News
CE-IVD certification for SARS-CoV-2 Neutralizing Antibody Rapid Test
September 29, 2021
A highly-sensitive and specific immunoassay, (SKU: 41A260) SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold Immunochromatography), developed by ImmunoDiagnostics for rapid detection of COVID-19 neutralizing antibodies has been granted the CE-IVD certification. It is a simple test which does not require any special equipment or training. The testing kits are available in various sizes.
Brazil ANVISA IVD approval for SARS-CoV-2 Spike-ACE2 Binding Assay Kit
September 21, 2021
Our SARS-CoV-2 Spike-ACE2 Binding Assay Kit (SKU: 41A249R) has been officially approved by Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) for IVD-use and publicly announced in the country's Official Diary of the Union, with 12 months shelf stability and 10 years registration expiry date, in partnership with Seegene Brazil.
Official IVD-use Approval by ANVISA
Brazil ANVISA IVD approval for COVID-19 Rapid Antigen Detection Kit
August 17, 2021
Our COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) (SKU: 41A254) has been officially approved by Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) for IVD-use and publicly announced in the country's Official Diary of the Union, with 12 months shelf stability and 10 years registration expiry date, in partnership with Seegene Brazil.
Official IVD-use Approval by ANVISA
CE-IVD certified COVID-19 Rapid Antigen Detection Tests
May 28, 2021
Two highly-sensitive immunoassays developed by ImmunoDiagnostics for rapid detection of COVID-19 antigen have been granted the CE-IVD certification. These kits have been clinically validated in individuals with COVID-19 infection, and have superior sensitivity and specificity, with detection sensitivity below 100 pg/mL.
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(SKU: 41A254) COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography)
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(SKU: 41A255) COVID-19 Ag Detection Kit (Immunofluorescence-Based)
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High Throughput Assays to Measure Neutralising Antibodies before and after COVID-19 Vaccination
May 23, 2021
Several highly sensitive assays developed by ImmunoDiagnostics can be used to quantify and evaluate neutralising antibodies against COVID-19 in individuals who have received vaccination. These assays have been calibrated against WHO International Standard (NIBSC code: 20/136) and are a highly sensitive method to determine vaccine success.
Assays Calibrated with WHO International Standard (NIBSC Code: 20/136) to Evaluate COVID-19 Vaccine Efficiency
Mar 08, 2021
IMD has developed several assays to quantify neutralizing antibodies against SARS-CoV-2 in both patients and individuals after vaccination. The assays have been calibrated with WHO International Standard reference serum (NIBSC Code: 20/136) to ensure accurate quantification, and inter-lab comparison and standardisation. These assays have been widely validated in thousands of individuals post-vaccination.
Immunodiagnostics’s COVID-19 products are highlighted by spotlights of Euronews (a European television network )
Jul 14, 2020
Immunodiagnostics has now developed six highly specific and sensitive diagnostics immunoassays, and has distributed these products to over 20 countries for both population-based screening and rapid detection of COVID-19 patients.
Immunodiagnostics Receives European CE marking approvals for three diagnostic products to detect SARS-CoV-2 (COVID-19)
March 28, 2020
The three highly-specific and sensitive immunoassays developed by Immunodiagnostics for serological detection of antibodies against the major nucleocaspid protein (NP) of SARS-CoV-2, including SARS-COV-2 NP Ab ELISA (Cat No:41A225); SARS-COV-2 NP IgG ELISA (Cat No: 41A222); SARS-COV-2 NP IgM ELISA (Cat No: 41A224) have been granted with CE marking certification from European Union (CE marking: NL-CA002-2020-49738; NL-CA002-2020-49739; NL-CA002-2020-49737). These products were fully validated in patients diagnosed with COVID-19 in different centers . The detection rate of anti-NP total Ab and anti-NP IgG is approximately 90% in serum of >74 COVID-19-patients tested. These serological tests can be used to detect individuals with ongoing or previous infection with SARS-CoV-2, and to monitor the disease progression. Besides, the Free Sale Certificate (FSC) will further enable these products to be used for diagnostic applications in Iran, South Korea, Turkey, Malaysia and Thailand (in application). These CE-marked products are manufactured by Uniten Biotech Limited , the industrial partner of Immunodiagnostics.
New release: Colloidal gold-based rapid test for diagnosis of COVID-19
May 01, 2020
IMD has successfully developed a highly accurate colloidal gold-based point-of-care test (POCT) for rapid and simultaneous detection of anti SARS-COv2 NP IgG and IgM antibodies with a tiny drop of blood samples. The quality and reproducibility of this test was validated in a multi-center study in COVID-19 patients, with detection rate and sensitivity of >83% and> 95% respectively. This product, in combination of a series of high throughout ELISA products previously developed by IMD, enables the company to provide a comprehensive range of high quality assays for detection of both antibodies and antigens of SARS-COV2
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“Our assay detects biomarker in circulation. Some biomarkers reflect a certain disease condition, and some can detect diseases at a very early stage, even before any clinical symptoms,” said Dr Kelsey Zhongling, deputy executive director of ImmunoDiagnostics.