The product is CE marked according to Directive 98/79/EC (in vitro Diagnostic Devices, IVDD).
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1 PRODUCT LIST 2017
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3 SYMBOLS The product is CE marked according to Directive 98/79/EC (in vitro Diagnostic Devices, IVDD). The product is listed in the Annex II of Directive 98/79/EC (in vitro Diagnostic Devices, IVDD) and CE conformity was verified by a Notified Body.
4 INFECTIOUS DISEASES REAL-TIME PCR assays RQ-09-4M RQ-09-6M RQ-CMV Kit for detection of Cytomegalovirus RQ-10-SM RQ-CMV 4 60 µl Quantification standards for Cytomegalovirus RQ-11-4M RQ-11-6M RQ-EBV Kit for detection of Epstein-Barr virus RQ-122-SM RQ-EBV 4 60 µl Quantification standards for Epstein-Barr virus RQ RQ RS-HSV 1 Kit for detection of Herpes simplex virus type 1 RQ-06-ST RQ-HSV µl Quantification standards for Herpes simplex virus type 1 RQ RQ RS-HSV 2 Kit for detection of Herpes simplex virus type 2 RQ-108-ST RQ-HSV µl Quantification standards for Herpes simplex virus type 2 RQ RQ RS-HHV 6 Kit for detection of Herpes simplex virus type 6 RQ-16-ST RQ-HHV µl Quantification standards for Herpes simplex virus type 6 RQ-19-4M RQ-19-6M RQ-HHV 7 Kit for detection of Herpes simplex virus type 7 RQ-20-SM RQ-HHV µl Quantification standards for Herpes simplex virus type 7 RQ-17-4M RQ-17-6M RQ-HHV 8 Kit for detection of Herpes simplex virus type 8 RQ-18-SM RQ-HHV µl Quantification standards for Herpes simplex virus type 8 RQ RQ RS-VZV Kit for detection of Varicella-zoster virus RQ-36-ST RQ-VZV 4 60 µl Quantification standards for Varicella-zoster virus RQ-49-4M RQ-49-6M RQ-BKV Kit for detection of BK virus RQ-50-ST RQ-BKV 4 60 µl Quantification standards for BK virus RQ-83-4M RQ-83-6M RQ-JCV Kit for detection of JC virus RQ-84-SM RQ-JCV 4 60 µl Quantification standards for JC virus 2
5 INFECTIOUS DISEASES REAL-TIME PCR assays RQ RQ RQ-ENTERO Kit for detection of Enterovirus RQ-90-ST RQ-ENTERO 4 60 µl Quantification standards for Enterovirus RQ-37-4M RQ-37-6M RQ-PARVO B19 Kit for detection of Parvovirus B19 RQ-38-SM RQ-PARVO B µl Quantification standards for Parvovirus B19 RQ RQ RQ-MBT COMPLEX Kit for detection of the Mycobacterium tuberculosis complex RQ-86-ST RQ-MBT COMPLEX 4 60 µl Quantification standards for Mycobacterium tuberculosis complex RQ-93-4M RQ-93-6M RQ-ADENO Kit for detection of Adenovirus RQ-94-SM RQ-ADENO 4 60 µl Quantification standards for Adenovirus RQ-117-4M* RQ-117-6M RQ-TOXO Kit for detection of the Toxoplasma gondii *Products soon available SEXUALLY TRANSMITTED INFECTIONS (STI) REAL-TIME PCR assays RQ RQ RQ-STI CT/NG/MG Kit for detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium RQ RQ RQ-STI CT/NG Kit for detection of Chlamydia trachomatis and Neisseria gonorrhoeae RQ RQ RQ-STI MG/MH Kit for detection of Mycoplasma genitalium and Mycoplasma hominis RQ RQ RQ-STI UU/UP Kit for detection of Ureaplasma urealyticum and Ureaplasma parvum RQ RQ RQ-STI CT Kit for detection of Chlamydia trachomatis RQ RQ RQ-STI TV Kit for detection of Trichomonas vaginalis Validated with Lysis Buffer SW for rapid manual extraction of nucleic acids (see page 8). HUMAN PAPILLOMAVIRUS REAL-TIME PCR assays RQ RQ RQ-HPV HR Detection of 14 high-risk Human Papillomavirus genotypes and genotyping of HPV 16 and 18 (genes E6 and E7) RQ RQ RQ-HPV HR/LR MULTIPLEX Detection of 14 high-risk, 6 possibly high-risk and 2 low-risk Human Papillomavirus genotypes and genotyping of HPV 6, 11, 16 and 18 (genes E6 and E7) RQ RQ RQ-MULTI HPV DETECTION Detection of 14 high-risk, 6 possibly high-risk and 8 low-risk Human Papillomavirus genotypes and genotyping of HPV 16 and 18 (genes E6 and E7) Validated with Lysis Buffer SW for rapid manual extraction of nucleic acids (see page 8). 3
