May 20, 2022, Biotime announced that its SARS-CoV-2 Antigen Rapid Qualitative Test has received approval from the China's National Medical Products Administration (NMPA). The details are as follows: The SARS-CoV-2 Antigen Rapid Qualitative Test has also obtained CE mark for self-testing, which is another effective tool for the company to actively support global anti-epidemic. It can be operated by individuals who collect the front nasal swab sample by themselves, and the result can be quickly delivered in 20-30 minutes. Since the outbreak of COVID-19, Biotime as a global innovation-driven healthcare company has fully integrated its business and global resources with timely response and actively undertaking the social responsibilities in combating COVID-19 pandemic control and minimizing its impact. Biotime has developed a growing number of diagnostic solutions that help to diagnose and detect the infection, and we will continue to play our role and increase production to support availability of tests globally.

INTRODUCTION Immunoassay analysers are applied to a situation where one wants to detect or isolate a molecule within a mixture, usually using an antibody as a reagent. (Beckmancoulter, 2021) These devices perform a variety of tests including those targeting cancer, allergies, therapeutic drug monitoring and more. And they typically include an autosampler, a reagent dispenser, a washer, and a detection system. (Who.int, 2021) Modern immunoassay analysers often come with advanced, user-friendly features such as touchscreen interface, easy-to-use software and ready-to-use reagents. With advanced analysers, laboratories can benefit from simple and trouble-free operation, workflow flexibility, fast turnaround times, and broad measuring ranges. (Block Scientific Inc, 2021) TYPES AND VARIATIONS Five types of immunoassay, enzyme immunoassay (EIA), radioimmunoassay (RIA), fluoroimmunoassay (FIA), chemiluminescent immunoassay (CLIA) and counting immunoassay (CIA), are generally used. Depending on configuration and levels of sophistication, as well as available testing options, different immunoassay analysers could vary greatly. (Martínez, 2021) Radioimmunoassay The radioimmunoassay is perhaps the oldest types of immunoassays. Here, a radioisotope is attached to an antigen of interest and bound with its complementary antibody. Then a sample with the antigen to be measured is added. It competes with the radioactive antigen, kicks it out of the binding spot and replaces it. After washing away unbound antigens the radioactivity of the sample is measured. The amount of radioactive signal is inversely related to the amount of target antigen. The health hazards of using radioactive substances caused a movement toward safer methods. (Martínez, 2021) Counting immunoassay In a counting immunoassay, polystyrene beads are coated with many antibodies complementary to the target antigen. During incubation the beads bind to multiple antigens and group together into a large mass. Some beads remain unbound. The entire solution is passed through a cell counter and only the unbound beads are counted. The number of unbound beads is inversely proportional to the amount of antigen. (Martínez, 2021) Enzyme-linked immunosorbent assay The Enzyme-Linked Immune Sorbent Assay, also known as ELISA, determines various entities such as the presence of antibodies to an infectious disease and also detects and measures antibodies in human samples as a reaction to specific antigens. ELISA-tests are commonly used to test the concentration of Vitamin D, insulin, COVID-19 or hepatitis antigens in samples. (Future Diagnostics, 2021) Fluorescence and Chemiluminescence Immunoassays Besides the use of immunoassays based on colour intensity to detect antibodies in specimens, detection can also be done by fluorescent tracers and light-generating molecules. These are called Fluorescent Immunoassay (FIA) and Chemiluminescence Immunoassay (CLIA). The basis of these immunoassays is a variant of ELISA. T...

Biotime announced today that, it had now achieved CE Marking for its COVID-19 Ag & Flu A/B Combo Test from the European certification body CeCert to be used as a consumer self-test in the European Union (EU) and other regions that recognized the CE Mark. The details are as follows:  The test detects N protein from SARS-CoV-2, influenza A and influenza B directly from a nasal swab with results in 15 minutes from sample application in people with COVID-19 symptoms or influenza A or influenza B infection. The test has the advantage of being consistent in sensitivity and easy handling, it well meets the needs of epidemic prevention and control at home in various countries. Biotime will keep supporting the cause of global COVID-19 prevention and control, and actively respond to the market demand for testing products in COVID-19.

