. Contains calibrator and positive control. ZOONOSIS Chorus BORRELIA IgG 36 tests For the determination of anti-borrelia IgG antibodies in human serum. 30 tests 81046/C03 Contains calibrator and positive control. Chorus BORRELIA IgM 36 tests For the determination of anti-borrelia IgM antibodies in human serum. 30 tests 81047/C03 Contains calibrator and positive control. Chorus BORRELIA IgG CSF 12 tests For the determination of anti -Borrelia Bourgdoferi IgG in liquor. Contains calibrator and positive control. Chorus TICK-BORNE ENCEPHALITIS VIRUS IgG 36 tests For the determination of anti -Tick-Borne Encephalitis Virus IgG in human serum. Contains calibrator and positive control. Chorus TICK-BORNE ENCEPHALITIS VIRUS IgM 36 tests For the determination of anti-tick-borne Encephalitis Virus IgM in human serum. Contains calibrator and positive control. URINARY ANTIGENS Chorus LEGIONELLA URINARY ANTIGEN 12 tests For the determination of Legionella pneumophila urinary antigen in human urine. Contains calibrator and positive control.

26 CHORUS LINE infectious diseases STOOL ANTIGENS Chorus CALPROTECTIN 12 tests For the determination of Calprotectin in human stool. Contains 16 tests 86600/C03 calibrator and positive control. Chorus CALPROTECTIN K 12 tests For the determination of Calprotectin in human stool. Contains calibrator and positive control. Range of calibration up to mg/kg. Chorus COPROCOLLECT 20 pcs Device for the collection, transport and extraction of stool human samples. Chorus CLOSTRIDIUM DIFFICILE A/B TOXINS 12 tests For the determination of A/B Toxins of Clostridium difficile in human stool. Contains calibrator and positive control Chorus CLOSTRIDIUM DIFFICILE GDH 12 tests For the determination of the Clostridium difficile GDH antigen in human stool. Contains calibrator and positive control Chorus HELICOBACTER PYLORI Ag 12 tests For the determination of Helicobacter pylori antigen in human stool. Contains calibrator and positive control BONE METABOLISM Chorus 25 OH VITAMIN D TOTAL 36 test For the determination of 25 (OH) vitamin D in human serum. Contains calibrator and positive control. 24

27 25 infectious diseases control sera Quality control materials used in conjunction with Chorus Infectious Diseases ELISA based kits and constituted by unassayed positive sera with single specificity. Chorus CYTOMEGALOVIRUS IgG control serum 2x0,4 ml Chorus CYTOMEGALOVIRUS IgG AVIDITY control serum 2x0,4 ml Chorus CYTOMEGALOVIRUS IgM control serum 2x0,4 ml Chorus DIPHTERIA IgG control serum 2x0,4 ml Chorus EPSTEIN-BARR VCA IgG control serum 2x0,4 ml Chorus EPSTEIN-BARR VCA IgM control serum 2x0,4 ml Chorus EPSTEIN-BARR EBNA IgG control serum 2x0,4 ml Chorus EPSTEIN-BARR EARLY ANT. IgG control serum 2x0,4 ml Chorus EPSTEIN-BARR EARLY ANT. IgM control serum 2x0,4 ml Chorus HELICOBACTER PYLORI IgA control serum 2x0,4 ml Chorus HELICOBACTER PYLORI IgG control serum 2x0,4 ml Chorus HERPES SIMPLEX 1+2 IgG control serum 2x0,4 ml Chorus HERPES SIMPLEX 1+2 IgM control serum 2x0,4 ml Chorus MEASLES IgG control serum 2x0,4 ml Chorus MUMPS IgG control serum 2x0,4 ml Chorus MUMPS IgM control serum 2x0,4 ml Chorus MYCOPLASMA PNEUMONIAE IgG control serum 2x0,4 ml Chorus MYCOPLASMA PNEUMONIAE IgM control serum 2x0,4 ml Chorus RUBELLA IgG control serum 2x0,4 ml Chorus RUBELLA IgG AVIDITY control serum 2x0,4 ml Chorus RUBELLA IgM control serum 2x0,4 ml 81525

