7/26/2023 0 Comments Semi quant total abThe test is based on antibody-capture method. The test should not be used as the sole basis for diagnosis. It is intended for testing of patients suspected of recent infection with the SARS-CoV-2 virus. Wantai SARS-CoV-2 lgM ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of lgM-class antibodies to SARS-CoV-19 virus in human serum or plasma. Subsequently, WANTAI SARS-CoV-2 Ab ELISA received FDA Emergency Use Authorization on August.05,2020. Downloads: Letter of Authorization, HCP, Recipients, IFU , NCI Report. In the United States, validation study conducted by the National Cancer Institute (NCI) showed sensitivity of 96.7% (29/30) and specificity of 97.5% (78/80) of the test. ICMR/NIV in India evaluated the kit, the sensitivity was 98% and the specificity was 100%. In Belgium, AZ Delta Medical Laboratories and Ghent University concluded that Wantai SARS-COV-2 Ab ELISA is suitable for sensitive and specific screening of a SARS-CoV-2 infection from 10 days after symptom onset. Over 98% agreement with automated immunoassays has been demonstrated during a study conducted by the University Hospital in Padova, Italy. In other studies conducted in the Netherlands, Erasmus Medical Center showed sensitivity of 98% (100% >14days) and Sanquin Blood Bank calculated PPV of 99%, 88%, and 72% in areas with prevalence of 4-10%, 2-4%, and 20days) respectively. In the Netherlands, reporting by the Dutch Serology Taskforces shows sensitivity of the kit of 98.1% for samples collected > 14 days after onset of illness, the Dutch Serology Taskforce report can be downloaded from HERE. The kit detects TOTAL ANTIBODIES (IgG, IgM and IgA) against S-RBD and it has been extensively evaluated and validated in Europe. Performance evaluations (click on the links to open each study report) The prevalence of SARS-CoV-2 infection in the area where testing has occurred should be considered when interpreting positive test results. The 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. WANTAI SARS-CoV-2 Ab ELISA detects total antibody as indicative of an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection, or for the detection of seroconversion in patients following known recent SARS-CoV-2 infection. SARS-CoV-2 Total Ab ELISA - Download Brochure The WANTAI SARS-CoV-2 IgG ELISA (Quantitative) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, or as an aid in individual vaccination management decisions. The quantitative result obtained with this kit is as a reference for clinician only, cannot be used as the sole basis for further individual vaccination and treatment. WANTAI SARS-CoV-2 IgG ELISA (Quantitative) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for quantitative detection of IgG-class antibodies to SARS-CoV-2 virus in human serum or plasma. SARS-CoV-2 IgG ELISA (Quantitative) - Download Brochure The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection, or as an aid in individual vaccination management decisions. WANTAI SARS-CoV-2 NAbs ELISA is an enzyme-linked immunosorbent assay for the quantitative detection of neutralizing antibodies to SARS-CoV-2 virus in human serum or plasma. SARS-CoV-2 Neutralizing Antibodies ELISA (Quantitative) - Download Brochure It is intended for use as an aid in the diagnosis of specific T cellular immune response of SARS-CoV-2 spike protein after vaccination or infection. WANTAI SARS-CoV-2 IGRA is an enzyme-linked immunosorbent assay for quantitative detection of Interferon Gamma (IFN-γ) that responds to in-vitro stimulation by spike protein of SARS-CoV-2 in human whole blood. SARS-CoV-2 IGRA ELISA (Quantitative) - Download Brochure
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