6 THROMBOPHILIA REAL-TIME PCR assays RQ RQ RS-FACTOR V Leiden Detection and genotyping of the G1691A mutation (Leiden) in the gene coding for Coagulation Factor V RQ RQ RS-FACTOR II G20210A Detection and genotyping of the G20210A mutation in the gene coding for Coagulation Factor II RQ RQ RS-MTHFR C677T Detection and genotyping of the C677T mutation in the gene coding for MTHFR RQ RQ RS-MTHFR A1298C Detection and genotyping of the A1298C mutation in the gene coding for MTHFR RQ RQ RS-FACTOR V H1299R Detection and genotyping of the H1299R mutation (HR2 haplotype) in the gene coding for Coagulation Factor V RQ-69-4M RQ-69-6M RQ-FATTORE V Y1702C Detection and genotyping of the Y1702C mutation in the gene coding for Coagulation Factor V RQ-119-4M RQ-119-6M RQ-PAI-1 4G/5G Detection and genotyping of the G/5G polymorphism in the gene coding for the plasminogen activator type 1 inhibitor RQ-75-4M RQ-75-6M RQ-ACE (I/D) Detection and genotyping of the insertion/deletion (I/D) polymorphism in the intron 16 of the gene coding for the Angiotensin-Converting Enzyme (ACE) HEMOCHROMATOSIS REAL-TIME PCR assays RQ RQ RS-HEMO C282Y Detection and genotyping of the C282Y mutation in the HFE gene RQ RQ RS-HEMO H63D Detection and genotyping of the H63D mutation in the HFE gene RQ-43-4M RQ-43-6M RQ-HEMO S65C Detection and genotyping of the S65C mutation in the HFE gene PHARMACOGENETICS REAL-TIME PCR assays RQ RQ RS-IL28B rs Detection and genotyping of polymorphism rs in the gene coding for Interleukin 28B RQ RQ RQ-IL28B rs Detection and genotyping of polymorphism rs in the gene coding for Interleukin 28B 4
7 ONCOHEMATOLOGY REAL-TIME PCR assays RQ RQ RQ-BCR-ABL p210 ONE-STEP Reverse transcription and PCR in one step Kit for detection of translocation t(9;22)(q34;q11), variant p210 BCR-ABL p210 (M-bcr) RQ-54-ST RQ-BCR-ABL p µl Single-plasmid quantification standards for BCR-ABL p210 (M-bcr), ABL and GUSB transcripts RQ-115-4M RQ-115-6M RQ-BCR-ABL p190 ONE-STEP Reverse transcription and PCR in one step Kit for detection of translocation t(9;22)(q34;q11), variant p190 BCR-ABL p190 (m-bcr) RQ-116-SM RQ-BCR-ABL p µl Single-plasmid quantification standards for BCR-ABL p190 (m-bcr), ABL transcripts RQ-57-4M* RQ-57-6M RQ-WT-1 ONE-STEP Reverse transcription and PCR in one step Kit for quantification of the expression of the Wilms Tumor 1 gene (WT1) Must be used with quantification standard (RQ-58-SM) RQ-58-SM* RQ-WT µl Single-plasmid quantification standards for WT1 and ABL transcripts RQ-59-4M* RQ-59-6M RQ-AML1-ETO ONE-STEP Reverse transcription and PCR in one step Kit for detection of translocation t(8;21)(q22;q22) AML1-ETO RQ-60-SM* RQ-AML1-ETO µl Single-plasmid quantification standards for AML1-ETO and ABL transcripts RQ-61-4M* RQ-61-6M RQ-INV 16 ONE-STEP Reverse transcription and PCR in one step Kit for detection of inv(16)(p13;q22) CBFß-MYH11 type A fusion transcript RQ-62-SM* RQ-INV µl Single-plasmid quantification standards for inv(16)(p13;q22) and ABL transcripts RQ-63-4M RQ-63-6M RQ-PML-RARa bcr1 ONE-STEP Reverse transcription and PCR in one step Kit for detection of translocation t(15;17)(q22;q21), variant bcr1 PML-RARa bcr1 RQ-64-SM RQ-PML-RARa bcr µl Single-plasmid quantification standards for PML-RARa bcr1 