28 CHORUS LINE infectious diseases control sera Chorus SYPHILIS SCREEN RECOMBINANT control serum 2x0,4 ml Chorus TETANUS IgG control serum 2x0,4 ml Chorus TOXOPLASMA IgG control serum 2x0,4 ml Chorus TOXOPLASMA IgG AVIDITY control serum 2x0,4 ml Chorus TOXOPLASMA IgA control serum 2x0,4 ml Chorus TOXOPLASMA IgM control serum 2x0,4 ml Chorus TREPONEMA IgG control serum 2x0,4 ml Chorus TREPONEMA A IgM control serum 2x0,4 ml Chorus VARICELLA IgG control serum 2x0,4 ml Chorus VARICELLA IgM control serum 2x0,4 ml

29 27 autoimmunity REUMATOLOGY Chorus ANA-8 36 tests For the determination of IgG autoantibodies to 8 different nuclear antigens: 12 tests 86010/12 U1-snRNP 70 kda, SS-B, SS-A 60/52 kda, Scl-70, Cenp-B, Jo-1, snrnp complex (snrnp/ Sm), Sm (screening) in human serum. Contains liquid calibrator and positive control. Chorus ANA SCREEN 36 tests For the determination of IgG autoantibodies against HEp2 cells extract 12 tests 86014/12 enriched with purified nuclear antigens (dsdna, SS-B, SS-A 60/52 kda, Scl- 70,Jo-1, snrnp complex (snrnp/sm), Sm) in human serum. Contains liquid calibrator and positive control. Chorus anti-ccp 36 tests For the determination of IgG autoantibodies against cyclic citrullinated 12 tests 86094/12 peptides in human serum. Contains liquid calibrator and positive control. Chorus Cenp-B 36 tests For the determination of IgG oantibodies to the 80 kda centromere 12 tests 86028/12 protein B (Cenp-B) in human serum. Contains liquid calibrator and positive control. Chorus dsdna-g 36 tests For the determination of IgG antibodies to double stranded DNA 12 tests 86032/12 (dsdna) in human serum. Contains liquid calibrator and positive control. Chorus dsdna-m 36 tests For the determination of IgM antibodies to double stranded DNA 12 tests 86034/12 (dsdna) in human serum. Contains liquid calibrator and positive control. Chorus ENA-6 S 36 tests For the determination of IgG antibodies to 6 different 12 tests 86012/12 nuclear antigens: SS-B, SS-A 60/52 kda, Scl-70, Jo-1, snrnp complex (snrnp/ Sm), Sm (screening) in human serum. Contains liquid calibrator and positive control. Chorus Jo-1 36 tests For the determination of IgG antibodies to human histidyl-trna 12 tests 86030/12 synthetase (Jo-1) in human serum. Contains liquid calibrator and positive control. Chorus RF-G 36 tests For the determination of IgG rheumatoid factors in human serum. 12 tests 86038/12 Contains liquid calibrator and positive control. Chorus RF-M 36 tests For the determination of IgM rheumatoid factors in human serum. 12 tests 86040/12 Contains liquid calibrator and positive control.

30 CHORUS LINE autoimmunity Chorus Scl tests For the determination of IgG antibodies to the 70 kda fragment of human 12 tests 86026/12 DNA-topoisomerase I (Scl-70) in human serum. Contains liquid calibrator and positive control. Chorus SM 36 tests For the determination of IgG antibodies to Sm proteins 12 tests 86016/12 in human serum. Contains liquid calibrator and positive control. Chorus SN RNP-C 36 tests For the determination of IgG antibodies to snrnp Complex in 12 tests 86092/12 human serum (U1-snRNP Complex). Contains liquid calibrator and positive control. Chorus SS-A 36 tests For the determination of IgG antibodies to the SS-A 60/52 kda proteins 12 tests 86018/12 (formerly called Ro) in human serum. Contains liquid calibrator and positive control. Chorus SS-B 36 tests For the determination of IgG antibodies to the 48 kda SS-B protein 12 tests 86024/12 (formerly called La) in human serum. Contains liquid calibrator and positive control. Chorus U1-70 RNP 36 tests For the determination of IgG antibodies to 70 kda fragment of 12 tests 86088/12 ribonucleoprotein U1 in human serum (U1-70 RNP). Contains liquid calibrator and positive control. THYROID Chorus a-tpo 36 tests For the determination of IgG autoantibodies to thyroid 12 tests 86074/12 peroxidase (TPO) in human serum. Contains liquid calibrator and positive control. Chorus TG 36 tests For the determination of thyroglobulin (Tg) in human serum. 12 tests 86076/12 Contains liquid calibrator and positive control. Chorus a-tg 36 tests For the determination of IgG autoantibodies to thyroglobulin 12 tests 86072/12 (Tg) in human serum. Contains liquid calibrator and positive control. 28

