Shown below are some of the posts by LEPU medical technology. To meed the growing demand from global market for the COVID-19 testing, I'd like to introduce you Lepu Antigen rapid test kit/self-test, which is CE marked and can get the result within 15-20 minutes for testing Omicron: Sensitivity: 95% ; Specificity: 99.26% The simplest, most affordable, legally approved antigen self-test. Lepu Medical Technology is recalling their SARS-CoV-2 Antigen Rapid Test Kit and their Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). It is a self-diagnostic test designed for the qualitative detection of antigen against SARS-CoV-2 in clinical specimens (nasal swab). COVID-19 Lateral Flow Test Kits / Rapid Tests. The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. (Nasal Selbsttest, einzelverpackt) Dank seiner einfachen Handhabung mit Abstrich im vorderen Nasenraum und der unkomplizierten Auswertung ohne Röhrchen ist der NASOCHECK comfort Schnelltest perfekt für die Eigenanwendung optimiert. It is specialized in developing, manufacturing and marketing high-tech medical devices and equipment. On 26th Jan 2021, report from PEI of an official test that The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) authorized to perform, declared that Lepu Medical SARS-CoV-2 Antigen Rapid Test Kit has fulfilled all the minimum criteria for antigen tests conducted by PEI in consultation with the Robert Koch-Institut (RKI). Materials and methods To investigate diagnostic accuracy of SARS-CoV-2 anti-gen in clinical samples (NPS (#20CG2701X, Lepu Medi-cal) or Saliva (#901101, Lepu Medical)) the colloidal gold labeled SARS-CoV-2N protein monoclonal anti-body based immunochromatographic rapid test kits หน้าแรก > LEPU Medical 2019-nCoV Rapid Antigen Test Kit 2019-nCoVAntigen Rapid Test Kit (Colloidal Gold Immunochromatography) 2019-nCoV antigen test kit is based on specific antibody-antigen reaction and immunoassay technique to qualita. 2,39 € zzgl. Antigen Rapid Test Kit LEPU . The LEPU MEDICAL Anitgen Rapid Test is one of the best-selling rapid antigen tests in Europe and its ease of use makes it an ideal rapid test. LEPU MEDICAL SARS-CoV-2 Antigen Rapid Test Kit [pdf] User Manual LEPU MEDICAL, SARS-CoV-2, Antigen, Rapid, Test Kit: References. Negative reference products compliance rate . With a specificity of 99.7%, this test could be used to direct simplified ant … It is a rapid test for detecting Covid-19 antibodies that can be performed outside the laboratory and its reliability is higher . The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Hence the company has claimed that the sensitivity of the LEPU SARS-CoV2 Antigen Rapid Test Kit is evaluated by IDC Islamabad Pakistan. Lepu will constantly deliver high-quality and innovative products to keep addressing the global medical needs. Thanks to its simple handling with swabbing in the anterior nasal cavity and the uncomplicated evaluation, the Lepu Medical® rapid test saves considerable time in collection. SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography). This quick test gives results easily and within 15 minutes. This rapid test is one of the rapid antigen tests that have received special approval for private use as so-called lay tests or self-tests. Rating * Name Review Subject * Comments * 6 Reviews Hide Reviews Show Reviews 4 superb packing . Pack of 5 Tests Kit includes; 5 test cards - individually packed 5 nasal swabs,individually packed 5 single-dose dropper of diluent solution (1 ml) cost efficient Appliable for broad screening. Principle of testing The Green Spring® SARS-CoV-2 Antigen Rapid Test is a qualitative, membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens. ชี้แจงถึงการกระบวนการพิจารณาอนุญาตชุดตรวจ ATK ว่า อย.ได้พิจารณาอนุญาต ATK (Antigen Test Kit) แล้วทั้งสิ้น 86 รายการ (ข้อมูลวันที่ 12 . RESULTS IN 15 MINUTES. Rapid test for antigen indicated for self-testing -CE 0197. In models according to population prevalence, all Ag-RDTs will have a NPV >99% and a PPV<50% at 1% prevalence. Stück. Based on a framework agreement, we can ensure the medium- and long-term availability of corona antigen tests for municipalities and companies. This standard metric is explained in depth in the Guidance Document on the Technical Requirements for SARS-COV-2 Rapid Antigen Tests published by HTAC in September 2020. Certified EU CE, BfArM and Paul Ehrlich Institut in Germany, authorized representative in the EU, proof & trace APP: with Application for Smartphone, environmental friendly - no plastic waste. Lepu Medical SARS-CoV-2 Antigen Test Kit is used for COVID-19 Rapid