and ABL transcripts RQ-67-4M RQ-67-6M RQ-PML-RARa bcr2 ONE-STEP Reverse transcription and PCR in one step Kit for detection of translocation t(15;17)(q22;q21), variant bcr2 PML-RARa bcr2 RQ-68-SM RQ-PML-RARa bcr µl Single-plasmid quantification standards for PML-RARa bcr2 and ABL transcripts RQ-65-4M RQ-65-6M RQ-PML-RARa bcr3 ONE-STEP Reverse transcription and PCR in one step Kit for detection of translocation t(15;17)(q22;q21), variant bcr3 PML-RARa bcr3 RQ-66-SM RQ-PML-RARa bcr µl Single-plasmid quantification standards for PML-RARa bcr3 and ABL transcripts *Products soon available For further information and for availability of the Real-Time PCR assays, please contact us at sales@abanalitica.it. 5
8 ONCOHEMATOLOGY REAL-TIME PCR assays REVERSE TRANSCRIPTION 06-R R1-50 REV-T KIT RQ VARIANT 25 tests Kit for reverse transcription of RNA for Real-Time PCR assays REFERENCE BCR-ABL p210 REFERENCE 4 x 15 µl RNA reference for molecular assays for detection and/or quantification of the BCR-ABL p210 transcript For further information and for availability of the Real-Time PCR assays, please contact us at sales@abanalitica.it. AMPLIQUALITY HEPATITIS C VIRUS TYPING ON STRIP Kit for the identification of HCV genotypes 1 to 7 and subtypes a and b of genotype 1, by One-Step RT-PCR and Reverse Line Blot of the 5 UTR and the CORE region AMPLIQUALITY HCV TYPE PLUS 20 tests The kit includes: dutp/ung system to prevent carry-over contamination internal control included positive control included interpretation software included The system can identify the following 7 HCV genotypes and relative subtypes: 1, 1a, 1b, 2, 2a, 2c, 2b, 3, 3a, 3b/g/i, 3c, 3f/k, 3h, 4, 4a/b/c/d/f, 4e, 4h/k, 4m, 4n, 4q, 4r, 4v, 5a, 6, 6a/b, 6c, e-v, 7a. HUMAN PAPILLOMAVIRUS TYPING ON STRIP Kit for rapid screening and genotyping of Human Papillomavirus by One-Step PCR and Reverse Line Blot A-20 AMPLIQUALITY HPV-TYPE EXPRESS v tests Reagents for PCR and genotyping included dutp/ung system to prevent carry-over contamination Coamplification of housekeeping gene TST Easy detection of coinfections Simple, fast and reliable Tested and calibrated on WHO HPV proficiency panel Allows genotyping of 40 HPV strains: 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68a, 68b, 69, 70, 71, 72, 73, 81, 82, 83, 84, 87, 89, 90. Non-listed genotypes are detected by the Universal HPV Sequence. 08-RLB-32 AMPLIQUALITY HPV-TYPE EXPRESS STRIP READER 1 CD ROM Software for interpretation and report generation for the AMPLIQUALITY HPV-TYPE EXPRESS v 3.0 kit 6
9 HEMATOLOGY 04-71A-20 AB-THROMBO TYPE PLUS 20 tests Kit for simultaneous detection of mutations related to thrombosis by PCR and Reverse Line Blot Detected mutations: Factor V Leiden, G1691A (Arg505Gln); Factor II, G20210A; MTHFR C677T; MTHFR A1298C, PAI 1 4G/5G, Factor V (HR2) H1299R END-POINT PCR 04-20A A-50 STR-VNTR 25 tests Kit for detection of chimerism after allogenic bone marrow transplantation by analysis of Short Tandem Repeats (STR) and Variable Number of Tandem Repeats (VNTR) 04-20R R-50 STR-VNTR AMPLIFICATION REAGENTS 25 tests Target regions: HumARA, HumTH01, SE33, vwf2, D1S80, YNZ22, vwf1 and 3 -HVR PHARMACOGENETICS 04-47A-20 IL28B-ITPA TYPE 20 tests Kit for simultaneous detection and genotyping of polymorphisms in the genes for IL28B and ITPA by Reverse Line Blot 04-74A-20 AB WARFARIN TYPE 20 tests Kit for simultaneous detection of polymorphisms in the CYP2C9, CYP4F2 and VKORC1 genes by Reverse Line Blot END-POINT PCR 04-76A A-50 HLA B*57:01 25 tests Kit for HLA-B*57:01 typing for identification of subjects at risk of a hypersensitivity reaction to Abacavir 04-76R R-50 HLA B*57:01 AMPLIFICATION REAGENTS 25 tests Kit for HLA-B*57:01 typing for identification of subjects at risk of a hypersensitivity reaction to Abacavir 7
