At Creative Biolabsin vitro diagnostic IVD kit or assay development services are backed by years of experience and over a hundred immunoassay kits that have been developed, manufactured, and distributed to countries across the globe. We have scientists that are expert in the development of immunoassays of different formats.
With our reliable newly developed antibodies and antigens, and state-of-the-art facilities, we can develop the most sensitive, reproducible immunoassays and immunodiagnostic kits in the world. Enzyme-Linked Immuno Sorbent Assay ELISA kits are widely used for the in vitro quantitative measurement of different disease biomarkers in human serum, urine or stool samples. The principle of ELISA is the binding of a labeled specific antibody to the target antigen, which is also called analyte. The enzyme or other labels can react with the substrates, producing detectable signals.
A RIA is an immunoassay that uses radiolabeled 3 H, I, and 14 C molecules in a stepwise formation of immune complexes. The radioactivity of the molecules can be measured to analyze and quantitate small molecules, peptides, and proteins in biological samples. It is an old assay technique but it is still widely used and continues to offer distinct advantages in terms of simplicity and sensitivity.
LFIA is a simple and rapid diagnostic device used to confirm the presence or absence of a target analyte e. Lateral flow tests are widely used in human health for point of care testing. Creative Biolabs develops lateral flow assays with different labels e. LETIA is an accurate and stable assay commonly used to quantify serum protein in a homogenous system. In LETIA, antibodies are covalently attached to polymer latex microspheres with antigen binding sites exposed.
The turbidity of the solution is changed when the antibody-microsphere-antigen complex is formed and the absorbance at a specific range is correlated to antigen concentration. This assay does not require specific instruments, merely a general automated analyzer, and have the advantages of decreased operating time and reduced costs together with an overall integration with other clinical chemistry analyses.
Western Blot. The western blot method is composed of a gel electrophoresis to separate native proteins, followed by an electrophoretic transfer onto a membrane and an immunostaining procedure to visualize a certain protein on the blot membrane.
Generally, HIV viral antigens are transferred onto test strips for detection of specific antibodies. This assay is sensitive, reliable, and easy to run.
Lateral flow test
Immunohistochemical staining is widely used in the diagnosis of abnormal cells such as tumors. It exploits the principle of antibodies binding specifically to antigens in biological tissues. The visualization of the interaction can be accomplished by using different antibody conjugates, such as enzymes and fluorophores. Flow Cytometry. Flow cytometry is a technology that is used to analyze the physical and chemical characteristics of particles in a fluid as it passes through at least one laser.
Cell components are fluorescently labeled and then excited by the laser to emit light at varying wavelengths. Specific antibodies for flow cytometry can be produced targeting cell surface antigens. Microplate Coating. Creative Biolabs offers a wide range of microplate coating services including poly-D-lysine, collagen, streptavidin coating, antibody coating, and other coatings on request.
We offer plates of different sizes and formats. Moreover, we work side-by-side with our clients to select the right coating surfaces and coating process designs. Using novel techniques and formulations, they are often able to overcome obstacles in development and build robust, reproducible assays for our clients.
If you are interested in any of our services or have a specific assay that you want to develop, please contact us and we would be happy to help.
Our knowledgeable team will be able to provide you with a highly competitive quote with realistic turnaround times. Western Blot The western blot method is composed of a gel electrophoresis to separate native proteins, followed by an electrophoretic transfer onto a membrane and an immunostaining procedure to visualize a certain protein on the blot membrane. Immunohistochemistry Immunohistochemical staining is widely used in the diagnosis of abnormal cells such as tumors.
Flow Cytometry Flow cytometry is a technology that is used to analyze the physical and chemical characteristics of particles in a fluid as it passes through at least one laser.
Microplate Coating Creative Biolabs offers a wide range of microplate coating services including poly-D-lysine, collagen, streptavidin coating, antibody coating, and other coatings on request.International Journal of Infectious Diseases 91 — LIONEX is a leading manufacturer of highly purified, endotoxin free, mycobacterial antigens for research on tuberculosis and other mycobacterial diseases.
