The product is CE marked according to Directive 98/79/EC (in vitro Diagnostic Devices, IVDD).

Size: px
Start display at page:

Download "The product is CE marked according to Directive 98/79/EC (in vitro Diagnostic Devices, IVDD)."

Transcription

1 PRODUCT LIST 2017

2

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

17 15

18 16

19

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 -

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

More information

ON O C N O C H O E H M E A M T A O T L O O L G O Y

ON O C N O C H O E H M E A M T A O T L O O L G O Y REAL TIME PCR KITS von AB Analitica www.bioproducts.at ONKOHÄMATOLOGIE INFEKTIOLOGIE HUMANGENTIK CE IVD gleiches PCR Protokoll REALQUALITY CATALOGUE REALQUALITY REAL TIME PCR KITS Characteristics: CE IVD

More information

MOLECULAR DIAGNOSTIC PANELS and REAGENT KITS for NUCLEIC ACID EXTRACTION and RT-PCR of INFECTIOUS DISEASES and GENOMICS. Sep 2018

MOLECULAR DIAGNOSTIC PANELS and REAGENT KITS for NUCLEIC ACID EXTRACTION and RT-PCR of INFECTIOUS DISEASES and GENOMICS. Sep 2018 MOLECULAR DIAGNOSTIC PANELS and REAGENT KITS for NUCLEIC ACID EXTRACTION and RT-PCR of INFECTIOUS DISEASES and GENOMICS Sep 2018 STANDARDISED & EASY APPROACH TO PCR DIAGNOSTICS The diagnostic kits of MOLgen

More information

PRODUCT RANGE

PRODUCT RANGE PRODUCT RANGE 2010-2011 MICROBIOLOGY - VIROLOGY Q - CMV Real Time Complete kit 96 RTK015 Detection of CMV DNA (MIEA) 4 Plasmidic controls at known titre for quantitative assays and CPE-DNA included in

More information

About HPV. Human papillomavirus (HPV) is a group of viruses that are extremely common worldwide. Theree are more than 100 types of HPV, of which at

About HPV. Human papillomavirus (HPV) is a group of viruses that are extremely common worldwide. Theree are more than 100 types of HPV, of which at Cervical Cancer & HPV What is HPV Human papillomavirus (HPV) is a group of viruses that are extremely common worldwide. About HPV Theree are more than 100 types of HPV, of which at least 13 are cancer-causing

More information

AMPLIRUN TOTAL A RELIABLE QUALITY CONTROL SOURCE FOR NUCLEIC ACID TESTS

AMPLIRUN TOTAL A RELIABLE QUALITY CONTROL SOURCE FOR NUCLEIC ACID TESTS AMPLIRUN TOTAL A RELIABLE QUALITY CONTROL SOURCE FOR NUCLEIC ACID TESTS Take Control, Molecular Control. 02 04 05 06 06 07 08 08 AMPLIRUN TOTAL RESPIRATORY INFECTIONS TUBERCULOSIS INFECTIONS GASTROINTESTINAL

More information

DEPARTMENT OF MICROBIOLOGY IMPORTANT NOTICE TO USERS Turnaround Times (TATs) for Microbiology Investigations

DEPARTMENT OF MICROBIOLOGY IMPORTANT NOTICE TO USERS Turnaround Times (TATs) for Microbiology Investigations Dear User, ISSUE: M008 DEPARTMENT OF MICROBIOLOGY IMPORTANT NOTICE TO USERS Turnaround Times (TATs) for Microbiology Investigations In order to comply with national quality guidance and as part of our

More information

Multiplexing; what is it good for? Dr. S.M. Jazayeri MD, PhD, Virologist. Tehran University of Medical Sciences

Multiplexing; what is it good for? Dr. S.M. Jazayeri MD, PhD, Virologist. Tehran University of Medical Sciences Multiplexing; what is it good for? Dr. S.M. Jazayeri MD, PhD, Virologist Tehran University of Medical Sciences In a clinical laboratory setting In a clinical laboratory setting 1.Speed is utmost In a clinical

More information

R&D AND INNOVATION. Francesco Colotta Senior Corporate VP and Chief Medical Officer

R&D AND INNOVATION. Francesco Colotta Senior Corporate VP and Chief Medical Officer R&D AND INNOVATION Francesco Colotta Senior Corporate VP and Chief Medical Officer IN VITRO DIAGNOSTICS: BASICS DETECTION IN BIOLOGICAL FLUIDS... E.G. BLOOD, URINE, CSF, IN VITRO DIAGNOSTICS...OF A MOLECULE......

