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Abnova/COVID-19 Human IgM IgG Rapid Test/1kit/DC0301
  • Abnova/COVID-19 Human IgM IgG Rapid Test/1kit/DC0301

Abnova/COVID-19 Human IgM IgG Rapid Test/1kit/DC0301

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貨號: DC0301
品牌: Abnova
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      • Specification
      • Specification
      • Product Description:
      • COVID-19 Human IgM IgG Rapid Test provides a fast, convenient, and qualitative testing of human whole blood, serum and plasma for COVID-19 (SARS-CoV-2) IgM and IgG.
      • Supplied Product:
      • 20 Test Kit:Testing Strips (20)a. Colloidal Gold-Labeled COVID-19 Nucleocapsid (N) Proteinb. Colloidal Gold-Labeled COVID-19 Receptor-Binding Domain (RBD) Proteinc. Colloidal Gold-Labeled Chicken IgY Antibody with less than 0.1% Sodium Azided. Goat Anti-Human IgM Antibodye. Goat Anti-Human IgG Antibodyf. Goat Anti-Chicken IgY Antibody with less than 0.1% Sodium AzideSample Buffers (20)
      • Storage Instruction:
      • Store product at 15-30°C and avoid direct exposure to sunlight.Do not open until ready to use.Do not freeze or store the product outside the temperature range described above.Do not use after the expiration date.
      • Note:
      • Product Image
      • Venous Whole Blood, Serum and Plasma Test ProcedureFinger Prick Whole Blood Test Procedure
      • Suitable Sample:
      • Human Venous Whole Blood (dipotassium EDTA, sodium heparin, sodium citrate), Serum, Plasma (dipotassium EDTA, sodium heparin, sodium citrate), and Finger Prick Whole Blood (dipotassium EDTA, tripotassium EDTA, no anticogulant)
      • Features:
      • Fast result in 15 minutesEasy to operateHighly sensitive via visual inspection
      • Intended Use:
      • This product is a lateral flow chromatographic immunoassay for rapid, qualitative detection of human IgM and IgG antibodies against COVID-19 virus in human venous whole blood (dipotassium EDTA, sodium heparin, sodium citrate), serum, plasma (dipotassium EDTA, sodium heparin, sodium citrate), and finger prick whole blood (dipotassium EDTA, tripotassium EDTA, no anticogulant).
      • Regulatory Status:
      • GMP gradeCE-IVD approved
      • Factsheets:
      • PDF DownloadFact Sheet for Healthcare ProvidersPDF DownloadFact Sheet for Patients
      • Adverse Events:
      • Reporting adverse events
      • Notification:
      • Clinical laboratories must include this information in their patient test report as specified in FDA guidance:This test has not been reviewed by the FDA.Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
      • COA:
      • PDF DownloadCOA Download
      • InstructionsFor Use:
      • PDF DownloadInstructions For Use (CE-IVD)PDF DownloadInstructions For Use (CE-IVD)(German)PDF DownloadInstructions For Use (pre-EUA)PDF DownloadInstructions For Use (Japanese)
      • Datasheet:
      • PDF DownloadDownload
      • Video:
      • Applications
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • Result zone of the COVID-19 Testing Strip indicates human IgM line (M line), IgG line (G line) and control line (C line). C line must appear to ensure the quality of sample processing. Please refer to the diagram below for interpretation.
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • 31 known COVID-19 positive and 75 known negative EDTA whole blood samples were collected, confirmed with EUA authorized RT-PCR, and tested for COVID-19 IgM and IgG reactivity following symptom onset with results read by two blinded, independent viewers.
      • Application Image
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • enlarge
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • enlarge
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