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HPV Diagnostics

HPV diagnostics on the advance - S3 guideline for the prevention of cervical cancer strengthens the role of HPV testing in cancer screening

Due to an almost 100% etiological link between carcinogenic HPV and cervical cancer, HPV testing is being considered for primary cervical cancer screening in many countries.

The recently published S3 guideline on the prevention of cervical cancer (Germany, December 2017) also focuses on a reliable early detection of precancerous lesions in need of treatment. In Germany, women aged 35 and over, have now access to HPV testing every three years as part of the cervical cancer screening in addition to cytology.

However, HPV test systems suitable for screening must demonstrate an optimized balance between clinical sensitivity and specificity for the detection of cervical intraepithelial neoplasia of the 2nd or 3rd degree and treatable cancer. Given the low prevalence of ≥CIN 2 lesions, low clinical specificity or high clinical sensitivity can have a dramatic impact on the number of unnecessary follow-up procedures and associated costs.

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PapilloCheck® meets exactly these sensitivity and specificity requirements and is one of only 7 HPV test systems recommended for screening in the new S3 guideline.

Source : Int. J. Cancer: 124, 516–520 (2009)
Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older
Chris J.L.M. Meijer, Johannes Berkhof, Philip E. Castle, Albertus T. Hesselink, Eduardo L. Franco, Guglielmo Ronco, Marc Arbyn, F. Xavier Bosch, Jack Cuzick, Joakim Dillner, Danie¨lle A.M. Heideman and Peter J.F. Snijders
S3 Guide Line

Genotyping of 24 pathogenic HPV types with PapilloCheck®

The HPV test PapilloCheck® is an in vitro diagnostic (CE-IVD) for the qualitative detection and genotyping of 24 pathogenic HPV types (18 high-risk and 6 low-risk) in human cervical smears.

The PapilloCheck® test system is based on the detection and identification of a fragment of the viral E1 gene using a DNA microarray and allows the simultaneous analysis of 12 cervical samples.

  • Kit with biochips and solutions for HPV genotyping of 48 samples
  • Each biochip contains 12 DNA arrays allowing simultaneous analysis of 12 cervical samples
  • Simultaneous genotyping of 24 human pathogenic HPV types (18 high-risk and 6 low-risk types)
  • Differentiation between single and multiple infections
  • Classification according to risk potential
  • High clinical sensitivity and specificity
  • Integrated quality control system: Extensive on-chip controls for reliable results
  • Automatic scanning, analysis, data collection and reporting with CheckScanner™ and CheckReport™Software