More information

Controls & Calibrators. Disease Quality Controls

Controls & Calibrators. Disease Quality Controls Controls & Calibrators Infectious Disease Quality Controls Infectious Disease Quality Controls A broad selection of controls designed to monitor assay precision of hepatitis, retrovirus, sexually transmitted

More information

MENU PRODUCT MOLECULAR. International Product Listing. Simplexa Molecular Kits Integrated Cycler Molecular Reagents and Primer Pairs

MENU PRODUCT MOLECULAR. International Product Listing. Simplexa Molecular Kits Integrated Cycler Molecular Reagents and Primer Pairs International Product Listing MOLECULAR PRODUCT MENU Simplexa Molecular Kits Integrated Cycler Molecular Reagents and Primer Pairs Products are not intended for donor screening. Simplexa Molecular Kits

More information

Prevalence of human papillomavirus and bacteria as sexually transmitted infections in symptomatic and asymptomatic women

Prevalence of human papillomavirus and bacteria as sexually transmitted infections in symptomatic and asymptomatic women Prevalence of human papillomavirus and bacteria as sexually transmitted infections in symptomatic and asymptomatic women Background: Sexually transmitted infections (STI) are common around the world, and

More information

Fifteen years of molecular EQA: progress and challenges

Fifteen years of molecular EQA: progress and challenges Fifteen years of molecular EQA: progress and challenges Anton M van Loon 1, Stuart West 2 and Paul Wallace 2 1 Department of Virology, UMC Utrecht, The Netherlands 2 QCMD, Glasgow, Scotland Key Issues

More information

Schedule of Accreditation

Schedule of Accreditation Schedule of Accreditation Organisation Name National Virus Reference Laboratory INAB Reg No 326MT Contact Name Eimear Malone Address University College Dublin, Belfield, Dublin Contact Phone No 01-7161319

More information

Non-reproductive tissues and cells

Non-reproductive tissues and cells Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding on national level More stringent - recommended on national level Not legy binding and not recommended on

More information

Molecular Diagnosis Future Directions

Molecular Diagnosis Future Directions Molecular Diagnosis Future Directions Philip Cunningham NSW State Reference Laboratory for HIV/AIDS & Molecular Diagnostic Medicine Laboratory, SydPath St Vincent s Hospital Sydney Update on Molecular

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Royal Liverpool & Broadgreen University Hospitals NHS Trust Department of Virology Liverpool Clinical Laboratories Royal Liverpool and Broadgreen

More information

Association for Molecular Pathology Promoting Clinical Practice, Basic Research, and Education in Molecular Pathology

Association for Molecular Pathology Promoting Clinical Practice, Basic Research, and Education in Molecular Pathology Association for Molecular Pathology Promoting Clinical Practice, Basic Research, and Education in Molecular Pathology 9650 Rockville Pike, Bethesda, Maryland 20814 Tel: 301-634-7939 Fax: 301-634-7990 Email:

More information

Non-reproductive tissues and cells

Non-reproductive tissues and cells Colour key Tested pathogen VIRAL Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recommended on national level Not

More information

ExiPrep TM Dx Fully Automated Nucleic Acid Extraction

ExiPrep TM Dx Fully Automated Nucleic Acid Extraction 20150629 Ver.1(EN) ExiPrep TM Dx Fully Automated Nucleic Acid Extraction 8-11 Munpyeongseo-ro, Daedeok-gu, Daejeon, 34302, Republic of Korea Tel: +82-42-930-8777 Fax: +82-42-930-8688 E-mail: sales@bioneer.com

More information

7/13/2018. NEW TESTS - Please update your EMR catalog with those appropriate to your practice

7/13/2018. NEW TESTS - Please update your EMR catalog with those appropriate to your practice NEW TESTS - Please update your EMR catalog with those appropriate to your practice 6987003 MySwab Vaginosis Profile MySwab Vag Group LOINC Result Code Mnemonic Result Name Reference Range UOM Result Type

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK West of Scotland Specialist Virology Centre New Lister Building Level 5 Glasgow Royal Infirmary 10-16 Alexandra Parade Glasgow G31 2ER Contact:

More information

Clinical Microbiology CLS 2019 Clinical Microbiology Laboratory Scheme Application Form

Clinical Microbiology CLS 2019 Clinical Microbiology Laboratory Scheme Application Form Laboratory Scheme Application Form complete all sections below and return to LGC Standards Proficiency Testing by email, fax or post. Returning customer Lab ID: Purchase order no.: (compulsory) Round Despatch

