At present, Our Coronavirus Testing Kits the only product which is tested by latex test on the Chinese market . The raw material has higher sensitivity, stronger stability and more accurate test results;
Common name: Novel Coronavirus(Sars-CoV-2) IgM Antibody Rapid Test Kit (Latex Assay)
25 Tests / Box
This product is used for the qualitative detection of new coronavirus 2019-nCoV IgM antibodies in human serum, plasma or whole blood.
Coronaviruses are a large family of viruses that are known to cause colds and more serious diseases such as the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Coronaviruses are systematically classified as Coronaviridae (Coronaviridae). Coronaviruses are single-stranded RNA viruses with positive envelopes that infect only human, mouse, pig, cat, dog, and avian vertebrates. The Ninth International Committee on Classification of Virology divided the Coronaviridae into three genera, namely, alpha, beta, and gamma. Coronavirus is excreted through respiratory secretions, transmitted through oral fluid, sneeze, contact, and transmitted through air droplets.
The 2019 novel coronavirus (or '2019-nCoV', 'COVID-19', 'SARS-CoV-2') was discovered because of Wuhan virus pneumonia cases in 2019, and was named by the World Health Organization on January 12, 2020. The new coronavirus is a new coronavirus strain that has never been found in humans before.
This product is composed of the novel coronavirus 2019-nCoV specific dominant epitope antigen fixed on a nitrocellulose membrane, a colored latex-labeled anti-human IgM antibody release pad and other reagents. The latex immunochromatographic technology was used to detect the new coronavirus 2019-nCoV antibody in human serum / plasma / whole blood using the principle of capture method.
During the test, a blood sample is added to the sample well of the kit. The sample is first mixed with the colored latex-labeled anti-human IgM on the release pad, and then chromatographed on a nitrocellulose membrane. If the sample contains new coronavirus 2019-nCoV antibodies, these antibodies will first bind to colored latex-labeled anti-human IgM, so that when the mixture is chromatographed on a nitrocellulose membrane, it will be immobilized with the new coronavirus 2019-nCoV antigen. The detection line (T line) was captured to form a colored latex-labeled anti-human IgM-antibody-antigen immune complex. Therefore, a red line appeared on the T line, which was a positive result. If no new coronavirus 2019-nCoV antibody is present in the blood of the subject, a red line will not be formed on the test line (T line), which is a negative result. The quality control line (C line) on the test card is coated with goat anti-mouse antibody. Under normal circumstances, a red line should appear on the quality control line(C line) during the test to prove that the test card is working properly.
Main Ingredients in the Novel Coronavirus Test Kit
Storage Conditions And Validity
Store at 4-30℃, protected from light, valid for 12 months. Do not freeze.
Interpretation of test results
Limitations Of Detection Methods
The test results of this product are only used as a supplement for doctors or other diagnosis.
Product Performance Index
Registrant / Manufacturer: GenSure Biotech Inc.,
Address: B1-78, Rizhongtian Science and Technology Park, No.585 Tianshan Street, Shijiazhuang High-tech Zone, Hebei,China.
Utill now Chinese goverment has selected 9 products from 8 companies from the 300 companies who declared, and submitted the 9 products to the National Medical Products Administration of China for emergency approval.
This product is one of the 9 products listed above that have been approved, it was jointly developed by GenSure Biotech Inc., PLA General Hospital (301 Hospital), Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Second Hospital of Hebei Medical University and Beijing Jinwufu Biological Engineering Technology Co., Ltd.
Below is the video to show you how to use Novel Coronavirus COVID-19 IgM Antibody Rapid Testing Kit:
Diagnostic Test Kit for Novel Coronavirus 2019-nCov IgM testing result video
More information about Coronavirus Testing Kit from Gensure Biotech Inc. Company
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