31 29 THROMBOSIS Chorus BETA 2-GLYCOPROTEIN-G 36 tests For the determination of IgG autoantibodies to β2-glycoprotein 12 tests 86050/12 I in human serum. Contains liquid calibrator and positive control. Chorus BETA 2-GLYCOPROTEIN-M 36 tests For the determination of IgM antibodies to β2-12 tests 86052/12 glycoprotein I in human serum. Contains liquid calibrator and positive control. Chorus CARDIOLIPIN-G 36 tests For the determination of IgG antibodies to the cardiolipin-β2-glycoprotein 12 tests 86046/12 I complex in human serum. Contains liquid calibrator and positive control. Chorus CARDIOLIPIN-M 36 tests For the determination of IgM antibodies to the cardiolipin-β2-glycoprotein 12 tests 86048/12 I complex in human serum. Contains liquid calibrator and positive control. HEPATOLOGY Chorus AMA-M2 36 tests For the determination of anti-mitochondrial autoantibodies 12 tests 86084/12 (IgG) to M2 in human serum. Contains liquid calibrator and positive control. Chorus LKM-1 36 tests For the determination of LKM-1 antibodies (IgG) to liver-kidney 12 tests 86080/12 microsomes in human serum. Contains liquid calibrator and positive control. VASCULITIS Chorus GBM 36 tests For the determination of IgG antibodies to human glomerular 12 tests 86070/12 basement membrane protein (GBM) in human serum. Contains liquid calibrator and positive control. Chorus MPO 36 tests For the determination of IgG antibodies to myeloperoxidase 12 tests 86068/12 (MPO) in human serum. Contains liquid calibrator and positive control. Chorus PR3 36 tests For the determination of IgG antibodies to proteinase 3 (PR3) in 12 tests 86066/12 human serum. Contains liquid calibrator and positive control.

32 CHORUS LINE autoimmunity DIABETES Chorus INSULIN 36 tests For the determination of IgG antibodies to insulin in human serum. 12 tests 86086/12 Contains liquid calibrator and positive control. GASTROENTEROLOGY Chorus ASCA-A 36 tests For the determination of IgA antibodies to cell wall proteoglycans of 12 tests 86062/12 Saccharomyces cerevisiae in human serum. Contains liquid calibrator and positive control. Chorus ASCA-G 36 tests For the determination of IgG antibodies to cell wall proteoglycans of 12 tests 86064/12 Saccharomyces cerevisiae in human serum. Contains liquid calibrator and positive control. Chorus DEAMIDATED GLIADIN-A 36 tests For the determination of IgA antibodies against deamidated 12 tests 86098/12 gliadin peptides in human serum. Contains liquid calibrator and positive control. Chorus DEAMIDATED GLIADIN-G 36 tests For the determination of IgG antibodies against deamidated 12 tests 86100/12 gliadin peptides in human serum. Contains liquid calibrator and positive control. Chorus GLIADIN-A 36 tests For the determination of IgA antibodies to alpha gliadin in 12 tests 86054/12 human serum. Contains liquid calibrator and positive control. Chorus GLIADIN-G 36 tests For the determination of IgG antibodies to alpha gliadin in 12 tests 86056/12 human serum. Contains liquid calibrator and positive control. Chorus INTRINSIC FACTOR 36 tests For the determination of IgG antibodies to human intrinsic 12 tests 86090/12 factor in human serum. Contains liquid calibrator and positive control. Chorus ttg-a 36 tests For the determination of IgA antibodies to tissue-transglutaminase 12 tests 86058/12 in human serum. Contains liquid calibrator and positive control. Chorus ttg-g 36 tests For the determination of IgG antibodies to tissue-transglutaminase 12 tests 86060/12 in human serum. Contains liquid calibrator and positive control. 30

