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contents index figures about contact -- -- -- -- -- x search search x share: x the internet site that you are about to view is an online educational resource intended for medical professionals based in the united kingdom. the site contains up-to-date information on the binding site’s products, and may therefore contain information on medical devices and other products or uses of those products that are not approved or cleared in other countries or regions. this site is not intended to promote off label use of any of the binding site’s products. to obtain appropriate product information for your country of residence, please contact your local distributor. do you wish to continue to this site? no yes proceed to -- -- -- -- sflcs should be the target of response evaluation in lcmm rather than urines normalisation of sflcs after induction was associated with improved lcmm clinical outcome, but a negative upe/uife was not [1] . dejoie t et al. blood 2016 read more -- -- contents -- -- -- -- -- imwg consensus criteria for response and minimal residual disease assessment in multiple myeloma the imwg recommend further study of hevylite in mrd assessment, as a marker of tumour eradication and immune system recovery [1] . kumar s et al. international myeloma working group consensus criteria for response and minimal residual disease assessment in multiple myeloma. lancet oncol 2016 read more -- -- contents -- -- -- -- -- imwg recommendations for the diagnosis and management of myeloma-related renal impairment the imwg recommend sflc analysis as part of a panel of laboratory tests for the diagnosis of ri in patients with mm [1] . it should also be performed at disease assessment. dimopoulos ma, et al. international myeloma working group recommendations for the diagnosis and management of myeloma-related renal impairment. j clin oncol 2016. read more -- -- contents -- -- -- -- -- nice guidelines: myeloma diagnosis and management (2016) english guidelines recommend spe and sflc analysis to screen for a monoclonal protein in patients with suspected myeloma. at myeloma diagnosis, the sflc ratio should be used to assess prognosis [1] . myeloma: diagnosis and management. nice guidelines 2016. read more -- -- contents -- -- -- -- -- welcome to .com, an online educational resource with continually updated information on serum free light chain (freelite) and hevylite analysis contents index categories what's new on the biology and measurement of immunoglobulins practical considerations of freelite assays practical considerations of hevylite assays monoclonal gammopathies diseases with monoclonal light chain deposition other diseases with monoclonal or increased polyclonal flcs instrumentation and external quality assurance table of contents .com preface over the past twelve years, there have been seven editions of the monograph entitled, serum free light chain analysis (plus hevylite). with the ever expanding literature on serum free light chains and hevylite, each new edition of the book quickly becomes out of date. hence, .com, an online resource in which the hundreds of new publications are reviewed and rapidly integrated into a changing and challenging subject. all are familiar with wikipedia. it has some superb features such as a great search engine, hyperlinks with the literature, and an escalating data base. furthermore, it can be accessed by all without the need to destroy a rain forest. this format seems to be an ideal way to present the latest information on serum free light chain analysis plus hevylite. .com is available on a read-only basis. the revision process involves a team of clinical and scientific staff at binding site working together to provide updates on their specific areas of expertise. there is also a chief editor who provides consistency of content and style and monitors updates on a continuous basis. in this manner, we intend to maintain