More information

Update on the development of clinical diagnostic run controls at NIBSC. Neil Almond Division of Virology

Update on the development of clinical diagnostic run controls at NIBSC. Neil Almond Division of Virology Update on the development of clinical diagnostic run controls at NIBSC Neil Almond Division of Virology BACKGROUND Molecular techniques are increasingly being used for microbiological diagnoses Assays

More information

Commercial Assays an Overview. Molecular Workshop

Commercial Assays an Overview. Molecular Workshop Commercial Assays an Overview Molecular Workshop Commercial Assays By Discipline Infectious Disease Blood borne viruses Respiratory Viruses and Bacteria Enteropathogens STD s bacteria, viruses and parasites,

More information

Chain of Infection Agent Mode of transmission Contact (direct, indirect, droplet spread) Airborne Common-vehicle spread Host

Chain of Infection Agent Mode of transmission Contact (direct, indirect, droplet spread) Airborne Common-vehicle spread Host Goals Microbiology of Healthcare-associated Infections William A. Rutala, Ph.D., M.P.H. Director, Statewide Program for Infection Control and Epidemiology and Research Professor of Medicine, University

More information

Perform Gram stain only. Select Survey D5, Gram Stain

Perform Gram stain only. Select Survey D5, Gram Stain www.cap.org Bacteriology This flowchart is provided as a guide for ordering the appropriate Bacteriology Surveys for your laboratory s testing menu. In order to meet CLIA requirements for the subspecialty

More information

New diagnostic tests for sexually transmitted infections. Jens Van Praet 30/11/2018

New diagnostic tests for sexually transmitted infections. Jens Van Praet 30/11/2018 New diagnostic tests for sexually transmitted infections Jens Van Praet 30/11/2018 Introduction Data from our national microbiological labs suggest STIs are an important clinical issue Correlation with

More information

The Study of Congenital Infections. A/Prof. William Rawlinson Dr. Sian Munro

The Study of Congenital Infections. A/Prof. William Rawlinson Dr. Sian Munro The Study of Congenital Infections A/Prof. William Rawlinson Dr. Sian Munro Current Studies SCIP Study of Cytomegalovirus (CMV) Infection in Pregnancy ASCI Amniotic Fluid Study of Congenital Infections

More information

EC CERTIFICATE. National Institute for Biological Standards and Control (NIBSC) Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG UK

EC CERTIFICATE. National Institute for Biological Standards and Control (NIBSC) Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG UK National Institute for Biological Standards and Control (NIBSC) EC Certificate - Full Quality Assurance System Approval Certificate Annex IV (excluding sections 4 and 6) of Council Directive 98/79/EC on

More information

Pre-Assessment Review: Microbiology, Part 2: Virology. Dr. David Hillyard

Pre-Assessment Review: Microbiology, Part 2: Virology. Dr. David Hillyard Pre-Assessment Review: Microbiology, Part 2: Virology Dr. David Hillyard 1. Mutations or deletions within which gene are associated with the hyper-toxin producing strain of Clostridium difficile? a. tcda

More information

Immunohistochemical Confirmation of Infections

Immunohistochemical Confirmation of Infections Immunohistochemical Confirmation of Infections Danny A. Milner, Jr, MD, MSc, FCAP The Brigham and Women s Hospital Harvard Medical School Boston, Masschusetts USA Judicious Use of Immunohistochemistry

More information

Technical Bulletin No. 98b

Technical Bulletin No. 98b CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 98b Chlamydia trachomatis and Neisseria gonorrhoeae Dual Target PCR Assay UPDATED Specimen Requirements October 13, 2016 Contact: Susan

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy Identification of Microorganisms Using Nucleic Acid Probes File Name: Origination: Last CAP Review: Next CAP Review: Last Review: identification_of_microorganisms_using_nucleic_acid_probes

More information

ExiStation System 3. AccuPower Real-Time PCR Diagnostic Kits 7. ExiPrep Dx Nucleic Acid Extraction Kits 43. Ordering Information 49

ExiStation System 3. AccuPower Real-Time PCR Diagnostic Kits 7. ExiPrep Dx Nucleic Acid Extraction Kits 43. Ordering Information 49 A B C D ExiStation System 3 7 B-1. Human Immunodeficiency Virus B-2. Hepatitis Virus B-3. BCI Blood Screening B-4. Mycobacterium Tuberculosis B-5. Sexually Transmitted Infections B-6. Transplantation related

