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Qnostics (Scotland, United Kingdom) is a leading provider of Quality Control solutions for Molecular Infectious Disease testing. Designed to meet the demands of today’s molecular diagnostics laboratories carrying out Nucleic Acid Testing (NAT), including molecular characterized viral, bacterial and fungal targets cover a wide range of infectious diseases. In addition to product supply, Qnostics has, since 2003, been a service provider to molecular diagnostics in-vitro Diagnostic (IVD) assay manufacturers, EQA providers, Pharmaceutical and CRO organizations. Q Controls Analytical Q Panels Molecular Q Panels Evaluation Panels visit Qnostics website ► QCMD Past Panels

Multiplex Resp. Flu A + Flu B Flu A, Flu B & RSV RSV A+B Flu Typing I (H1N1 & H3N2) Flu Typing II (H1N1, H5N1, H3N2 & H7N9) Respiratory Viral Panel I [(Flu A, Flu B & RSV) + (H1N1, H5N1, H3N2 & H7N9)] Parainfluenza (1, 3 & 2, 4) Adenovirus, Metapneumovirus & Bocavirus Rhinovirus + Enterovirus Aspergillus differentiation MERS Coronavirus Quick SARS-CoV-2 Coronavirus (229E + NL63 + OC43 + HKU1) SARS-CoV-2 (ORF1ab and N genes) SARS-CoV-2 (N1 + N2) SARS-CoV-2 Triplex (ORF1ab, E & N genes) Flu A, Flu B & SARS-CoV-2 SARS-CoV-2, FLU & RSV SARS-CoV-2 & UK Variant (S UK, S wt and N genes) SARS-CoV-2 del 69/70, ORF1ab & N genes SARS-CoV-2 Variant I SARS-CoV-2 Variant II SARS-CoV-2 Variant III Bordetella (B. pertussis, B. parapertussis & B. holmesii) C. pneumoniae, M. pneumoniae & L. pneumophila H. influenzae + S. pneumoniae + M. catarrhalis M.tuberculosis complex + non-tuberculous mycobacteria Monoplex Resp. Bocavirus Human Metapneumovirus Influenza A Influenza (H1N1) pdm09 Influenza B RSV A RSV B Legionella pneumophila M. tuberculosis complex Group A Streptococcus Pneumocystis jirovecii (q) Panels Gastro. Respiratory Panel I Respiratory Panel II Respiratory Panel I Respiratory Panel I Respiratory Panel I BD MAX™ System Pneumocystis jirovecii – BD MAX™ System Bordetella – BD MAX™ System Flu A, Flu B & RSV – BD MAX™ System SARS-CoV-2 (N1 + N2) – BD MAX™ System SARS-CoV-2, Flu (A+B) & RSV – BD MAX™ System SARS-CoV-2 Variant – BD MAX™ System SARS-CoV-2 Variant II – BD MAX™ System VIASURE Respiratory Real-Time PCR Detection Kit ​ VIASURE Real Time PCR Detection Kit are available in l yophilised format for Monoplex and Multiplex assays which require minimal preparation and compatible with various open system thermal cyclers, allowing flexibility and ease of use. ​ ❮ BACK TO CERTEST MAIN

Features & Benefits One tube per sample means no need for sample splitting Reduce hands-on time from days to under 45 minutes Direct detection of CNVs Detect all mutations in the coding regions of the CFTR gene Determination of poly-T and TG repeats Choice of several validated software options, including CNV analysis Devyser CFTR NGS Devyser CFTR NGS is a single tube NGS library prep kit for targeted, complete CFTR gene sequencing. For further information on the Devyser CFTR NGS Kit, click here . To download the Devyser CFT NGS Kit handbook, click here . ​ ❮ BACK TO HEREDITARY ❮ BACK TO DEVYSER MAIN Devyser CFTR NGS Anchor Features & Benefits Detects 68 CFTR mutations, the polyT tract and associated number of TG repeats Only two mixes required to detect both wild-type and mutation status Mutation mix also includes the wild-type allele for the F508 deletion to check its zygosity Cross-mix ID markers to detect sample mix-up Fragment-analysis based CE-IVD Devyser CFTR 68 Devyser CFTR 68 is a fragment analysis-based kit that enables fast and reliable detection of cystic fibrosis-causing mutations, using a multi-ethic panel of 68 CFTR mutations that achieves high detection rates while keeping the workload and costs to a minimum. For further information on the Devyser CFTR 68 NGS Kit, click here . To download the Devyser CFTR NGS Kit handbook, click here . ​ ❮ BACK TO HEREDITARY ❮ BACK TO DEVYSER MAIN Devyser CFTR Anchor Features & Benefits Detects polythymidine variants (5T/7T/9T) within intron 9 (IVS8) of the CFTR In case of a 5T variant, also detects the TG repeat number Runs on all Thermofisher/ABI capillary electrophoresis instruments * View full list of mutations detected in product details Devyser CFTR Core Anchor Devyser CFTR Core Allele-specific genotyping of a panel of normal and mutated alleles in the CFTR gene common in the European population. For further information on the Devyser CFTR Core Kit, click here . To download the Devyser CFTR Core Kit handbook, click here . ​ ❮ BACK TO HEREDITARY ❮ BACK TO DEVYSER MAIN Detection of the following CFTR mutations 711+5A, 1898+3G, 2184delA, 4016insT, 4382delA, M1V, P5L, Q39X, D110E, D110H, G178R, R352Q, S549R(A>C), Q552X, D579G, E585X, R1066H, D1152H, R1158X, G1244E, CFTRdele1, CFTRdele2, CFTRdele2ins182, CFTRdele14b-17b, CFTRdele17a-18, CFTRdele22,23, CFTRdele22-24, 852del22, 1259insA, G1349D, c.1584+18672A>G and corresponding wild type alleles. Devyser CFTR Italia A Cystic fibrosis diagnostic test specifically for patients with Italian ancestry. Enables detection of 31 mutations specifically found in the Italian population with parallel detection of the corresponding normal alleles. Devyser CFTR Italia also includes analysis of cross-mix ID markers for sample identity confirmation between different Devyser CFTR products. For further information on the Devyser CFTR Italia Kit, click here . To download the Devyser CFTR Italia Kit handbook, click here . ​ ❮ BACK TO HEREDITARY ❮ BACK TO DEVYSER MAIN Devyser CFTR Italia Anchor Features & Benefits Detects the following mutations Q1100P, M1101K, 1812-1G>A, 1609delCA, 1898+3A>G, R709X, V232D, S549R (T>G), L206W, P205S, H199Y, 712-1G>T, 2869insG, 1811+1,6kbA>G, Q890X and corresponding wild type alleles. Devyser CFTR Iberia A Cystic fibrosis diagnostic test specifically for patients with Italian ancestry. Enables detection of 15 mutations specifically found in patients of Spanish and Portuguese ancestry, with parallel detection of the corresponding normal alleles. Devyser CFTR Iberia also includes analysis of cross-mix ID markers for sample identity confirmation between different Devyser CFTR products. For further information on the Devyser CFTR Iberia Kit, click here . To download the Devyser CFTR Iberia Kit handbook, click here . ​ ❮ BACK TO DEVYSER MAIN Features & Benefits Detects the following CFTR mutations E60X, P67L, Q98X, 621+2T>C, L218X, 1154insTC, 1161delC, 1525-1G>A, Q493X, V520F, S549N, Y569D, S589N, 1898+5G>T, D1152H, R1158X, R1283M and corresponding wild type alleles. Devyser CFTR UK A Cystic fibrosis diagnostic test specifically for the UK population, including common Celtic, Chinese and Pakistani mutations. Enables detection of 17 mutations specifically found in the Italian population with parallell detection of the corresponding normal alleles. Devyser CFTR UK also includes analysis of cross-mix ID markers for sample identity confirmation between different Devyser CFTR products. For further information on the Devyser CFTR UK Kit, click here . To download the Devyser CFTR UK Kit handbook, click here . ​ ❮ BACK TO DEVYSER MAIN

Anatomical Pathology QAP ALK Translocation for non-small cell lung carcinoma (NSCLC) Breast Diagnostic Dermatopathology Diagnostic Electron Microscopy Diagnostic Paediatric Diagnostic Forensic Diagnostic Gastrointestinal Diagnostic Neuropathology Diagnostic Gynaecology Diagnostic Haematopathology Diagnostic Head and Neck Diagnostic Fluorescence in-situ Hybridisation (FISH) Diagnostic Biosecurity QAP Bacterial Specimen Module Biopreparedness Exercise – Bacteria Emerging Biological Threats – Molecular Emerging Biological Threats – Serology Environmental Specimen Module SSBA eLearning Module – Anthrax SSBA eLearning Module – Botulism SSBA eLearning