a fully up-to-date literature review for all those who are interested in serum free light chain analysis and hevylite . important notice unless stated clearly to the contrary, all quantitative serum free light chain data within has been generated using freelite® kits manufactured by the binding site and all guidelines and proposed clinical utilities have been based upon freelite data. in some countries, products intended for measurement of serum free light chains, have been made available by other manufacturers. trials of such products have produced poor correlations with free light chain concentrations determined using freelite. therefore, it cannot be assumed that other products will have the same clinical utility or give compliance with current guidelines, such as those issued by the international myeloma working group (imwg) and the national comprehensive cancer network (nccn). -- -- -- index contents what's new on key updates the biology and measurement of immunoglobulins 1 - the clinical importance of serum free light chain and hevylite analysis 1.1. introduction 1.2. overview of established uses 1.3. recent progress 1.3.1. monoclonal flc studies 1.3.2. polyclonal flc studies 1.3.3. hlc studies 1.3.4. new guidelines 2 - a brief history of diagnostic tests for myeloma: bence jones protein and beyond 2.1. the identification of bence jones protein 2.2. the identification of serum monoclonal proteins ​2.3. free light chain assays 2.4. immunoglobulin heavy/light chain assays 3 - the biology of immunoglobulins 3.1. immunoglobulin structure 3.2. immunoglobulin diversity ​3.3. isotypic and allotypic variation of light chain constant domains 3.4. immunoglobulin and flc production 3.5. clearance and metabolism 3.5.1. half-life of sflcs 3.5.2. renal clearance of flcs 3.5.3. half-life of igg, iga and igm 4 - laboratory techniques for monoclonal immunoglobulin measurement 4.1 introduction 4.2 detection and quantification of serum monoclonal proteins 4.2.1. serum protein electrophoresis 4.2.2. capillary zone electrophoresis 4.2.3. diagnostic sensitivity of spe and cze compared with other laboratory techniques 4.2.4. serum free light chain analysis 4.2.5. hevylite immunoassays 4.3. typing of serum monoclonal proteins 4.3.1. immunofixation electrophoresis 4.3.2. immunosubtraction 4.4. other serum assays 4.4.1. total immunoglobulin assays 4.4.2. total κ/λ assays 4.5. detection and quantification of urine monoclonal proteins 4.5.1. urine protein electrophoresis 4.5.2. urine capillary zone electrophoresis 4.5.3. urine free light chain assays practical considerations of freelite assays 5 - development and validation of freelite immunoassays 5.1. assay overview 5.2. polyclonal antisera versus monoclonal antibodies 5.3. antisera specificity testing 5.3.1. immunoelectrophoresis 5.3.2. western blot analysis 5.3.3. haemagglutination assays 5.3.4. nephelometry 5.4. accuracy and standardisation 5.5. maintaining batch-to-batch consistency of polyclonal antisera-based latex reagents 5.6. overview of freelite assay validation 5.7. overview of freelite kit manufacture 5.8. immunoassay development on different platforms 6 - freelite reference intervals 6.1. freelite® serum reference intervals 6.1.1. ethnic influences 6.2 borderline freelite results 6.3 freelite renal reference intervals 6.4 freelite urine reference intervals 7 - implementation and interpretation of freelite immunoassays 7.1. implementation of freelite assays 7.1.1. choice of instrument 7.1.2. reporting units 7.1.3. choice of sample 7.1.4. sample and reagent stability 7.1.5. changing batch of reagent or instrument 7.2. interpretation of freelite assays 7.2.1. normal reference intervals 7.2.2. terminology 7.2.3. the flc dot plot 7.2.4. result interpretation 7.2.5. sflcs and intact immunoglobulins are independent tumour markers 7.2.6. biological variation 7.3. freelite linearity 7.3.1. managing non-linearity 7.4. antigen excess 7.4.1. incidence of