More information

Product Information and Testing - Amended. Product Information

Product Information and Testing - Amended. Product Information Product Information and Testing - Amended Product Information Product Name ips(foreskin)-3 Alias ips(foreskin) clone (#3) Lot Number WB0002 Depositor University of Wisconsin Laboratory of Dr. James Thomson

More information

Non-reproductive tissues and cells

Non-reproductive tissues and cells Colour key Minimum requirements as set out in Directive 2004/23/EC and its technical Directives (particularly 2006/17/EC) More stringent -legally binding, applies for all donations and all donor profiles

More information

QUALITY CONTROL for MOLECULAR DIAGNOSTICS Quality issues highlighted through international external quality assessment

QUALITY CONTROL for MOLECULAR DIAGNOSTICS Quality issues highlighted through international external quality assessment QUALITY CONTROL for MOLECULAR DIAGNOSTICS Quality issues highlighted through international external quality assessment William G MacKay PhD Neutral Office Coordinator QCMD The Altum Building, Todd Campus

More information

STI Multiplex Array. Rapid, simultaneous detection of 10 sexually transmitted infections

STI Multiplex Array. Rapid, simultaneous detection of 10 sexually transmitted infections STI Multiplex Array Rapid, simultaneous detection of 10 sexually transmitted infections STI Multiplex Array Rapid, simultaneous detection of 10 sexually transmitted infections Introduction The STI Multiplex

More information

STI Multiplex Array. Rapid, simultaneous detection of 10 sexually transmitted infections

STI Multiplex Array. Rapid, simultaneous detection of 10 sexually transmitted infections STI Multiplex Array Rapid, simultaneous detection of 10 sexually transmitted infections STI Multiplex Array Rapid, simultaneous detection of 10 sexually transmitted infections Introduction The STI Multiplex

More information

At the forefront of multiplex PCR

At the forefront of multiplex PCR Prodesse At the forefront of multiplex PCR 2005 PRODUCT CATALOG Distributed by Standard Format Assays Real Time Format Assays Hexaplex Influenza A Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza

More information

Memo No: Date: 25-Nov NEW Serology and Virology Testing

Memo No: Date: 25-Nov NEW Serology and Virology Testing Memo No: 2014-61 Date: 25-Nov-2014 www.hicl.on.ca Re: NEW Serology and Virology Testing In Common Laboratories has been working hard to expand our test menu. We are pleased to announce the availability

More information

AZOOSPERMIA Chromosome Y

AZOOSPERMIA Chromosome Y AZOOSPERMIA Chromosome Y M i c r o d e l e t i o n Ref.: PI EDP003024-40 testspi EDP002024 1. INTRODUCTION In 1976, Tiepolo and Zuffardi reported de novo, microscopically detectable deletions of the distal

More information

Molecular Diagnostics Overview JAN A. NOWAK, PHD, MD PATHOLOGY AND LABORATORY MEDICINE MOLECULAR DIAGNOSTICS LABORATORY FEBRUARY 15, 2018

Molecular Diagnostics Overview JAN A. NOWAK, PHD, MD PATHOLOGY AND LABORATORY MEDICINE MOLECULAR DIAGNOSTICS LABORATORY FEBRUARY 15, 2018 Molecular Diagnostics Overview JAN A. NOWAK, PHD, MD PATHOLOGY AND LABORATORY MEDICINE MOLECULAR DIAGNOSTICS LABORATORY FEBRUARY 15, 2018 Some Key Points Molecular Testing has applications in every section

More information

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR Real-Time (DNA) Real-time Exicycler 96 Rotor-Gene Q/6000 IU Mix1 Mix2 IU/μl IU/μl IU/μl IU/μl IU/μl IPC NTC C 1 Lot# 2 Freeze & thawing 1 MSDS: Material Safety Data Sheets Real- (TaqMan time ' FAM ' BHQ1

More information

New technologies reaching the clinic

New technologies reaching the clinic New technologies reaching the clinic Martin Däumer May 31, 2018 Deep-sequencing Standard Sanger-sequencing...PQIYMDDHTRE... Ultra-deep-sequencing...PQIYMDDHTRE......PQIYMDDHTRE......PQIYVDDHTRE......PQIYMDDHTRE......PQIYMDDHTRE......PQIYMDDHTRE...