Module – Ebola SSBA eLearning Module – History of Biowarfare/Bioterrorism SSBA eLearning Module – Plague SSBA eLearning Module – Smallpox SSBA eLearning Module – Toxins SSBA eLearning Module – Tularemia Viral Specimen Module Whole Genome Sequencing Module The RCPAQAP Anatomical Pathology discipline offers programs in the areas of diagnostic and technical proficiency of histopathology laboratories. Diagnostic survey cases are selected to demonstrate either classical histological features of a disease process, common disease processes observed in routine pathology laboratories or critical disease processes of educational value to participants. The diagnostic proficiency programs offer enrolments for laboratories, individual pathologists and trainees. ​ ❮ BACK TO RCPA MAIN Anatomical Pathology In 2008 the Australian Government established a two-tiered list of Security Sensitive Biological Agents (SSBA) as part of the SSBA Regulatory Scheme for the control of select agents and toxins. Funding was subsequently made available through the Department of Health to establish RCPAQAP Biosecurity , with the aim of providing a quality assurance and proficiency testing program (PTP) for Tier 1 and Tier 2 SSBA, other potential agents and communicable disease threats. The program now offers surveys free of charge to Australian laboratories and for a fee to approved overseas laboratories with a view to building and enhancing laboratory capacity and capability to detect, analyze, identify and report on these agents. ​ ❮ BACK TO RCPA MAIN Biosecurity Chemical Pathology QAP Alcohol and Ammonia B Natriuretic Peptide (BNP) Blood Gases: CO-oximetry C Reactive Protein Condensed PoCT: Troponin CSF: Oligoclonal Bands Dried Blood Spot Endocrine Faecal Occult Blood General Urine Chemistry HbA1c: Whole Blood Neonatal Bilirubin Porphyrins: Plasma Salivary Cortisol Special Drugs Serum Indices Special Lipids Sweat Testing Toxicology Screening: On-Site Urine Trace Elements: Whole Blood Tumour Markers Urine Pregnancy Vitamin C Vitamins: Serum Cytopathology QAP Gynaecological Non-Gynaecological Performance Measures Technical Gynaecological Conventional Liquid based SurePath Liquid based ThinPrep Non-Gynaecological General Fine Needle Aspiration Specialty Performance Measures Technical Chemical Pathology The RCPAQAP Chemical Pathology discipline programs are run in association with the Australasian Association of Clinical Biochemists (AACB) whose members provide expertise and assistance via specialized Advisory Committees. All Chemical Pathology Full Programs are made up of data management and a complete set of material containing all the samples to be analyzed for the full enrolment year is distributed to participants following enrolment. ​ ❮ BACK TO RCPA MAIN The RCPAQAP Cytopathology discipline offers external quality assurance programs that encompass both gynaecological and non-gynaecological Cytopathology practice. Laboratories may enrol in any or all of the programs. Technical exercises are selected to assess common or critical features demonstrated by routine methods in the laboratory. Questionnaires on laboratory practice may also be issued. ​ ❮ BACK TO RCPA MAIN Cytopathology Haematology QAP Bone Marrow Morphology Coagulation Factors: II, V, VII, X, XI, and XII D-Dimer: Semi-quantitative ESR Full Blood Count G6PD Reticulocyte Oncology Immunophenotyping Paroxysmal Nocturnal Haemoglobinuria Thromboelastography Thromboelastometry Special Haemostasis The RCPAQAP Haematology has a comprehensive range of EQA programs covering a variety of diagnostic tests used in blood disease screening and monitoring level of blood components. Surveys are dispatched each month within the year with a wide range of samples for both routine and specialist Haematology testing. Various sample type such as lyophilised plasma and stabilised whole blood will be provided for different