antigen excess 7.4.2. distinguishing between non-linearity and antigen excess 7.5. polymerisation 7.6. discrepant results 7.6.1. monoclonal flcs in urine, normal sflcs 7.6.2. monoclonal flcs detectable by sife but undetectable by sflc immunoassay 7.6.3. no monoclonal proteins detectable by any routine laboratory method 7.7. biclonal gammopathies 8 - other free light chain immunoassays 8.1. introduction 8.2. overview of commercial flc assays 8.3. monoclonal vs. polyclonal antisera 8.3.1. monoclonal antibody production 8.3.2. polyclonal antisera production 8.3.3. requirements for anti-flc antibodies for use in flc immunoassays 8.4. analytical performance of monoclonal and polyclonal antibody-based flc assays 8.4.1. calibration 8.4.2. precision 8.4.3. linearity 8.4.4. antigen excess 8.5. reference intervals 8.5.1. normal reference intervals 8.5.2. renal reference interval 8.6. clinical performance 8.6.1. comparison of absolute values 8.6.2. diagnostic performance in mm 8.6.3. rationale for the diagnoses of lcmm missed by monoclonal antibody-based flc assays 8.6.4. monitoring mm 8.6.5. diagnostic performance in cast nephropathy 8.6.6. diagnostic performance in al amyloidosis 8.6.7. monitoring al amyloidosis 8.7. compliance with guidelines 8.8. conclusion practical considerations of hevylite assays 9 - development and validation of hevylite immunoassays 9.1. assay overview 9.2. polyclonal antisera production 9.3. antisera specificity testing 9.4. accuracy and standardisation 9.4.1. primary standards and internal reference standards 9.4.2. kit calibrators and controls 9.4.3. calibration curves 9.4.4. correlation with total immunoglobulin measurements 9.5. maintaining batch-to-batch consistency of polyclonal antisera-based reagents 9.6. overview of hevylite assay validation 9.7. overview of hevylite kit manufacture 9.8. immunoassay development on different platforms 10 - hevylite reference intervals 10.1. introduction 10.2. standardisation of immunoglobulin assays 10.3. hevylite standardisation 10.4. hevylite reference intervals 10.4.1. binding site hevylite reference intervals 10.4.2. other hevylite reference intervals 10.5. choice of reference interval 11 - implementation and interpretation of hevylite immunoassays 11.1. implementation of hevylite assays 11.1.1. choice of instrument 11.1.2. reporting units 11.1.3. choice of sample 11.1.4. sample and reagent stability 11.1.5. changing batch of reagent or instrument 11.2. interpretation of hevylite assays 11.2.1. normal reference intervals 11.2.2. terminology 11.2.3. result interpretation 11.2.4. the hlc dot plot 11.2.5. freelite and hevylite are independent tumour markers 11.2.6. biological variation 11.3. linearity 11.3.1. managing non-linearity 11.4. antigen excess 11.5. comparison of hevylite results with other immunoglobulin tests 11.5.1. comparison of hevylite and total immunoglobulin measurements 11.5.2. comparison of hevylite and immmunoglobulin measurements by spe 11.5.3. comparison of hevylite and immunofixation electrophoresis monoclonal gammopathies 12 - an overview of multiple myeloma and related disorders 12.1. introduction 12.2. multiple myeloma and related malignant disorders 12.3. mgus and smm 12.4. improving our understanding of disease pathogenesis and response to therapy 13 - monoclonal gammopathy of undetermined significance 13.1. mgus definition and frequency 13.2. risk factors for mgus progression 13.2.1. prognostic value of serum flcs in mgus 13.2.2. prognostic value of hevylite in mgus 13.3. mgus as the precursor condition for mm and related disorders 13.3.1. mgus consistently precedes mm 13.3.2. light chain mgus 13.3.3. prior knowledge of mgus improves multiple myeloma survival 13.3.4. mgus is associated with increased mortality 14 - smouldering multiple myeloma 14.1. introduction 14.2. monoclonal sflcs and smm progression 14.3. the prognostic value of hlc analysis at baseline 14.4. the prognostic value of changes in monoclonal