10 GENETIC DISEASES 02-12A-20 CD-TYPE (READY-TO-USE SINGLE-DOSE FORMAT) 20 tests Kit for identification of genetic predisposition for Celiac Disease by Reverse Line Blot The test comes with the CD-TYPE Strip Reader Software, which allows reliable and automated interpretation of the strips 02-14A-20 CD-TYPE (MASTER-MIX FORMAT) 20 tests Kit for identification of genetic predisposition for Celiac Disease by Reverse Line Blot The test comes with the CD-TYPE Strip Reader Software, which allows reliable and automated interpretation of the strips 04-18A-20 AZF Y-TYPE 20 tests Kit for detection of deletions in the AZF locus, involved in male infertility by Reverse Line Blot END-POINT PCR 04-23A A-25 AZF-MX 12 tests 25 tests Kit for detection of deletions in the AZF locus, involved in male infertility by End-Point PCR 04-23R R-25 AZF-MX AMPLIFICATION REAGENTS 12 tests 25 tests Target regions (multiplex PCR): sy84, sy86, DFFRY, DBY, sy95, sy117, sy125, sy127, sy134, sy254, sy255, ZFX/ZFY, SRY. Internal control: ZFX/ZFY ONCOLOGY 04-40A-50 CALR MUTATION Kit for detection of mutations in exon 9 of the human Calreticulin gene (CALR) by single-step PCR 04-40R-50 CALR MUTATION AMPLIFICATION REAGENTS Kit for detection of mutations in exon 9 of the human Calreticulin gene (CALR) by single-step PCR EXTRACTION OF NUCLEIC ACIDS 04-X X LYSIS BUFFER SW 50 extractions 100 extractions Kit for rapid extraction of viral and bacterial DNA from swabs and urine 8
11 EXTRACTION OF NUCLEIC ACIDS AUTOMATED EXTRACTION OF NUCLEIC ACIDS INSTRUMENTS X120 Platform for automated nucleic acid extraction and plate preparation (64 simultaneous extractions) X120 TRACK Platform for automated nucleic acid extraction and plate preparation with labware and biobanking management (64 simultaneous extractions) REAGENTS 04-X10-96 X120 BLOOD KIT 96 extractions Kit for extraction of genomic DNA from whole blood based on magnetic beads using the automated extraction platform X X12-96 X120 PATHOGEN KIT 96 extractions Kit for extraction of viral DNA/RNA and bacterial DNA from different types of biological samples based on magnetic beads using the automated extraction platform X120 Available only in selected countries. For availability in your country, please contact us at 9
12 FERTILITY ANALYSIS OF SEMINAL FLUID Ready-to-use solutions for treatment or staining of sperm cells on glass slides for microscopic analysis R-50 FERTILITY LIFE TEST Test for identification of living spermatozoa independent of motility 00-02R-50 FERTILITY SWELLING TEST Test for assessment of the membrane integrity of sperm cells 00-03R-50 FERTILITY HISTON COLOR TEST Test for assessment of the maturation state of sperm cells by staining of histones in the cell nucleus 00-04R-50 FERTILITY DECON TEST Test for assessment of the maturation state of sperm cells by analysis of the chromosome-decondensation process in the cell nucleus 00-05R-50 FERTILITY ROUND CELL TEST Test for analysis of the quality of seminal fluid. Asseses the structural integrity of sperm chromatin 00-06R-50 FERTILITY CUSTOM SERVICE Kit containing the solutions of LIFE TEST, SWELLING TEST, HISTON COLOR TEST, DECON TEST and ROUND CELL TEST. Each solution is sufficient for 10 tests MAKLER CHAMBER 1 unit Device