testing ​ ❮ BACK TO RCPA MAIN Haematology Immunology QAP Adrenal Antibodies Bee Venom IgE Coeliac Disease Antibodies Cyclic Citrullinated Peptide Drug Allergens dsDNA and Associated Antibodies Food Allergens Fungal and Avian Antibodies High Sensitivity C Reactive Protein (hsCRP) Immunoglobulin Immunoglobulin D Immunoglobulin E Immunoglobulin G Subclasses Immunophenotyping Inhalant Allergens Liver Antibodies Myositis Specific and Scleroderma Antibodies Neuronal Antibodies Procalcitonin Rheumatoid Factor Skin Antibodies Thyroid antibodies Tissue Autoantibodies Type I Diabetes Antibodies Vasculitis Antibodies Participating laboratories may select from a group of RCPAQAP Immunology program modules that comprehensively cover the assays performed in Clinical Immunology. ​ All Immunology programs are made of two components: Data Management – which includes result entry and all associated reports. A Participant Handbook and Schedules, along with all Result and Method Sheets are supplied in the RCPAQAP myQAP online customer portal. Purchasing a Data Management enrolment is useful when the material from the Full Program can be shared with a second instrument or a satellite/branch laboratory on the same site. ​ Full program (material) – a complete set of material containing all the samples to be analysed for the full enrolment year is distributed to participants following enrolment. ​ ❮ BACK TO RCPA MAIN Immunology

Features & Benefits Detects down to 0.05% fraction of chimerism – Allows earlier detection of graft rejection and disease relapse Accurate and precise measurement over the entire dynamic range from 0.05 – 100% chimerism using a single method – One measurement method regardless of the level of mixed chimerism A single workflow for both screening and monitoring – Eliminates the need for sample-specific primers and patient-specific marker tracking Single-tube NGS method – One universal reagent mix for all patients helps reduce reagent wastage and the need for keeping multiple reagents in stock User-friendly, designed-for-purpose software with automatic marker identification and chimerism calculation – Speeds up results analysis and eliminates manual data input Screening samples are sequenced only once – Saves time and increases lab productivity Transplantation Devyser Chimerism NGS Devyser Chimerism NGS utilizes NGS technology for very early detection of graft rejection and disease relapse in hematopoietic stem cell transplanted patients. For further information on the Devyser Chimerism NGS Kit, click here . To download the Devyser Chimerism NGS Kit handbook, click here . ​ ❮ BACK TO DEVYSER MAIN Features & Benefits Single-tube NGS assay for simultaneous comprehensive analysis of the HBA and the HBB gene clusters‍ Full gene sequencing of HBA1, HBA2 and HBB genes enables detection of all SNVs‍ Robust CNV detection with two combined strategies for CNV detection: Direct detection of 17 CNVs Coverage based detection of CNVs in both the HBA and the HBB gene clusters‍ Built in rapid sample mix-up control through sex chromosome markers Features & Benefits Detect all mutations in BRCA1 and BRCA2 One tube per sample means no need for sample splitting Reduce hands-on time from days to under 45 minutes One kit for both germline and somatic mutations Choice of several validated software options, including CNV analysis Thalassemia Devyser BRCA NGS Devyser BRCA NGS utilizes NGS technology and proprietary multiplex PCR primer chemistry to provides full and uniform coverage of BRCA1 and BRCA2, covering all exons and exon/intron junctions. The kit uses overlapping primer design to ascertain superior INDEL coverage and downstream CNV analysis. It can be used to detect both germline and somatic mutations. For further information on the Devyser BRCA NGS Kit, click here . To download the Devyser BRCA NGS Kit handbook, click here . ​ ❮ BACK TO DEVYSER