Antigen Test, which is based on specific antibody-antigen reactions and immunassay procedures to detect the novel coronavirus antigen (2019-nCoV) in clinical specimen with rapid and to determine exact results qualitatively. Not painful, not bothersome. The product was bought by the German, the Austrian and the Czech Republic governments as well as the EU and is also distributed in Italy. Lepu Medical SARS-CoV-2 antigen test kit is used for COVID-19 antigen rapid test, based on specific antibody-antigen reaction and immunoassay technique to qualitatively detect the novel coronavirus (2019-nCoV) antigen in clinical specimen with rapid and accurate results. Further studies are needed to evaluate different options to improve screenings based on rapid antigen test, such as the use of clinical questionnaires to select higher risk-participants, the confirmation of negative results with RT-PCR or the use of repetitive sequential testing. Intended Use The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). The SARS-CoV-2 Antigen Rapid Test Kit was compared with nucleic acid method (PCR) using the collected clinical samples. This is Kevin from Lepu medical. This fully searchable directory currently lists all commercially available immunoassays and molecular tests for COVID-19 of which FIND is aware. Short Description: Easy handling, per rod in the anterior nasal region. Principle : Rapid detection of sars-cov-2 nucleo protein antigen Standard: In vitro diagnostic devices, Directive 981 791 EC, EC Clinical sensitivity =96.17% Clinical specificity > 99.9% Accuracy=98.79%. Specificity: 99.26% - Sensitivity: 92% (96.67% total coincidence rate). Then take out test card from outer package. Test Antigenico Covid LEPU Medical Registrazione Ministero della Salute: 2025941. SARS-CoV-2Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) SARS-CoV-2 Antigen Rapid Test Kits for Self-testing SARS-CoV-2 A V-2 i e K s o g l G Im c a) SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold . The urinary antigen test is a method with good sensitivity and excellent specificity in diagnosing pneumococcal pneumonia, and its use greatly increased the recognition of community-acquired pneumonia due to S. pneumoniae. Please feel free to let me know if you have any questions. Test Sensitivity: 95.06% (Clinical Trial)Test Specificity: 98.2% (Clinical Trial)This product is already being sold throughout Europe, including Germany, Italy . Buy COVID-19 Rapid Antigen Tests from Lepu Medical. Index tests included the following Ag-RDTs: PanBio TM COVID-19 Ag Rapid test (Abbott), CLINITEST® Rapid COVID-19 Antigen Test (Siemens), SARS-CoV-2 Rapid Antigen Test (Roche Diagnostics), SARS-CoV-2 Antigen Rapid Test Kit (Lepu Medical), and COVID-19 Coronavirus Rapid Antigen Test Cassette (Surescreen). Write a Review Write a Review ×. For specimens with cycle threshold (Ct) <30 in RT-qPCR, all Ag-RDT achieved a sensitivity of at least 70%, with Siemens, Roche, and Lepu assays showing sensitivities higher than 80%. The LEPU Medical SARS-CoV-2 antigen rapid test is an anterior nasal test, in which a swab can be taken from the anterior nasal cavity in an uncomplicated and painless way. a SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold . Test Sensitivity: 95.06% (Clinical Trial)Test Specificity: 98.2% (Clinical Trial)This product is already being sold throughout Europe, including Germany, Italy . Description. -CoV-2 viral antigen-detecting LFDs focussing on the Innova SARS-CoV-2 Antigen Rapid Qualitative Test which has a viral antigen detection sensitivity of 788 when performed by laboratory scientists and a specificity of 997 using RT-PCR as gold . The rapid tests can be used by trained staff and lay person. (Nasal Selbsttest, einzelverpackt) Dank seiner einfachen Handhabung mit Abstrich im vorderen Nasenraum und der unkomplizierten Auswertung ohne Röhrchen ist der NASOCHECK comfort Schnelltest perfekt für die Eigenanwendung optimiert. Lepu Medical Technology -Beijing- Co., Ltd. . SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography). The Lepu Medical COVID-19 Antigen Saliva Test Kit MSLDNA12 is used for the qualitative detection of novel coronavirus (COVID-19) antigen in saliva sample, only for in vitro diagnostic use. LEPU Medical Antigen Test. Non . Sensitivity 97% Specivity 99% Child-friendly Not invasive. Versand innerhalb der EU möglich. However saliva based RDT (Lepu Medical China) analysis showed 21% reactivity among males and 23% among females, and no reactivity in children. For Rapid Antigen Test Kits to be used in COVID-19 testing, HTAC recommends a