WHAT IS IL-6 IL-6 is an immune protein promptly and transiently produced in response to tissue damage and infections. On the other hand, IL-6 is also a pyrogen and is responsible for fever in autoimmune, infectious, or non-infectious diseases. IL-6 is produced in the body, wherever there is inflammation, either acute or chronic. This includes situations such as trauma, burns, cancers, and infection. (Thomas, 2021)   RELATIONSHIP BETWEEN IL-6 AND COVID-19 During the pandemic, scientists have explored the role of IL-6 as a predictor for patients with severe coronavirus disease.   Based on the finding that infection by the severe acute respiratory syndrome-associated coronavirus induces a dose-dependent production of IL-6 from bronchial epithelial cells, a study involving nearly 11,000 patients discovered that treating hospitalized COVID-19 patients with drugs that block the effects of interleukin-6 reduces the risk of death and the need for mechanical ventilation. (Henderson, 2021)   According to the study, in hospitalized patients, administering the interleukin-6 antagonists (such as tocilizumab and sarilumab) in addition to corticosteroids reduces the risk of death by 17%, compared to the use of corticosteroids alone. In patients not on mechanical ventilation, the risk of mechanical ventilation or death is reduced by 21%, compared to the use of corticosteroids alone. (Henderson, 2021)   Some also conducted data analysis of COVID-19 cases at long-term care facilities in Slovakia Patients with hypoxemia had significantly higher concentrations of IL-6, C-reactive protein, procalcitonin, fibrinogen, total bilirubin, aspartate aminotransferase and alanine aminotransferase at initial screening among which IL-6 was identified as the most robust predictor of hypoxemia. (Sabaka et al., 2021)   Given the current situation of global vaccine inequity, people in the lowest income countries will be the ones most at risk of severe and critical COVID-19. Therefore, further work is necessary to clarify the exact role of IL-6 during coronavirus infections and the potential role of this cytokine to be used as a biomarker of viral virulence. Additional work exploring the potential therapeutic use of blocking IL-6 or different products affected by its activity might provide insight into controlling persistent COVID-19 infections. (Velazquez-Salinas et al., 2019)   BIOTIME IL-6 Biotime IL-6 is an in vitro diagnostic test for the quantitative determination of IL 6 in human serum or plasma. As researchers have pointed out a portion of severely ill COVID-19 patients experience rapid deterioration and need for mechanical ventilation due to development of ARDS. Being an unconventional way to address the issue, Biotime IL-6 can also be used to assist in identifying severe inflammatory response in patients with confirmed COVID 19 illness who need mechanical ventilation in conjunction with clinical findings.     References Thomas, L. (2...

14-17, Nov. 2022, the 54th Medica Exhibition will be held in the Dusseldorf Convention Center, Germany. At that time, Biotime's full range of products will be displayed. Medica is recognized as the largest hospital and medical equipment exhibition in the world. With its irreplaceable scale and influence, it ranks first place in the world medical trade exhibition. Every year, nearly 4000 exhibitors from more than 60 countries and regions gather here. On site, new automatic glycated hemoglobin analyzer, HLC-100, and six-channel chemiluminescence analyzer, CLi-1600 will make a wonderful appearance. In addition to the new chemiluminescence platform, the highly praised immunofluorescence platform will also debut. Biotiem immunofluorescence platform has covered multiple series, such as cardiovascular and cerebrovascular, inflammation, hormones, thyroid function, diabetes and kidney injury. The fastest test results can be obtained in 3mins. Biotime aims to meet the needs of different medical institutions and provides users with more comprehensive POCT solutions. It will be a great honor to welcome you to visit Hall 1, Biotime Booth G39-2

Biotime's SARS-CoV-2 Antigen test obtains CE mark for self-testing, the details are as follows: The SARS-CoV-2 Antigen Rapid Qualitative Test that has completed CE certification, this time is another effective tool for the company to actively support global anti-epidemic. It can be operated by individuals who collect the front nasal swab sample by themselves, and the result can be quickly obtained in 20-30 minutes, which is convenient for individuals and families to quickly detect Covid-19, well meets the needs of epidemic prevention and control at home in various countries, and further enriches the Biotime COVID-19 Solution. The company will fully support the cause of global COVID-19 prevention and control, and actively respond to the market demand for testing products in COVID-19.

