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NowCheck COVID-19 Ag rapid diagnosis kit for Nasal swab, CE certification complete
Bionote developed a nasal swab test version of the COVID-19 antigen rapid diagnostic kit, in addition to the existing nasopharyngeal swab test. This new version has also obtained Certification of EU product notification as well. Antigen rapid diagnostic kit is a widely used screening and diagnosing method for infectious diseases such as influenza in hospitals. The test procedure for a rapid kit is simple, fast, and efficient, requiring only 15 to 30 minutes without the need for any additional equipment. With such efficiency, antigen tests enable more massive testing with a faster diagnosis compared to a molecular diagnostic method such as a PCR test. The NowCheck COVID-19 Ag Test, which is manufactured and sold by Bionote, is a diagnostic kit that quickly determines SARS-CoV-2 infection (COVID-19). Until now, it previously came only with nasopharyngeal swab specimens, but a new nasal swab type has recently been added. A clinical evaluation conducted in Brazil between July and August confirmed an excellent performance of 89.2% (91/102) sensitivity and 97.3% (290/298) specificity. In particular, the sensitivity was found to be up to 92.2% in patients when the days from symptom onset were ≤ 7 days. While most conventional COVID-19 antigen tests are performed by inserting a swab deep into a nostril to collect the specimen from the nasopharynx, it may cause discomfort among the patients during the collection process. That is why patients will find Bionote's newly developed nasal swab version relatively easier to use compared to the previous nasopharyngeal swab test. The nasal cavity is located outward compared to the nasopharynx, making it easier to collect the specimens with less discomfort and thus requiring less proficiency from inspectors. Since there is no effective treatment for COVID-19, a more active response to the COVID-19 pandemic should be made possible with rapid diagnostic kits. CE certified NowCheck COVID-19 test offers not only accurate results, but also more swab options for the consumers to choose from. For those who are interested in NowCheck COVID-19 Tests, please contact your local distributor or mail to [bionote@bionote.co.kr].
- 2020.11.27
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BIONOTE provides diagnostic solutions for COVID-19Coronavirus 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
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BIONOTE will Launch Vcheck Canine NT-proBNP during AprilVcheck 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 to distinguish 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 apparently 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. If you are interested in Vcheck Canine NT-proBNP, please contact your local distributor or mail to [bionote@bionote.co.kr].
- 2020.05.04
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