protein concentration 15 - light chain multiple myeloma 15.1. diagnosis of light chain multiple myeloma 15.2. monitoring light chain multiple myeloma 15.3. prognostic value of the sflc response in light chain multiple myeloma 16 - nonsecretory multiple myeloma 16.1. introduction 16.2. diagnosis of nonsecretory multiple myeloma 16.3. monitoring nonsecretory multiple myeloma 17 - intact immunoglobulin multiple myeloma - monoclonal immunoglobulins at presentation 17.1. introduction 17.2. free light chains at diagnosis 17.3. international guidelines for the quantification of monoclonal immunoglobulins in iimm 17.4. limitations of electrophoresis 17.5. limitations of total immunoglobulin measurements 17.6. immunoglobulin hlc immunoassays (hevylite) at diagnosis 18 - intact immunoglobulin multiple myeloma - monitoring monoclonal immunoglobulins 18.1. introduction 18.2. current guidelines for monitoring iimm 18.2.1. detection of free light chain escape 18.2.2. definition of a stringent complete response 18.3. other uses of sflc analysis in iimm response assessment 18.3.1. rapid assessment of response 18.3.2. prediction of overall response 18.3.3. early detection of ineffective therapy 18.3.4. early detection of disease relapse 18.3.5. monitoring patients treated with monoclonal antibody-based therapies 18.4. monitoring iimm patients using hlc assays 18.4.1. hlc assays are quantitative and non-subjective 18.4.2. hlc assays to monitor oligosecretory patients 18.4.3. hlc assays in mrd assessment 18.4.4. hlc assays improve detection of relapse 18.4.5. discrepancies between hlc and ife during follow-up 19 - clonal evolution in multiple myeloma 19.1. introduction 19.2. clonal populations in multiple myeloma 19.3. clonal changes and clonal escape in multiple myeloma 20 - multiple myeloma prognosis 20.1. introduction 20.2. sflcs at diagnosis 20.2.1. sflcs combined with the iss 20.2.2. association between sflcs and other prognostic markers 20.3. sflcs during response assessment 20.3.1. normalisation of the sflc ratio and importance of a scr 20.3.2. early sflc response predicts outcome 20.3.3. prognostic implications of relapse with flcs 20.4. hlc analysis at diagnosis 20.5. hlc analysis during response assessment 20.6. prognostic value of combining sflc and hlc measurements 21 - plasmacytoma 21.1. introduction 21.2. solitary plasmacytoma of bone 21.2.1. monoclonal proteins in patients with solitary plasmacytoma of bone 21.2.2. prognostic factors in patients with solitary plasmacytoma of bone 21.2.3. monitoring solitary plasmacytoma of bone using sflcs 21.3. solitary extramedullary plasmacytoma 21.4. multiple solitary plasmacytoma 22 - plasma cell leukaemia 22.1. introduction 22.2. diagnosis and monitoring of plasma cell leukaemia using sflcs 23 - screening studies using serum free light chain analysis 23.1. introduction 23.2. screening panels for the detection of monoclonal gammopathies 23.3. incorporation of sflc analysis into routine screening for monoclonal gammopathies 23.3.1 screening for monoclonal gammopathy in patients presenting with renal dysfunction 23.3.2 interpretation of borderline sflc ratios 23.4. the sensitivity of abnormal sflc ratios for bence jones proteinuria 23.5. issues with urine compliance 23.6. organisational and cost implications of screening algorithms 24 - serum versus urine tests for free light chains 24.1. introduction 24.2. renal threshold for flc excretion 24.3. problems measuring urine samples 24.4. urine compliance 24.5. urine flc immunoassays 24.6. clinical benefits of sflc analysis 24.7. elimination of urine studies when screening for monoclonal gammopathies 24.8. comparison of sflcs and urinalysis for monitoring patients 24.9. discrepant serum and urine results 24.10. organisational cost savings and other benefits of sflc analysis 24.11. conclusions 25 - guidelines for multiple myeloma and related disorders 25.1. introduction 25.2. international myeloma working group