minimum sensitivity and specificity of 80% and 97%, respectively. This study suggests that rapid antigen tests are less effective in asymptomatic population, when compared with RT-PCR. Lepu medical COVID-19 Antigen Rapid Swab Test kit MSLRPA76. . Lepu Antigen Test Kit. This LEPU Medical Antigen Test stands out from all conventional rapid tests due to its intuitive operation with only a few steps. Title: SARS-CoV-2:Antigen Rapid Test Kit - Gebrauchsanleitung: Englisch Author: Bundesministerium für Bildung Wissenschaft und Forschung \(BMBWF\) Created Date: 1/8/2021 . LEPU MEDICAL SARS-CoV-2 Antigen Rapid Test Kit [pdf] User Manual LEPU MEDICAL, SARS-CoV-2, Antigen, Rapid, Test Kit: References. Summary For the detection of sensitivity reference material, the positive detection rate should be no less than 90%. 5% Rabatt für Vorbesteller Jetzt für Lieferung in KW07 vorbestellen und 5% Rabatt auf alle Mengen erhalten. Manufacturer: Beijing Lepu Medical Technology Co, Ltd. CE certified • Beijing Lepu Medical Technology, SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold immunochromatography) • BIOSYNEX SWISS SA, BIOSYNEX COVID-19 Ag BSS • CerTest Biotect S.L., CerTest SARS-CoV-2 CARD TEST • Hangzhou Clongene Biotech, Clungene COVID-19 Antigen Rapid Test Kit Hence the company has claimed that the sensitivity of the LEPU SARS-CoV2 Antigen Rapid Test Kit is evaluated by IDC Islamabad Pakistan. Negative reference products compliance rate . The test results are . 2 2.Place test card flat on table, remove cover-layer of adhesive. For the detection of sensitivity reference material, the positive detection rate should be no less than 90%. Covid 19-Antigen Rapid Tests. fast result You can read the result within 15 minutes. LEPU-MEDICAL SARS-CoV-2- Antigentest ist registriert in Liste des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) (Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2) Testdauer: ~ 15 . Sensibilità Ct ≤32: 96,60%. Lepu Medical SARS-CoV-2 Antigen rapid test (front nasal swab) - box of 25 quantity. The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples. Thanks to its simple handling with swabbing in the anterior nasal cavity and the uncomplicated evaluation, the Lepu Medical® rapid test saves considerable time in collection. The LEPU Medical SARS-CoV-2 antigen rapid test is an anterior nasal test, in which a swab can be taken from the anterior nasal cavity in an uncomplicated and painless way. 10 June 2021, the FDA recommended that all Innova antigen tests be destroyed and issued a Class 1 recall (the most serious type of recall). Our study shows that the majority of SARS-CoV-2 Ag RDT correctly identify high viral loads of Cq ≤ 25 (> 10 6 virus RNA copies/mL) in samples from the respiratory tract with a sensitivity of > 75 . Supplementary Table 1 provides further . Manufacture Address: Beijing Lepu Medical Technology Co., Ltd. Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. Lepu Medical Technology ( Beijing ) Co., Ltd was established in 1999. Samples were collected between December 2020-January 2021 during the third wave of the epidemic in Spain. Next, our company will continue to follow up on the mutation of Covid- 19, perform sequence alignment analysis in time, and evaluate and verify the detection ability of key mutation sites to ensure the sensitivity and specificity of the kit. Specificity 99.26%. Ans# 02, This is the new Test That's Why Still under the test (COMING SOON) Q # 03, What Are the difference Between Lepu & Abbott Advanced Antigen Test Kit? Add to cart. Packaging. The test results were both acceptable for layman and professionals. Manufacturer performance data (sensitivity and specificity) are included, where known, alongside data from independent evaluations conducted by FIND, where applicable. BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD. about:blank . testing strategy for diagnosis of SARS-CoV-2 in Pakistani population. product "SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)". no extra instruments Everything you need is included in the package. Benefits. Versand innerhalb der EU möglich. Lepu Medical Lepu Antigen Test. EU approved Colloidal-Gold Immunochromatography SARS-Cov-2 Rapid Antigen Test. EU approved Colloidal-Gold Immunochromatography SARS-Cov-2 Rapid Antigen Test. Our antigen test is one of the best selling rapid tests in Europe. Evaluation of SARS-CoV-2 antigen-based rapid diagnostic kits in Pakistan: formulation of COVID-19 national testing strategy. คณะกรรมการอาหารและยา (อย.) The LEPU Medical Antigen Test detects pathogen-specific N-proteins (Nucleocapsid-N) and thus also identifies the new virus mutations. Thanks to a simple process where you take a swab from the nasal cavity and the easy evaluation, Lepu Medical Antigen Rapid Self-test is perfectly suited for personal use. SARS-CoV-2 RT-qPCR Assay is a real-time reverse transcriptase polymerase chain reaction (PCR) test intended for qualitative detection of ORF1ab and N genes of the SARS-CoV-2 . dubai to sri lanka flight time; parenting a child with developmental delays; waco army flying school; 2003 cricket world cup warm-up matches; pale waves television romance The use of a test card and the simple sample collection make the antigen test easy to handle and intuitive to perform. . There were few tests with high and many tests with sufficient sensitivity, but also quite a few tests (21%) that did not meet the minimum criterion. Quick response in just 15 minutes.Test sensitivity 97%. ähnliche Produkte. . Full coverage COVID-19 infection period. VAT).. Take the test before going to work, a meeting, or a social gathering and within 15 minutes it provides you peace of mind, with a 96.9% accurate result! Shown below are some of the posts by LEPU medical technology. To investigate diagnostic accuracy of SARS-CoV-2 antigen in clinical samples (NPS (#20CG2701X, Lepu Medical) or Saliva (#901101, Lepu Medical)) the colloidal gold labeled SARS-CoV-2N protein monoclonal antibody based immunochromatographic rapid test kits were evaluated in comparison with RT-PCR (Bio-rad, CFX96, USA). Testing time: 10 minutes Sensitivity: 84.4% Specificity:>99%. The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography). Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands Tel: +31-515-573399 Fax: +31-515-760020 False negative results were significantly more pronounced in saliva based RDT as compared to NSP-RDT. The LEPU Medical SARS-CoV-2 antigen rapid test is an anterior nasal test, in which a swab can be taken from the anterior nasal cavity in an uncomplicated and painless way. LEPU Medical Antigen Test. The sensitivity of these NSP-RDT and saliva based RDT were 52% and 21% respectively. Sensitivity 92.00%. This SARS-CoV-2 (Covid-19) Antigen Test Card is an immediate and reliable solution. Why Lepu Medical SARS-CoV-2 Antigen Rapid Tests? GUTSCHEIN CODE: LIEFERUNG-KW07. The test line region is coated with SARS-CoV-2 antibody. The FDA is aware that. Mwst. Antigen-Schnelltest COVID-19 Schnelltests Antikörper-Schnelltest. LEPU Medical NasoCheck Comfort Antigen lay rapid test - 1 pack = 1 lay rapid test Sampling in the anterior nasal cavity, optimized for personal use Details at a glance Self-application by laypeople SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) China European Representative: Lepu Medical (Europe) Cooperatief U.A. The diagnostic sensitivity was 95.90%, and the specificity was 100% in the study done by Biomex in June 2021. The sample reacts with the SARS-CoV-2 antibody in the test line region. Clear. Posted by Finnegan on 8th Dec 2021 . SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Instructions for Use SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Instructions for Use PRODUCT NAME SARS-CoV-2 Antigen Rapid Test Kit (Colloidal… Lepu Medical (Europe) Cooperatief U.A. Q# 02, What is Lepu Antigen Test Kit Sensitivity and specificity? Using a pleasant nasal swab. Test quickly, easily and painlessly for COVID-19. Introducing SARS-Cov-2 Antigen Rapid Test Kit from Lepu Medical SARS-COV-2 Antigen Rapid Test KitClinically trialed Antigen Rapid Test Kit (SARS-CoV-2). SELF TEST. Ans # 03, Lepu Medical technology Kits Have Better design; Lower price and the same function; Related News. Rapid Antigen Test Card Self-test received notified body approved CE marking on Apr.1,2021 A home test for the rapid qualitative detection of antigen in anterior nasal swabs within 7days of symptom onset Sample type: nasal swabTime to result: 15-20 minSensitivity: 99.77%Specificity: 99.20%Accuracy: 98.72%Layperson study statistics:>99.10% of non-professionals carried out the test without . 4) Salixium COVID-19 Rapid Antigen Rapid Test 5)Gmate COVID-19 Ag Saliva 6)Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) 7)Sichuan Xincheng SARS-CoV-2 Antigen Assay 8)Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing) 9) STANDARD Q COVID-19 Ag Saliva Home Test 10)ProDetect ™ COVID-19 Antigen Rapid . 