PapilloCheck® Publications

Publications HPV

Sample materialYearTitelAuthoresLink
Comparison2019The absence of high-risk human papillomavirus in Czech non-small cell lung cancer cases.Jaworek H, Koudelakova V, Slavkovsky R, Drabek J, Hajduch M.https://www.ncbi.nlm.nih.gov/pubmed/30631209
Self sampling2018A Head-to-Head Analytical Comparison of Cobas 4800 HPV, PapilloCheck HPV Screening, and LMNX Genotyping Kit HPV GP for Detection of Human Papillomavirus DNA in Cervical and Cervicovaginal Swabs.Jaworek H, Koudelakova V, Drabek J, Vrbkova J, Zborilova B, Oborna I, Brezinova J, Marek R, Huml K, Vanek P, Hajduch M.https://www.ncbi.nlm.nih.gov/pubmed/30165205
Anal swab specimens2018Prevalence and Risk Factors for Anal Human Papillomavirus Infection in
Human Immunodeficiency Virus-Positive Men Who Have Sex with Men.		Combes JD1, Heard I2,3,
Poizot-Martin I4,5, Canestri A6, Lion A7, Piroth L8,9, Didelot JM10, Ferry T11, Patey O12, Marchand L13, Flejou JF14,15, Clifford GM1, Etienney I16; ANRS EP57 APACHES Study group.		https://www.ncbi.nlm.nih.gov/pubmed/29590262
Comparison2018PCR-RFLP assay as an option for primary HPV testGolfetto L1, Alves EV1, Martins TR2,
Sincero TCM3, Castro JBS4, Dannebrock C5, Oliveira JG6, Levi JE2, Onofre ASC3, Bazzo ML1,3.		https://www.ncbi.nlm.nih.gov/pubmed/29394362
Comparison, genotyping2018Comparison of PapilloCheck and Linear Array to Detect and
Differentiate Human Papillomaviruses in Cervical and Tonsillar Smears from Females with Cervical Intraepithelial Lesions
Donata Grimm, Linn Woelber,Katharina Prieske, Barbara Schmalfeldt, Sascha Kürti,1 Chia-Jung Busch, Ingo Teudt, Oliver Brummer, Volkmar Mueller, and Thomas Meyerhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6348707/
Epidemiology study2018Predictors of abnormal cytology among HPV-infected women in remote territories of French Guiana.Adenis A, Dufit V, Douine M, Ponty J, Bianco L, Najioullah F, Kilié O, Catherine D, Thomas N, Deshayes JL, Brousse P, Carles G, Grenier C, Lacoste V, Molinie V, Cesaire R, Nacher M.https://www.ncbi.nlm.nih.gov/pubmed/29368607
Epidemiology study2017The singular epidemiology of HPV infection among French Guianese women with normal cytology.Adenis A, Dufit V, Douine M, Ponty J, Bianco L, Najioullah F, Kilié O, Catherine D, Thomas N, Deshayes JL, Brousse P, Carles G, Grenier C, Lacoste V, Molinie V, Cesaire R, Nacher M.https://www.ncbi.nlm.nih.gov/pubmed/28340612
Epidemiology study2017High prevalence of HPV infection in the remote villages of French Guiana: an epidemiological study.Adenis A, Dufit V, Douine M, Corlin F, Ayhan G, Najioullah F, Molinie V, Brousse P, Carles G, Lacoste V, Cesaire R, Nacher M.https://www.ncbi.nlm.nih.gov/pubmed/28091335
FFPT samples2017Papillomavirus genotyping on formaldehyde fixed paraffin-embedded
tissues in vulvar intraepithelial neoplasia.		Mazellier S1, Dadone-Montaudie B2,
Chevallier A2, Loubatier C3,4, Vitale S3, Cardot-Leccia N2, Angeli K5, Trastour C6, Delotte J6, Giordanengo V3, Ambrosetti D2.		https://www.ncbi.nlm.nih.gov/pubmed/28795241
HPV DNA methylation2017Human Papillomavirus DNA Methylation Predicts Response to Treatment
Using Cidofovir and Imiquimod in Vulval Intraepithelial Neoplasia 3.		Jones SEF1, Hibbitts S2, Hurt CN3,
Bryant D4, Fiander AN2, Powell N2, Tristram AJ2.		https://www.ncbi.nlm.nih.gov/pubmed/28600473
FFPE vulvar biopsis2017Papillomavirus genotyping on formaldehyde fixed paraffin-embedded tissues in vulvar intraepithelial neoplasia.Mazellier S1, Dadone-Montaudie B2, Chevallier A2, Loubatier C3,4, Vitale S3, Cardot-Leccia N2, Angeli K5, Trastour C6, Delotte J6, Giordanengo V3, Ambrosetti D2.https://www.ncbi.nlm.nih.gov/pubmed/28795241
HPV and HIV2017Human Papillomavirus infection and cervical lesions in HIV infected
women on antiretroviral treatment in Thailand.		Delory T1, Ngo-Giang-Huong N2,
Rangdaeng S3, Chotivanich N4, Limtrakul A5, Putiyanun C6, Suriyachai P7, Matanasarawut W8, Jarupanich T9, Liampongsabuddhi P10, Heard I11, Jourdain G2, Lallemant M2, Le Coeur S12; PapilloV study group.		https://www.ncbi.nlm.nih.gov/pubmed/28254419
Genotyping2017Effectiveness of Human Papillomavirus Vaccination on Prevalence of
Vaccine Genotypes in Young Sexually Active Women in France.		Heard I1,2, Tondeur L3, Arowas L1,
Demazoin M1, Falguières M1, Parent Du Chatelet I4; pour le groupe CHlaHPV.		https://www.ncbi.nlm.nih.gov/pubmed/28011911
biopsis collected during
bronchoscopy and transported in PreservCyt		2017Investigating the role of HPV in lung cancerArgyri E1, Tsimplaki E1, Marketos C2, Politis G2, Panotopoulou E1.https://www.ncbi.nlm.nih.gov/pubmed/28720459
FFPE cervical biopsis2016Analysis of the Prevalence of HTLV-1 Proviral DNA in Cervical Smears and Carcinomas from HIV Positive and Negative Kenyan WomenHe X1, Maranga IO2,3, Oliver AW4, Gichangi P5, Hampson L6, Hampson IN7.https://www.ncbi.nlm.nih.gov/pubmed/27608036
Genotyping2016HPV genotype distribution in Brazilian women with and without cervical
lesions: correlation to cytological data.		Martins TR1,2, Mendes de Oliveira C3,
Rosa LR3, de Campos Centrone C3, Rodrigues CL3, Villa LL4,5, Levi JE3,5.		https://www.ncbi.nlm.nih.gov/pubmed/27515763
clinical and analytical evaluation,
HPV screening		2016Clinical and analytical performance of the PapilloCheck HPV-Screening assay
using the VALGENT framework.		Heard I1, Cuschieri K2, Geraets DT3, Quint W3, Arbyn M4.https://www.ncbi.nlm.nih.gov/pubmed/27262102
Genotyping, anal swab specimens2015HPV infection-associated anogenital cyto-colpo-histological findings and molecular typing in HIV-positive women.Tso FK1, Rodrigues CL2, Levi JE2, Mattosinho de Castro Ferraz MG3, Speck NM1, Ribalta JC1.https://www.ncbi.nlm.nih.gov/pubmed/26782408
