Search Results

Features & Benefits Time-saving state-of-the-art application software Loading dialogue guides through each loading step to ensure completeness of setup procedure Can be connected to one or several real-time PCR instruments Automatic programming of connected real-time PCR instruments Bidirectional LIMS interface / lab integration Import of sample information and worklist Export of results data Data import via barcode reader or via LIMS Predefined purification protocols Automated selection of controls and standards Features & Benefits Multiple CFX96™ Deep Well DX Systems can be connected with the AltoStar® Molecular Diagnostic Workflow (AltoStar® Connect software) Sensitive detection for up to five targets Time-saving management via data import through use of handheld barcode scanner or via LIMS (AltoStar® Connect software) Automatic programmimg of real-time PCR instruments via AltoStar® Connect software Streamline data analysis with built-in analysis modules PCR quantification with standard curve analysis Export of results (see AltoStar® Connect software, additional information see CFX Manager™ Dx software) Product list AltoStar® Processing Plate AltoStar® Eluate Plate AltoStar® Eluate Plate Sealing Foil PCR Plate & AltoStar® PCR Plate Sealing Foil AltoStar® PCR Plate Sealing Foil 1000 µl CO-RE Tips & 300 µl CO-RE Tips Pooling Tube Waste Bag Sample Tube & Sample Tube Caps AltoStar® Container Re-Sealing Foil Screw Caps - red, blue, orange, purple, white Dymo Labels 2 ml Tube AltoStar® Starter Kit AltoStar® Plate Sealer Table with table holder and Ergotron arm AltoStar Connect software AltoStar® Connect software The AltoStar® Connect software is used to operate the AltoStar® Automation System AM16. The user of the AltoStar® Connect software must be trained to operate the AltoStar® Connect software together with the AltoStar® AM16 instrument and the reagents, which are provided by altona Diagnostics GmbH for use with the AltoStar® system. ​ ❮ BACK TO ALTOSTAR MAIN AltoStar® Detection AltoStar® Detection completes the final part of the AltoStar® Automation System AM 16 workflow with two units of the real-time PCR cycler CFX96™ Deep Well Dx System (Bio-Rad). All other relevant hardware, like a fully equipped PC and handheld barcode scanner, are included. The CFX96™ Deep Well Dx System is CE-IVD marked, in compliance with the European Union diagnostic medical device manufacturing standards. ​ ❮ BACK TO ALTOSTAR MAIN AltoStar Detection AltoStar® Consumables Below is a list of all AltoStar® Consumables relevant for the AltoStar® Molecular Diagnostic Workflow. For optimized consumables managment all material is carefully selected and specially tailored (e.g. barcode) to the needs of each part of the workflow. ​ To download the AltoStar® list of consumables, click here . ​ ❮ BACK TO ALTOSTAR MAIN AltoStar Equipment