5% Rabatt für Vorbesteller. Artron Laboratories Inc.'s enhanced COVID-19 IgM / IgG Antibody Test and COVID-19 Antigen Test Kit are both equipped to help us provide a better solution for mass diagnosis of coronavirus. As of 28 May 2021, the FDA ordered a recall of Lepu Medical Technology antigen tests. Our COVID-19 IgM / IgG antibody test has a sensitivity of 97.22% (with a 95% confidence interval of 95.20% - 98.56%) and a specificity of 97.88% (with a 95% . Product Reviews. The LEPU MEDICAL rapid antigen test is also widely used in hospitals in Luxembourg and the Netherlands to test visitors and patients to authorize access in hospital settings if they fail. The test results are . Methods: We used 286 nasopharyngeal specimens from unexposed asymptomatic individuals collected between December 2020 and January 2021 to assess five Ag-RDTs marketed by Abbott, Siemens, Roche Diagnostics, Lepu . The use of a test card and the simple sample collection make the antigen test easy to handle and intuitive to perform. The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). Introducing SARS-Cov-2 Antigen Rapid Test Kit from Lepu Medical SARS-COV-2 Antigen Rapid Test KitClinically trialed Antigen Rapid Test Kit (SARS-CoV-2). Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) Operating Steps 1 Wash and dry hands. COVID-19 Antigen Test (Siemens), SARS-CoV-2 Rapid Antigen Test (Roche Diagnostics), SARS-CoV-2 Antigen Rapid Test Kit (Lepu Medical), and COVID-19 Coronavirus Rapid Antigen Test Cassette (Surescreen). The results were summarized in the table below: 【Explanation of Symbols】 【Basic Information】 【Approval Date and Revision Date of the Instruction】 Beijing Lepu Medical Technology Co., Ltd. Introducing Lepu Medical's COVID 19 Rapid Test Kit SARS Cov 2 Antibody Test Kit IgGIgTeste Corona Virus COVID-19 1 Please help EMBL-EBI keep the data flowing to the scientific community! Lepu medical COVID . Sars-CoV-2 Antigen and Leccurate Antibody Test, products by Lepu Medical Technology, were recalled in the United States on May 28 due to "a high risk of false results when using these tests . The test results are available within 15 minutes. Sensitivity of the test decreases after the first 5 days after the onset of symptoms; LEPU Medical Antigen Rapid Test. The use of a test card and the simple sample collection make the antigen test easy to handle and intuitive to perform. Test directory. Lepu Medical SARS-CoV-2 - Nasotest - Antigen Rapid Self-Test The test kit consists of a test card, disposable cotton swab and a dose of test liquid. The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). Title: Lepu Medical - SARS-CoV-2 Antigen Rapid Test Kit - Quick Guide Created Date: 9/4/2020 7:30:44 PM Rapid Antigen Test Kit (Colloidal Gold Immunochromatography) Positiv Negativ . A great help in the fight against COVID-19: the new detection kit allows a quick test on suspected contagion from the virus in just 15 minutes. according to Cooley medical supply limited, a customer of this product, the company did not provide any necessary documents related to this. Thanks to its simple handling with swabbing in the anterior nasal cavity and the uncomplicated evaluation, the Lepu Medical® rapid test saves considerable time in collection. Lepu Medical Poc Testing Sars Cov 2 Antigen Rapid Test Kit Manufacturer Company Immunochromatograph . Specificità: 99,62%. according to Cooley medical supply limited, a customer of this product, the company did not provide any necessary documents related to this. Antigen-detecting rapid diagnostic tests (Ag-RDT) may be suitable for testing strategies; however, benchmark comparisons are scarce. Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands Product information: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold EU-approved and starts at €1.99 per test (ex. All authentic Lepu SARS-CoV-2 Antigen Rapid Tests for self-testing carry a light-blue label with miniature Lepu logo, anti-counterfeiting shading, regiment floral pattern, gilding, and temperature-sensitive ink used for fire discoloration. Sensibilità Ct ≤25: 98,54% Sensibilità Total coincidence rate 97,44%. At least the US FDA is keeping track and holding antigen test providers accountable. Test specificity 100%. Currently 100,000 to 5 million rapid antigen tests are available from stock in Germany. Description. Before sharing sensitive information, make sure you're on a federal government site. CE-IVD approved. Company name: BEIJING LEPU MEDICAL TECHNOLOGY CO. LTD,CHINA Agent in UAE: Hyper Health - Dr Bobby Ahmed Email: bobby@hyperhealth.org Short Description of the Technology: It is a rapid antigen test for the qualitative detection of COVID-19 antigens (N protein) using chromatographic immunoassay in nasopharynx using nasal swab only.

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