- Antibiotic assays
- Instrument validations
- Validation of neutralization methods
- Water tests
- Disinfectant qualification
-
Two passage reference cultures in our signature KWIK-STIK format Introducing KWIK-STICK Plus, from Microbiologics®. Some laboratory applications require strains that are a fewer passages from the original reference culture. For those special instances, we offer KWIK-STIK Plus, which combines microorganisms that are just two passages from their reference strains, with our signature KWIK-STIK format. Each device features a qualitative lyophilised microorganism pellet, ampoule of hydrating fluid and inoculating swab; so everything you need for growing control cultures is included in one handy device. Applications & Test Methods -
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- ISO 17025 laboratories requiring CRM
- Validation/verification of processes and instruments
- Presence/Absence
- Identification 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
-
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
-
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>
-
Available for use with serological and molecular assays, SeraCare’s portfolio of AccuSet performance panels contains highly characterized, raw, undiluted plasma specimens collected from unique individuals positive for your analytes of interest. Each panel contains a comprehensive comparative data sheet with test results from a wide variety of leading commercially available assays and platforms. AccuSet performance panels can be used to evaluate assay specificity, sensitivity, repeatability, and reproducibility to assist you in validating new test methods and equipment, run head-to-head assay comparisons, demonstrate lab proficiency, and train laboratory personnel. -
Validate and Monitor your assays AccuSpan linearity panels from SeraCare are designed to span the dynamic range of quantitative infectious disease assays and evaluate instrumentation analytical sensitivity. Linearity panels effectively challenge assay performance at defined intervals to ensure consistency throughout the entire reportable range. In addition to linearity studies, these panels are useful in validation procedures for new assay implementation, operator training, and troubleshooting signs of assay deterioration. -
Assess your assay development milestones When your assay development requires natural patient specimens that represent the body’s true response to an infection, you can depend on AccuVert seroconversion panels as a gold standard with which to assess your assay development milestones. The SeraCare seroconversion panels are developed using raw, undiluted plasma collected from a single individual during the development of an infection and subsequent immunological response. Spanning an array of infectious diseases from HIV to hepatitis and syphilis, SeraCare's panels provide you with a diverse selection of products with high-quality datasets to help evaluate your assay. A Rich History in Seroconversion Panels SeraCare have been a trusted provider of seroconversion panels for over 30 years, IVD diagnostic manufacturers worldwide have used our panels in the development and validation of their assays for decades. As shown in the World Health Organisation HIV test evaluation kit reports, SeraCare HIV seroconversion panels have been used for comparative studies for HIV test kit evaluations, and are also frequently referenced in package inserts of leading IVD infectious disease platforms. -
Ensure reagents are operating effectively from lot-to-lot AccuTrak qualification panels from SeraCare are designed as a cost-effective solution to deliver the consistent results you need to gain confidence in your assay’s performance and ensure reagents are operating effectively from lot-to-lot. SeraCare's AccuTrak qualification panels are utilised by clinical laboratories worldwide to help strengthen quality control protocols and procedures for infectious disease diagnostic assays. With products for HIV, hepatitis, CMV, syphilis, HPV, and HTLV, SeraCare offers a comprehensive portfolio to help effectively monitor assay performance. Reliable, Consistent, Cost-Effective Solutions for Your Assay QC Program -
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.
-
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