More information

The New Regulations - Special IVD Issues

The New Regulations - Special IVD Issues The New Regulations - Special IVD Issues Dirk Stynen, Ph. D. President - Principal Consultant Qarad Geel, Belgium RMD Brussels October 2018 The IVD Regulation 2017/746 October 29, 2018 www.qarad.com 2

More information

Viral RNA / DNA purification products from MACHEREY-NAGEL. MN guide for viral RNA / DNA purification Multiple solutions for many needs

Viral RNA / DNA purification products from MACHEREY-NAGEL. MN guide for viral RNA / DNA purification Multiple solutions for many needs Viral RNA / DNA Purification Guide Viral RNA / DNA purification products from MACHEREY-NAGEL MN guide for viral RNA / DNA purification Multiple solutions for many needs Single or high throughput Human

More information

About the LIAISON MDX

About the LIAISON MDX The quality of treatment starts with diagnosis International Molecular Product MENU Simplexa Molecular Kits LIAISON MDX Molecular Reagents Primer Pairs About the LIAISON MDX The LIAISON MDX is an innovative

More information

SP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World

SP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World MIT OpenCourseWare http://ocw.mit.edu SP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World Spring 2009 For information about citing these materials or our

More information

Non-reproductive tissues and cells Recommending authority/ association

Non-reproductive tissues and cells Recommending authority/ association Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More stringent - recommended Not legy binding and not recommended Tested pathogen Donor test/ technique

More information

USER GUIDE FOR SPECIMEN COLLECTION

USER GUIDE FOR SPECIMEN COLLECTION DIAGNOSTIC LAB SPECIMEN COLLECTION GUIDE USER GUIDE FOR SPECIMEN COLLECTION ACM GLOBAL LABORATORIES DIAGNOSTIC SERVICES ACM Global Laboratories offers a comprehensive menu of services that support many

More information

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR

(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR Real-Time (DNA) Real-time Exicycler 96 Rotor-Gene Q/6000 IU Mix1 Mix2 IU/μl IU/μl IU/μl IU/μl IU/μl IPC NTC C 1 Lot# 2 Freeze & thawing 1 MSDS: Material Safety Data Sheets (TaqMan Real-time ' FAM ' BHQ1

More information

MOLECULAR DIAGNOSTICS OF INFECTIOUS DISEASES: STABILITY OF SPECIMENS DURING PREANALYTICS

MOLECULAR DIAGNOSTICS OF INFECTIOUS DISEASES: STABILITY OF SPECIMENS DURING PREANALYTICS MOLECULAR DIAGNOSTICS OF INFECTIOUS DISEASES: STABILITY OF SPECIMENS DURING PREANALYTICS OVERVIEW (1) Background (2) Sample collection vials useful for different types of specimens (3) Stability of nucleic

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Schedule of Accreditation 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK National Infection Service, Public Health England Colindale 61 Colindale Avenue London NW9 5EQ Contact: Dr Sanjiv

More information

For purification of viral DNA and RNA from a wide range of sample materials

For purification of viral DNA and RNA from a wide range of sample materials QIAamp virus kits For purification of viral DNA and RNA from a wide range of sample materials Automatable on QIAGEN s proven QIAamp Kits set the standard for purification of viral DNA and RNA. QIAamp virus

More information

ACMG/CAP Cytogenetics CY

ACMG/CAP Cytogenetics CY www.cap.org Cytogenetics Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services ACMG/CAP Cytogenetics CY Analyte CY Challenges per Shipment

More information

Menu and flexibility with the QIAscreen HPV PCR Test

Menu and flexibility with the QIAscreen HPV PCR Test Menu and flexibility with the QIAscreen HPV PCR Test Sample to Insight HPV and Cervical cancer Worldwide, HPV is one of the most common STIs Persistent infection with high-risk HPV types is linked to virtually

More information

Test Requested Specimen Ordering Recommendations

Test Requested Specimen Ordering Recommendations Microbiology Essentials Culture and Sensitivity (C&S) Urine C&S Catheter Surgical (excluding kidney aspirates) Voided Requisition requirements o Specific method of collection MUST be indicated o Indicate

More information

ENG MYCO WELL D- ONE REV. 1.UN 29/09/2016 REF. MS01283 REF. MS01321 (COMPLETE KIT)

ENG MYCO WELL D- ONE REV. 1.UN 29/09/2016 REF. MS01283 REF. MS01321 (COMPLETE KIT) ENG MYCO WELL D- ONE MYCO WELL D-ONE System for the presumptive identification and antimicrobial susceptibility test of urogenital mycoplasmas, Gardnerella vaginalis, Trichomonas vaginalis, Candida albicans

More information

Non-reproductive tissues and cells

Non-reproductive tissues and cells Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legally binding on national level More stringent testing - recommended on national level Not legally binding