MAIN Oncology Devyser Thalassemia NGS With the Devyser Thalassemia kit you can detect all mutations in HBA1, HBA2 and HBB using a single, one-tube NGS assay. The assay detects single nucleotide polymorphisms (SNVs), indels and CNVs. The extremely simple procedure makes it an excellent choice for any lab, whether you are running advanced second level genetic testing or large scale mutation screening. The fast, simple and robust NGS workflow replaces complex multi-step protocols and eliminates the need for maintaining multiple thalassemia assays in your lab. For further information on the Devyser Thalassemia NGS Kit, click here . To download the Devyser Thalassemia NGS Kit handbook, click here . ​ ❮ BACK TO HEREDITARY ❮ BACK TO DEVYSER MAIN Features & Benefits Detect mutations in genes with a recognised connection to the development of breast and ovarian cancers Can be used as a follow-up after negative BRCA testing, or combined with Devyser BRCA for analysis of 14 genes in total End-to-end CE-IVD solution including NGS library preparation and a customised data interpretation software Targeted sequencing with high uniformity reduces sequencing costs by maximising sample capacity on every NGS flowcell User friendly workflow with 45 mins hands-on time and a total laboratory process time of five hours from DNA to sequencing Devyser HBOC NGS Devyser HBOC NGS utilizes NGS technology for targeted sequencing of 12 genes relevant for hereditary breast and ovarian cancers (HBOC). It can be used as a follow-up after negative BRCA testing, or combined with Devyser BRCA NGS Kit for analysis of 14 genes in total For further information on the Devyser HBOC NGS Kit, click here . To download the Devyser HBOC NGS Kit handbook, click here . ​ ❮ BACK TO DEVYSER MAIN

QCMD (Scotland, United Kingdom) is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases. QMCD helps to monitor and improve quality within the clinical laboratory by assessing a laboratory's ability to use molecular diagnostic technologies within the routine clinical setting. The QCMD EQA programmes support the clinical laboratory's regulatory requirements and are also educational in application. The reports and practical feedback QCMD provides participants allows them to identify and resolve potential problems whilst monitoring the effectiveness of their laboratory quality assurance processes. Blood Borne Virus Central Nervous System Exotic Disease Gastrointestinal Disease Sexually Transmitted Infections Transplant Associated Disease visit QCMD website ► Congenital Infections Drug Resistance Exotic/Emerging Diseases Transplant Associated Disease Immunocompromised Diseases Multiple Pathogen/Syndromic Respiratory Diseases Typing

Pathonostics is founded in Maastricht, Netherlands in 2011 and is affiliated to PathoFinder. The company offers multiplex real-time PCR assays for the diagnosis of superficial and invasive fungal infections, as well as the identification of multi-drug resistance. These assays will greatly advance the diagnosis of fungal infections and promote the appropriate antifungal therapy. All real-time PCR kits are validated according to IVD guidelines and annually verified using quality assessment programs. AsperGenius® DermaGenius® 2.0 PneumoGenius® MucorGenius® visit Pathonostics website ►

Exotic/Emerging Diseases EQA Programme Plasmodium spp. (Malaria) Chikungunya Virus Dengue Virus RNA MERS Coronavirus SARS-CoV-2 Antigen Testing SARS-CoV-2 Trypanosoma cruzi (Chagas disease) West Nile Virus RNA Yellow Fever Virus Zika Virus Francisellatularensis Respiratory I Plus Exotic/Emerging diseases can be caused by newly identified pathogens, pathogen strains such as SARS or the mutation of existing strains such as Influenza virus. In addition, the spread of known pathogens (e.g. West Nile virus & dengue virus) into new geographical areas leading to new potential endemics account for a large number of exotic/emerging diseases. The EQAs within this group focus on those emerging diseases that are frequently being identified within progressive geographic regions. ​ ❮ BACK TO QCMD MAIN

