COVID-19 Trace™ IgG MICRO-ELISA Kit
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Product DetailsDescription The COVID-19 TraceTM IgG MICRO-ELISA assay is designed to detect immunoglobulin class G (IgG) antibodies to the receptor binding domain (RBD) protein antigen of SARS-CoV-2 in serum and plasma from individuals who are suspected to have had coronavirus disease (COVID-19), or in serum or plasma from subjects infected by the virus SARS-CoV-2 but may be asymptomatic at the time of the test. Leinco's SARS-CoV-2 MICRO-ELISA assay has completed Section IV.D notification process under FDA’s “Policy for Coronavirus Disease – 2019 Test During the Public Health Emergency (Revised)“ and has not been reviewed by FDA. Please refer to product-specific insert for a complete description of COVID-19 TraceTM IgG MICRO ELISA Kit Materials Provided Refer to product-specific inserts for a complete list of contents for assay.
Storage Conditions Unopened: This test kit must be stored at 2 – 8°C upon receipt. For the expiration date of the kit refer to the label on the kit box. All components are stable until this expiration date. Opened: Once opened, the kit reagents are stable when stored at 2 – 8°C. Refer to label on the kit box for expiration date. Indication of Instability or Deterioration: Deterioration of kit reagents may be indicated when a quality control value is out of the specified range. Associated test results are invalid, and samples must be retested with a new kit where the control values are within the specified ranges. Recombinant Standards Recombinant IgG Monoclonal Antibodies to SARS-CoV-2 RBD Assay Procedure The test procedure must be followed as written. Any deviations from this procedure may produce erroneous results.
Refer to product-specific inserts for a complete step-by-step procedure.
CAUTION: Do not stack plates on top of each other. They should be spread out as a single layer for even temperature distribution. CAUTION: Do not stack plates on top of each other. They should be spread out as a single layer for even temperature distribution. CAUTION: The plate should be read at 20 minute +/- 1 minute. If not read within this time period, results may not be accurate. The test must be repeated. BackgroundChinese authorities identified an outbreak caused by a novel—or new—coronavirus termed SARS-CoV-2. The virus can cause mild to severe respiratory illness; known as Coronavirus Disease 2019 (COVID-19) formerly called 2019-nCoV.1 SARS-CoV-2 is different from six other previously identified human coronaviruses, including those that have caused previous outbreaks of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). The SARS-CoV-2 Spike (S) Protein consists of the S1 and S2 domains.2 The S1 domain contains the receptor-binding domain (RBD) that can specifically bind to angiotensin-converting enzyme 2 (ACE2) receptors on target cells.2 The SARS-CoV-2 nucleocapsid (N) protein plays a role in transcription, replication, and packaging of the viral RNA genome, while also affecting host cell responses such as cell cycle and translation.3 SARS-CoV-2 is closely related to the SARS virus, which was first identified in 2002-2003.3 In-depth analysis has identified the SARS-CoV-2 RBD as being essential for ACE2 binding.3 Both SARS-CoV and SARS-CoV-2 utilize the ACE2 cellular receptor to gain entry into cells, with SARS-CoV-2 binding with higher affinity.4 Vaccine and therapeutic development are targeting portions of the spike protein, including the RBD portion.5 References & Citations1.) van Dorp L. et al. (2020)Infec Genet Evol 83:104351. Doi:10.1016/j.meegid.2020.104351 2.) Hoffmann et al. (2020) Cell 181: 271–280 3.) Kang, S. et al. (2020) Acta Pharm Sin B. Apr 20. doi: 10.1016/j.apsb.2020.04.009 4.) Wrappet et al. (2020) Science: 2020. 5.) Tai et al. (2020) Cellular & Molecular Immunology 17: 613 – 620. 6.) Gilchuk, P. et al. (2022) ISCIENCE 103602 Journal Link |
Products are for research use only. Not for use in diagnostic or therapeutic procedures.