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    PRODUCT Introducing BIONOTE’s Products.
    • Rapid Immunoassay
      Rapid
    • Fluorescence Immunoassay
      Vcheck F
    • Enzyme Immunoassay
      ELISA
    • Molecular Diagnostics
      Vcheck M
    • Biochemistry
      Vcheck C
    NEWS Stay in the know of the latest Bionote updates. More
    Excellent performance verification of Vcheck Canine NT-proBNP (SCI journal)

    A paper on the analytical validation of Vcheck Canine NT-proBNP (BIONOTE) has been published in the international journal, Veterinary Clinical Pathology (Science Citation Index, Impact factor 1.18).Paper: Analytical validation of a novel point-of-care immunoassay for canine N-terminal pro-brain natriuretic peptide analysis (Vet Clin Pathol. 2022;00:1–10.) See the attached document for the summary and click here for the full paper (open access).   This study aimed to analytically validate a Vcheck NT-proBNP assay according to American Society of Veterinary Clinical Pathology (ASVCP) and Clinical Laboratory Improvement Amendments (CLIA) specifications.   Precision Imprecision was considered acceptable with a coefficient of variation ranging from 9% at 4000 pmol/L to 20% at 600 pmol/L.   Accuracy Comparison of the Vcheck assay with the Cardiopet NT-proBNP assay revealed an excellent correlation with minimal bias (y=0.9x+37, R2=0.9) when preanalytical factors were controlled.   Preanalytical error Significant degradation of NT-proBNP occurred when current methods were used at refrigerated (average loss of 20%) and room temperatures (loss of at least 50%), which could change diagnostic and prognostic decision-making.   Interferents (analytical specificity) Spiking samples across the linear range of the assay with 35 mg/dL hemoglobin and 1000 mg/dL Intralipid did not reveal a statistically significant difference.   Reference intervals Age-partitioned reference intervals (95%) have upper reference limits of 750 pmol/L and 1280 pmol/L for 36 juvenile and 125 adult dogs, respectively.     According to this study, the Vcheck assay provides analytically acceptable results. Onsite testing can minimize variability related to preanalytical error and provide clinically useful contemporaneous results.   Also, the author emphasized that samples should be centrifuged immediately and analyzed within 2 hours of collection, due to significant degradation of NT-proBNP.   Results of this study demonstrate that the Vcheck NT-proBNP assay is a valid point-of-care cardiac biomarker using the canine serum.   Vcheck Canine NT-proBNP can be quantitatively measured using a fluorescent immunoassay analyzer (Vcheck) in a short time (15 minutes) and can be tested using a small amount of sample (serum 100 µl). Learn more

    2022.04.07
    BioNote USA, attending the Western Veterinary Conference which is the largest Veterinary Science Society in the United States

    Bionote USA attended the Western Veterinary Conference to be held March 6th to March 9th, 2022 at the Mandalay Bay Convention Center in Las Vegas, Nevada.WVC’s Annual Conference is one of the largest, most influential gatherings of veterinary professionals in the world. Bionote USA communicated with veterinary workers and vets who attended the conference through participation in the booth about how Vcheck could develop and help veterinary medicine.   On this day, renowned Dr. Rozanski sponsored by Bionote, spoke about the role of NT-proBNP in clinical decision making and the benefits of point-of-care testing. NT-proBNP is correlated with heart size and systolic function, suggesting that the concentrations can be used to detect dogs with early disease. In addition, Vcheck Canine NT-proBNP is an in vitro diagnostic test kit for the quantitative measurement of NT-proBNP concentration in canine serum. This test kit precisely quantifies the degree of elevation in NT-proBNP levels in dogs. The ability to distinguish cardiac from non-cardiac causes of respiratory signs is important for further decisions on diagnostics and therapy. NT-proBNP allows distinguishing cardiac from respiratory disease in dogs with dyspnea. Also, this marker helps to detect dogs with Myxomatous Mitral Valve Degeneration (MMVD), which is the most common heart disease in dogs. In dogs with stable Congestive Heart Failure (CHF) due to MMVD, NT-proBNP is of value in monitoring the effectiveness of medical treatment for CHF. In large breeds, Dilated Cardiomyopathy (DCM) is the most common cause of heart disease. Annual screening tests are recommended to determine if DCM is present even if dogs at elevated risk are healthy. The measurement of NT-proBNP increases the diagnostic accuracy with Holter monitoring (91% accuracy). Vcheck Canine NT-proBNP: The one-step test procedure is easy to follow and provides fast results within 15 minutes using serum samples from dogs. Bionote USA completed the 2022 Western Veterinary Conference, and in addition, Bionote KOREA and Bionote CHINA also plan to hold various external activities and conferences. 