Immunoglobulin E (IgE) is an antibody produced by the body's immune system in response to a perceived threat. It is one of the five types of immunoglobulins (A, G, M, D, and E) and is usually found in very small amounts in the blood. The total IgE test can be used to help screen and detect allergic diseases. It measures the total amount of immunoglobulin E in the blood. Immunoglobulin is a protein that plays a key role in the human immune system. They are produced by specific immune cells called plasma cells. Immunoglobulins are produced against bacteria, viruses, and other microorganisms and substances that are recognized as "non-self" or provide harmful antigens to the immune system. Elevated concentrations of total immunoglobulin E (IgE) can be found in a variety of clinical diseases, including allergic diseases, certain primary immune deficiencies, infections, inflammatory diseases, and malignant tumors, and to a lesser extent, are related to the immunity of parasites is related. Occasionally, an IgE test may be needed to help diagnose a very rare genetic disease called high immunoglobulin E syndrome (Job syndrome). People with this disease usually have significantly higher IgE levels than normal, and may have eczema, recurrent sinus and lung infections, bone defects, and severe skin infections. A large increase in IgE concentration may indicate that a person has inherited this condition. When a person experiences periodic or persistent symptoms due to an allergic reaction, especially when the underlying allergen is unknown, a total IgE test may be required. Symptoms may include those that indicate involvement of the skin, respiratory system, and/or digestive system, such as: -Periodic or persistent itching -Urticaria -Itchy eyes -Eczema -Nausea, vomiting, persistent diarrhea -Sneezing, coughing, congestion -Difficulty breathing -Asthma symptoms: wheezing, difficulty breathing, coughing, chest tightness Biotime IgE rapid quantitative test kit is in great demand right now. It allows use of different sample material: whole blood, plasma, and serum with results conveniently available, making the process a lot less cumbersome and genuinely helping screen and detect a variety of clinical diseases. Reference 1. Homburger HA: Allergic diseases. In: Clinical Diagnosis and Management by Laboratory Methods. 21st ed. WB Saunders Company. 2007;961-971 2. Martins TB, Bandhauer ME, Bunker AM, Roberts WL, Hill HR: New childhood and adult reference intervals for total IgE. J Allergy Clin Immunol. 2014 Feb;133(2):589-591 3. Bernstein IL, Li JT, Bernstein DI, et al: Allergy diagnostic testing: An updated practice parameter. Ann Allergy Asthma Immunol. 2008 Mar;100(3 Suppl 3):S1-148 4. Ansotegui IJ, Melioli G, Canonica GW, et al: IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper. World Allergy Organ J. 2020 Feb;13(2):100080. doi: 10.1016/j.waojou.2019.100080

Big News Day！Biotime SARS-CoV-2 Antigen Rapid Qualitative Test has been recognized by SFDA. Saudi Food and Drug Authority (SFDA) is an independent body for the Kingdom of Saudi Arabia that aims to ensure food and drug safety for the nation.  The Saudi Ministry of Health has given it responsibility for the regulation of pharmaceuticals, and it is an influential organization among states within the region. Biotime SARS-CoV-2 Antigen Rapid Qualitative Test based on colloidal gold immunochromatography method and intend to use as the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasal swabs, throat swabs, and sputum from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. SFDA authoritative certification means that SARS-CoV-2 Antigen Rapid Qualitative Test is available for sale in Saudi Arabia. If you are interested in this product, please contact us.