All products are manufactured in Germany. LIONEX partners and clients are large diagnostic companies, distributors, research institutions, universities, hospitals located on all continents. Bovine tuberculosis tests are also available for research. Research fields include diagnostics, vaccine and drug development, bladder cancer biomarkers. Email Address. Consent form Consent form I agree that my details from the contact form will be collected and processed to answer my request.
The data will be deleted after the processing of your request. Note: You can revoke your consent at any time for the future by e-mail to info lionex. General Terms and Conditions of Sale. Lionex Diagnostics and therapeutics.
Covid 19 Rapid test: IgG. Covid 19 Rapid test: IgM. Call us Tel. Email Us info lionex. Contact us. Research Products. OEM products. Read more. IVD Products. OEM Products. Lionex Gmbh Lionex Products are known for their easy, effective and fast use.
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Info sys4industry. Manufacturing equipment for rapid tests, lateral flow tests or strip tests, microfluidic cartridges. Packaging equipment heat sealers for rapid tests, lateral flow tests or strip tests. Equipment and supplies for diagnostic test kit manufacturers. Manufacturing components like plastic parts and plastic cassettes for rapid tests, lateral flow tests.
Product identification and printing equipment for marking diagnostic test kit products and test kit packaging. We supply equipment, materials and components for diagnostic test kit manufacturers. Foil bags and foil rollstock. IVD Test kit assembly machines. Desiccants for diagnostic test kits. IVD Test kit packaging machines. Product identification for test kits and packaging. Heat sealers for microfluidic cartridges. Plastic cassettes for test kits. Precision filling equipment.
Manufacturing Equipment. Packaging Equipment. Packaging Materials. Manufacturing Components. Product Identification. Main St. Suite Smithtown, NY Info sys4industry. Packaging Machinery. Product Identificatiion Equipment. Heat Sealers for microfluidic cartridges. High Production Rotary Band Sealer. Assembly Machinery with integrated packaging. Constant Heat Sealer.In vitro diagnostic IVD devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick.
IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. Any test developer requesting an EUA that intends to leverage data from another EUA-authorized device must obtain a right of reference to leverage the performance data for that EUA-authorized device.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA:. The templates reflect FDA's current thinking on the data and information that developers should submit to facilitate the EUA process.
Developers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. This table includes information about authorized in vitro diagnostic tests that may be used in the management of patients with COVID that have been authorized individually.
These include molecular tests and antigen tests. Once patients are diagnosed with COVID disease, these additional tests can be used to inform patient management decisions. Specifically, FDA determined that it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks.
FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Hangzhou Co. AvellinoCoV2 test. COV IDx assay. PhoenixDx CoV. Allplex nCoV Assay. BioFire Respiratory Panel 2. EUA Summary. Babson Diagnostics aC19G1. Elecsys ILHigh-quality products require highly experienced partners with a wide range of expertise. Find out more about partners here or contact us for more details. Secure, reliable and fully compliant, the solutions that Bond create have made them a preferred partner and a trusted ally for lateral flow leaders in human health, animal health and agri-food globally.
Assay specifications have become far more demanding, requiring high sensitivity, quantification, multiplexing and speed. Markets have also shifted, with the opening up of applications in health and wellness, consumer diagnostics, field deployed biological, chemical and nuclear defense applications, as well as in ever expanding human and veterinary diagnostic applications. Requirements for networking and back-end laboratory information systems for clinical applications such as rapid assays have also become paramount in the thinking of specification owners.
All products are manufactured in Germany. All productions are done under ISO certified conditions. We are a highly reliable partner for OEM products for companies active in manufacturing and distribution of such products worldwide. Microcoat possesses unique expertise in immunological and molecular assay and product development.
In close collaboration with its customers, the company identifies the ideal assay concept and develops it straightforward into a product from feasibility to production. In addition to established test formats, Microcoat is able to introduce new technologies and methodologies. Microcoat is a preferred supplier for well-known and market-leading diagnostic companies.
JOYSBIO (Tianjin) Biotechnology Co., Ltd.
