COVID-19 Rapid Test Kits

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.

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.

Rapid detection within 15 mins
Compatible with serum, plasma, whole blood, and fingertip blood
Qualitative detection of both IgG and IgM antibodies
Point of care (POC) testing with easy-to-read visual interpretation

COVID-19 IgG IgM Antibody Rapid Test Kit (Colloidal Gold)

20 tests/box, includes:
20 Test Cassettes, 20 Desiccant Bags, 1 Dilution Buffer
Lancets (upon request), Droppers (upon request)

JOYSBIO’s COVID-19 IgG/IgM Rapid Test Kit is manufactured under ISO 13485 QMS. The test kit is CE certified and FDA EUA pending.

In June 2020, JOYSBIO Biotechnology proudly released a new COVID-19 Antigen Rapid Test Kit (Colloidal Gold). The new coronavirus antigen test kit is a lateral flow immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in upper respiratory samples with nasal swabs during the acute phase of infection. An uncut sheet format is available.

15-minute rapid detection
Easy-to-operate coronavirus antigen test
Less-invasive nasal (NS) swab sample collection
CE-IVD marked

There are two kinds of tests available for COVID-19: viral tests and antibody tests. RT-PCR test and antigen test are both viral test which detects the presence of SAR-CoV-2 from upper respiratory samples. The RT-PCR test targets the genomic information of the virus (RNA); however, the COVID-19 antigen test kit detects pieces of proteins that make up the SARS-CoV-2 virus. The WHO recommends both RT-PCR tests and antigen tests for the diagnosis of active coronavirus infection. Please visit the US FDA page for more information about Coronavirus Testing Basics.

On July 4, 2020, JOYSBIO launched a rapid COVID-19 Neutralizing Antibody Test Kit (lateral flow cassette) for semi-quantitative detection of neutralizing antibody (NAb) level.

Similar to many infectious diseases, neutralizing antibodies can help to inhibit SARS-CoV-2 replication, which means the level of neutralizing antibody correlates to the immunity of future SARS-CoV-2 infections. A semi-quantitative or quantitative detection of neutralizing antibodies can help with vaccine development, plasma therapy, and immunology study.

Rapid detection within 15 mins
Compatible with serum, plasma, whole blood, and fingertip blood
Detects NAb that blocks RBD-ACE2 interaction

The 2019 novel coronavirus (SARS-CoV-2) has several structural proteins, including spike (S), envelope (E), membrane (M), and nucleocapsid (N). The S-protein contains a receptor binding domain (RBD), which can recognize the cell surface receptor, angiotensin-converting enzyme-2 (ACE2). In a recent study, neutralizing antibody (NAb) can block the interaction between the receptor-binding domain (RBD) of the novel coronavirus spike protein with the ACE2 cell surface receptor.

The level of NAb, therefore, can be used to analyze a patient’s immunity against future SARS-CoV-2 infection. This COVID-19 neutralizing antibody lateral flow assay rapidly detects any antibodies that can neutralize the RBD-ACE2 interaction.

Researchers have been using traditional viral neutralization assay for testing SARS-CoV-2 neutralizing antibodies and there are several ELISA based neutralizing antibody test kits available in the market since May 2020. However, performing COVID-19 neutralization assays or ELISA requires complex laboratory settings, and it is time-consuming, despite a higher sensitivity and specificity. JOYSBIO’s neutralizing antibody rapid test cassette provides an easy way for the preliminary screening of NAb to estimate patients’ immunity to novel coronavirus infection.

In March 2020, JOYSBIO was one of the first manufacturers who developed the 2019 novel coronavirus IgM/IgG antibody test kit for the qualitative detection of IgM and IgG antibodies against SARS-CoV-2. JOYSBIO now supplies the COVID-19 antibody test uncut sheet to help medical device suppliers quickly set up their own lateral flow assay manufacturing facilities to expand testing capacity during the pandemic.

Manufacturing from uncut sheets is the fastest way beside our lateral flow assay private label service to bring your own product to the market. With the uncut sheet, the production process only requires to cut the sheet and assemble a two-piece plastic cassette before packing into a pouch. Pre-cut strips are available at JOYSBIO.

Inquire today to learn more about our new product: COVID-19 Antigen (Ag) Rapid Test Uncut Sheet.