self sampling2015[Utilization of self-sampling kits for HPV testing in cervical cancer screening - pilot study].Ondryášová H, Koudeláková V, Drábek J, Vaněk P, Slavkovský R, Hajdúch M.https://www.ncbi.nlm.nih.gov/pubmed/26741158
clinical validation2016VALGENT: A protocol for clinical validation of human papillomavirus assays.Arbyn M1, Depuydt C2, Benoy I2, Bogers J2, Cuschieri K3, Schmitt M4, Pawlita M4, Geraets D5, Heard I6, Gheit T7, Tommasino M7, Poljak M8, Bonde J9, Quint W5.https://www.ncbi.nlm.nih.gov/pubmed/26522865
HPV screening2015The PapilloCheck Assay for Detection of High-Grade Cervical Intraepithelial Neoplasia.Crosbie EJ1, Bailey A2, Sargent A2, Gilham C3, Peto J3, Kitchener HC4.https://www.ncbi.nlm.nih.gov/pubmed/26338859
HPV screening2015Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening?Arbyn M1, Snijders PJ2, Meijer CJ2, Berkhof J3, Cuschieri K4, Kocjan BJ5, Poljak M5.https://www.ncbi.nlm.nih.gov/pubmed/25936581
Comparison2015Comparison of two techniques for HPV genotyping in women with high-grade squamous intraepithelial lesion].Serravalle K1, Levi JE2, Oliveira C2, Queiroz C1, Dantas Á1, Studart E1.https://www.ncbi.nlm.nih.gov/pubmed/25760629
anal swab specimens2015Anal human papillomavirus (HPV) prevalences and factors associated with abnormal anal cytology in HIV-infected women in an urban cohort from Rio de Janeiro, Brazil.Cambou MC1, Luz PM, Lake JE, Levi JE, Coutinho JR, de Andrade A, Heinke T, Derrico M, Veloso VG, Friedman RK, Grinsztejn B.https://www.ncbi.nlm.nih.gov/pubmed/25361401
Comparison2014Resequencing microarray technology for genotyping human papillomavirus in cervical smears.Berthet N1, Falguières M2, Filippone C1, Bertolus C3, Bole-Feysot C4, Brisse S5, Gessain A1, Heard I6, Favre M7.https://www.ncbi.nlm.nih.gov/pubmed/25383888
Genotyping2014[Distribution of human papillomavirus genotypes amongst HIV-negative and HIV-positive women diagnosed with ASC-US cytology. Preliminary data of a local retrospective study].Gonfrier G1, Delotte J2, Chevallier A3, Giordanengo V4.https://www.ncbi.nlm.nih.gov/pubmed/25281479
Genotyping2014[Genotype distribution of human papillomavirus in women from the state of Bahia, Brazil].Bruno A1, Serravalle K2, Travassos AG2, Lima BG3.https://www.ncbi.nlm.nih.gov/pubmed/25272363
Comparison2014Hybrid capture II and PapilloCheck® tests for detection of anal high-risk human papillomavirus.Maia LB1, Marinho LC1, Bocca AL1, Cavalcante Neto FF1, Velasco LF2, Costa PG2, Carneiro FP1, Oliveira PG3.https://www.ncbi.nlm.nih.gov/pubmed/24861299
penile shaft, balanopreputial sulcus and urethra collected in Digene (Qiagen)2014Genital prevalence of HPV types and co-infection in men.Freire MP1, Pires D2, Forjaz R2, Sato S2, Cotrim I3, Stiepcich M4, Scarpellini B4, Truzzi JC5.https://www.ncbi.nlm.nih.gov/pubmed/24642151
Genotyping2014Genotypes and prevalence of HPV single and multiple concurrent infections in women with HSIL.Beca F1, Pinheiro J, Rios E, Pontes P, Amendoeira I.https://www.ncbi.nlm.nih.gov/pubmed/24623593
Genotyping2014Global improvement in genotyping of human papillomavirus DNA: the 2011 HPV LabNet International Proficiency Study.Eklund C1, Forslund O, Wallin KL, Dillner J.https://www.ncbi.nlm.nih.gov/pubmed/24478473
untreated biopsis of laryngeal tumors collected in PreservCyt2014Prevalence of human papillomavirus infection in Greek patients with squamous cell carcinoma of the larynx.Laskaris S1, Sengas I2, Maragoudakis P3, Tsimplaki E4, Argyri E4, Manolopoulos L2, Panotopoulou E5.https://www.ncbi.nlm.nih.gov/pubmed/25275084
biopsis of oral tongue tumors collected in PreservCyt2014Prevalence and expression of human papillomavirus in 53 patients with oral tongue squamous cell carcinoma.Tsimplaki E1, Argyri E, Xesfyngi D, Daskalopoulou D, Stravopodis DJ, Panotopoulou E.https://www.ncbi.nlm.nih.gov/pubmed/24511049
swab specimens from oral tongue, maxilla, mandible, mouth, buccal mucosa collected in PreservCyt2013Prevalence of human papillomavirus in 45 greek patients with oral cancer.Kouvousi M1, Xesfyngi D, Tsimplaki E, Argyri E, Ioannidou G, Ploxorou M, Lazaris AC, Patsouris E, Panotopoulou E.https://www.ncbi.nlm.nih.gov/pubmed/23533409
Genotyping2013Prevalence of type-specific HPV infection in Uruguay.Berois N1, Heard I, Fort Z, Alonso R, Sica A, Moerzinger P, Rodriguez G, Sancho-Garnier H, Osinaga E, Favre M.https://www.ncbi.nlm.nih.gov/pubmed/24375018
anal swab specimens2013Value of human papillomavirus typing for detection of anal cytological abnormalities.Maia LB1, Marinho LC, Barbosa TW, Velasco LF, Costa PG, Carneiro FP, de Oliveira PG.https://www.ncbi.nlm.nih.gov/pubmed/24339460
Comparison2013The cytology and DNA detection by the PapilloCheck(®) test in the diagnosis of human papillomavirus infection.Vieira L1, Almeida A.https://www.ncbi.nlm.nih.gov/pubmed/24265920
Genotyping2013Human papillomavirus types distribution in organised cervical cancer screening in France.Heard I1, Tondeur L, Arowas L, Falguières M, Demazoin MC, Favre M.https://www.ncbi.nlm.nih.gov/pubmed/24244490
HPV and HIV2013HIV Infection Alters the Spectrum of HPV Subtypes Found in Cervical Smears and Carcinomas from Kenyan Women.Maranga IO1, Hampson L, Oliver AW, He X, Gichangi P, Rana F, Opiyo A, Hampson IN.https://www.ncbi.nlm.nih.gov/pubmed/23494633
Genotyping2013Poor prognosis associated with human papillomavirus α7 genotypes in cervical carcinoma cannot be explained by intrinsic radiosensitivity.Hall JS1, Iype R, Armenoult LS, Taylor J, Miller CJ, Davidson S, de Sanjose S, Bosch X, Stern PL, West CM.https://www.ncbi.nlm.nih.gov/pubmed/23332225