for the analysis of seminal fluid. Used for counting of sperm cells and assessment of cell motility NEUBAUER CHAMBER 1 unit Device for cell counting and analysis of seminal fluid. Method recommended by the WHO AB CELL-VU SINGLE USE SLIDES 2 tests for 25 slides Single-use slides with dual chamber for cell counting. Include cover slip with laser-etched grid AB C-CHIP SINGLE USE SLIDES 50 slides Dual-chamber slides for cell counting in hematology, microbiology and andrology 00-08R-100 FRUCTOSE 100 slides 00-12R-50 ZINC Test for assessment of the D-Fructose content in seminal fluid (UV absorption spectrophotometry) Test for assessment of the Zinc content in serum, plasma, urine and seminal fluid without deproteinization (by colorimetry) 00-10R-100LS CITRIC ACID (FOR SEMINAL FLUID) Test for assessment of the Citric Acid content in seminal fluid by UV absorption spectrophotometry 00-11R-03 SET OF CONTROLS FOR FRUCTOSE, ZINC, CITRIC ACID 3 vials of 1mL Controls for analysis of biochemical parameters of seminal fluid. Three solution of graded concentrations of controls 10
13 BREATH TEST SOLUTIONS BREATHQUALITY UBT 13C-UREA BREATH TEST FOR DIAGNOSIS OF GASTRODUODENAL INFECTION BY HELICOBACTER PYLORI. Oral solution, single dose (75 mg 13C urea/10 ml), for breath testing for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in adults and children liquid ready to use complete authorized for pediatric use free of preservatives, colorants and flavors tested for allergic reactions BREATHQUALITY-UBT Oral solution, single dose (75 mg 13C urea/10 ml) 1 test Breath test for in vivo diagnosis of gastroduodenal infection by Helicobacter pylori BREATHQUALITY-UBT is a medicinal product. ATC CODE: V04CX (pharmacotherapeutic group other diagnostics ) ACCESSORIES FOR BREATH TESTING Kit content: TEST TUBES FOR BREATH TEST: 2 glass vials (12 ml) with blue cap, labeled (BASE-) 2 glass vials (12 ml) with red cap, labeled (POST-) The vials have a flat base, a silicon coating baked onto the inside wall of the vial, giving a clearer visible breath sample without interfering with the analysis and a screw-cap with pierceable rubber septum. Suitable for analysis with Mass Spectrometer and Infrared Analyzer. Conform to Directive 98/79/EC on in vitro diagnostic medical devices. STRAWS: 2 straws in Polypropylene (PP) Conform to directives 93/42/EEC and 2007/47/EC (Class I Medical Device) CODE PRODUCT DESCRIPTION 13-01A-75 AB 13C-AMINOPIRINA 13 C Aminopyrine: Substrate for study of liver function 13-02A-75 AB 13C-METACETINA 13 C Methacetin: Substrate for study of liver function 13-07A-250 AB 13C-TRIGLICERIDI MISTI Mixed 13 C triglycerides: Substrate for study of pancreatic lipase activity in the duodenum 13-09A-100 AB 13C-ACIDO OTTANOICO 13 C Octanoic Acid: Substrate for evaluation of gastric emptying 13-13A-15 AB 13C-LATTOSIO 13 C Lactose: Substrate for lactose intolerance test * All products are supplied with accessories for performing the test. 11
14 BREATH ANALYZERS FOR DETERMINATION OF THE 13C/12C ISOTOPE RATIO ABCA2 13 C ANALYZER * ISOTOPE-RATIO MASS SPECTROMETER (IRMS) FOR BREATH ANALYSIS CODE PRODUCT DESCRIPTION ABCA2 Automated Breath Carbon Analyzer Mass spectrometer for 13 C/ 12 C-isotope-ratio analysis in breath samples, with autosampler HELIFANPLUS * INFRARED ANALYZER FOR BREATH ANALYSIS CODE PRODUCT DESCRIPTION 08-28A-00 HeliFANplus Infrared Analyser Infrared Analyzer for 13 C/ 12 C-isotope-ratio analysis (NDIRS) in breath samples, with FAN as autosampler * Please ask for product availability in your country RAPID TEST FOR DETECTION OF HELICOBACTER PYLORI 21-80R R-100 AB HP UREASI TEST Liquid urease test for detection of Helicobacter Pylori in gastric tissue biopsy 12
