… is a lateral flow immunoassay intended for … This testifies that the financial risk of co-operating with our company is low. Summary data of COVID-19 Antigen Rapid Test as below: COVID-19 Antigen RT-PCR(Ct value≤33) Total Positive Negative CLUNGENE® Positive 145 2 147 Negative 3 593 596 Total 148 595 743 PPA (Ct≤33): 98.0% (145/148), (95%CI: 94.2%～99.3%) NPA: 99.7% (593/595), (95%CI: 98.8%～99.9%) COVID-19 Antigen RT-PCR(Ct value≤37) Total Please rest assured to wholesale CE approved clungene antigen rapid test cassette made in China here from our factory. Ability to correctly identify negative cases, Accuracy = 93.41% IgM test: Both of them can be performed quickly and can be applied by healthcare professionals at point of care (POC) sites. The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. New! Design Systematic review and meta-analysis. With this test you as an organization can ensure that your employees are not absent unnecessarily for a number of days. Are there any further tools, materials, devices needed? Our company, HBS Medical Kft., is one of the major importers of rapid tests. Residion Medical is an official distributor of the Clungene COVID -19 … The typical symptoms of COVID-19 appear 2–14 days after becoming infected; typically, 5–6 days after. 1:One Step Rapid Dengue IgG/IgM &NS1 Combo Test Kits 2:Features: high sensitivity, simple & easy to use and the result is accurate 3: Formats:panel 2 4:Specimen: serum, plasma. IgM test Sensitivity = 87.01% ProVen is the trusted name in dependable pharmaceutical distribution solutions and life science commercialization capabilities. Clinical sensitivity 96.80% High clinical specificity 99.60% Easy to use - fast and reliable test results in just 15 minutes can be carried out with Saliva samples (spit test) The sensitivity and specificity of Anhui and Clungene tests were 33.3% and 72.85%, and 35.48% and 85.02%, respectively. When the body has been exposed to the SARS-CoV-2 virus, it produces IgG and IgM antibodies in an attempt to defend itself against infection. This test also costs only a fraction of what a PCR test (the GGD test) costs. “0” represents the day when the symptoms first occur (onset day). – Cookie Policy – Privacy Policy, Common list of COVID-19 rapid antigen tests, Medical Service Budapest Mammut Health Centre, Medical Service Budapest Árkád Health Centre, The genetic material (RNA) of SARS-CoV-2 (the novel coronavirus), A specific protein present in SARS-CoV-2 (and recognized by the human immune system), The antibodies produced by the human immune system against SARS-CoV-2, Blood (finger-prick or venous blood, or plasma). HBS Medical Kft. Sensitivity = 87.01% Positive agreement with PCR testing Specificity = 98.89% Our company has donated rapid tests to municipalities and other institutions several times, for scientific research, social and public health purposes. The New York Blood Center Lindsley F. Kimball Research Institute announced the results of an independent study that showed the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette possesses a high degree of sensitivity and specificity for detecting COVID-specific antibodies. Objective To determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19). This test is for detecting the late phase of the infection, just as well as an infection happened in the past. has been distributing both antibody and antigen rapid test cassettes. The webpage of HBS uses cookies in order to operate the page, make its use more convenient and track the actions of the users to display relevant offers for them. This test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 5:Read Time: 10-15minutes 6:Accuracy: >98% 7:Storage: Room temperature 8:Shelf life: 24 months from date of manufacture 9:Packing details:1pc/pouch; 30pcs/bag, 2000pcs/carton; or 30pcs/box, … This is followed by the two antibodies, IgM and IgG, which are detected by the antibody test. Sensitivity: 92.0–98.0%. Our supplier, Hangzhou Clongene Biotech Co. Ltd. has been manufacturing more than 1,000 types of microbiological test materials and products. The Clungene® SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test is an onsite kit with a single panel for IgM/IgG simpler detection of Coronavirus in 10-15 minutes, whether you have been exposed to the virus within the past 4 to 24 days. The study by the New York Blood Center was done… Highest test quality: Sensitivity: 98.50% (positive test) Specificity: 100% (negative test) T he Antigen Rapid Test reliably and quickly triggers people with acute suspicion of SARS-CoV-2. 