Microcoat offers the entire spectrum of methods from protein expression to final kit assembly to deliver sophisticated and high-end diagnostic products.
It focuses on implementing robust and cost-effective manufacturing processes in order to ensure reliable longtime product supply. Their systems are designed to be easy to use, have the flexibility to meet application needs, and provide the reproducibility and robustness required in the manufacturing environment. With origins in medical device automation, BioDot decided to focus its efforts on the emerging market of lateral flow devices. Building upon a broad expertise in low volume dispensing technologies and automation, BioDot has developed a complete line of equipment for the development and manufacturing of lateral flow devices.
Today, with nearly units in the field BioDot is one of the largest suppliers of manufacturing equipment in the diagnostic test market. BioDot is a global company with international offices in China and the United Kingdom.
In the area of point-of-care tests, the name Gerresheimer Medical System stands for full service: whether drug detection, pregnancy tests, detection of emergency parameters, or allergy tests. At the start of the development, we select the best material to suit the required flexibility of the point-of-care test.
Our point-of-care experts then develop a customer-friendly housing design that is easy to handle. The optimal joining technology snap lock, gluing, or welding and the optimal functional support of the membrane pressure points includes the development of a user-friendly and safe point-of-care test.
Due to the extremely high contamination sensitivity of point-of-care tests, we offer our customers the entire production and assembly process in the clean room according to ISO ISO class 8 — including sealing in an aluminum pouch offering maximum protection prior to shipping.
Lateral-Flow Immunochromatographic Assay (LFIA) Based Kits Development
With the help of a safe selection of materials and high-cavity molds that are designed for a clean room production, we create the conditions necessary to produce these sensitive products in perfect quality.
Large quantities require highly automated production processes. We develop and build product-specific complete solutions for this purpose. Handling robots that are directly coupled with the injection molding machine, nest-specific removal systems, test systems, for example, for testing the seal, as well as automated assembly and packaging systems ensure efficient production.
Efficiency and accuracy are two key factors when it comes to improving qualitative and quantitative test methods. Its new sample and conjugate pads designed for Lateral Flow Immuno Assays applications represent a rapid, cost-effective, easy-to-use and close-to-the-patient solution for achieving reliable and consistent results.
The in vitro diagnostic series is available in a wide range of thicknesses, absorption levels and compositions. At AnteoTech we understand the challenges that our industry partners face in immunoassay development and manufacturing — reproducibility, cross-reactivity, pair matching, high background and achieving a low limit of detection.
AnteoTech offers AnteoBind integrated products and modularised service solutions to improve assay reproducibility and boost assay performance.
We are proud to serve and collaborate with customers globally in lateral flow, biosensors and multiplex immunoassay development. Plasmonic nanomaterials such as colloidal gold have long been used to signal binding events in lateral flow immunoassays. Its proprietary GL adhesive is the worldwide standard for lateral flow devices. The lateral flow reagents of nanoComposix are sold under their BioReady product line, which includes 40 nm and 80 nm colloidal gold and nm gold nanoshells.
Gold nanoshells have greater optical density per particle than colloidal gold, providing up to fold increased sensitivity at the test line. All nanoComposix products are delivered with critical characterization data including dynamic light scattering DLStransmission electron microscopy TEMpH, zeta potential and mass concentration measurements ICP-MS to ensure lot-to-lot consistency.Creative Biolabs is a famous expert in the in vitro diagnostics IVD manufacture, including IVD antibody productions and fast kit developments.
Currently, we offer lateral-flow immunochromatographic assay LFIA based kits developed services to complete disease screening and diagnosis, infection detection and therapeutic monitoring. LFIA, also known as lateral flow immunoassay, lateral flow assay LFAlateral flow test LFT or lateral flow device LFDis a type of solid-phase immunoassay that combines the principles of thin layer chromatography and immune recognition reaction.
In this assay, colored particles colloidal gold, colloidal carbon, colloidal selenium, liposome, latex, quantum dot, and so on can be selected as labels of antibody to detect the presence of an analyte.