15 TERMS AND CONDITIONS OF SALE AB ANALITICA prices are ex-works. Prices do not include taxes or insurance. Merchandise travels at risk of the purchaser. Orders must clearly state the following information: product code and description quantity ordered quotation ref N. prices as indicated in the price list or in the quotation the complete and detailed address of the delivery VAT number of the purchaser Orders MUST be sent directly to AB ANALITICA s.r.l. Contact us by fax or at the following address: AB ANALITICA srl Via Svizzera PADOVA - ITALY Tel Fax sales@abanalitica.it Complaints must be forwarded within eight days of merchandise receipt. 13
16 AB ANALITICA has been certified according to norm UNI EN ISO 9001:2008 for design, development, production and commercialization of in-vitro diagnostic medical devices (IVD) based on molecular biology methods for use in infectious diseases, hematology, oncology, genetic tests, pharmacogenetics and Next-Generation Sequencing (NGS); design, development, production management, commercialization and technical assistance regarding instruments for the preparation of samples for use in in-vitro diagnostics; commercialization and technical assistance for in-vitro diagnostic instruments; design, development, production management and commercialization of breath tests; and provision of clinical chemistry laboratory services (IAF 12, 13, 19, 38). In addition, AB ANALITICA has been certified according to norm UNI CEI EN ISO 13485:2012 for design, development, production and commercialization of in-vitro diagnostic medical devices (IVD) based on molecular biology methods for use in infectious diseases, hematology, oncology, genetic tests, pharmacogenetics and Next-Generation Sequencing (NGS); design, development, production management, commercialization and technical assistance regarding instruments for the preparation of samples for use in in-vitro diagnostics; and commercialization and technical assistance for in-vitro diagnostic instruments. Most of the company s products have been certified as CE devices in accordance with directive 98/79/EC on in-vitro diagnostic medical devices (CE marking), including the devices for: Genotyping of the Hepatitis C Virus conforms to annex 2, list A of directive 98/79/EC End-point PCR and Real-Time PCR on nucleic acids for detection of infection markers of Chlamydia and Cytomegalovirus conforms to annex 2, list B of directive 98/79/EC HLA analysis by PCR on nucleic acids for detection of disease-related genetic predisposition conforms to annex 2, list B of directive 98/79/EC AB ANALITICA ensures quality and reliability of its devices through an internal quality management system and regular external quality controls. AB ANALITICA is authorized for export to and registered for sale in 40 different countries. 14
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20 AB ANALITICA srl Via Svizzera, Padova P.IVA Tel Fax _PRODUCT_LIST_e
We design and produce solutions for better diagnostics. Everyday we innovate, imagine and grow with our Customers - 3 -
Product Catalog AB ANALITICA, established in 1990 and located in Padua (North-East Italy), was one of the first Italian companies to operate in the field of molecular diagnostics. As of today, it has
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