updated criteria for the diagnosis of multiple myeloma 25.2.1. definition of multiple myeloma 25.2.2. definition of smouldering multiple myeloma 25.2.3. definition of monoclonal gammopathy of undetermined significance 25.3. international myeloma working group guidelines 25.3.1. guidelines for serum free light chain analysis in multiple myeloma and related disorders (2009) 25.3.2. guidelines for monoclonal gammopathy of undetermined significance and smouldering multiple myeloma (2010) 25.3.3. guidelines for standard investigative work-up of patients with suspected multiple myeloma (2011) 25.3.4. guidelines for risk stratification in multiple myeloma (2011) 25.3.5. consensus criteria for response and minimal residual disease assessment in multiple myeloma (2016) 25.3.6. recommendations for global myeloma care (2013) 25.3.7. recommendations for the diagnosis and management of myeloma-related renal impairment (2016) 25.4. european society of medical oncology: clinical practice guidelines for diagnosis, treatment and follow-up of multiple myeloma (2017) 25.5. uk myeloma forum and nordic myeloma study group: guidelines for the investigation of newly detected monoclonal proteins and management of monoclonal gammopathy of undetermined significance (2009) 25.6. british committee for standards in haematology guidelines (2014) 25.7. national institute for health and care excellence guideline 35: myeloma diagnosis and management (2016) 25.8. nccn clinical practice guidelines in oncology (nccn guidelines®) for multiple myeloma v.4.2018 25.9. management of multiple myeloma in asia: resource-stratified guidelines diseases with monoclonal light chain deposition 26 - an overview of the kidney and monoclonal free light chains 26.1. introduction 26.2. renal clearance of free light chains 26.3. renal impairment and free light chains 26.4. nephrotoxicity of monoclonal flcs 26.4.1. monoclonal gammopathy of renal significance 27 - cast nephropathy in multiple myeloma 27.1. renal impairment in multiple myeloma 27.2. screening for multiple myeloma in patients with unexplained aki 27.3. cast nephropathy 27.4. light chain removal strategies in cast nephropathy 27.4.1. plasma exchange 27.4.2. high cut-off haemodialysis 27.4.3. haemodialysis and adsorption 27.5. renal recovery is associated with reductions in flcs 28 - al amyloidosis 28.1. introduction 28.2. diagnosis of al amyloidosis 28.2.1 localised amyloid disease 28.3. guidelines for the diagnosis of al amyloidosis 28.3.1. international myeloma working group (2009) 28.3.2. british committee for standards in haematology (2015) 28.4. prognostic value of sflcs at diagnosis 28.5. patients with low amyloidogenic flcs have distinct clinical features 28.6. monitoring patients with al amyloidosis 28.7. guidelines for monitoring al amyloidosis 28.7.1. international myeloma working group (2009) 28.7.2. consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis (2012) 28.7.3. british committee for standards in haematology (2015) 28.8. prognostic value of sflc response 28.8.1. sflc response predicting cardiac outcomes 28.8.2. sflc response and renal outcome 28.9. sap scintigraphy and sflcs 28.10. hevylite in al amyloidosis 29 - light chain deposition disease 29.1. introduction 29.2. sflc assays support a diagnosis of lcdd 29.3. monitoring lcdd using sflc assays other diseases with monoclonal or increased polyclonal flcs 30 - an overview of other diseases with monoclonal or increased polyclonal immunoglobulins 30.1. introduction 30.2. sflcs in lymphoid malignancies 30.3. hevylite in lymphoid malignancies 30.4. sflcs as a biomarker of immune stimulation and inflammation 30.5. cerebrospinal fluid flcs and multiple sclerosis 30.6. sflcs as a marker of mortality 30.7. combylite assay 31 - lymphoma 31.1. introduction 31.2. hodgkin lymphoma 31.3. non-hodgkin lymphoma: diffuse large b-cell lymphoma 31.3.1. sflcs and hlc in dlbcl 31.3.2. prognostic value of sflcs and hlcs in dlbcl 