Solutions for Lateral Flow Assays & In Vitro Diagnostics Kit (IVD) Manufacturers
Diagnostic OEM Membranes, Tailored Lab Instruments & Consumables, Upstream Process Development & Characterization Tools
The diagnostic industry plays an essential role in healthcare, not only by providing essential tools to clinicians, but also by supplying a range of at-home testing solutions. Recently, the field has been shifting from curative to preventative diagnosis, with a greater emphasis on personalized offerings. To meet aggressive milestones and tough standards for performance, there is a need for continued innovation in the field as well as solutions that streamline the development and quality control workflows.
Sartorius is globally recognized for an expertise in biotherapeutics, including solutions for in vitro diagnostics kit (IVD) manufacturers. We can help you:
- Design a standardized sample preparation protocol before diagnosis with tailored lab instruments and consumables
- Get optimal performance characteristics on your lateral flow rapid tests with consistent and homogeneous UniSart® membranes
- Monitor and trace your critical Quality Control parameters
- Accelerate your analyte discovery steps, development and production
Development of a Novel IVD Test
Membranes for In Vitro Diagnostics, Microarray & OEM
Unisart® nitrocellulose membranes are specifically designed to be the ideal solid phase bind proteins on test and control lines and to transport the sample-conjugate complex in diagnostic lateral flow immunoassays (LFIAs).
- Inter- and intra-lot consistency to maintain production parameters between lots
- Reduced scrap rates with smooth, defect-free membrane surfaces
- High-sensitivity membrane allows detection of minimal biomarker concentrations
- Complete lot traceability over the entire casting process, from mixing of raw materials to the final slit roll
- ISO certified manufacturing, 100% controlled by backlight inspection
Lateral Flow Assay Resources
Label-free Bio-Layer Interferometry (BLI) technology
The Octet® R8 system utilizes Sartorius’ label-free Bio-Layer Interferometry (BLI) technology, enabling direct detection of specific proteins and other biomarkers. It can be used for a wide range of analyses including kinetic analysis, quantitation of IgGs and other proteins, immunoassay development, quality analysis, epitope binning/mapping and ligand binding assays.
- Eight channels can be used independently to measure samples for screening purposes or in tandem, pairing the sample read with a dedicated reference for high-quality kinetic characterization.
- Monitors binding events in real- time measuring binding association (ka) and dissociation (kd) kinetics, and affinity constants (KD).
- Optional 21 CFR Part 11 software available along with installation and qualification (IQOQ) and performance qualification (PQ) kits.
- Human antibody titer using Protein A biosensors can be determined in minutes.
- Excellent alternative to assays performed using time- and labor-intensive methods such as ELISA and HPLC.
Accelerate Your Progress with Sartorius
Applications for Lateral Flow Assays & IVD Manufacturers
Customized Preparation of Patient Samples
Clinical, immunological, biochemical and molecular diagnostic testing often involves many repetitive but critical steps that are well suited to automation. IVD systems are expected to be small in size with increased capacity and throughput to reduce low-value tasks in clinical labs and be closer to the patient.
Sartorius provides application-specific instruments and consumables that ensure error-proof, accurate and reproducible preparation of patient samples such as urine, blood and saliva. These include:
- Liquid handling instruments with embedded workflows to standardize your strictly defined protocol
- High-purity pipette tips free of DNase, RNase and endotoxins - available in bespoke packaging formats
- General Laboratory Use (GLU) ultrafiltration devices with volumes and membranes tailored optimizing human specimen sample preparation
- Dispensing heads for easy integration into robotic micro-volume dispensing solutions
- Weigh cells designed for integration into automated systems to control and monitor filling routines from 1 µL to 8
Read the Publication: "The Impact of IVD Regulations on Manufacturing"
Membranes for Lateral Flow Assays
Lateral flow assays (LFAs) are a type of Immunochromatography assay widely used for rapid detection of pathogens, toxins, environmental contaminants, and other substances. Nitrocellulose UniSart® membranes are designed to be the best substrate for rapid diagnostic tests and are highly used in longitudinal strip or vertical flow-through devices. Sartorius has also developed a microfluidic design that delineates hydrophobic barriers in the membrane zones, allowing multiparameter assays.
Sartorius’ broad variety of UniSart® membranes allows selection of the best performing characteristics for your device.
- Highly efficient matrix with reliable capillary speed and protein binding developed to offer high reproducible readouts and protein binding
- Precise traceability and consistent membrane quality for a reliable supply, from many m² of one batch down to the few cm² of a lateral strip
- Smooth, and defect-free surface allows for a consistent dispensing of sharp capture and control reagents lines
Read the Publication: "The Emergence of Lateral Flow Assays in Diagnostics"
Quality Control of Target Analyte
Inadequate sample preparation tools can lead to false-positive or false-negative identification of interferences. Microbial contamination encountered during production steps and detected late can affect analytical performance, efficiency and the time-to-market. All chemicals used in the test should be carefully monitored from incoming, in-process and packing materials to finished goods.
