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.

  • (SKU: 41A254) COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography)

  • (SKU: 41A255) COVID-19 Ag Detection Kit (Immunofluorescence-Based)

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.

New Product: COVID-19 Ag Detection Kit

Nov 10, 2020

Immunodiagnostics has successfully developed a rapid COVID-19 antigen detection kit, with a detection sensitivity below 100 pg/ml, This product will meet the urgent need for the rapid diagnosis of SARS-CoV-2 infection.

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. 

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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


GBA injects new impetus to biotech start-ups

August 21, 2019

“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.


Research team of Professor Aimin Xu, the founder of ImmunoDiagnostics Limited, won a Gold Medal at the 47th International Exhibition of Inventions in Geneva.

April 14th, 2019

A novel method for risk predication and accurate diagnosis of autoimmune diabetes by measuring enzymatic activities and protein concentrations of neurophil elastase (NE) and proteinase 3 (PR3) in human plasma. It is developed by the research team of Professor XU Aimin, Department of Medicine, Li Ka Shing Faculty of Medicine, HKU.

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