Key features of our company
Responsive
At HygiaDx, we prioritize responsiveness to our customers, fostering a collaborative environment that ensures IVD application and approval challenges are swiftly addressed. Our team works harmoniously with you, listening to your needs and concerns to develop effective solutions tailored to your specific situation. We understand that the path to FDA approval can be complex, and we are dedicated to providing timely guidance and support every step of the way. By maintaining open lines of communication and leveraging our expertise, we help you navigate obstacles efficiently, ensuring a smoother journey toward successful IVD clearance. With HygiaDx, you have a partner that is fully committed to your success..
Passion
At HygiaDx, we are passionate about empowering our customers to manufacture high-quality IVD products and successfully navigate the FDA clearance process. Our dedicated team is committed to providing tailored support and expert guidance at every stage of development, ensuring that your products meet rigorous standards and regulations. We understand the importance of delivering reliable diagnostic solutions, and we work collaboratively with you to optimize design, enhance manufacturing processes, and streamline submissions. With HygiaDx, you have a trusted partner dedicated to turning your vision into reality while ensuring compliance and quality at every step.
Design
At HygiaDx, we believe that effective planning and design are crucial for successfully clearing IVD products through the FDA. Our team leverages extensive experience and in-depth knowledge of regulatory requirements to develop a strategic roadmap tailored to your specific product and goals. We emphasize proactive communication with the FDA, ensuring that every step of the submission process is meticulously planned and executed. By combining our expertise with clear, open dialogue, we guide you through the complexities of IVD development and clearance, helping you navigate challenges and achieve timely approvals. With HygiaDx as your partner, you can trust that your pathway to market is well-defined and supported by a team committed to your success.
Support
The support provided by HygiaDx is pivotal to achieving successful and timely IVD clearance applications. Our comprehensive services encompass every aspect of the process, from initial planning and regulatory strategy to documentation and submission. We offer expert guidance on compliance with FDA regulations, ensuring that all technical and clinical data meet the necessary standards. Our team's proactive approach and deep industry knowledge allow us to identify potential challenges early and implement effective solutions. By partnering with HygiaDx, you can trust that you have the resources and expertise needed to navigate the complexities of IVD clearance efficiently, positioning your product for a successful market entry.
At HygiaDx, we are experts in In Vitro Diagnostic (IVD) design and manufacturing, with extensive experience navigating the complexities of FDA clearance processes. Our team possesses a deep understanding of regulatory requirements, quality management systems, and clinical validation, enabling us to streamline the pathway for IVD products from concept to market. We leverage our comprehensive knowledge of industry standards and our proven methodologies to ensure that our clients achieve successful FDA submissions efficiently and effectively. With HygiaDx, you can trust that your IVD projects are in capable hands, backed by years of expertise in delivering compliant and innovative diagnostic solutions.
The Products that are protecting you and the world
H5 Bird Flu Dection Kit
The H5 Bird Flu Variant Test is a precise and adaptable solution for detecting the H5 subtype of avian influenza virus. Designed for ease of use, this test includes:
This test offers exceptional specificity, detecting the H5 bird flu virus without cross-reactivity to other subtypes like H1N1 or H3N2, making it a critical tool in managing the risk of H5 virus outbreaks. It is ideal for use in agricultural safety testing, food supply chain monitoring, and the research and development of avian influenza diagnostics.
Our product is versatile and can be customized for different stages of development, from early testing to large-scale production. We provide comprehensive data on the antibodies used, validated virus samples, and detailed specificity information for other influenza subtypes, including H1N1 and H3N2. This ensures that the H5 Bird Flu Variant Test meets your specific needs for reliable and accurate virus detection.
COVID-19
The COVID-19 Antigen Detection Kit is a rapid diagnostic tool designed to detect the presence of the SARS-CoV-2 virus, which causes COVID-19. This test is an essential resource for quickly identifying infected individuals, especially in settings where immediate results are required. The kit offers the following features:
Rapid Results: Provides quick results, typically within 15-30 minutes, making it ideal for point-of-care testing.