Sartorius can help monitor and trace critical parameters with:
- Octet® Label-free Bio-Layer Interferometry (BLI) technology enabling direct detection of specific receptor proteins, ligands, antibodies and other analyte specific reagents (ASRs)
- Cubis® II Pharma Compliant Weighing and sample management solutions, designed to follow data integrity principles and regulations such Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) principle, FDA’s (21 CFR Part 11) and EU’s (Annex 11)
- Rapid detection of mycoplasma, bacteria and fungi in your product in just three hours with ATMP Microsart® qPCR kits
- Microsart® family for microbial enumeration, bioburden testing, with touch-free membrane transfer
Analyte Specific Reagent (ASR) Discovery & Optimization
In a highly competitive environment, speed is crucial and companies must be strategic about prioritizing projects. The COVID-19 pandemic has also underscored the importance of first-to-market advantage when developing a novel analyte-specific reagent ASR.
This is achieved by using in-house expertise to optimize analyte performance, discover new binding abilities and improve processes or standardize methods for more efficient operations.
Backed with a strong expertise in biologics molecule development, Sartorius can help you accelerate your antibody development.
- Identify diagnostic antibodies with Incucyte® Live-Cell Analysis Systems
- Search the best binding pairs among different nucleoproteins concentration with Octet® Bio-Layer Interferometry (BLI) Detection Systems for Label-Free detection
- Achieve cultivation and media optimization for optimal growth and protein production with Ambr® 15 Cell Culture Bioreactor System
Sartorius IVD Manufacturing Solutions Offer:
Our international team of qualified experts understand what is needed when developing a novel diagnostic test. Your partnership with Sartorius is strictly confidential and backed by personalized support throughout the entire project.
OEM supplies are vital in diagnostic development. Sartorius products are developed, produced and distributed to ISO 9001 Quality Management System standards. They meet stringent quality control standards throughout all manufacturing steps and are backed by quality assurance certificates that guarantee conformity to specifications.
In additional to expertise in the production of reliable nitrocellulose membranes, Sartorius has also developed a comprehensive portfolio of scalable solutions for manufacturing and development of biomarkers, from media to bioproduction and capture. Finally, our compliant QC solutions help you ensure that your product is safe, effective and pure.
Solutions for Lateral Flow Assays and IVD ManufacturersPDF | 865.8 KB
Quality Control Of Biotherapeutics Using Octet® SystemsPDF | 1.9 MB
Octet® R2 System DatasheetPDF | 681.8 KB
UniSart® CN 180 DX MembranePDF | 595.2 KB
Converting ELISA Assay Into Octet® Quantitation AssayPDF | 207.5 KB
See the UniSart® Nitrocellulose Membranes in Action
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Frequently Asked Questions
In vitro molecular or nucleic acid-based diagnostics identify genetic, infectious, viral diseases or tumors by targeting and amplifying a specific nucleic acid fragment among millions of other DNA/RNA fragments.
During RNA preparation, cDNA synthesis and RT-PCR are pipetting-intensive protocols. It is crucial that the tips used are free of RNase and DNase with a barrier-filter that protect patient samples from cross-contamination.
The role of the nitrocellulose membranes in a lateral flow immunoassay (LFIA) is highly critical. The membrane acts as the main motor of the test, drawing the samples and conjugates from one end of the strip to the other end. Concurrently, the sample-conjugate complex can be captured by reagents that are pre-bound to the test and control lines.
Forward and reverse protein arrays are used in many multiparameter clinical diagnostic tests. The multiplicity of protein spots (in picoliter range), displayed in an intricate pattern on the slide surface, allow looking at various interactions simultaneously. The UniSart® 3D slide is a special glass slide that is coated with a thin microporous nitrocellulose membrane. The pad on the slide is a three-dimensional microporous nitrocellulose membrane, which shows high protein affinity and binding capacity in all microarray applications.
In Vitro Diagnostics (IVD) refers to a broad range of tests performed to detect diseases and various conditions and can be used to monitor an individual’s overall health. The diagnostics are done on blood, tissue, saliva or urina samples. They vary widely in targeted molecules and are aimed at the detection of low expressing biomarkers. The targeted diagnostic biomarker detects or confirms the presence of a disease or condition of interest, or identifies an individual with a subtype of the disease. In Vitro diagnostics products typically include systems and analyte specific reagents such as receptor proteins, ligands or antibodies that are designed with high specificity and sensitivity to detect and quantify changes in the targeted biomarker level as a function of the disease state