anal swab specimens, urine2012Assessing urine human papillomavirus polymerase chain reaction testing as a tool for screening anal HPV infection in HIV-positive MSM.Lanoix JP1, Pannier C, Borel A, El Samad Y, Robin C, Douadi Y, Woimant M, Fouche B, Lecaque C, Ganry O, Duverlie G, Sevestre H, Schmit JL.https://www.ncbi.nlm.nih.gov/pubmed/22320265
paraffin embedded samples of
vaginal or vulvar cancerous tissue		2012Human papillomavirus genotyping and e6/e7 mRNA expression in greek women with intraepithelial neoplasia and squamous cell carcinoma of the vagina and vulva.Tsimplaki E1, Argyri E, Michala L, Kouvousi M, Apostolaki A, Magiakos G, Papassideri I, Panotopoulou E.https://www.ncbi.nlm.nih.gov/pubmed/22187556
FFPE cervical biopsis2012Improvement of DNA Extraction for Human Papillomavirus Genotyping from Formalin-Fixed Paraffin-Embedded TissuesIsabelle Cannavo,1,2 Céline Loubatier,2,3 Anne Chevallier,4 and Valérie Giordanengocorresponding author1,2,3https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3559202/
Genotyping2011Human Papillomavirus genotype testing combined with cytology as a 'test of cure' post treatment: the importance of a persistent viral infection.Jones J1, Saleem A, Rai N, Shylasree TS, Ashman S, Gregory K, Powell N, Tristram A, Fiander A, Hibbitts S.https://www.ncbi.nlm.nih.gov/pubmed/21831706
Comparison2011Evaluation of a novel microplate colorimetric hybridization genotyping assay for human papillomavirus.Barcellos RB1, Almeida SE, Sperhacke RD, Verza M, Rosso F, Medeiros RM, Perizzolo PF, Cortez-Herrera E, Rossetti ML.https://www.ncbi.nlm.nih.gov/pubmed/21807028
Comparison, HPV screening2011Comparison of the PapilloCheck® assay with the digene HC2 HPV DNA assay for the detection of 13 high-risk human papillomaviruses in cervical and anal scrapes.Didelot MN1, Boulle N, Damay A, Costes V, Segondy M.https://www.ncbi.nlm.nih.gov/pubmed/21678441
Genotyping2011Human papillomavirus type distribution in vulval intraepithelial neoplasia determined using PapilloCheck DNA Microarray.Bryant D1, Rai N, Rowlands G, Hibbitts S, Jones J, Tristram A, Fiander A, Powell N.https://www.ncbi.nlm.nih.gov/pubmed/21618551
HPV screening2011A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: extended follow up in the ARTISTIC trial.Kitchener HC1, Gilham C, Sargent A, Bailey A, Albrow R, Roberts C, Desai M, Mather J, Turner A, Moss S, Peto J.https://www.ncbi.nlm.nih.gov/pubmed/21334200
Comparison2010Stepwise algorithm combining HPV high-risk DNA-based assays and RNA-based assay for high grade CIN in women with abnormal smears referred to colposcopy.Halfon P1, Benmoura D, Agostini A, Khiri H, Pénaranda G, Martineau A, Blanc B.https://www.ncbi.nlm.nih.gov/pubmed/21263189
Epidemiological study2010Prevalence of low-risk and high-risk types of human papillomavirus and other risk factors for HPV infection in Germany within different age groups in women up to 30 years of age: an epidemiological observational study.Iftner T1, Eberle S, Iftner A, Holz B, Banik N, Quint W, Straube AN.https://www.ncbi.nlm.nih.gov/pubmed/20872721
Comparison2010Increase in viral load, viral integration, and gain of telomerase genes during uterine cervical carcinogenesis can be simultaneously assessed by the HPV 16/18 MLPA-assay.Theelen W1, Speel EJ, Herfs M, Reijans M, Simons G, Meulemans EV, Baldewijns MM, Ramaekers FC, Somja J, Delvenne P, Hopman AH.https://www.ncbi.nlm.nih.gov/pubmed/20813962
Comparison2010Evaluation of the performance of the novel PapilloCheck HPV genotyping test by comparison with two other genotyping systems and the HC2 test.Schopp B1, Holz B, Zago M, Stubenrauch F, Petry KU, Kjaer SK, Iftner T.https://www.ncbi.nlm.nih.gov/pubmed/20166179
HPV and HIV, anal swab specimens2010Human papillomavirus (HPV) prevalence and type distribution, and HPV-associated cytological abnormalities in anal specimens from men infected with HIV who have sex with men.Damay A1, Fabre J, Costes V, Didelot JM, Didelot MN, Boulle N, Segondy M.https://www.ncbi.nlm.nih.gov/pubmed/20166175
clinical validation, HPV screening2010Comparison of the clinical performance of PapilloCheck human papillomavirus detection with that of the GP5+/6+-PCR-enzyme immunoassay in population-based cervical screening.Hesselink AT1, Heideman DA, Berkhof J, Topal F, Pol RP, Meijer CJ, Snijders PJ.https://www.ncbi.nlm.nih.gov/pubmed/20042622
comparison, clinical validation2010Comparison of the clinical performance of carcinogenic HPV typing of the Linear Array and Papillocheck HPV-screening assay.Halfon P1, Benmoura D, Khiri H, Penaranda G, Blanc B, Riggio D, Sandri MT.https://www.ncbi.nlm.nih.gov/pubmed/19939732
Comparison2009Comparison of the PapilloCheck DNA micro-array Human Papillomavirus detection assay with Hybrid Capture II and PCR-enzyme immunoassay using the GP5/6+ primer set.Jones J1, Powell NG, Tristram A, Fiander AN, Hibbitts S.https://www.ncbi.nlm.nih.gov/pubmed/19394266
Comparison2009Human Papillomavirus negative but dyskaryotic cervical cytology: re-analysis of molecular testing.Peevor R1, Bowden S, Jones J, Fiander AN, Hibbitts S.https://www.ncbi.nlm.nih.gov/pubmed/19264544
Analytical evaluation, Genotyping2009Analytical evaluation of the PapilloCheck test, a new commercial DNA chip for detection and genotyping of human papillomavirus.Dalstein V1, Merlin S, Bali C, Saunier M, Dachez R, Ronsin C.https://www.ncbi.nlm.nih.gov/pubmed/19041893
Comparison2008Comparison of molecular assays for detection and typing of human papillomavirus.Koidl C1, Bozic M, Hadzisejdic I, Grahovac M, Grahovac B, Kranewitter W, Marth E, Kessler HH.https://www.ncbi.nlm.nih.gov/pubmed/18439557

