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CE marked SARS-CoV-2 total antibody ELISA

The Wantai CE marked SARS-CoV-2 total antibody ELISA from Beijing Wantai Biological Pharmacy is a highly sensitive and specific diagnostic kit for the fast, high-throughput antibody screening of patients suspected of COVID-19 infection. This kit has been extensively evaluated and validated in Europe demonstrating a high specificity (>98%) in clinical studies.

This two-step incubation antigen “sandwich” enzyme immunoassay utilises polystyrene microwell strips pre-coated with recombinant SARS-CoV-2 antigen. Patient’s serum or plasma specimen is added and during the first incubation, specific SARS-CoV-2 antibodies are captured inside the wells if present. This kit contains reagents sufficient for testing of maximum of 91 specimens in a test run.SARS-CoV-2 Ab ELISA

Kit indications
The kit detects total antibodies (IgG, IgM and IgA) against the S1-RBD of SARS-CoV-2 which is indicative of:
• An immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection
• Detection of seroconversion in patients following known recent SARS-CoV-2 infection
• Test may also be used to aid in the diagnosis of acute or past SARS-CoV-2 infection in conjunction with other tests and clinical information

Nature evaluation
In a recent Nature communications article, this kit was evaluated and compared to seven other commercial COVID-19 serology assays and the following was stated:
"The Wantai ELISA detecting total immunoglobulins against the receptor binding domain of SARS CoV-2, has the best overall characteristics to detect functional antibodies in different stages and severity of disease, including the potential to set a cut-off indicating the presence of protective antibodies."
GeurtsvanKessel, C.H., Okba, N.M.A., Igloi, Z. et al. An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment. Nat Commun 11, 3436 (2020). https://doi.org/10.1038/s41467-020-17317-y

Clinical study evaluations
Numerous clinical studies have shown the very high specificity (>98%) of the Wantai SARS-CoV-2 Ab ELISA.
• Dutch Serology Taskforces
In the Netherlands, the Dutch Serology Taskforces showed kit sensitivity of 98.1% for samples collected >14 days after the onset of illness.
Dutch Serology Taskforce report
• Erasmus Medical Center
Conducted in the Netherlands, the Erasmus Medical Centre showed kit sensitivity of 98% (100% >14 days)
Erasmus Medical Centre article
• Sanquin Blood Bank
The Sanquin Blood Bank calculated a PPV of 99%, 88%, and 72% in areas with prevalence of 4-10%, 2-4% and <2%.
Sanquin Blood Bank article
• Statens Serum Institut
The Statens Serum Institut in Denmark showed a kit sensitivity of 71% (7~13 days) ~ 100% (10 days)
Statens Serum Institut article
• Medizinische Universität Wien
The Medizinische Universität Wien in Austria calculated sensitivity of 92~100%
Medizinische Universität Wien article
• French National Reference Center
The French National Reference Center (CNR) evaluated the kit and concluded a sensitivity of 100% (7-13 days), 95% (14-19 days) and 98% (>20 days) respectively.
• University Hospital in Padova
The University Hospital in Padova in Italy demonstrated over 98% agreement with automated immunoassays
University Hospital in Padova article
• AZ Delta Medical Laboratories and Ghent University
In Belgium, AZ Delta Medical Laboratories and Ghent University concluded that this kit is suitable for sensitive and specific screening of a SARS-CoV-2 infection from 10 days after symptom onset.
AZ Delta Medical Laboratories and Ghent University article

UK Government COVID-19 testing guidance
The UK Government’s guidance regarding the use of the COVID-19 diagnostic assays can be found here

The test should not be used as the sole basis for diagnosis.

Products

Note: product availability depends on country - see product detail page.

Details Cat number & supplier Size Price
SARS-CoV-2 Total Ab ELISA (CE-IVD) WS-1096 · Beijing Wantai Biological Pharmacy
WS-1096
Beijing Wantai Biological Pharmacy
96 wells POA
96 wells
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