Microbiology QAP Bacteriology Module Clostridioides difficile: Laboratory Detection Endoscope and Bronchoscope Surveillance Culture Molecular Alphavirus and Flavivirus Molecular Bordetella pertussis Molecular Chlamydia trachomatis and Neisseria gonorrhoeae Molecular Coronavirus SARS-CoV-2 Molecular CSF Molecular Cytomegalovirus Molecular Enterovirus Molecular Gastrointestinal Pathogens: Bacteria / Parasites / Viral Molecular Hepatitis B Virus DNA / Hepatitis C Virus RNA / Hepatitis C Virus RNA Genotyping Molecular Herpes simplex virus type 1 and 2 Molecular HIV-1 RNA Molecular Human Papillomavirus DNA Molecular Influenza Molecular Malaria Molecular mec A/nuc gen Molecular Mycobacterium tuberculosis and M. avium complex Molecular Neisseria meningitidis Molecular Rapid Diagnostics Influenza/RSV/SARS-CoV-2 Molecular Respiratory Pathogens Molecular Sexually Transmitted Pathogens Molecular Vaccine Preventable Pathogens Molecular Varicella zoster virus Multi-drug resistant gram-negative bacteria (MDR) Mycology Non-tuberculous mycobacteria (NTM) Parasitology STAT Microscopy: Gram Stain / Urine Microscopy Streptococcus pneumoniae: urinary antigen detection Urine Dipstick Chemistry Vancomycin-Resistant Enterococci (VRE) The RCPAQAP Microbiology discipline has been developed and evolved under the guidance of the RCPAQAP Microbiology Advisory Committee. Within this discipline, a Molecular Infectious Diseases sub-committee further guides the development of microbiology molecular diagnostics. ​ The last two decades have seen enormous change in Medical Microbiology. ‘New’ organisms (Helicobacter pylori, HIV, Hepatitis C virus) have been discovered and characterised. ‘New’ infectious diseases (AIDS, Lyme disease and Legionnaires’ disease) have been described. ‘Old’ infections (tuberculosis, malaria, and pertussis) have re-emerged as major threats and have become increasingly resistant to previously effective antibiotics (MRSA, Streptococcus pneumoniae, VRE). Over this time, advances in technology and molecular medicine (automation, polymerase chain reaction) have added greatly to the Microbiologist’s diagnostic armamentarium. At the same time, Microbiology remains very much a ‘hands-on’ discipline. In many ways, it is an art as much as a science, and one in which an individual pathologist’s experience, judgment and interpretive skills are pivotal. ​ Clinical aspects involve control of outbreaks of infectious disease and dealing with the problems of infections caused by antibiotic-resistant bacteria. ​ ❮ BACK TO RCPA MAIN Microbiology Molecular Genetics QAP Acute Myeloid Leukemia NGS Panel Testing BCR-ABL Qualitative Chimerism Analysis Coeliac Disease HLA Genotyping FLT-3 ITD and TKD Hereditary Haemochromatosis (HFE) Human Leukocyte Antigen B*57 IDH Mutation Analysis in AML (IDH1, IDH2) Immunogenotyping (IgH,TCR) Kennedy’s Disease Maternal Cell Contamination Molecular Testing in Glioma (IDH1/2, MGMT) Mutation Detection in Colorectal Cancer / Lung Cancer (NSCLC) / Melanoma Myeloproliferative Neoplasms (JAK2, CALR, MPL) NPM1 PML-RARA PTEN Quality Assessment of DNA Extracts / FFPE DNA Extract Sanger DNA Sequencing Thalassaemia (alpha, beta) Thrombosis (F5, F2) TP53 Deletions at 17p13.1 in CLL (FISH) Genetics is an integral part of pathology with implications in disease pathogenesis and progression, identification of diagnostic and prognostic biomarkers, as well as targeted treatments. The RCPAQAP Molecular Genetics discipline offers diagnostic and technical proficiency testing programs for inherited diseases, oncology, molecular haematology and rare genetic disorders (as sample exchanges). ​ In addition, the RCPAQAP Molecular Genetics discipline partners with major external quality assurance providers to provide customers with as many options for molecular genetics testing as is currently available, this includes the: European Molecular Genetics Quality Network (EMQN) Cystic Fibrosis European Network (CF Network) UK National External Quality Assessment Scheme for Leucocyte Immunophenotyping (UK NEQAS LI) Quality Control for Molecular Diagnostics (QCMD) Genomics Quality Assessment (GenQA) Australasian Society of Diagnostic Genomics (ASDG) ​ ❮ BACK TO RCPA MAIN Molecular Genetics Serology QAP Bordetella pertussis Coagulation Factors: II, V, VII, X, XI, and XII Chlamydia genus Coronavirus SARS CoV-2 Antibodies/Antigen Dengue virus Epstein Barr virus Flavivirus Herpes simplex Human T-Lymphotropic Virus Helicobacter pylori Human Immunodeficiency Virus Hydatid Hepatitis Hepatitis A Hepatitis B Hepatitis C Hepatitis D Hepatitis E Influenza A and B Antibody Legionella Antibody/ Antigen Measles Mycoplasma Rubella Streptococcus Syphilis Varicella zoster Serology The RCPAQAP serology has a comprehensive range of EQA programs covering a variety of diagnostic tests used in infectious serological screening, surveillance and immunity evaluation. ​ Key features of the program include: One sample dispatch per year with the exception of HIV Point-of-Care Comprehensive assessment of over 50 analytes; Detection of antibodies, antigens; Result entry via the website; Trend analysis with a minimum of 2 surveys/year (for most analytes) ​ ❮ BACK TO RCPA MAIN Transfusion QAP Blood Grouping and Antibody Screen/Identification Foeto-Maternal Haemorrhage Estimation General Transfusion – Antibody Titre / Basic Compatibility / General Compatibility / Phenotyping Snake Venom Detection Transfusion Competency – Antibody Identification Module / Antibody Screen Module / Blood Grouping Module / rossmatching / Compatibility Testing Module / DAT Module / Phenotyping (Rh / K antigens only) Module (Overseas participants only) Transfusion Competency – Full Program The RCPAQAP Transfusion discipline covers all routine tests performed in a pre-transfusion testing laboratory including clinical decision making on given scenarios. The Individual Assessment program is designed to assist laboratory supervisors to maintain and assess individual staff competencies while also enabling individual staff to meet EQA participation requirements as stipulated by the guidelines. The Foetal Maternal Haemorrhage Estimation program is for assessing laboratories on methods used in estimating foetal red cells in maternal samples. ​ ❮ BACK TO RCPA MAIN Transfusion

Gastrointestinal EQA Programme Adenovirus DNA Bacterial Gastroenteritis Clostridium difficile DNA Diarrheagenic Escherichia coli Helicobacter pylori Norovirus RNA Parasitic Gastroenteritis Viral Gastroenteritis In recent years molecular diagnostic techniques such as real-time PCR have also been introduced for the laboratory diagnosis of gastroenteritis, including the ability to simultaneously screen for a wide range of enteric pathogens using multiplex assays. As a result, molecular diagnostic techniques are increasingly being used in the routine laboratory setting for detection, determination and surveillance of a wide range of enteric pathogens. The general aim of this group of EQA schemes is to allow laboratories to assess their ability in the use of molecular diagnostic tests for a range of viral, bacterial and parasitic enteric pathogens. ​ ❮ BACK TO QCMD MAIN