    2022.03.14
    NowCheck COVID-19 Spike IgG Test Obtains CE Mark … Awaiting for the U.S. FDA EUA

       | The SARS-CoV-2 Antibody for Spike IgG can be detected within 15 minutes | Completed CE mark certification and is awaiting FDA Emergency Use Authorization.   Bionote has announced the acquisition of CE marking for its NowCheck™ COVID-19 Spike IgG Test to detect specific antibodies to SARS-CoV-2. This is the company’s third addition to the existing COVID-19 product portfolio, following the NowCheck™ COVID-19 Ag Test and COVID-19 IgM/IgG Test.  Antibody rapid diagnostic test is a widely used screening method for determining antibodies in the blood of people who have been previously infected with or vaccinated against a virus that causes a disease. The test procedure for a rapid test is simple, fast, and efficient, requiring only 15 to 30 minutes without the need for any additional equipment.  COVID-19 vaccines are becoming mandatory in many countries around the globe, and among the vaccines, the major type is the mRNA vaccine which uses the spike protein. As the number of people receiving the COVID-19 mRNA vaccine increases, the demand for COVID-19 antibody testing is also growing.  Currently, the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of the antibodies for many viral diseases, but as the PRNT requires biological safety level 3 laboratory (BSL3), this testing method has limitations with wide implementation. Compared to the PRNT test, antibody rapid diagnostic test can quickly be performed without any need for a standardized environment.  Bionote’s NowCheck COVID-19 Spike IgG Test can detect specific antibodies against SARS-CoV-2 within 15 minutes. This test also demonstrated high accuracy in the clinical evaluation using a total of 102 serum specimens, with percent positive agreement of 82% (41/50) and percent negative agreement of 100% (52/52).  Bionote is expecting the demand for COVID-19 antibody testing to continue to increase as more people receive vaccination and begin to realize the importance of immunity. The company is planning to launch its NowCheck COVID-19 Spike IgG Test in the U.S. market soon after its completion of the U.S FDA EUA.  For those who are interested in NowCheck COVID-19 Tests, please contact your local distributor or mail to [bionote@bionote.co.kr]. 

    2022.01.11
    BIONOTE Inc. won the prize of ‘$100- Million Export Tower’ in exports at the 58th Trade Day ceremony

       The Korea International Trade Association announced that BIONOTE won the prize of ‘$100- Million Export Tower’ in exports at the 58th Trade Day ceremony. The Ministry of Trade and the Korea International Trade Association hold a ceremony every December 5th to mark Trade Day, and select and reward companies that have contributed to export performance, such as pioneering overseas markets and creating jobs. BIONOTE is a company specializing in diagnostic devices for animals with 19 years of business experience and has branches in the U.S. and Shanghai, China, where the diagnostic market is large. BIONOTE obtained United States Department of Agriculture (USDA) approval for the first time in Korea and succeeded in entering overseas markets in recognition of the accuracy of various products such as the world's first development of Middle East Respiratory Syndrome (MERS) simple diagnostic kits and World Organization for Animal Health (OIE) certification. Based on its core source technology, the company has a portfolio of various products such as rapid diagnosis (Rapid), fluorescent immunoassay (Immunoassay), and enzyme Immunoassay (ELISA) for disease diagnosis. In particular, Vcheck which is the main diagnostic device of the bio-note is receiving high response at home and abroad as it can quantitatively measure various biomarkers based on fluorophores with excellent sensitivity, and recorded 110% year-on-year sales growth. Next year, serum chemical analysis equipment with high market demand and Point of Care (POC) molecular diagnostic equipment capable of quantitative polymerase chain reaction (PCR) testing at the site will be released to expect greater sales growth. 

    2021.12.29
    BIONOTE to Launch Vcheck Canine TnI Next Month

     Bionote, a leading veterinary diagnostic company based in Korea, is introducing a new biomarker, TnI, as a part of the Vcheck series. Vcheck Canine TnI is an in vitro diagnostic test kit for the quantitative measurement of cardiac Troponin I (TnI) concentration in canine serum. This test kit precisely quantifies the degree of elevation in TnI levels in dogs.    Troponin consists of 3 subunits (troponin I, T, and C) which together function as the molecular switch of cardiomyocyte contraction. Among them, cardiac Troponin I (TnI) is a sensitive and specific circulating marker of cardiac injury for dogs.  Cardiac injury causes the release of TnI into the circulation, where its concentration is correlated to the severity of the damage. Vcheck Canine TnI can provide important diagnostic and prognostic information in patients with cardiovascular or non-cardiac diseases as a cardiac injury marker of choice.  A combined measurement of TnI and NT-proBNP is prognostically superior to measuring each alone in dogs with mitral valve disease (MMVD). NT-proBNP is also one of the Vcheck biomarkers. Vcheck Canine TnI: This one-step test procedure is easy to follow and provides fast results within 10 minutes using serum samples from dogs. Meanwhile, Vcheck Feline TnI, which measures cardiac TnI in feline blood, will be released later this year.   If you are interested in Vcheck Canine TnI, please contact your local distributor or mail to [bionote@bionote.co.kr].