More information

Real-Time PCR Detects Viral Nucleic Acids in Universal Transport Medium (UTM-RT) with Flocked Swabs

Real-Time PCR Detects Viral Nucleic Acids in Universal Transport Medium (UTM-RT) with Flocked Swabs Real-Time PCR Detects Viral Nucleic Acids in Universal Transport Medium (UTM-RT) with Flocked Swabs S. CASTRICIANO*, A. PETRICH, M. SMIEJA and M.A. CHERNESKY Departments of Pathology & Molecular Medicine,

More information

Microbiology EQA Product Portfolio

Microbiology EQA Product Portfolio Labquality EQAS Microbiology EQA Product Portfolio Clinically relevant external quality assessment program for microbiology Bacterial serology Bacteriology Mycology Parasitology Preanalytics Virology Labquality

More information

Diagnostics: Bench to Bedside Pathway

Diagnostics: Bench to Bedside Pathway Diagnostics: Bench to Bedside Pathway Rosanna W Peeling Professor and Chair, Diagnostic Research Director, International Diagnostics Centre London School of Hygiene & Tropical Medicine www.idx-dx.org The

More information

Non-reproductive tissues and cells Recommending authority/ association

Non-reproductive tissues and cells Recommending authority/ association Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recomd on national level Not legy binding and not recomd

More information

Human diagnostics. Better be Sure: Quantify HDV & HBV viral load. RoboGene product family

Human diagnostics. Better be Sure: Quantify HDV & HBV viral load. RoboGene product family Human diagnostics Better be Sure: Quantify HDV & HBV viral load. RoboGene product family 2 RoboGene Product Family Improved patient management: Standardized monitoring of HBV DNA and HDV RNA viral load.

More information

Purification of viral nucleic acid from serum, plasma, cell-free biological fluids MACHEREY- NAGEL

Purification of viral nucleic acid from serum, plasma, cell-free biological fluids MACHEREY- NAGEL Purification of viral nucleic acid from serum, plasma, cell-free biological fluids Purification of viral nucleic acid from serum, plasma, cell-free biological fluids viral RNA: viral DNA: NucleoSpin RNA

More information

Neonatal Pneumonia-2 assay

Neonatal Pneumonia-2 assay Neonatal Pneumonia-2 assay For the detection of Ureaplasma species (Ureaplasma parvum and Ureaplasma urealyticum), Chlamydia trachomatis and Mycoplasma hominis using the BD MAX TM system. Instructions

More information

PRODUCT# PRODUCT NAME VOLUME

PRODUCT# PRODUCT NAME VOLUME The quality of treatment starts with diagnosis International Molecular Product MENU Simplexa Molecular Kits LIAISON MDX Molecular Reagents Primer Pairs About the LIAISON MDX The LIAISON MDX is an innovative

More information

EQA PROGRAMME CATALOGUE. Version number CAT2019/01

EQA PROGRAMME CATALOGUE.   Version number CAT2019/01 2019 EQA PROGRAMME CATALOGUE www.qcmd.org Version number CAT2019/01 Contents An Introduction to the QCMD EQA Schemes 5 EQA Groups Blood Borne Virus 6 Central Nervous System 6 Congenital Infections 7 Drug

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Department of Microbiology Princess Alexandra Hospital Hamstel Road Harlow CM20 1QX Contact: D Orriss Tel: +44 01279 827138 E-Mail: Debbie.Orriss@pah.nhs.uk

More information

Rubina Ghani, Professor Department of Biochemistry,

Rubina Ghani, Professor Department of Biochemistry, IDENTIFICATION OF 12 STD PATHOGENS IN SEMEN USING POLYMERASE CHAIN REACTION (PCR) AND FLOW-THROUGH HYBRIDIZATION TECHNOLOGY Rubina Ghani, Professor Department of Biochemistry, Pathological & Molecular

More information

Code CPT Descriptor Test Purpose and Method Crosswalk Recommendation SEPT9 (Septin9) (e.g., colorectal cancer) methylation analysis

Code CPT Descriptor Test Purpose and Method Crosswalk Recommendation SEPT9 (Septin9) (e.g., colorectal cancer) methylation analysis ASSOCIATION FOR MOLECULAR PATHOLOGY Education. Innovation & Improved Patient Care. Advocacy. 9650 Rockville Pike. Bethesda, Maryland 20814 Tel: 301-634-7939 Fax: 301-634-7995 amp@amp.org www.amp.org August

More information

Non-reproductive tissues and cells

Non-reproductive tissues and cells Ministry of Health: Institute for Transplantation and Biomedicine / Colour key VIRAL HIV 1 and HIV 2 Hepatitis B Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More

More information

Programme Groupings. For 2013, the preliminary molecular external quality assessment (EQA) programme schedule has been displayed by Disease Group.

