- ISO 17025 laboratories requiring CRM
- Validation/verification of processes and instruments
- Presence/Absence
- Identification methods
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Qualitative control strains as Certified Reference Material for ISO 17025 accredited labs Increasing regulatory oversight in food, pharmaceutical and water industries has prompted many microbiology labs to seek accreditation to ISO 17025 standards. The Lab-Elite CRM, from Microbiologics®, is designed to help those labs meet the requirements of this standard which specify that “reference materials shall, where possible, be traceable to SI units of measurements, or to Certified Reference Materials (section 5.6.3.2)”. Lab-Elite CRM microorganisms are just one passage from the reference culture and are delivered in our signature KWIK-STIK format. As a Certified Reference Material, Lab-Elite comes with a comprehensive Certificate of Analysis detailing the strains identity and characteristics. Applications & Test Methods -
Qualitative control strains for QC testing It doesn’t get much easier than the LYFO-DISK from Microbiologics®. Simply rehydrate LYFO DISK qualitative microorganism pellets with a diluent, such as phosphate buffer or saline, and you’re ready to inoculate your culture media. LYFO DISK, packaged in a glass vial containing 6 pellets of a single strain, offers a ton of flexibility. It's an ideal solution for many quality control applications including presence/absence testing, microbial identification methods, antimicrobial susceptibility testing, media QC, water testing and more! Applications & Test Methods- Culture Purposes
- Media and reagent QC
- QC of Antimicrobial Susceptibility Test
- QC of microbial identification including biochemical, PCR and rapid molecular methods
- Water tests (e.g. enzyme substrates)
- Disinfectant studies
- Verifications and Validations
- Proficiency tests
- Daily QC
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QC microorganisms with Green Fluorescent Protein (GFP) markers It’s not uncommon for food samples to inadvertently become contaminated with control strains used in the laboratory. This leads to false-positive results which can have severe financial and regulatory implications. UV-BioTAG, our line of reference strains containing green fluorescent protein (GFP) markers, make it easy to distinguish standard microorganism strains from laboratory control strains. Optimised for highly visible fluorescence, UV-BioTAG strains provide better stability because the GFP marker is integrated into the chromosome rather than the plasmid. With UV-BioTAG, you can quickly and reliably establish whether a positive test result can be traced back to a control strain cross-contamination issue, or if it is from another source. Applications & Test Methods- Enumeration Methods
- Detection Methods
- Demonstration of Capability (DOC)
- Media QC
- Validation/Verification
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Microbial Controls made from your Environmental Isolates Tracking and trending environmental microbial isolates is a growing concern for pharmaceutical, nutraceutical, medical device, personal care product and food manufacturing laboratories. Microbiologics offers a comprehensive program for environmental isolate management. Our team of experts will identify, characterise, preserve and manufacture your strain into a test-ready control format for ongoing QC. Partner with TECHNOPATH and Microbiologics to reduce cost, minimize risk and increase confidence in your environmental monitoring program. Applications & Test Methods- Antimicrobial Effectiveness Testing - USP <51>
- Aseptic Processing Environment - USP <1116>
- Disinfectant Qualification - USP <116>
- Growth Promotion Testing - USP <61>, <62>, <71>
- Suitability Testing - USP <51>, <61>, <62>, <71>
- Validation of Neutralisation Methods - USP <1227>
- Water for Pharmaceutical Purposes - USP <1231>
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Ensure antibody testing accuracy and performance AccuSet™ SARS-CoV-2 Performance Panel from SeraCare - This eleven-member validation panel consists of undiluted, naturally occurring human-plasma members. Ten panel members represent collections from multiple individuals positive for antibodies to SARS-CoV-2; a single negative member is also included. Test results from commercially available SARS-CoV-2 antibody assays are included for comparative analysis. AccuSet™ SARS-CoV-2 Performance Panel is intended to provide an out-of-the-box solution to evaluate SARS-CoV-2 antibody detection assays with highly characterized human specimens whether generating validation data for a regulatory submission or performing assay verification in a clinical laboratory setting. ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is designed to support assay installation and monitoring of day-to-day assay performance, providing a complete quality solution for SARS-CoV-2 antibody testing. -
Ensure antibody testing accuracy and performance To support the many SARS-CoV-2 serology assay formats available, the kit is currently offered in two configurations, one designed for IgG-specific assays and the other for total antibody tests. Series 1000 is released using the Abbott ARCHITECT SARS-CoV-2 IgG assay, and Series 2000 is released using the Roche cobas® Elecsys® Anti-SARS-CoV-2 assay. Reference materials are specifically formulated to exhibit low positive reactivity in true patient-like matrices, to test assay performance near critical signal cutoff boundaries. AccuSet™ SARS-CoV-2 Performance Panel is intended to provide an out-of-the-box solution to evaluate SARS-CoV-2 antibody detection assays with highly characterised human specimens whether generating validation data for a regulatory submission or performing assay verification in a clinical laboratory setting.