    2021.08.30
    High immunogenicity following WSAVA guidelines, confirmed by Vcheck

     A paper using Vcheck CPV Ab testing has been published with results proving that regular vaccinations under the WSAVA guidelines increase the protection rate against parvovirus. ​- [Related document] Evaluation materials  Canine parvovirosis is a systemic disease caused by CPV-2 (canine parvovirus type 2). Typical symptoms of parvovirus include lack of appetite, vomiting, and bloody diarrhea.The most effective way to prevent the parvovirus is prophylactic vaccination, and according to the WSAVA guidelines, it is recommended that booster vaccines be performed not more often than every 3 years after the initial puppy vaccination. Based on the history of the vaccination against CPV, the study population was divided into three groups: - Group I (n=59): Dogs regularly vaccinated against the disease according to WSAVA guidelines- Group II (n=77): Dogs that completed the full course of CPV immunization as puppies but have not received a booster dose in the past three years- Group III (n=64): Dogs that have not received vaccination against parvovirus in their lifetime Statistical analysis showed a significantly greater number of dogs with high titers of antibodies against CPV of HI ≥ 80 in Group I (86%) compared to Group II (73%), and Group III (72%). Table 1. Values of antibody titers in HI test for CPV in dogs in each group  Gender and race were not found to have an influence over the value of antibody titers against CPV. Regular vaccinations by WSAVA recommendations increase protection against CPV, as evidenced by the lowest percentage of dogs with HI < 80 in Group I, which were regularly vaccinated at least every 3 years.  Additionally, the presence of dogs with high antibody titers against CPV in Group III indicates widespread contamination of the pathogen within the environment. Bionote's immunofluorescence analyzer, Vcheck, is designed to generate fast and accurate diagnoses for in-clinic testing through its automative blood testing system that can run 24 quantitative and semi-qualitative tests (NT-proBNP, SDMA, D-dimer, CRP, SAA, cPL, fPL, cCortisol, T4, TSH, Progesterone, and Antibody titers). 

    2021.03.24
    BIONOTE provides diagnostic solutions for COVID-19

     Coronavirus disease 2019 (COVID-19) is a new disease, caused by a novel coronavirus (SARS-CoV-2) that has not previously been seen in humans. It is a respiratory illness that can spread from person to person. The rapid diagnosis of COVID-19 is critical for the prevention and control of this pandemic. Antigen and antibody tests are highly accurate, easy to perform, and require minimal education for users. As a reference standard method, RT-PCR has been performed to make a definitive diagnosis of COVID-19 infection. However, even PCR may result in high false negative results and requires long turn-around-time. Antigen testing can be a "breakthrough" innovation to help screen more people for viruses. It detects the presence of viral proteins, which enables the identification of acute or early infection. Antibody status can be used to aid the clinical diagnosis of suspected cases that present 7 days or more after the start of symptoms. IgM is an early phase immunoglobulin that will develop first during acute infection. IgG is largely responsible for long-term immunity after infection. All patients will develop IgM and IgG by day 14.  ü  NowCheck COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of specific SARS-CoV-2 antigens present in the human nasopharynx. - In a retrospective, multi-center, randomized, and single-blinded study, the NowCheck COVID-19 Ag Test showed 88.68% sensitivity (47/53) and 98.25% specificity (112/114) compared to PCR assays.     - No cross-reaction with potential cross-reactive substances except SARS-coronavirus.     - No interference with Endogenous/Exogenous interfering substances such as anti-viral drugs, antibiotics, or anti-inflammatory medications.   ü  NowCheck COVID-19 IgM/IgG Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies to SARS-CoV-2 present in human serum, plasma, or whole blood.  - In a retrospective, multi-center, randomized, and single-blinded study, the NowCheck COVID-19 IgM/IgG Test showed 96.77% sensitivity (30/31) and 98.65% specificity (73/74), compared to PCR assays. - Additional quality control for NowCheck COVID-19 Ag and IgM/IgG Tests are available to be purchased as optional contents.   For those who are interested in NowCheck COVID-19 Tests, please contact your local distributor or mail to [bionote@bionote.co.kr]. 

    2020.06.08