Hangzhou Clongene Biotech Co Ltd
Hangzhou Clongene Biotech Co.,Ltd. is established in 2004 with a registered capital of 50.1 million RMB. Area scales to 19,000 square meters in R&D and manufacturing base with about 2700m2 100-thousand-grade Purification Workshop, which is located in No.1 Yichuang Road, Yuhang Sub-district, Yuhang District, Hangzhou, China. Clongene is a high-tech biotechnology company in manufacturing biology raw materials, the second and third class of 6840 in vitro diagnostic tests, food safety tests, veterinary diagnostic tests, etc.
World Certifications & Recognitions
Clongene obtains several certifications and honors: ISO13485, ISO9001 certification & European Union CE certification; The U.S. FDA 510K marketing permit; 27 items China CFDA marketing approval; Recommend enterprise of drug abuse testing device in Ministry of Public Security; Put on record in China Ministry of Agriculture on food safety test device; Be selected as one of Military procurement suppliers; Evaluated as a SMB Technology Enterprise in Zhejiang province; Hangzhou R&D center; AAA-Credit enterprise.
Lungene® Antigen Test Cassette
The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.
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Lungene® COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
For professional and in vitro diagnostic use only.
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Intended Use Covid-19 Rapid Test Cassette
The test is intended to be used at clinical laboratories or by healthcare workers at the point-of-care, not for home use. The test should not be used for screening of donated blood.
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Summary Caused by Coronavirus
Coronavirus disease 2019 (COVID-19) is caused by a coronavirus. Coronaviruses are a large family of viruses which may cause illness in animals or humans.
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Principal Proper Volume of Specimen
The COV/0-19 tgG/lgM Rapid Test Cassette consists of- 1) a burgundy colored conjugate pad containing SARS-CoV-2 recombinant antigens conjugated with colloid gold (SARS-CoV-2 conjugates).
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Warnings and Precautions Vitro Diagnostic Use
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
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Composition The quantity of tests was printed on the labeling.
The test contains a membrane strip coated with Mouse anti-Human lgM antibody on the test line, and a dye pad which contains colloidal gold coupled with SARS-CoV-2 virus recombinant antigen.
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Storage and Stability Expiration date are printed.
Store as packaged in the sealed pouch at the temperature (4-30 °C or 40- 86 °F). The kit is stable within the expiration date printed on the labeling.
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Specimen Avoid interference on result interpretation.
The test can be used to test whole blood (venipuncture blood and capillary finger prick blood) /serum /plasma (EDTA, heparin, citrate) specimens.
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Test Procedure 2 drops of buffer
Allow the test device and specimens to equilibrate to temperature (15-30°C or 59-86 ° F) prior to testing.
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Interpretation of Results Negative
One colored line appears in the control region (C). No apparent colored line appears in the test line region.
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Quality Control Procedural Control
A colored line appearing in the control region (CJ is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
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Limitations Qualitative Detection.
The COV/0-19 !gG/lgM Rapid Test Cassette is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antibody in the blood.
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Performance Characteristics Acuracy
Regarding the lgM test, testing was performed on 167 clinical specimens from individuals suspected of COVID-19 infection compared to RT-PCR. COV/0-19 lgM.
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Performance Characteristics Biological Analytes
Some other common biological analytes were spiked into the Novel coronavirus positive and negative specimens and tested separately.
The FDA is allowing Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Test to be made available under its new policy dated May 4, 2020. (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency). As required, the completed EUA template and associated documentation were submitted on May 15, 2020 to the FDA. The submission (EUA#201121) included updated validation reports and additional clinical data. Clungene's establishment registration & device number on the FDA's website is 3009414546.
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Certification for Sale Transport of Chemical Goods
Shanghai Research Institute of Chemical Industry Testing Co., Ltd