31.3.3. use of sflcs for monitoring dlbcl 31.4. non-hodgkin lymphoma: mantle cell lymphoma 32 - waldenström's macroglobulinaemia 32.1. introduction 32.2. igm quantitation by routine laboratory tests 32.3. sflcs in waldenström's macroglobulinaemia 32.3.1. sflcs and wm diagnosis 32.3.2. monitoring wm using sflcs 32.3.3. sflc and wm prognosis 32.4. igm hlc in waldenström's macroglobulinaemia 32.4.1. igm hlc and wm diagnosis 32.4.2. monitoring wm using igm hlc 32.4.3. igm hlc and wm prognosis 32.5. use of sflc and hlc analysis in igm mgus and asymptomatic wm 33 - chronic lymphocytic leukaemia 33.1. introduction 33.2. monoclonal and polyclonal sflcs in cll 33.3. prognostic value of sflcs at baseline 33.4. prognostic value of combined flc measurements 33.5. monitoring cll with sflcs 34 - other diseases with abnormal immunoglobulin production 34.1. introduction 34.2. cryoglobulinaemia 34.3. heavy chain diseases 34.4. poems syndrome 35 - diseases with elevated polyclonal free light chains 35.1. introduction 35.2. chronic kidney disease 35.3. cardiovascular disease 35.4. rheumatic diseases 35.4.1. systemic lupus erythematosus 35.4.2. primary sjögren’s syndrome 35.4.3. rheumatoid arthritis 35.4.4. systemic sclerosis 35.5. diabetes mellitus 35.6. human immunodeficiency virus 35.7. allergies 35.8. other diseases 35.8.1. respiratory disease 35.8.2. hepatitis c virus and liver disease 35.8.3. renal transplantation 35.8.4. post-transplant lymphoproliferative disorder 35.8.5. igg4-related disease 35.9. flcs as bioactive molecules in inflammatory diseases 35.10. general population studies 35.11. conclusions 36 - cerebrospinal fluid and free light chains 36.1. introduction 36.1.1. multiple sclerosis and intrathecal immunoglobulin synthesis 36.2. csf flcs as a marker of intrathecal immunoglobulin synthesis 36.3. prognostic significance of csf flcs instrumentation and external quality assurance 37 - freelite immunoassay instrumentation 37.1. introduction 37.2. binding site spaplus 37.3. binding site optilite 37.4. binding site mininephplus 37.5. other analytical platforms 38 - hevylite immunoassay instrumentation 38.1. introduction 38.2. binding site spaplus 38.3. binding site optilite 39 - external quality assurance schemes for freelite and hevylite immunoassays 39.1. introduction 39.2. the binding site schemes 39.2.1. qa003 39.2.2. qa003.h 39.3. united kingdom national external quality assessment service scheme 39.4. college of american pathologists scheme 39.5. randox international quality assessment scheme 39.6. german institute for standardisation scheme 40 - disclaimer 40.1 disclaimer 40.2 contact information 40.3 terms and conditions contents index figures about contact © copyright 2018 last update: 27/03/2018 sitemap | privacy policy | disclaimers

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https://www.facebook.com/sharer/sharer.php?u=www.wikilite.com/
http://www.wikilite.com/hevyite-development-and-validation
http://www.wikilite.com/content-index/index
http://www.wikilite.com/nice-guidelines-2016
http://www.wikilite.com/site/table-of-contents
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http://www.wikilite.com/multiple-myeloma
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Whois Information

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Domain Name: WIKILITE.COM
Registry Domain ID: 772186251_DOMAIN_COM-VRSN
Registrar WHOIS Server: whois.joker.com
Registrar URL: http://www.joker.com
Updated Date: 2016-01-19T14:50:09Z
Creation Date: 2007-01-23T22:08:40Z
Registry Expiry Date: 2020-01-23T22:08:40Z
Registrar: CSL Computer Service Langenbach GmbH d/b/a joker.com
Registrar IANA ID: 113
Registrar Abuse Contact Email: [email protected]
Registrar Abuse Contact Phone: +49.21186767447
Domain Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited
Name Server: CARL.NS.CLOUDFLARE.COM
Name Server: KAY.NS.CLOUDFLARE.COM
DNSSEC: unsigned
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