Comparison of the PapilloCheck® DNA micro-array Human Papillomavirus detection assay with Hybrid Capture II and PCR-enzyme immunoassay using the GP5/6+ primer set.

J Clin Virol. 2009 Jun;45(2):100-4. Epub 2009 Apr 24
J. Jones, N.G. Powell, A. Tristram, A.N. Fiander, S. Hibbitts

Department of Obstetrics and Gynaecology, Cardiff University, School of Medicine, Heath Park, Cardiff, CF14 4XN, United Kingdom

BACKGROUND: Cervical screening detects precancerous cells and routine screening could be improved by testing for Human Papillomavirus (HPV), the virus that causes cervical cancer. HPV infection is common and the benefit of HPV testing would be identification of women who are HPV negative and at low risk of developing cancer. STUDY DESIGN: The aim of this study was to evaluate the Greiner Bio-One PapilloCheck® micro-array assay (PapilloCheck®) for detection of HPV in comparison with Hybrid Capture II (hc2) and PCR-enzyme immunoassay (PCR-EIA) using the GP5/6+ primers. RESULTS: Samples from a cytologically defined population (n=878) were analysed and 187 samples also had histology information. Overall, 674 out of 878 samples gave a consistent result (76.8%; 95% CI 73.83-79.52%) on all three platforms. The genotype results obtained by PapilloCheck® and PCR-EIA were compared and 94% were consistent (95% CI 92.1-96.4%). The main difference was the poor Kappa agreement for detection of high risk (HR) type 35 (Kappa=0.190) with all inconsistent results being HR positive by PCR-EIA assay but negative on the PapilloCheck® platform. There was no statistically significant difference between the performance of each assay when HR HPV positive samples were linked with clinical result (cytology and histology grade). PapilloCheck® detected the highest number of HR HPV infections in samples with histology confirmed as CIN1, CIN2 and CIN3 (76.6%, 85% and 91.7%, respectively). CONCLUSIONS: Overall, PapilloCheck® proved to be a sensitive, reproducible, robust molecular assay for HPV genotyping with the potential for high throughput of specimens in a clinical setting.

Evaluation of the Performance of the Novel PapilloCheck® HPV Genotyping Test by Comparison With Two Other Genotyping Systems and the HC2 Test.

J Med Virol. 2010 Apr;82(4):605-15
B. Schopp,1 B. Holz,1 M. Zago,1 F. Stubenrauch,1 K.U. Petry,2 S. Krüger Kjaer,3 and T. Iftner1

1 Sektion of Experimentelle Virologie, Institute of Medical Virology, University Hospital Tuebingen, Tuebingen, Germany
2 General Hospital Wolfsburg, Wolfsburg, Germany
3 Danish Cancer Society, Copenhagen, Denmark

The novel PapilloCheck® genotyping test was compared with SPF10 PCR LiPav1 and PGMY09/11 on hybrid capture 2 (HC2)- pretested samples. From results of 826 cervical samples detection rates and kappa values for the tests were calculated using a HPV type consensus definition. With PapilloCheck® HPV types 53, 56 and 33 were found with a sensitivity of 100%. The lowest detection rate was observed for HPV 35 (72.2%). The SPF10 PCR LiPav1 was found to be 100% positive for HPV 18, 31, 53, 56 and 35 and lowest for HPV 59 (81%). The PGMY09/11 system detected only HPV 59 at 100% detection rate and showed lowest sensitivity for HPV 56 (40.5%). Multiple infection rates ranged from 25.8% (PGMY09/11 PCR-LBA), over 39.5% (PapilloCheck®) to 55.9% (SPF10 PCR LiPav1). In samples with higher viral DNA load detection rates and concordance between the genotyping tests increases. The kappa values in comparison to the HPV consensus type ranged from k=0.21 to k=0.82 for comparing SPF10 PCR with the HPV consensus type, while values for PGMY09/11 PCR ranged from k=0 to k=0.96 and were best for the PapilloCheck® (k=0.49-0.98). Detection rates for the identification of high grade cervical intraepithelial neoplasia (CIN2+) ranged from 93.7% (PGMY09/11 PCR) to 98.4% (PapilloCheck®, SPF10 PCR, HC2). In conclusion, this study shows that the PapilloCheck® gives comparable results to established PCR methods. However, these results also show a necessity for the standardization of genotype-specific HPV detection assays.

PapilloCheck® Test KitOrder no. 465060
PapilloCheck® Collection KitOrder no. 465075
oCheck® DNA Extraction KitOrder no. 515040
CheckScanner™Order no. 862070

02

Quality Control Pharma

Detection of virus or mycoplasma contamination in cell cultures

The Inspect™ product line of Greiner Bio-One has been specifically developed for quality control in the biopharmaceutical industry to ensure the absence of any adventitious agents such as mycoplasmas and viruses in cell-culture based manufacturing processes.

CytoInspect is a DNA based microarray test system that is used for the detection and identification of mycoplasmas in cell culture by biopharmaceutical customers since 2006.