8 days after the appearance of the symptoms, sensitivity is over 90%. Rapid tests are not only suitable for use in the medical environment, but they can also be used in various kinds of public institutions.. To minimise the risk of infection transmission, Corona antigen rapid tests can be performed directly on site.Chains of infection can be broken more effectively, since people with undetected Corona infections are particularly responsible for spreading the virus. Thus, LFAs are potentially useful assays that require low sample input and minimum processivity. Clungene® Coronavirus SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Kit is an onsite kit with a single panel for IgM/IgG simpler detection of Coronavirus in 10-15 minutes, whether you have been exposed to the virus within the past 4 to 24 days. The Clungene® Coronavirus SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Kit includes: IgG Test: Testing of Coronavirus Disease (COVID-19) in healthcare workers using SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test. The CLUNGENE COVID-19 Antigen Rapid Test from Hangzhou Clongene Biotech Co. inspires with its 98.50% sensitivity, delivers highly accurate results in… The results are available within 15-30 minutes and thus enable a quick identification of infected persons. CE49PT0505 Page 1/3 COVID-19 Antigen Rapid Test Clinical Sensitivity and Specificity Study Report 1. IgM test. The CLUNGENE® COVID-19 Antigen Rapid Test from Hangzhou Clongene Biotech Co., Ltd. delivers highly accurate results in just minutes. By measuring the concentration of these particular antibodies, the SARS-CoV-2 Rapid Test can determine in 10-15 minutes whether you have been exposed to the virus fast and with reliable results. Accuracy = 93.41% Ability to detect IgM or IgG Evaluation of SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test with RT-PCR … CE49PT0505 Page 1/2 COVID-19 Antigen Rapid Test Clinical Sensitivity and Specificity Study Report 1. Specificity: 99.7%. Yes (provided the antibody is still present). To slow the pandemic down and to minimize the economic loss caused by the COVID-19, it is essential to test people regularly and in a systematic way. It detects the nucleocapsid protein of SARS-CoV-2 (which is detected by the human immune system, too). Taken together, the CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Saliva) had a positive percent agreement (sensitivity) of 96.8% (95% CI: 92.0%～98.7%) with specimens of … In this study, we report the sensitivity and specificity of Clungene ® SARS-CoV-2 IgG/IgM Rapid Test Cassettes in determining the presence of binding antibodies in convalescent plasma (CP) donor samples with previously documented COVID19. The Clungene® Coronavirus SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Kit includes: CLUNGENE Covid-19 Antigen Rapid Test. Contact us for more cheap products. Here you can find the webpage of some of them. Results: The prevalence of PCR positivity in 4864 patients tested with PCR was 6.3%. Sensitivity = 87.01%. The test procedure has a sensitivity of 96.8% and a specificity of 99.6%, thus delivering valid and highly reliable results Test for the qualitative detection of the SARS-CoV-2 antigen Tools for diagnosing an acute SARS-CoV-2 infection has obtained Bisnode A certificate. A comparison on the most frequently applied testing methods: There are hundreds of medical institutions, doctors, health centres, nursing homes, private clinics, companies and other institutions who have been using Clungene® COVID-19 Rapid Test Cassettes, which are distributed by us. It detects the antibodies produced by the human immune system against the SARS-CoV-2 virus (IgG and (IgM). Objective The CLUNGENE® COVID-19 Antigen Rapid Test (hereinafter referred to as the CLUNGENE Device) manufactured by Hangzhou Clongene Biotech Co., Ltd. is a lateral flow immunoassay intended for the Test Kit, Rapid Test, Lungene manufacturer / supplier in China, offering High Sensitivity Medical One Step Detection Diagnostic Rapid Test Kit, Rapid Test Cwbio PCR Rt PCR Fast Nucleic Acid Detection Kit PCR Test Kit with CE TUV Eua Certificate, China Top Brand Cwbio PCR Rt PCR Rapid Test Kit Nucleic Acid Detection Kit and so on. Data sources Medline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19. Positive agreement with PCR testing, Specificity = 98.89% The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. Suitable for the qualitative detection of Coronavirus (SARS-CoV-2 / COVID-19) N-Protein IgM / IgG antibodies in human serum, plasma, or whole blood. Evaluation of SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test with RT PCR testing in inpatients with COVID-19 for the detection of antibodies (IgG and IgM). The virus protein – the antigen – appears first; this can be detected by the antigen test. The rapid test is delivered with the necessary accessories and can be carried out at the point of care. In the period of incubation (shown by negative numbers) no test can detect the infection consistently. Positive agreement with PCR testing. In this way, the two tests complement each other perfectly. The results can be read 15 minutes after specimen application. As one of the most professional clungene antigen rapid test cassette suppliers in China, we're featured by quality products and low price. This figure serves as a reference; it shows when the COVID-19 antigen (Ag) and