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Have confidence in your multiplex assay results for SARS-CoV-2 & Flu A/B AccuPlex™ SARS-CoV-2, Flu A/B and RSV Verification Panel, from SeraCare, is optimised for assay verification at installation by documenting test performance along the assay’s range, enabling laboratories to establish lower limits of detection, perform assay comparisons, and evaluate staff proficiency. Designed for use with multiplexed molecular assays that can detect SARS-CoV-2, influenza A/B and respiratory syncytial virus (RSV). AccuPlex™ SARS-CoV-2, Flu A/B and RSV Verification Panel, coupled with the AccuPlex™ SARS-CoV-2, Flu A/B and RSV Reference Material Kit, is a complete Quality Solution designed to challenge the entire molecular test procedure ensuring clinical laboratories can have confidence in their multiplex assay results.
- Non-infectious and replication deficient, enables safe handling of positive material
- Fully-extractable with a real viral protein coat; serves as a full-process reference material
- 2 year stability at 2 - 8°C
- Optimised for assay verification and day-to-day performance monitoring
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Measure day-to-day performance AccuPlex™ SARS-CoV-2, Flu A/B and RSV Reference Material Kit, from SeraCare, is designed to measure day-to-day performance of the assay, providing both a positive and a negative reference solution. Designed for use with multiplexed molecular assays that can detect SARS-CoV-2, influenza A/B and respiratory syncytial virus (RSV). AccuPlex™ SARS-CoV-2, Flu A/B and RSV Reference Material Kit, coupled with the AccuPlex™ SARS-CoV-2, Flu A/B and RSV Verification Panel, is a complete Quality Solution designed to challenge the entire molecular test procedure ensuring clinical laboratories can have confidence in their multiplex assay results.
- Non-infectious and replication deficient, enables safe handling of positive material
- Fully-extractable with a real viral protein coat; serves as a full-process reference material
- 2 year stability at 2 - 8°C
- Optimised for assay verification and day-to-day performance monitoring
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Bio-Cuff™ Reusable Blood Pressure Cuff A complete range of reusable cuffs in single and dual hose options from GBUK Healthcare. Colour-coded for easy identification, all Bio-Cuff designs feature durable easy-clean material with gently rounded corners. Each Bio-Cuff has clear artery and range markers with advisory indicators to show when a smaller or larger Bio-Cuff would be the more appropriate choice. Every Bio-Cuff is brightly and distinctly colour-coded according to size. -
Bio-Cuff™ Single Patient Blood Pressure Cuff A complete range of six single patient use cuffs in single and dual hose options. Colour-coded for easy identification, all Bio-Cuff designs feature soft-feel material with rounded corners. Each Bio-Cuff has clear artery and range marks, with advisory indicators to show when a smaller or larger Bio-Cuff would be the more appropriate choice. Every Bio-Cuff Single Patient Use cuff is a clean, bright white with large easy-to-read markings, colour-coded according to size. -
Neo-Cuff™ Single Patient Neonatal Blood Pressure Cuff A complete range of five single patient use neonatal cuffs in single and dual hose options. Colour-coded for easy identification, all Neo-Cuff designs feature super-soft material with gently rounded corners. Every Neo-Cuff has clear artery and range marks, with advisory indicators to show when a smaller or larger Neo-Cuff would be the more appropriate choice. Each Neo-Cuff is brightly decorated with nursery characters to ease parental anxiety at the sight of clinical equipment. -
Clinical Diagnostic Quality Solutions for SARS-CoV-2 Variant Analysis AccuPlex SARS-CoV-2 Variant Panel 1 contains the full SARS-CoV-2 genomic RNA with a focus on S-gene mutations (Table 1) in three prominent variants of concern (VOC): UK variant B.1.1.7, South Africa variant B.1.351, and Brazil variant P.1. The kit has one vial for each variant as well as a fourth wild type (reference sequence NC_045512) control vial. An RNase P negative control vial is also included.
- Performance confirmation of existing SARS-CoV-2 molecular assays with different variants
- Reference materials for SARS-CoV-2 variant genotyping assays
- Reference materials for SARS-CoV-2 NGS assays
- Non-infectious and replication deficient, enables safe handling of positive material
- Fully extractable with a real viral protein coat; superior to “naked” transcribed RNA
- 2 year stability at 2 - 8°C