33 31 complement fixation test BACTERIAL SEROLOGY ANTIGENS Chorus BORDETELLA PERTUSSIS 12 tests Chorus BORRELIA 12 tests Chorus BRUCELLA 12 tests Chorus CAMPYLOBACTER JEJUNI 12 tests Chorus LEGIONELLA PNEUMOPHILA 12 tests Chorus LEPTOSPIRA MIX 12 tests Chorus LISTERIA MONOCYTOGENES 12 tests Chorus SHIGELLA FLEXNERI 12 tests Chorus YERSINIA ENTEROCOLITICA 12 tests NEUROTROPIC ANTIGENS Chorus ECHO VIRUS N MIX 12 tests Chorus POLIOVIRUS MIX 12 tests PNEUMOTROPIC ANTIGENS Chorus ADENOVIRUS 12 tests Chorus CHLAMYDIA 12 tests Chorus ECHO VIRUS P MIX 12 tests Chorus INFLUENZA A VIRUS 12 tests Chorus INFLUENZA B VIRUS 12 tests Chorus MYCOPLASMA PNEUMONIAE 12 tests Chorus PARAINFLUENZA MIX 12 tests Chorus Q-FEVER 12 tests Chorus REOVIRUS 12 tests Chorus RESPIRATORY SYNCYTHIAL VIRUS 12 tests 85236

34 CHORUS LINE complement fixation test COXSACKIE ANTIGEN Chorus COXSACKIE VIRUS A MIX 12 tests Chorus COXSACKIE VIRUS B MIX 12 tests OTHER ANTIGENS Chorus ECHINOCOCCUS 12 tests

35 33 control sera Chorus ADENOVIRUS CONTROL SERUM 0,5 ml Chorus BORDETELLA PERTUSSIS CONTROL SERUM 0,5 ml Chorus BORRELIA CONTROL SERUM 0,5 ml Chorus CAMPYLOBACTER CONTROL SERUM 0,5 ml Chorus CHLAMYDIA CONTROL SERUM 0,5 ml Chorus COXSACKIE B CONTROL SERUM 0,5 ml Chorus INFLUENZA A CONTROL SERUM 0,5 ml Chorus INFLUENZA B CONTROL SERUM 0,5 ml Chorus LEGIONELLA PNEUMOPHILA CONTROL SERUM 0,5 ml Chorus LEPTOSPIRA CONTROL SERUM 0,5 ml Chorus LISTERIA MONOCYTOGENES CONTROL SERUM 0,5 ml Chorus MYCOPLASMA PNEUMONIAE CONTROL SERUM 0,5 ml Chorus Q-FEVER CONTROL SERUM 0,5 ml Chorus PARAINFLUENZA CONTROL SERUM 0,5 ml Chorus RESPIRATORY SYNCYTHIAL CONTROL SERUM 0,5 ml Chorus SHIGELLA CONTROL SERUM 0,5 ml Chorus YERSINIA CONTROL SERUM 0,5 ml 85931

