Factory Rapid Diagnostic Test for COVID Neutralizing Antibodies
Product Main Parameters
| Parameter | Detail |
|---|---|
| Specimen | Serum, plasma, whole blood |
| Certification | CE/ISO13485/White List |
| MOQ | 1000 test kits |
| Delivery Time | 1 week after payment |
| Packaging | 1 test kit/box, 20 test kits/box |
| Cutoff | 50ng/mL |
| Shelf Life | 18 months |
| Production Capacity | 1 Million/Week |
| Payment | T/T, Western Union, Paypal |
Common Product Specifications
| Specification | Detail |
|---|---|
| Speed | 10 mins |
| Sample Volume | Serum/plasma: 10µL, Whole blood: 20µL |
| Storage Conditions | Store at 2-30°C |
Product Manufacturing Process
The manufacturing process involves sophisticated biotechnology techniques to produce recombinant proteins like the RBD of SARS-CoV-2. These proteins are then coated onto the test strip through a precision-driven assembly line. Quality control measures, such as ISO9001 and ISO13485 compliance, ensure consistent product efficacy and safety.
According to a study published in the Journal of Clinical Microbiology, the precision of such lateral flow assays is maintained by regular intra-assay and inter-assay validation tests, showing a >99% correct identification rate across 15 replicates and independent assays. This rigorous process underscores the reliability of our factory's rapid diagnostic tests.
Product Application Scenarios
Our rapid diagnostic tests are essential in both clinical and non-clinical settings. In healthcare facilities, they serve as a quick tool for assessing patient immunity to COVID-19, which is crucial for managing patient care and public health measures. In field settings, their portability and rapid turnaround enable mass screening initiatives, which are vital in outbreak situations or vaccination drives.
Research from the Lancet Infectious Diseases journal highlights the pivotal role of rapid diagnostic tests in resource-limited environments, where access to laboratory infrastructure is scarce. The World Health Organization's guidelines also underscore the importance of RDTs in accelerating disease intervention strategies in pandemic scenarios.
Product After-Sales Service
- 24/7 customer support for troubleshooting and inquiries.
- Replacement guarantee for defective products.
- Comprehensive online resources and user manuals.
Product Transportation
Our factory ensures safe and timely delivery via air and sea freight options, with packaging designed to maintain product integrity during transit. International shipping adheres to all regulatory compliance requirements.
Product Advantages
- Quick results in 10 minutes, enhancing clinical efficiency.
- High accuracy (>99% precision) ensuring reliable diagnostics.
- Wide specimen compatibility providing versatile application.
- Cost-effective with bulk production capability.
- ISO-certified factory production guaranteeing quality standards.
Product FAQ
- What is the turnaround time for the test results? The rapid diagnostic test delivers results in approximately 10 minutes, facilitating prompt clinical decisions.
- Can this test be used in remote locations? Yes, the test's portability makes it ideal for use in remote or resource-limited settings without sacrificing accuracy.
- What certifications does the product have? Our tests are CE certified and adhere to ISO13485 standards, confirming their compliance with international quality benchmarks.
- What is the shelf life of the test kits? The kits have a shelf life of 18 months, provided they are stored under recommended conditions.
- What should be done if a test kit arrives damaged? Customers are encouraged to contact our after-sales service for replacements or solutions.
- Can the test detect current infections? This test is designed to detect neutralizing antibodies, indicating previous exposure or successful vaccination, not current infections.
- Are there any contraindications for using this test? There are no specific contraindications, but results should be interpreted considering the patient's clinical background.
- What is the minimum order quantity (MOQ)? The minimum order quantity is 1000 test kits.
- How should the test be stored? Store the test kits at temperatures between 2-30°C to maintain efficacy.
- Is there technical support available? Yes, we offer comprehensive technical support through various channels including phone, email, and our website.
Product Hot Topics
- Enhancing Global Health Security: Our factory's rapid diagnostic tests play a crucial role in enhancing global health security by providing tools for early detection and management of infectious diseases. The integration of RDTs into public health strategies can significantly reduce the burden on healthcare systems, particularly during pandemics or outbreaks.
- The Role of RDTs in Vaccine Efficacy Monitoring: As global vaccination efforts continue, understanding the level of immunity in populations becomes vital. Our rapid diagnostic tests for COVID neutralizing antibodies help assess the effectiveness of vaccines, offering a quicker alternative to traditional laboratory tests and supporting public health initiatives effectively.
- Advantages of Lateral Flow Assays in Diagnostics: Lateral flow assays, the technology behind our tests, have revolutionized point-of-care diagnostics. The simplicity and speed of these tests make them indispensable tools in both clinical and field applications, driving a shift towards more decentralized healthcare delivery models.
- Meeting the Demand in Pandemic Responses: The demand for rapid diagnostic tests surged during the COVID-19 pandemic, highlighting their essential role in infectious disease control. Our factory's enhanced production capabilities ensure timely supply, supporting both local and international health response efforts.
- Technological Advancements in RDT Manufacturing: Ongoing innovations in biotechnology and materials science continue to improve the sensitivity and specificity of rapid diagnostic tests. Our factory remains at the forefront of these advancements, ensuring that our products meet the highest standards of diagnostic accuracy.
- Integrating RDTs with Digital Health Platforms: The integration of rapid diagnostic tests with digital health platforms opens new possibilities for real-time data collection and analysis. This synergistic approach can optimize disease monitoring and control, facilitating more effective public health interventions globally.
- Challenges in RDT Quality Control: Maintaining high-quality production standards is critical for the reliability of rapid diagnostic tests. Our factory's adherence to ISO and CE standards ensures that every test kit produced meets rigorous quality control criteria, ensuring consistent performance.
- The Importance of RDTs in Early Disease Detection: Early detection is key to effective disease management and control. Our rapid tests provide a frontline tool for healthcare providers, enabling timely interventions that can curb the spread of infectious diseases significantly.
- Cost-Effectiveness of RDTs for Healthcare Systems: Rapid diagnostic tests offer a cost-effective solution for healthcare systems around the world, reducing the need for extensive laboratory infrastructure and associated costs. This economic advantage is particularly beneficial in developing regions with limited resources.
- The Future of Rapid Diagnostic Testing: The future of diagnostics is moving towards more personalized, rapid, and decentralized testing solutions. Our factory is committed to pioneering advancements in this space, ensuring that our rapid diagnostic tests meet the emerging needs of global healthcare environments.
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