PneumoGenius® multiplex kit (25 rxn) Targets: Pneumocystis jirovecii DHPS mutations (codon 55 and 57) Internal Control (IC)‍ Quantification standards: Standard 1: 10000 copies/μl Standard 2: 1000 copies/μl Standard 3: 100 copies/μl Standard 4: 10 copies/μl ​ ​ Features & Benefits: Aids in the diagnosis of Pneumocystosis Direct detection in BAL samples Quantification standards included Sample-to-result in less than 3 hours Sulfa drug resistance markers included (DHPS mutations) High sensitivity due to detection of conserved multi copy genes (mtLSU) Clinically validated on BAL samples (published data) PneumoGenius® ​ PneumoGenius® is a multiplex real-time PCR assay that detects Pneumocystis jirovecii in respiratory tract samples within 2.5 hours. Pneumocystis jirovecii is a common cause of life-threatening pneumonia in immunocompromised patients. The PneumoGenius® multiplex PCR assay is suitable for real-time PCR instruments using melting curve analysis, and has been validated on LightCycler 480 (Roche) and Rotor-Gene Q (Qiagen). ​ ❮ BACK TO PATHONOSTICS MAIN PneumoGenius® MucorGenius® multiplex kit (25 rxn) Pan-Mucormycetes -Rhizopus spp. -Mucor spp. -Lichtheimia spp. -Cunninghamella spp. -Rhizomucor spp. Internal Control (IC) Features & Benefits Aids in the diagnosis of mucormycosis The only commercial real-time PCR kit available Direct detection in BAL samples Sample-to-result in less than 3 hours Detection of clinically relevant species: undefined Rhizopus spp., Mucor spp., Rhizomucor spp., Lichtheimia spp. and Cunninghamella spp. High diagnostic value resulting in adapted patient management and in therapeutic decisions Can be used in parallel with the AsperGenius® PCR kit (same protocol) MucorGenius® ​ MucorGenius® is a multiplex real-time PCR assay that detects Mucormycosis in respiratory tract samples in less than 3 hours. Mucormycosis is a rare invasive fungal infection with exceedingly high mortality and few therapeutic options. The MucorGenius® multiplex PCR assay is suitable for real-time PCR instruments using melting curve analysis, and has been validated on LightCycler 480 II (Roche) and Rotor-Gene Q (Qiagen), CFX96™ (Bio-Rad), Mic qPCR (BMS) ​ and QuantStudio 5 (Thermo Fisher Scientific). ​ ❮ BACK TO PATHONOSTICS MAIN MucorGenius®

Features & Benefits ≥99.9% Diagnostic sensitivity (95 % – CI [99,86 % - 99.99 %]) ≥99.9% Diagnostic specificity (95 % – CI [99,48 % - 99.98 %]) ≥99.9% Correlation to Rhesus serology of the newborn Devyser RHD Devyser RHD is a single-exon real-time PCR assay intended to detect the fetal Rhesus D (RHD) gene from fetal circulating cell-free DNA in the blood plasma of RhD-negative maternal plasma during the first trimester (as early as gestation week 10). For further information on the Devyser RHD Kit, click here . To download the Devyser RHD Kit handbook, click here . ​ ❮ BACK TO DEVYSER MAIN Fetal RHD screening NIPT Features & Benefits Multiplex detection of relevant HFE mutations and corresponding wild-types Single tube PCR minimises hands-on time Streamlined protocol to fit workflow with other Devyser assays Single tube PCR reduces analysis time Single tube PCR minimises risk of sample mix up Devyser HFE Devyser HFE is a multiplex PCR reagent kit for simultaneous detection of the three most common mutations, and corresponding wildtypes, in the HFE gene. For further information on the Devyser HFE Kit, click here . To download the Devyser HFE Kit handbook, click here . ​ ❮ BACK TO DEVYSER MAIN Hereditary Other Devyser’s Hereditary Test Kits Devyser Thalassemia NGS Devyser FH NGS Devyser Thrombophilia Devyser CFTR NGS Devyser CFTR 68 Devyser CFTR Core Devyser CFTR Italia Devyser CVD