36 ENZY-WELL LINE infectious diseases ToRCH CMV SCREEN 96 tests For the determination of anti-cytomegalovirus immunoglobulins in human serum. Immunoenzymatic competitive method. CYTOMEGALOVIRUS IgG 96 tests For the determination of anti-cytomegalovirus IgG antibodies in human serum. Contains ready for use calibrators for the preparation of the calibration curve in International Units (IU/ml). CYTOMEGALOVIRUS IgG AVIDITY 24 tests For the determination of anti-cytomegalovirus IgG antibodies avidity in human serum. CYTOMEGALOVIRUS IgM 96 tests For the determination of anti-cytomegalovirus IgM antibodies in human serum. Capture method. HERPES SIMPLEX 1+2 IgG 96 tests For the determination of anti-herpes simplex (type 1 and 2) IgG antibodies in human serum. HERPES SIMPLEX 1+2 IgM 96 tests For the determination of anti-herpes simplex (type 1 and 2) IgM antibodies in human serum. Capture method. HERPES SIMPLEX 1 IgG 96 tests For the determination of anti-herpes simplex type 1 IgG antibodies in human serum. HERPES SIMPLEX 1 IgM 96 tests For the determination of anti-herpes simplex type 1 IgM antibodies in human serum. Capture method. HERPES SIMPLEX 2 IgG 96 tests For the determination of anti-herpes simplex type 2 IgG antibodies in human serum. HERPES SIMPLEX 2 IgM 96 tests For the determination of anti-herpes simplex type 2 IgM antibodies in human serum. Capture method. TOXOPLASMA IgG 96 tests For the determination of anti-toxoplasma gondii IgG antibodies in human serum. Contains liquid ready for use calibrators for the preparation of the calibration curve in International Units (IU/ml). TOXOPLASMA IgG AVIDITY 24 tests For the determination of anti-toxoplasma gondii IgG antibodies avidity in human serum. 34

37 35 TOXOPLASMA IgA 96 tests For the determination of anti-toxoplasma gondii IgA antibodies in human serum. TOXOPLASMA IgM 96 tests For the determination of anti-toxoplasma gondii IgM antibodies in human serum. Capture method. RUBELLA IgG 96 tests For the determination of anti-rubella IgG antibodies in human serum. Contains liquid ready for use calibrators for the preparation of the calibration curve in International Units (IU/ml). RUBELLA IgG AVIDITY 24 tests For the determination of anti-rubella IgG antibodies avidity in human serum. RUBELLA IgM 96 tests For the determination of anti-rubella IgM antibodies in human serum. Capture method. CHILDHOOD INFECTIONS MEASLES IgG 48 tests For the determination of anti-measles IgG antibodies in human serum. MEASLES IgM 48 tests For the determination of anti-measles IgM antibodies in human serum. Capture method. MUMPS IgG 48 tests For the determination of anti-mumps IgG antibodies in human serum. MUMPS IgM 48 tests For the determination of anti-mumps IgM antibodies in human serum. Capture method. PARVOVIRUS B19 IgG 48 tests For the determination of IgG antibodies against Parvovirus B19 in human serum. PARVOVIRUS B19 IgM 48 tests For the determination of IgM antibodies against Parvovirus B19 in human serum VARICELLA IgG 48 tests For the determination of anti-varicella Zoster IgG antibodies in human serum. VARICELLA IgM 48 tests For the determination of anti-varicella Zoster IgM antibodies in human serum. Capture method.

38 ENZY-WELL LINE infectious diseases BACTERIAL RESPIRATORY INFECTIONS MYCOPLASMA PNEUMONIAE IgG 96 tests For the determination of anti-mycoplasma pneumoniae IgG antibodies in human serum. MYCOPLASMA PNEUMONIAE IgM 96 tests For the determination of anti-mycoplasma pneumoniae IgM antibodies in human serum. VIRAL RESPIRATORY INFECTIONS INFLUENZA A IgA 96 tests For the determination of anti-influenza A IgA antibodies in human serum. INFLUENZA A IgG 96 tests For the determination of anti-influenza A IgG antibodies in human serum. INFLUENZA B IgA 96 tests For the determination of anti-influenza B IgA antibodies in human serum. INFLUENZA B IgG 96 tests For the determination of anti-influenza B IgG antibodies in human serum. SEXUALLY TRANSMITTED DISEASES SYPHILIS SCREEN RECOMBINANT 2x96 tests For the determination of anti-treponema pallidum (Nichols strain) immunoglobulins in human serum, using recombinant antigens. Immunoenzymatic method. TREPONEMA IgG 96 tests For the determination of anti-treponema pallidum (Nichols strain) IgG antibodies in human serum. Recombinant antigen TREPONEMA IgM 96 tests For the determination of anti-treponema pallidum (Nichols strain) IgM antibodies in human serum. Recombinant antigen. Capture method. GASTROINTESTINAL DISEASES HELICOBACTER PYLORI IgA 96 tests For the determination of anti-helicobacter pylori IgA antibodies in human serum. 36