Based on the elements of recognition used, LFIA can be categorized into different types as follows. Koczula, K. LIFA is a paper-based system for the detection and quantification of the target analyte in complex mixtures, where the sample is put into a test device, and results showed within few minutes. Compared to the laboratory-oriented instrumental analysis, LFIA is a simple, inexpensive, and fast-response technique useful for medical diagnosis, basic research, home testing, and point of care testing, as well as detecting various agricultural and environmental contaminations.
As the increasing popularity of this method, there are a number of prominent and unique merits performed in LFIA, including:.Competitive ELISA Tutorial 1: How a Competitive ELISA Works
LFIA is designed to confirm the presence or absence of the desired analyte, including pathogens and biomarkers in humans or animals, or contaminants in foodstuffs, water supplies, or animal feeds.
The most commonly known application of this assay is the pregnancy test. Ease of productions and low development costs of LFIA have led the expansion of its applications to multiple areas in which rapid tests are basically required.
LFIA-based tests are widely applied in hospitals, biological and clinical laboratories for the qualitative and quantitative detection of specific antigens, antibodies, and gene amplification products.
By using our IVD kits, varieties of biological specimens can be tested, involving saliva, sweat, urine, serum, plasma, whole blood, and other fluids. Moreover, further industries in which LFIA-based kits can be served that include quality control, veterinary medicine, product safety of food production, and environmental health and safety.
For more detailed information, please feel free to contact us. Lateral-flow Immunochromatographic Assay LFIA, also known as lateral flow immunoassay, lateral flow assay LFAlateral flow test LFT or lateral flow device LFDis a type of solid-phase immunoassay that combines the principles of thin layer chromatography and immune recognition reaction.
Advantages of LFIA As the increasing popularity of this method, there are a number of prominent and unique merits performed in LFIA, including: Rapidity and less time analysis One step analysis Simple instruments and low operational cost High specificity and better sensitivity User-friendly format Mostly, no more extra pretreatment with samples Less or no interferences due to chromatographic separation Long-term stability under different environmental conditions Portability of the device LFIA-based Kits Development LFIA is designed to confirm the presence or absence of the desired analyte, including pathogens and biomarkers in humans or animals, or contaminants in foodstuffs, water supplies, or animal feeds.
Reference Koczula, K. Western Blot Based Kits Development. Immunohistochemistry Based Kits Development. Flow Cytometry Based Kits Development. Microplates Coating. Online Inquiry Name:. Project Description:.Critical raw materials, such as antigens, are key factors for establishing reproducible and robust immunodiagnostic test systems.
This guarantees that industrial requirements can be fulfilled at any time. The product portfolio includes antigens isolated from pathogen cultivation e. MeaslesMumpsB. HSVParvovirusaltogether covering a range of more than 80 individual antigens that are produced on a routine basis. All antigens are purified using a range of techniques to ensure optimal performance in diagnostic applications.
This includes extraction, ultra-centrifugation, filtration and different types of state of the art chromatography processes. Native antigens are known for their high sensitivity in diagnostics applications, especially in IgM detection, and recombinant antigens are well known for their specificity, especially in IgG assays. Our antigens cover a broad range of infectious diseases including viral, bacteria, fungal or parasitic diseases such as toxoplasmosis and are an ideal basis for the development and production of infectious disease kits and reagents.
Standard package sizes are 1 mg. However, 5 mg and 10 mg portions are just as possible as customer-specific package sizes. Product Finder Here you will find a complete, easily filterable overview of our product range, sortable by product groups, pathogens and diagnostic categories.
The viral, bacterial, fungal, parasitic and recombinant antigens you need! Get in touch Partners How to find us. Downloads Antigen Flyer Product Catalogue. View in the Product Finder Please let us know if you are interested in 0. Features and benefits: Proven track record in antigen development and manufacturing DIN EN ISO quality management system and large scale production capacities Fully licensed manufacturing site for processes up to biosafety level 3 BSL3 State of the art production equipment and a highly motivated team Full flexibility for customized antigen projects.