As a leading lateral flow test kits manufacturer in China, JOYSBIO has developed and launched one of the world’s first point-of-care lateral flow rapid test cassettes for the diagnosis of 2019 novel coronavirus disease. The COVID-19 Antibody Rapid Test Kit (Colloidal Gold) is for in vitro qualitative determination of both IgG and IgM antibodies in human serum, plasma, and fingertip blood. Clinical laboratories or healthcare workers can use this product for laboratory or point-of-care testing. The COVID-19 antibody lateral flow test is a fast and effective method for the SARS-CoV-2 antibody screening of a large population. For rapid detection of active infection, learn more about the new COVID-19 rapid antigen test kit.
20 tests/box, includes: 20 Test Cassettes, 20 Desiccant Bags, 1 Dilution Buffer Lancets (upon request), Droppers (upon request)
JOYSBIO implemented the quality management system from China Food and Drug Administration and obtained ISO9001, ISO13485 QMS certification, and CE 0197 from TÜV Rheinland LGA Products GmbH.
Currently, JOYSBIO produces more than 500,000 test cassettes per day to supply healthcare workers in the global pandemic.
CE CERTIFIED, ISO 13485
Files coming soon.
JOYSBIO has validated the COVID-19 IgG/IgM Test Kit by a clinical trial with a total of 400 clinical samples from individual patients: 367 serum samples, and 33 plasma samples (EDTA, heparin, and citrate). The study was performed at provincial hospitals in China from January to April 2020.
Across all study sites, serum and plasma samples from 182 COVID-19 patients with positive Real-Time RT-PCR results, and 218 patients with negative Real-Time RT-PCR results. The evaluation results are shown in the tables below. The sensitivity and specificity of JOYSBIO’s COVID-19 antibody test kit are confirmed to meet diagnosis standards.
JOYSBIO’s COVID-19 IgG IgM Antibody Test Kit (Colloidal Gold) detects both Immunoglobulin G and Immunoglobulin M antibodies of 2019 novel coronavirus on a single test cassette.
When the test operator adds sample to loading well of a test strip, the sample flows through the blood filter film. If the test sample contains the COVID-19 IgM antibody, it can combine with colloidal gold-labeled novel coronavirus antigen to form a complex. The mouse anti-human IgM antibody coated on the test cassette (M line) can capture the complex and develop a red color band. If the SARS-CoV-2 IgG antibody is present in the test sample, it combines with colloidal gold-labeled novel coronavirus antigen to form another type of complex. After the complex moves towards another end of the test cassette by capillary force, it can be captured by the mouse anti-human IgG antibody coated on the G line of the test cassette. A quality control line (C line) is designed on the test kit to act as procedural control.
The result of COVID-19 Antibody Rapid Test Kit should be read within 15~20 minutes after the sample and diluent are added into the sample loading well. The result displayed after 20 minutes is invalid.
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