39 37 HELICOBACTER PYLORI IgG 96 tests For the determination of anti-helicobacter pylori IgG antibodies in human serum. Contains ready for use calibrators for the preparation of the calibration curve in Arbitrary Units (AU/ml). INFECTIOUS MONONUCLEOSIS EPSTEIN-BARR VCA IgG 96 tests For the determination of IgG antibodies against Viral Capsid Antigen of Epstein-Barr Virus in human serum. EPSTEIN-BARR VCA IgM 96 tests For the determination of IgM antibodies against Viral Capsid Antigen of Epstein- Barr Virus in human serum. EPSTEIN-BARR EBNA IgG 96 tests For the determination of IgG antibodies against Nuclear Antigen of Epstein-Barr Virus in human serum. EPSTEIN-BARR EARLY ANTIGEN IgG 96 tests For the determination of IgG antibodies against Early Antigen of Epstein-Barr Virus in human serum. EPSTEIN-BARR EARLY ANTIGEN IgM 96 tests For the determination of IgM antibodies against Early Antigen of Epstein-Barr Virus in human serum. VECTOR TRANSMITTED DISEASES CHIKUNGUNYA IgG 96 tests For the determination of anti-chikungunya IgG antibodies in human serum. CHIKUNGUNYA IgM 96 tests For the determination of anti-chikungunya IgM antibodies in human serum. TOSCANA VIRUS IgG-IgM (Sandfly Fever Virus) tests For the determination of anti-toscana Virus IgG and IgM antibodies in human serum.

40 LINEA AUTO DAT instrument AUTO-DAT Instrument for the automation of the incubation phase of sero agglutination tests. Semiquantitative interpretation of results and through image analysis software. 38

41 39 accessories and reagents AUTO-DAT MICROPLATE 20 pcs To be used for sero agglutination reaction with AUTO-DAT instrument. WW-DAT 7x2,5 ml For serological diagnosis of bacterial infection (Widal-Wright) (700 tests) Panel of 7 coloured suspensions (TO, TH, AO, AH, BO, BH, Brucella) WF-DAT 3x1,5 ml For serological diagnosis of Rickettsial infection. RPR-DAT 500 tests Non Treponemal agglutination test for syphilis screening. Automated method. Includes controls and dedicated microplates..

42 RAPID TEST LINE coloured suspensions MONONUCLEOSIS IMN SLIDE 50 det. 024 Latex slide test for the diagnosis of infectious Mononucleosis. Includes controls and slides. SYPHILIS SYPHILIS FAST (modified TPHA) 50 tests 051 Latex agglutination test for the rapid assay of anti-treponema pallidum antibodies in human serum. Includes mixing sticks, slides, positive and negative controls. RPR COLOUR 500 tests 028 For the assay of reagents in syphilis serology with a carbon reagent. Slide method. Includes controls. STREPTOCOCCUS STREPTO SLIDE 6x50 tests 0210 Kit for the identification of Streptococcus Group Antigens (A,B,C,D,F and G) by latex agglutination. Includes chemical and enzymatic extraction reagents, reaction cards and mixing sticks. STREPTO SLIDE A 50 tests 0211 Latex for the identification of group A antigen. To be used with code STREPTO SLIDE B 50 tests 0212 Latex for the identification of group B antigen. To be used with code STREPTO SLIDE C 50 tests 0213 Latex for the identification of group C antigen. To be used with code STREPTO SLIDE D 50 tests 0214 Latex for the identification of group D antigen. To be used with code STREPTO SLIDE F 50 tests 0215 Latex for the identification of group F antigen. To be used with code STREPTO SLIDE G 50 tests 0216 Latex for the identification of group G antigen. To be used with code