Programme Groupings. For 2013, the preliminary molecular external quality assessment (EQA) programme schedule has been displayed by Disease Group. Equalis EQA s 2013 Preliminary Schedule For 2013, the preliminary molecular external quality assessment (EQA) programme schedule has been displayed by Disease Group. Note: EQA programmes may appear in

More information

Proficiency Testing Materials for use with FilmArray Panels

Proficiency Testing Materials for use with FilmArray Panels Proficiency Testing Materials for use with FilmArray Panels Introduction This document provides a listing of proficiency testing materials that have been tested at BioFire and are compatible with the FilmArray

More information

Non-reproductive tissues and cells Recommending authority/ association

Non-reproductive tissues and cells Recommending authority/ association Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legally binding More stringent - recommended Not legally binding and not recommended Non-reproductive tissues and cells

More information

IN SALIVA VERITAS. GBO Saliva Collection System from Greiner Bio-One

IN SALIVA VERITAS. GBO Saliva Collection System from Greiner Bio-One IN SALIVA VERITAS GBO Saliva Collection System from Greiner Bio-One GBO Saliva Collection System for the COLLECTION of SALIVA SAMPLES from both adults and young persons for ORAL FLUID TESTING Oral Fluid

More information

Innovation in Diagnostics. ToRCH. A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES

Innovation in Diagnostics. ToRCH. A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES Innovation in Diagnostics ToRCH A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES EN TOXOPLASMOSIS Toxoplasmosis is a parasitic disease caused by with the obligate intracellular

More information

Medicaid Family Planning Waiver Services CPT Codes and ICD-10 Diagnosis Codes

Medicaid Family Planning Waiver Services CPT Codes and ICD-10 Diagnosis Codes CPT Code Description of Covered Codes Evaluation and Management 99384FP 99385FP Family planning new visit 99386FP 99394FP 99395FP Family planning established visit 99396FP 99401FP HIV counseling (pre-test)

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Luton and Dunstable University Hospital NHS Foundation Trust Lewsey Road Luton Bedfordshire LU4 0DZ Contact: Pauline Philip Tel: +44 (0)1582

More information

Products for cfdna and mirna isolation. Subhead Circulating Cover nucleic acids from plasma

Products for cfdna and mirna isolation. Subhead Circulating Cover nucleic acids from plasma MACHEREY-NAGEL Products for cfdna and mirna isolation Bioanalysis Subhead Circulating Cover nucleic acids from plasma n Flexible solutions for small and large blood plasma volumes n Highly efficient recovery

More information

Multiplex-PCR in clinical virology benefits and limitations. Weihenstephan Multiplex-PCR the concept:

Multiplex-PCR in clinical virology benefits and limitations. Weihenstephan Multiplex-PCR the concept: Multiplex-PCR in clinical virology benefits and limitations ans itschko, elga Mairhofer, Anna-Lena Winkler Max von Pettenkofer-Institute Department of Virology Ludwig-Maximilians-University, Munich Weihenstephan

More information

DEFINITIVE GLOBAL ANNUAL REPORT Molecular Biology Microbiology 2015

DEFINITIVE GLOBAL ANNUAL REPORT Molecular Biology Microbiology 2015 EXPERTISE, SERVICE PROVISION AND CUSTOMER RELATIONS QUALITY OF MEDICAL LABORATORIES CLINICAL BIOLOGY COMMISSION COMMITTEE OF EXPERTS EXTERNAL QUALITY ASSESSMENT IN CLINICAL BIOLOGY DEFINITIVE GLOBAL ANNUAL

More information

H. pylori IgM CLIA kit

H. pylori IgM CLIA kit H. pylori IgM CLIA kit Cat. No.:DEEL0251 Pkg.Size:96 tests Intended use Helicobacter pylori IgM Chemiluminescence ELISA is intended for use in evaluating the serologic status to H. pylori infection in

More information

Professor Jonathan Ross

Professor Jonathan Ross SECOND JOINT CONFERENCE OF BHIVA AND BASHH 2010 Professor Jonathan Ross Whittall Street Clinic, Birmingham COMPETING INTEREST OF FINANCIAL VALUE > 1,000: Speaker Name Statement Professor Ross has received