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Thus, Greiner Bio-One has gained extensive experiences and a thorough understanding of both user demands and regulatory requirements in the quality control of manufacturing processes.

The Inspect™ platform has recently been extended with by two virus panels. by the addition of ViroInspect® Rodent 1 and ViroInspect® Rodent 2. ViroInspect® is a are rapid, highly sensitive and highly specific testing systems with integrated quality controls for the detection of viral contamination in cell cultures.

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Detection of mycoplasmas in cell cultures

CytoInspect™ is based on DNA microarray technology and enables the detection of all mycoplasma species, including the genera Acholeplasma, Spiroplasma and Ureaplasma. Additionally, 41 of the most important and most frequent mycoplasma pathogens can be clearly identified at species level (Table 1).

With results delivered in 5 hours, CytoInspect™ is a rapid and effective detection method compared to culture-based mycoplasma assays. Fast results mean that a contamination problem can be rapidly assessed and action can be taken, saving both time and money.

"In the GMP field, the CytoInspect™ from Greiner Bio-One for Mycoplasma testing is – in our experience – one of the best and most reliable test kits on the market. Manual processing of the samples is easy, evaluation is achieved automatically and results are quickly generated, which allow, in case of a positive mycoplasma finding, even the identification of the species.

In addition to that, the customer service is also particularly noteworthy: questions are answered immediately, cooperatively and in a highly professional way. In the GMP area, such a competent service is rarely found. We are more than satisfied to have established this technique in our laboratory and can offer it to our customers."

Dr. Stefanie Bayer
Labor LS, Bad Bocklet

The CytoInspect™ Kit is part of a complete assay system consisting of:
  •  CytoInspect™ Test Kit
  •  CytoInspect™ DNA-Extraction Kit
  •  CheckScanner™
  •  CheckReport™Software
  • DNA microarray-based mycoplasma detection system
  • Identification of 41 mycoplasma species
  • Fast results in 5 hours
  • Sensitivity of < 10 CFU/ml (Tabelle 2)
  • CytoInspect™ DNA Extraction Kit for high efficient DNA isolation
  • Extensive validation acc. to Ph. Eur (2.6.7, 2.6.21)
  • Automated results analysis and report generation
  • CheckReport™Software, FDA compliant (21 CFR part 11)

Fast results to drive decisions

Mycoplasma Testing Service

Fast results to drive decisions

Mycoplasma contamination is a serious problem in cell culture. Detailed investigations on the identity of the contaminating species showed that by far the largest portion of infections is caused by a relatively small number of mycoplasma and acholeplasma species: 90 – 95% of the contaminants were identified as either M. orale, M. hyorhinis, M. arginini, M. fermentans, M. hominis or A. laidlawii (Drexler and Uphoff, 2002).

Because the largest percentage of mycoplasma found in cell cultures are of human origin, one may assume that laboratory personnel is one of the major sources of contamination. Mycoplasmas are rapidly spread by using laboratory equipment, media, or reagents that have been contaminated by previous use in processing mycoplasma-infected cells

Advantages and Benefits

  • Sensitive and robust PCR based mycoplasma testing
  • Providing fast, reliable and affordable results
  • Cells, cell culture suspensions up to 107 cells/ml, protein rich samples, cell culture media can be used as sample material
  • Species identification of 9 of the most commonly contamination agents

Mycoplasma Testing Service
Safety thanks to relieable results

We have the ability to offer a fast and reliable detection of mycoplasma contaminations in biological materials such as cells and cell culture supernatants, with accurate species identification to facilitate resolution of some prevailing mycoplasma contamination issues. In addition to the species identification of nine of the most common contaminants (table 1), a Yes/No detection of all mycoplasma species is also included.

That's how it works:

  • Fill in the order form
  • Take the sample material you want to get analysed
  • Send your samples and the filled-out order form to our labour in Rainbach, Austria
  • Turnaround time 48 - 72 hours
  • You receive the results by email

Quality Virus Detection with ViroInspect® Rodent 1 & 2

Viral safety is a critical part of biological products throughout their development and their commercial release. Viral contamination can become a safety risk for patients having financial burdens on biopharmaceutical companies.

ViroInspect® is a rapid, highly sensitive and highly specific testing system for the usage in quality control of biopharmaceutical companies.

As >80 % of biopharmaceutical production is performed in rodent cells, the Rodent product line focuses on viruses, of which rodents are the natural host.

ViroInspect® Rodent 1 allows the detection and the identification of Rodent Parvoviruses 1, Porcine Circoviruses 1/2, Vesivirus 2117 and related isolates in biological materials such as cell culture samples.

Additionally, the ViroInspect® Rodent 2 enables the detection and identification of Rodent Calici-, Corona-, Paramyxo-, Picorna- and Reoviruses.

In a nutshell:

  • Short throughput times
  • High sensitivity and specificity
  • Robust
  • Repeatable

ViroInspect® features and benefits

  • Time-to-results in less than 9 hours, saving three weeks by replacing current in vitro and in vivo tests
  • Integrated sample preparation, extraction of viral DNA and RNA, reverse transcription, PCR amplification, microarray, hybridisation, and software-based evaluation
  • Comprehensive on-chip controls
  • Sensitivity equal to / better than in vitro and in vivo tests
  • Processing of sample volumes of up to 10 mL
  • Validated in compliance with the ICH Q2(R1) guideline
  • Virus detection and identification within one test
  • Parallel analysis of up to 24 samples
  • Simple, precise results and automated report generation enable ‘go’ /’no-go’ decisions in a timely manner
  • Less expensive than in vitro and in vivo tests