Ease of Use: The kit includes all necessary components, such as swabs, reagents, and test strips, designed for straightforward operation with minimal training.
High Sensitivity and Specificity: The test uses antibodies specifically targeting the SARS-CoV-2 virus’s antigen, ensuring accurate detection and reducing the likelihood of false positives or negatives.
Non-Invasive: The test uses a simple nasal or throat swab, which makes it less invasive compared to other testing methods.
Portable and Convenient: Compact and lightweight, the kit is portable, making it suitable for various environments, including clinics, schools, airports, and other high-traffic areas.
Applications include:
The COVID-19 Antigen Detection Kit is a vital tool for controlling the spread of the virus, enabling rapid identification of positive cases and prompt isolation to prevent further transmission.
RSV (Respiratory Syncytial Virus) Antigen Detection Kit:
RSV is a leading cause of respiratory illness in young children and the elderly. Antigen-based detection kits for RSV are commonly used in pediatric and geriatric care to rapidly diagnose infections, especially in emergency or outpatient settings. These tests help determine the need for further treatment or isolation.
Group A Streptococcus (Strep A) Antigen Test Kit:
These antigen-based tests are crucial for diagnosing strep throat, a common bacterial infection caused by Group A Streptococcus. Quick results help healthcare providers initiate treatment early, preventing complications like rheumatic fever..
Malaria Antigen Detection Kits
Malaria remains a major public health issue in many tropical regions. Malaria antigen tests are used to detect Plasmodium antigens in the blood. These tests are especially important in resource-limited settings, where rapid diagnosis can lead to quicker treatment and reduced transmission.
list of tests that we can help
COVID-19 PCR Test Kit
PCR-based tests for SARS-CoV-2, the virus that causes COVID-19, were essential throughout the pandemic for accurate and reliable diagnosis. These kits amplify viral RNA, providing a sensitive method for detecting even low levels of the virus, and are still widely used for screening and confirming infections in clinical settings worldwide.
HIV RNA Test Kits
Nucleic acid-based tests for HIV (Human Immunodeficiency Virus) detect the viral RNA in a patient’s blood. These tests are crucial for early detection of HIV infection, as well as monitoring viral load during antiretroviral therapy. The most commonly used test is the PCR-based HIV RNA test, which can detect infections even before antibodies develop.
Tuberculosis (TB) Nucleic Acid Test Kits
The detection of Mycobacterium tuberculosis, the causative agent of tuberculosis, is typically done using nucleic acid-based tests like GeneXpert MTB/RIF. These tests can detect the bacteria's DNA or RNA in sputum samples, offering a rapid and reliable diagnosis, including resistance to the drug rifampicin.
Hepatitis B and C Nucleic Acid Tests
Nucleic acid-based tests are commonly used for detecting hepatitis B (HBV) and hepatitis C (HCV) infections. These tests measure viral RNA (HCV) or DNA (HBV) in the blood, providing critical information for diagnosing infections, assessing viral load, and determining the effectiveness of antiviral treatments.
Zika Virus RNA Detection Kits
Nucleic acid-based detection kits for the Zika virus are important in diagnosing this mosquito-borne disease. The tests typically use PCR to detect the Zika virus's RNA in blood, urine, or saliva. These kits are essential for confirming infection, especially during outbreaks and in regions where Zika is endemic.
list of tests that we can help
HygiaQurdro® COVID-19, Influenza A/B, H5N and Influenza A
A multiplexed detection kit for COVID-19, Influenza A/B, and Respiratory Syncytial Virus (RSV) is a powerful diagnostic tool designed to simultaneously detect these four common respiratory pathogens from a single sample, typically using techniques like real-time PCR (Polymerase Chain Reaction) or lateral flow assays. This type of kit provides a quick, accurate, and efficient way to identify infections that share similar symptoms, such as cough, fever, and difficulty breathing, allowing for faster treatment and containment strategies.