Transplant Associated Disease EQA Programme Cytomegalovirus Drug Resistance Cytomegalovirus Whole Blood Epstein-Barr virus DNA Epstein-Barr virus Whole Blood Human Cytomegalovirus DNA Human Herpes Virus 6 DNA JC virus DNA Torque Teno Virus Toxoplasma gondii DNA Transplantation Advances in molecular diagnostics have allowed accurate pathogen assessment prior to transplant and accurate quantitative monitoring, particularly of viral activity over time, after the transplant has been performed. This in turn allows early and accurate pre-emptive intervention and antiviral drug therapy. The range of QCMD EQA schemes within this area focus on those pathogens known to play a significant clinical role in transplant medicine. The general aim of this group of EQA schemes is to assess the ability of laboratories in the detection of the selected pathogen and where appropriate quantitative estimation is also evaluated. ​ ❮ BACK TO QCMD MAIN

Sexually Transmitted Infections EQA Programme Chlamydia trachomatis DNA Chlamydia trachomatis and Neisseria gonorrhoeae DNA Herpes Simplex Virus Drug Resistance Herpes simplex virus DNA Human Papillomavirus (Preservcyt) Human Papillomavirus (Surepath) Mycoplasma genitalium Neisseria gonorrhoeae DNA Sexually Transmitted Infections I Sexually Transmitted Infections II Syphilis Trichomonas vaginalis In recent years molecular diagnostic techniques such as real-time PCR have also been introduced for the laboratory diagnosis of gastroenteritis, including the ability to simultaneously screen for a wide range of enteric pathogens using multiplex assays. As a result, molecular diagnostic techniques are increasingly being used in the routine laboratory setting for detection, determination and surveillance of a wide range of enteric pathogens. The general aim of this group of EQA schemes is to allow laboratories to assess their ability in the use of molecular diagnostic tests for a range of viral, bacterial and parasitic enteric pathogens. ​ ❮ BACK TO QCMD MAIN

CERTEST Biotec is founded in Zaragoza, Spain in 2002. The company is devoted to the development and manufacturing of rapid tests and real-time PCR assays. VIASURE Real Time PCR Detection Kits are designed for the diagnosis of infectious diseases caused by different pathogens in human sample. visit CerTest website ► Gastrointestinal Infections Respiratory Infections Antimicrobial Resistance Tropical & Vector-Borne Transmission Sexual Health Immunosuppressed & Meningitis Non infectious diseases

Devyser was founded in 2004 in Stockholm, Sweden, specialises in the development of genetic diagnostic tests for hereditary diseases, oncology, and transplantation, based on multiplexed PCR and QF-PCR technology. Their non-invasive products are well intended for guided targeted cancer therapies, rapid pre-natal diagnostics and post-transplantation monitoring. visit Devyser website ► Transplantation Thalassemias Oncology Fetal RHD screening NIPT Hereditary Cystic fibrosis Cardiovascular Male infertility Rapid aneuploidy analysis

The Royal College of Pathologists of Australasia, or RCPA, has long supported excellence in provision of external quality assurance (EQA) for pathology laboratories. Quality assurance programs began in 1968 in Chemical Pathology, Hematology, Blood Bank, Microbiology and Anatomical Pathology. These discipline-specific programs were originally offered by independent organisation that became increasingly large and complex. Our Program Options: Anatomical Pathology Biosecurity Chemical Pathology Cytopathology Haematology Immunology visit RCPAQAP website ► Microbiology Molecular Genetics Serology Transfusion

Clinical Performance Data (for Clinical Laboratories) The clinical performance of the IONA® NIPT Workflow is assessed as part of the development process prior to product launch. Post-launch, as required by the medical device regulation and for our quality system we monitor performance via a process called ‘post-market surveillance’. Post-market surveillance is a set of activities conducted by manufacturers to collect and evaluate experience gained from medical devices that have been placed on the market. It is done with the intention of ensuring we can identify any trends that suggest the need to take any action e.g. withdrawing a faulty batch from the market. The data from both the initial validation work and post-market surveillance activities is provided below. ❮ BACK TO NIPT MAIN ❮ BACK TO YOURGENE MAIN

Central Nervous System EQA Programme Arthropod-Borne Viruses BK virus DNA Borrelia burgdorferi spp. DNA Central Nervous System I (Viral Meningitis and Encephalitis) Central Nervous System II (Non-Viral Meningitis and Encephalitis) Herpes simplex virus DNA JC virus DNA Enterovirus RNA Measles and Mumps Toxoplasma gondii DNA Varicella-Zoster virus DNA Parechovirus RNA In recent years significant advances have been made in understanding CNS pathogenesis with the development of molecular technologies for the diagnosis and monitoring of disease, the introduction of effective treatment therapies and, in some cases, the development of vaccines (e.g. Japanese encephalitis & rabies). The range of QCMD EQA schemes within this area focus on pathogens known to play a significant clinical role in CNS infection. The general aim of this group of EQA schemes is to assess the laboratories’ ability in the detection and determination of the selected pathogen. ​ ❮ BACK TO QCMD MAIN