Publications CytoInspect™

TitleYearAuthoresLink
Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a veterinary modified live vaccine.2018Mbelo S, Gay V, Blanchard S, Abachin E, Falque S, Lechenet J, Poulet H, de Saint-Vis Bhttps://www.ncbi.nlm.nih.gov/pubmed/29753589
Validation of a PCR coupled to a microarray method for detection of
mycoplasma in vaccines.
>>see abstract below>>		2017Abachin E, Marius M, Falque S, Arnaud J, Detrez V, Imbert S, Mallet L, Bonnevay T.https://www.ncbi.nlm.nih.gov/pubmed/28951118
RMMs In-Depth Focus2016European Pharmaceutical Review (6) (Kilic)https://www.europeanpharmaceuticalreview.com/article/46555/rmms-supplement/
World Health Organization International Standard To Harmonize Assays for Detection of Mycoplasma DNA2015C. Micha Nübling, S.A. Baylis, K.M. Hanschmann, T. Montag-Lessing, M. Chudy, J. Kreß, U. Ulrych, S. Czurda, R. Rosengarten, and the Mycoplasma Collaborative Study Grouphttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4551258/
A microarray for mycoplasma detection and identification: CytoInspect™2013Encyclopedia of Rapid Microbiological Methods. Volume 4 (Stappert, Kilic) -

Validation of a PCR coupled to a microarray method for detection of mycoplasma in vaccines

Eric Abachin1, Marine Marius 1, Stephanie Falque, Julien Arnaud, Valerie Detrez, Sandy Imbert, Laurent Mallet2, Thierry Bonnevay2

1 Co-first author 2 Co-last author

Analytical Research and Development, Sanofi Pasteur, 69280 Marcy l’Etoile, France

Abstract

The revised section of the European, United States, and Japan Pharmacopeias on mycoplasma testing provided guidance for the set up and validation of a nucleic acid amplification technique (NAT) as an alternative method to agar culture and indicator cell culture compendial methods. The CytoInspect™ method, based on Polymerase Chain Reaction (PCR) coupled to microarray analysis, has been selected for detection and identification of mycoplasma in vaccines. To replace compendial methods, the alternative method must demonstrate equivalence in both limit of detection (LOD) and specificity compared with compendial methods.

Here, we summarize the validation of the CytoInspect™ method according to current pharmacopeia requirements. Validation of the robustness, sensitivity (at least 10 colony forming units/ml) and specificity of the CytoInspect™ method are demonstrated. Likewise, a comparability study was performed to compare the LOD for CytoInspect™ compared with the previously validated LOD for compendial culture tests.

© 2017 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Link zum Abstract

CytoInspect™ (10 tests/kit)Art.-Nr.: 464060
CytoInspect™ (60 tests/kit)Art.-Nr.: 464070
CytoInspect™ DNA Extraction Kit (60 prep)Art.-Nr.: 516070
ViroInspect® Rodent 1 (48 tests/kit)Art.-Nr.: 467011
ViroInspect® Rodent 2 (48 tests/kit)Art.-Nr.: 467015
Mycoplasma Testing ServiceArt.-Nr.: 463090

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HPV Automation

smart. efficient. accurate.

CX NIMBUS® and CX STARlet

CX NIMBUS® and CX STARlet enable a streamlined use of PapilloCheck®, the HPV genotyping kit from Greiner Bio-One. Both systems combine the advantages of automation with an outstanding methodology developed for the simultaneous screening and genotyping of human papilloma viruses.
Leading to a reliable detection of cervical cancer at an early stage.

Contact

smart.

  • Ready to use load & go reagents
  • Magnetic beats separation technology
  • Modular processing of extraction, PCR and hybridisation possible
  • Intelligent waste management

efficient.

  • Fully automated sample prep from primary tubes
  • Simultaneous processing of different collection media
  • Cost and time savings due to minimum Hands-On Time

accurate.

  • Robust DNA array technology
  • LIMS compatible for automated result reporting
  • Liquid level detection, aspiration and clot detection monitoring
  • Built-in controls and quality control reporting

Mid sized sample volumes

CX NIMBUS®

CX NIMBUS® is designed for laboratories with small to mid-throughput requirements. It is a compact liquid handling instrument that offers speed, flexibility and ease of use. CX NIMBUS® plus additionally automates the hybridisation set up.

PapilloCheck® is a test kit for the genotyping of 24 HPV types, including 18 hrHPV and 6 lrHPV types. Due to the parallel identification of all types detectable,the PapilloCheck® result enables the characterisation ofmultiple infections, it can help to identify type-specificpersistent HPV infections and it untangles the status of apatient in the course of HPV vaccination. Therefore, it has the potential to improve the classification of women according to their relative risk for developing cervical cancer and its high-grade precursor lesions. Recently, PapilloCheck® was validated according international guidelines for HPV test requirements incervical cancer screening and fulfilled demands regarding clinical sensitivity and specificity as well as reproducibility. Additionally, clinical studies confirm that PapilloCheck® is a robust HPV genotyping assay with the potential for high throughput of specimen in a clinical setting.

For high sample throughput

CX STARlet

The CX STARlet excels in automating multiple processing steps of the PapilloCheck® workflow through integrated DNA extraction, PCR set-up, PCR plate sealing and PCR. It offers our customers the comfort of minimal required staff interaction and maximal walkaway time with a weekly throughput of up to 864 patient samples.

Features and Benefits

  • 96 PapilloCheck® samples can be processed simultaneously
  • Primary tubes can be loaded directly into the CX STARlet
  • Different sampling systems can be used
  • Automated nucleic acid purification, PCR set-up, PCR and plate sealing
  • Automatic verification of barcoded samples and reagents
  • Integrated UV kit for the decontamination of DNA residues
  • Less than 90 minutes Hands-On Time

CX NIMBUS® und CX NIMBUS® plus - simultaneous processing of 48 samples

Following work steps are processed automatically in CX NIMBUS® plus:

  • DNA Extraction
  • PCR
  • Hybridisation

CX STARlet and CX STARlet plus - simultaneous processing of 96 samples

Following work steps are processed automatically in CX STARlet plus:

  • DNA Extraction
  • PCR
  • Hybridisation

Technical Support & Maintenance

Greiner Bio-One offers different service packages for the CX automation platforms as well as for the CheckScanner™.