More information

Version number CAT 2016/01

Version number CAT 2016/01 Version number CAT 2016/01 Contents An Introduction to the QCMD EQA Schemes 4 Disease Groups Blood Borne Virus 5 Central Nervous System 5 Congenital Infections 6 Drug Resistance 6 Exotic/Emerging Diseases

More information

AmpliSens EBV / CMV / HHV6-screen-FRT PCR kit

AmpliSens EBV / CMV / HHV6-screen-FRT PCR kit For Professional Use Only AmpliSens EBV / CMV / HHV6-screen-FRT PCR kit Instruction Manual AmpliSens Ecoli s.r.o., Studenohorska 12 841 03 Bratislava 47 Slovak Republic Tel.: +421 2 6478 9336 Fax: +421

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Clinical Microbiology QMC Campus Derby Road Nottingham NG7 2UH Contact: Jil Bowskill Tel: +44 (0) 1905 760192 Ext 30659 E-Mail: jilean.bowskill@nuh.nhs.uk

More information

DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I

DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I * Sensitivity HIV DS-EIA-ANTI-HIV-UNIF (Ab) I-153 96 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-150 192 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-155 480 115 24 DS-EIA-HIV-AG-SCREEN I-1452 96 115 12 0.025 IU/ml DS-EIA-HIV-AGAB-SCREEN

More information

Viral Antigens Recombinant Proteins. Life Science, Inc. Large Scale Manufacturing, R&D and Custom Services.

Viral Antigens Recombinant Proteins. Life Science, Inc. Large Scale Manufacturing, R&D and Custom Services. Viral Antigens Recombinant Proteins Large Scale Manufacturing, R&D and Custom Services Life Science, Inc. www.meridianlifescience.com Life Science, Inc. Meridian Life Science, (MLS) is an industry leader

More information

Persistent Infections

Persistent Infections Persistent Infections Lecture 17 Biology 3310/4310 Virology Spring 2017 Paralyze resistance with persistence WOODY HAYES Acute vs persistent infections Acute infection - rapid and self-limiting Persistent

More information

RealLine Mycoplasma genitalium Str-Format

RealLine Mycoplasma genitalium Str-Format Instructions for use ASSAY KIT FOR THE QUALITATIVE DETECTION OF MYCOPLASMA GENITALIUM DNA BY REAL-TIME PCR METHOD In vitro Diagnostics () VBD4396 96 Tests valid from December 2018 Rev06_1218_EN Page 1

More information

M O L E C U L A R G E N E T I C S

M O L E C U L A R G E N E T I C S MOLECULAR GENETICS ADVANTAGES OF MOLECULAR GENETICS Molecular genetics is a dynamic and transformative area of diagnostics, leading to insights in research and treatment in many disease states that are

More information

Advances in STI diagnostics. Dr Paddy Horner Consultant Senior Lecturer University of Bristol

Advances in STI diagnostics. Dr Paddy Horner Consultant Senior Lecturer University of Bristol Advances in STI diagnostics Dr Paddy Horner Consultant Senior Lecturer University of Bristol Advances in STI diagnostics Rapid expansion in on-line STI testing Outstripping NHS expert advice Increasing

More information

geneombio Technologies

geneombio Technologies MOLECULAR DIAGNOSTICS SERVICES geneombio Technologies SN Test Method Test code Type of Sample Type of container TAT* Frequency MRP Infectious diseases - detection, quantification, genotyping assays A MTB

More information

DX CT/NG/MG AUTO ASSAY

DX CT/NG/MG AUTO ASSAY DX CT/NG/MG AUTO ASSAY 5 x 96 37015 Direct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium by Real-Time PCR * 881106-2013/02 Table of Content 1- INTENDED USE...3 2-

More information

Be sure! Your Power for Health. PelvoCheck CT/NG Your test kit for Chlamydia trachomatis screening and Neisseria gonorrhoeae infections

Be sure! Your Power for Health. PelvoCheck CT/NG Your test kit for Chlamydia trachomatis screening and Neisseria gonorrhoeae infections Your Power for Health Laboratory Information CT/NG DNA-Chip Be sure! Your test kit for Chlamydia trachomatis screening and Neisseria gonorrhoeae infections is part of the ocheck product line from Greiner

More information

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Microbiology Department Contact: Dr David Ashburn Zone 3 Raigmore Hospital Tel: +44 (0) 1463 704108 Old Perth Road Fax: +44 (0) 1463 705648

More information

H. pylori Antigen ELISA Kit

H. pylori Antigen ELISA Kit H. pylori Antigen ELISA Kit Catalog Number KA3142 96 assays Version: 04 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of

More information