Simultaneous Detection:
Real-Time PCR or Lateral Flow:
Rapid and Accurate Results:
High Sensitivity and Specificity:
Ease of Use:
COVID-19, Flu, and RSV Surveillance:
Point-of-Care Testing:
Outbreak Monitoring:
Multiplexed detection kits for COVID-19, Influenza A/B, and RSV are critical in managing respiratory disease outbreaks. They offer a streamlined, cost-effective, and efficient solution for detecting multiple pathogens with high accuracy, improving clinical decision-making, and helping control the spread of infections in the community.
WELLlife COVID-19/Influenza A&B Test
The WELLlife™ COVID-19 / Influenza A&B Tests* use advanced immunoassay technology to quickly and accurately differentiate between SARS-CoV-2, influenza A, and influenza B from a single nasal swab. These tests are ideal for rapid diagnostics and are crucial tools for effective management of viral infections, enabling timely treatment decisions during flu season and public health concerns.
*For use under Emergency Use Authorization (EUA) only.
| SARS-COV-2 | Influenza A | Influenza B | |
|---|---|---|---|
| Positive Percent Agreement (PPA) | 87.5% | 85.9% | 86.8% |
| Negative Percent Agreement (NPA) | 99.7% | 99.7% | 99.7% |
|
Limit of Detection (TCID50/mL) * |
7.90 x102 |
1.01 x102 |
5.85 x101 |
* LOD for Influenza A A/Victoria/4897/2022(H1N1), LOD for Influenza B B/Florida/4/2006(Yamagata). Please refer to PI for more detailed informatio
In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/ or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
H5 Bird Flu Variant Test Solution
Our test delivers exceptional specificity, detecting H5 bird flu virus without cross-reactivity to other influenza subtypes such as H1N1 or H3N2. This precision makes it a critical solution for mitigating the growing risk of H5 virus outbreaks.
Whether you are in the early stages of development, scaling up production, or performing routine internal tests, our H5 bird flu variant test can be customized to meet your needs. We provide detailed information on the antibodies used, validated virus samples, and specificity data for H1N1, H3N2, and other influenza subtypes.
Key Applications:
If you are interested in leveraging this product for your testing or development, please inquire for detailed specifications and customization options. Together, we can help you build a robust solution to combat the threat of H5 bird flu virus.
H5 Bird Flu
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SARS-CoV-2
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list of tests that we can help
What we've done for helping protect people and their community
FDA Clearance
HygiaDx stands out as a comprehensive provider in the IVD (In Vitro Diagnostic) product landscape due to our multifaceted expertise and deep industry connections. Here’s why we excel in this domain:
Expertise in Regulatory Affairs: Our team is well-versed in FDA regulations and the complexities of obtaining clearances for IVD products. This knowledge enables us to navigate the regulatory landscape efficiently, ensuring that our clients meet all necessary compliance requirements.
Design and Development Capabilities: We have a robust team of designers and engineers who specialize in IVD product development. By integrating innovative design principles with clinical needs, we create products that are not only effective but also user-friendly.
Access to Certified Materials: HygiaDx sources high-quality, certified materials essential for IVD manufacturing. Our established relationships with trusted suppliers ensure that our clients receive reliable and compliant components, which is critical for the safety and efficacy of diagnostic products.
Market Access and Distribution Channels: With an extensive network in the healthcare industry, we facilitate the successful market introduction of approved IVD products. Our strategic partnerships and distribution channels streamline the process, helping our clients reach their target markets quickly and efficiently.
Holistic Approach: By offering a full suite of services—from regulatory support and product design to material sourcing and market entry—HygiaDx provides a seamless experience for our clients. This integrated approach minimizes risks and accelerates time to market, allowing our partners to focus on their core competencies.
In summary, HygiaDx combines regulatory expertise, innovative design, access to quality materials, and strong market connections to deliver comprehensive solutions for IVD product development and commercialization.
IVD Product Development
IVD Product Manufacturing
FDA Clearance of IVD Products
Tailed Service for Bringing Your Technology Into Helping Reality
Contributing to facilitating FDA clearanace, come and fill the following openings
HygiaDx, US
Phone: +001 858 36655597(us), China +86 13510567736 (Wechat)
Email: hygiadxams@mail.com