Our Maintenance Service is classified into preventive maintenance and corrective maintenance. Both services are provided by Greiner Bio-One during regular business hours based on the specific needs of a customer’s demand. The customer can choose between:

  • PREMIUM Service

  • ADVANCED Service

  • BASIC Service

For further information on the available service packages, please contact [email protected].

If you have any questions concerning Greiner Bio-One products, please do not hesitate to contact your local Greiner Bio-One distributor or our technical support team of highly skilled and experienced scientists.

Phone: +43 7949 2090 3090

E-Mail: [email protected]

Office hours for on-call service are:

Monday - Thursday 08:00 am - 03:00 pm (CET/CEST)
Friday 08:00 am - 12:00 noon (CET/CEST)
except local public holidays at the GBO Austria site

CX NIMBUS® Automated analysis of 48 samplesOrder no. 867070 
CX NIMBUS® plus
Automated analysis of 48 samples, with hybridisation		Order no. 867071
CX STARlet Automated analysis of 96 samplesOrder no. 867072
CX STARlet plus
Automated analysis of 96 samples, with hybridisation		Order no. 867073
 CX Extraction Kit 48 prepsOrder no. 517070
 CX Extraction Kit NIMBUS® 48 prepsOrder no. 517071

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Downloads

Here you can download further information about our diagnostic products.
Click on the download button of the desired file.

HPV Diagnostics

PapilloCheck® HPV-Genotyping

PapilloCheck® HPV-Genotyping

710.82 KB
Download

Quality Control Pharma

CytoInspect - Detection and Identification of Mycoplasma Species

CytoInspect - Detection and Identification of Mycoplasma Species

4.68 MB
Download
CytoInspect™ Publication

CytoInspect™ Publication

680.75 KB
Download
ViroInspect - High Speed Biopharmaceutical Quality Control

ViroInspect - High Speed Biopharmaceutical Quality Control

639.25 KB
Download

Automation

Automated HPV Diagnostic with PapilloCheck

Automated HPV Diagnostic with PapilloCheck

3.10 MB
Download

News / Events

Events

European Microbiology Conference, May 8–9 2019, Barcelona, Spain

Presentation of the CytoInspect™ The annual European Microbiology Conference 2019 in Barcelona pro­vides infor­ma­tion on newest devel­op­ments in micro­bi­o­log­i­cal qual­ity con­trol and offers the oppor­tu­nity to share expe­ri­ence in state-of-the art qual­ity test­ing and process con­trol and the respec­tive reg­u­la­tory require­ments within talks and open dis­cus­sions. On this con­fer­ence Greiner Bio-One will present the CytoInspect™…

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News

Review Eurogin 2018, Lisbon

Over the last decades, the EUROGIN (European Research Organization on Genital Infection and Neoplasia) con­gress has gained a solid rep­u­ta­tion as one of the lead­ing inter­na­tional meet­ings on human papil­lo­mavirus infec­tion and related can­cers. This year, over 2000 atten­dees from all over the world came together to engage in mul­ti­dis­ci­pli­nary inter­ac­tions with the goal to build…

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News

PharmaLab Congress 2019, 13–14th of November, Düsseldorf

The PharmaLab Congress in Düsseldorf, this year taking place for the sev­enths time in suc­ces­sion, is an event for all phar­ma­ceu­ti­cal lab­o­ra­tory areas and covers var­i­ous topics in ana­lyt­ics, bio­an­a­lyt­ics, micro­bi­ol­ogy and R&D within inter­est­ing con­fer­ences and lec­tures. Since this con­fer­ence pro­vides a broad overview of cur­rent inno­va­tions and knowl­edge in micro­bi­o­log­i­cal meth­ods as well as…

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News

Eurogin, December 2–5 2018, International HPV Congress, Booth No. 15

Visit Greiner Bio-One at the Eurogin in Lisbon. Over the past decades, EUROGIN has devel­oped a rep­u­ta­tion as one of the lead­ing inter­na­tional meet­ings on HPV (human papil­lo­mavirus) infec­tions and related dis­eases. The main objec­tive of the event remains unchanged: to pro­vide a high-level sci­en­tific forum to pro­mote mul­ti­dis­ci­pli­nary inter­ac­tions in order to bridge the gap between…

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News

Customer Feedback: Mycoplasma Test Service

“We are very sat­is­fied with the rapid pro­cess­ing of the sam­ples and the results. In addi­tion, we also get an answer to spe­cific ques­tions very quickly and within one day from your cus­tomer ser­vice. In addi­tion, they were very coop­er­a­tive with our new ideas for sample mea­sure­ment, offered solu­tions and were inter­ested in the fur­ther…

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Contact us







Contact Persons

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Mag. Doris Grünbart

Product Manager Diagnostics (HPV)

+43 7583 6791-1622
doris.gruenbart(at)gbo.com

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Kathrin Koeck

Product Expert Diagnostics (Pharma)

+43 7949 2090 - 3090
kathrin.koeck(at)gbo.com

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Dr. rer. nat. Silke Schütz-Ludwig

Global Dx Sales Coordinator

+49 162 2 758 347
[email protected]

Greiner Bio-One GmbH
Division Diagnostics
Gewerbepark 2
A-4261 Rainbach
Austria
Phone: +43 7949 2090-3090
Email: [email protected]