VisinArray Arrays fr DNA analysis Gentyping f Human Papillmavirus mplete C r u Y frm n i t u l S ctin a r t x E DNA sis! y l a n A t Simultaneus Detectin f 41 HPV Types High Sensitivity Easy t Handle
Imprtance f HPV Testing The human papillmavirus (HPV) has been cnclusively identified as the majr risk factr fr cervical cancer. It is the third mst cmmn cancer in wmen wrldwide, with an estimated number f 530,000 new cases and 280,000 deaths each year. Over the last years the relevance f HPV in the histry f rpharyngeal cancers has becme mre and mre imprtant which is indicated by a dramatically risen number f cancers f the ral cavity and pharynx linked t HPV. Cervical Cancer Prgressin Initial HPV infectin requires virin integratin int the basal epithelial cells. Whereas mst HPV infectins are transient and are cleared by the immune system, infectin with HPV high risk types may lead t cancer when infectin persists. Expsure Transient Infectin Persistant Infectin Infectin Prgressin Invasin Nrmal Cervix Clearance Prductive Infectin Regressin Precursr Lesin Cancer Cytlgy? Cytlgy? HPV Gentype? Cytlgy? HPV Gentype? Cytlgy? HPV Gentype? Duratin 0 16-18 mnths 24 mnths 7-15 years VisinArray HPV Chip Fast and Reliable Gentyping The VisinArray HPV Chip 1.0 is intended t be used with the VisinArray Analysis Package fr the qualitative detectin and gentyping f PCR amplificates f 41 clinically relevant HPV gentypes. + 6 11 16 18 26 High Risk HPV Types detected by the VisinArray HPV Chip 31 33 34 35 39 40 42 43 44 45 51 52 53 54 55 56 57 58 59 61 62 66 67 68a 68b 69 70 72 73 81 82 82 IS39 MM4 83 84 90 91 35 34 33 31 26 18 16 11 6 + 54 53 52 51 45 44 43 42 40 39 16 18 31 33 35 39 45 51 52 56 58 59 Prbably High Risk HPV Types detected by the VisinArray HPV Chip 26 34 53 66 67 68a 68a 67 66 62 61 59 58 57 56 55 81 73 72 70 69 68b 91 90 84 83 82 MM4 82 IS39 68b 69 70 73 82 (IS39) 82 (MM4) Lw Risk HPV Types detected by the VisinArray HPV Chip 6 11 40 42 43 44 54 55 57 High Risk Prbably High Risk Lw Risk Guide Dts/Psitive Cntrl 61 62 72 81 (CP8304) 83 (MM7) 84 (MM8) 90 91 References: Bumba LM, et al. (2014) BMC Public Health 14: 1320 Clmb N, et al. (2012) Ann Oncl 23 Suppl 7: vii27-32 Crw JM, et al. (2012) Nature 488: S2-S3 IARC (2012) Bilgical Agents. IARC Mngr Eval Carcing Risks Hum, 100B: 1-441 Pljak M, et al. (2016) J Clin Virl 76 Suppl 1: S3-S13 http://glbcan.iarc.fr
1. Sample Cllectin Fr the detectin f HPV gentypes with the VisinArray HPV system the fllwing raw material can be used fr DNA extractin: Frmalin-fixed, paraffin-embedded (FFPE) tissue samples Cervical swab/brush specimen Liquid based cytlgy specimen (ThinPrep ) 2. Detectin & Differentiatin f 41 HPV Types Step 1: Amplificatin and Labeling in a PCR Bitinylated primers are used t amplify and label different sectins f the L1 regin f the HPV genme. The human HLA-DQA1 gene is als amplified and serves as a PCR psitive cntrl and as a genmic cntrl. Step 2: Hybridizatin n the Glass Chip After amplificatin, the bitinylated sequences hybridize t cmplementary DNA capture sequences n the glass chip. Step 3: Detectin and Visualizatin Specifically bund and bitinylated sequences are visualized by secndary marking with a streptavidinperxidase cnjugate and a staining with tetramethylbenzidine. After clr develpment, evaluatin is perfrmed using the VisinArray Analyzer Sftware.