43 41 ACCESSORIES DISPOSABLE TEST CARD (BLACK) 50 pcs. 0746/C Black-background cards for latex agglutination reactions. STREPTO SLIDE EXTRAENT 50 tests 0217 Kit for the chemical and enzymatic extraction of the Streptococcal antigens. Includes reaction cards and mixing sticks (latex not enclosed). MICROPLATE TEST Ready to use coloured suspensions for the serological diagnosis (Widal-Wright) of bacterial infections on microplate. W.W. MICRO S. TYPHI O 5x5 ml W.W. MICRO S. TYPHI H 5x5 ml W.W. MICRO S. PARATYPHI A TOT. 5x5 ml W.W. MICRO S. PARATYPHI B O 5x5 ml W.W. MICRO S. PARATYPHI B TOT. 5x5 ml W.W. MICRO S. PARATYPHI B H 5x5 ml W.W. MICRO BRUCELLA 5x5 ml W.W. MICRO 6 6x5 ml Kit for serological diagnosis of bacterial infection (600 tests) (Widal-Wright) by micromethod. Coloured suspensions of 6 antigens (TO, TH, BO, BH, A Total and Brucella) ready for the micromethod. W.W. MICRO 5 5x5 ml Kit for serological diagnosis of bacterial infection (500 tests) (Widal-Wright) by micromethod. Coloured suspensions of 6 antigens (TO, TH, BO, BH, A Total and Brucella) ready for the micromethod.

44 RAPID TEST LINE coloured suspensions SLIDE TEST Ready to use coloured suspensions for the serological diagnosis (Widal-Wright) of bacterial infections in slide and tube titration. FEBRILE ANTIGEN S. TYPHI O 5 ml FEBRILE ANTIGEN S. TYPHI H 5 ml FEBRILE ANTIGEN S. PARATYPHI A O 5 ml FEBRILE ANTIGEN S. PARATYPHI A H 5 ml FEBRILE ANTIGEN S. PARATYPHI B O 5 ml FEBRILE ANTIGEN S. PARATYPHI B H 5 ml FEBRILE ANTIGEN S. PARATYPHI C O 5 ml FEBRILE ANTIGEN S. PARATYPHI C H 5 ml FEBRILE ANTIGEN BRUCELLA 5 ml W.W. SLIDE 7x5 ml 021 Kit for serological diagnosis of bacterial infection (700 tests) (Widal-Wright) by rapid slide test. Panel of 7 coloured suspensions (TO, TH, AO, AH, BO, BH, Brucella), positive and negative controls, disposables (slides) and mixing sticks. Ready to use coloured suspensions for the serological diagnosis of rickettsial infections (Weil-Felix) in slide and tube titration. W.F. SLIDE PROTEUS OX2 3 ml W.F. SLIDE PROTEUS OX19 3 ml W.F. SLIDE PROTEUS OXK 3 ml

45 43 TUBE TEST Ready to use suspensions for serological diagnosis (Widal-Wright) of bacterial infections in tube. W.W. TUBE S. TYPHI O 20 ml W.W. TUBE S. TYPHI H 20 ml W.W. TUBE S. TYPHI TOTAL 20 ml W.W. TUBE S. PARATYPHI A TOTAL 20 ml W.W. TUBE S. PARATYPHI B TOTAL 20 ml W.W. TUBE BRUCELLA 20 ml ACCESSORIES DISPOSABLE TEST CARD (WHITE) 50 pcs. 0741/C White-background cards for W.W. Slide. W.W. POSITIVE CONTROL 2 ml Widal-Wright positive control serum. W.F. POSITIVE CONTROL 2 ml Weil-Felix positive control. COLORIMETRIC TEST PAR TEST 96 tests 025 Colorimetric test for the detection of substances with antibacterial activity in urine. Micromethod.

46 QUALITY CERTIFICATIONS DIESSE Diagnostica Senese SpA has worked for many years in accordance with its quality management system certified UNI EN ISO 9001: 2008 Quality Management Systems and UNI EN ISO Quality Management System for Medical Devices. Ensuring traceability, transparency, conformity of production and also the quality of its products and services, focusing on continuous improvement. The products are CE marked under European Directive 98/79/EEC on in vitro Medical Devices and related applicable harmonized standards. The requirements of the Canadian MDR. 44

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48 46 NOTES

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50 48 Printed in Siena JANUARY 2018

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52 CONCEPT STAMPA IN STAMPA FIRENZE 2018_DEPL.1000 REV.01_2018 diagnostica senese