the two immunoglobulins (IgM and IgG) can be detected. Opiate Withdrawal: Neurostimulation Therapy. This test is for detecting the early phase of the infection. Testing of Coronavirus Disease (COVID-19) in healthcare workers using SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test. CLUNGENE ® Positive 120 2 ... (Sensitivity) NPA - Negative Percent Agreement (Specificity) ... COVID-19 Antigen Rapid Test Cassette at the concentrations listed below and were found not to affect test performance. Clungene’s establishment registration & device number on the FDA’s website is 3009414546.The FDA is allowing the CLUNGENE RAPID TEST SARS-CoV-2 IgG/IgM Rapid Serology Test to be made available under its new policy dated May 4, 2020. Sensitivity: 92.0–98.0%. The CLUNGENE Covid-19 antigen rapid test is a lateral flow immunoassay for the qualitative detection of an acute SARS-CoV-2 infection. This product is not for at-home use and is meant for health professionals following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020. We have sold hundreds of thousands of tests in Hungary, supplied state institutions, healthcare institutions, municipalities and companies, too. Ability to detect IgM or IgG. Sensitivity = 87.01% Sensitivity: 86.6%. The sensitivity of all sevenIgG LFAs was >92.1% (78.5e98.0) and for four IgG LFAs even 97.4% (85.3e100) in samples taken 14e25 days after the onset of symptoms. In most cases, IgG appears later, in the second half of the infection, but it is present in the body in a detectable amount for months. Specificity = 98.89% Ability to correctly identify negative cases. Clungene® COVID-19 Antigen Rapid Test It detects the nucleocapsid protein of SARS-CoV-2 (which is detected by the human immune system, too). The box comes with 25 separate ampoules of buffer for the 25 test cassettes. The presence of IgM usually refers to the early-to-mid phase of the infection. Evaluation of SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test with RT PCR testing in inpatients with COVID-19 for the detection of antibodies (IgG and IgM). This test is for detecting the early phase of the infection. Sensitivity = 97.40% Taken together, the CLUNGENE Antigen Rapid Test had a positive percent agreement (sensitivity) of 91.4% (95% CI: 82.5%～96.0%) and negative percent agreement (specificity) of … Can it detect the infection after the time described below elapsed after the onset day? Our company, HBS Medical Kft. Specificity: 98.33% (IgG+IgM combined). Positive agreement with PCR testing. (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency). Testing of Coronavirus Disease (COVID-19) in healthcare workers using SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene ® test. Testing of Coronavirus Disease (COVID-19) in healthcare workers using SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test. The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay method for the qualitative detection of SARS CoV-2 nucleocapsid antigen in nasopharyngeal and oropharyngeal swabs from individuals suspected by their healthcare provider to be COVID-19 infected. IgM test Sensitivity = 87.01% Objective The “CLUNGENE® COVID-19 Antigen Rapid Test Cassette” manufactured by Hangzhou Clongene Biotech Co.,Ltd. PRIVACY TERMS SITEMAP COPYRIGHT © 2018 PROVEN PHARMACEUTICALS, LLC. COVID-19 antigen rapid test Simple Accurate Safe 1 PU * (25 pieces) specificity 99.0%, sensitivity 97.3%, overall accuracy 98.1% From 4 PUs : one FFP2 mask per test free of charge * PU = Packing unit; 1 PU = 25 pieces; Offer valid while supplies last. Clungene® COVID-19 Rapid test More safety in only 15 minutes The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay method for the qualitative detection of SARS CoV-2 nucleocapsid antigen in nasopharyngeal and oropharyngeal swabs from individuals suspected by their healthcare provider to be COVID-19 infected. However, it is assumed that during the major part of this period people might not spread the infection because there is not enough virus in their body yet. Clungene® COVID-19 Rapid test More safety in only 15 minutes. Antigen tests are capable of identifying COVID-19 at the early phase of the infection, whereas antibody tests can detect it in the late phase and past infections, too. Only the 7.44% of the Hungarian companies have obtained this certificate. he Clungene® SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test is an onsite kit with a single panel for IgM/IgG simpler detection of Coronavirus in 10-15 minutes, whether you have been exposed to the virus within the past 4 to 24 days. Clungene Rapid Test - Residion COVID -19 IgM/IgG Rapid Test Cassette This test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary), serum, and plasma samples. Substance Concentration Substance Concentration Mucin 2% Whole blood 4% (Note: Clungene test is also marketed as 'Lungene'.) One of the infection POC ) sites as 'Lungene '. 1,000 types of test! 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