3. Wrkflw Schedule This is a cndensed prtcl fr the VisinArray methd and shuld nt replace the instructin fr use! 0 Min. PCR Fr the PCR the VisinArray Primer Kit is used The master mix is prepared by using the dntp/dutp Slutin, HPV Primer Mix, VisinArray PreCise Taq Plymerase, VisinArray Uracil-DNA Glycsylase and the crrespnding reactin buffers Alternatively: The VisinArray HPV PreCise Master Mix can be used DNA sample is added t the master mix Hybridizatin PCR prduct and Hybridizatin Slutin are mixed well Mix is applied nt the VisinArray Chip 30 Min. Duratin: 30 min Stringency Wash Unbund DNA fragments are remved using 1x Wash Buffer Drying f VisinArray Chip by centrifugatin Duratin: 2 min Detectin Marking f bitinylated sequences using the Detectin Slutin Visualizatin is perfrmed by applying the Blue Spt Slutin 50 Min. Duratin: 17 min Wash Remving f the Blue Spt Slutin by washing with 1x Wash Buffer Drying f VisinArray Chip by centrifugatin Duratin: 2 min Analysis 60 Min. Chips are scanned with VisinArray Scanner 8100 Autmated analysis is perfrmed by using the VisinArray Analyzer Sftware Duratin: 10 min Quick & easy 1 hur prtcl Autmated user-friendly evaluatin within a few minutes
HPV Tests in Cmparisn Assay Gentyping C-infectin N. f CE-IVD HPV Types (cpies/reactin) Anyplex TM II HPV28 Detectin 28 50 Cervista HPV HR 14 1.250 CLART HPV (3, 4) 35 10 HPV 16 + 18 HPV 16 + 18 14 150 cpies/ml digene HC2 HPV DNA Test 18 3100 INNO-LiPA HPV Gentyping Extra II 32 20 41 50 cbas HPV Test VisinArray * Sensitivity data are accrding t the respective instructin fr use VisinArray At a Glance Simultaneus gentyping f 41 different HPV types all certified fr in vitr diagnstic use All capture sequences and psitive cntrls are set up n the VisinArray Chip as duplicates High sensitivity and specificity Quick & easy 1 hur prtcl Autmated evaluatin using the VisinArray Analyzer Sftware simple visualizatin & quick analysis in just a few minutes Sensitivity*
VisinArray Arrays fr DNA analysis VisinArray HPV Chips Prd. N. Prduct Tests VA-0001-10 VisinArray HPV Chip 1.0 10 Incl. 10 pieces VA-0001-50 VisinArray HPV Chip 1.0 50 Incl. 5x 10 pieces VA-0002-10 VisinArray HPV High Risk Chip 1.0 10 Incl. 10 pieces VA-0002-50 VisinArray HPV High Risk Chip 1.0 50 Incl. 5x 10 pieces VisinArray DNA Extractin, PCR, and Detectin Prd. N. Prduct Tests VI-0001-50 VisinArray FFPE DNA Extractin Kit 50 Incl. Paraffin Disslver; Tissue Lysis Buffer; Decrsslink Buffer; DNA Wash Buffer; Prteinase K; Prteinase K Buffer; Elutin Buffer; Clumns; Cllectin Tubes VI-0002-50 VisinArray Cytlgy DNA Extractin Kit 50 Incl. Pre-Lysis Buffer; Cell Lysis Buffer; DNA Wash Buffer; Prteinase K; Prteinase K Buffer; Elutin Buffer; Clumns; Cllectin Tubes Prd. N. Prduct Tests VP-0001-50 VisinArray HPV Primer Kit 50 Incl. HPV Primer Mix; dntp/dutp Slutin VE-0001-100 VisinArray PreCise Taq DNA Plymerase 100 Incl. VisinArray PreCise Taq DNA Plymerase, Reactin Buffer, 10x; PreCise MgCl 2, 25 mm VE-0002-100 VisinArray Uracil-DNA Glycsylase 100 Incl. VisinArray Uracil- DNA Glycsylase (UDG), UDG Reactin Buffer, 10x ES-0007-50 VisinArray HPV PreCise Master Mix 50 Prd. N. Prduct Tests VK-0003-50 VisinArray Detectin Kit 50 Incl. Hybridizatin Slutin, 1 ml; Detectin Slutin, 5 ml; Blue Spt Slutin, 5 ml; 100x Wash Buffer, 250 ml E-4051-1 Mini Slide Centrifuge VisinArray Analysis Package Prd. N. E-4060-1 Prduct VisinArray Analysis Package Incl. Scanner 8100; Slide Hlder; Hand Scanner; PC with preinstalled VisinArray Analyzer Sftware; USB-Hub; External Hard Drive; Cmputer Muse nly available in certain cuntries. All ther cuntries research use nly! Please cntact yur lcal dealer fr mre infrmatin. M-5099-9-2017 Manufactured by: 42 life sciences GmbH & C. KG Fischkai 1 27572 Bremerhaven Germany Distributed by: ZytVisin GmbH Fischkai 1 27572 Bremerhaven Germany www.zytvisin.cm inf@zytvisin.cm VisinArray is a trademark f 42 life sciences GmbH & C. KG