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Abnova/COVID-19 Viral Antigen Rapid Test (CE IVD)/1kit/DC0302
  • Abnova/COVID-19 Viral Antigen Rapid Test (CE IVD)/1kit/DC0302

Abnova/COVID-19 Viral Antigen Rapid Test (CE IVD)/1kit/DC0302

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货号: DC0302
品牌: Abnova
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      • Specification
      • Specification
      • Product Description:
      • COVID-19 Viral Antigen Rapid Test provides a fast, convenient, and qualitative testing of SARS nucleocapsid antigens from nasal swabs in individuals who are suspected of COVID-19 (SARS-CoV-2) within first 12 days of symptom onset.
      • Supplied Product:
      • 25 Test Kit:COVID-19 Antigen Testing Strips (25) - Colloidal gold-labeled COVID-19 nucleocapsid murine monoclonal antibody  - COVID-19 nucleocapsid human monoclonal antibody  - Goat anti-murine polyclonal antibody Extraction Buffers (25) - Extraction reagentDroppers (25) - 100 uL Dropper for drawing sample mixturePositive Control Swab (1) - Non-infectious, recombinant viral nucleocapsid protein with less than 0.1% sodium azideNegative Control Swab (1) - Buffer with less than 0.1% sodium azideAssay Documentation (1) - Instructions for Use
      • Storage Instruction:
      • Store product at 15°C-30°C (59°F-86°F) and avoid direct exposure to sunlight.Do not freeze or store the product outside the temperature range described above.Do not open until ready to use.Do not use it after the expiration date.
      • Note:
      • Product Image
      • Fresh Specimen Sampling Procedure and Test
      • Suitable Sample:
      • Nasal Swab Specimen
      • Features:
      • Fast result in 15 minutesEasy to operateHighly sensitive via visual inspection
      • Material RequiredBut Not Provided:
      • Nasal specimen sampling swabs  - FLOQSwabs®, Cat# 519C501, COPAN ITALIA SpA  - Swabs, Cat# 0410, Labospace ITALIATube rack for specimensTimer or watchPersonal protective equipments
      • Intended Use:
      • This product is a chromatographic immunoassay for the rapid and qualitative detection of SARS nucleocapsid antigens from nasal swabs in individuals who are suspected of COVID-19 within first 12 days of symptom onset.
      • Regulatory Status:
      • GMP gradeCE-IVD approved
      • Adverse Events:
      • Reporting adverse events
      • InstructionsFor Use:
      • PDF DownloadInstructions For Use (English)PDF DownloadInstructions For Use (German)PDF DownloadInstructions For Use (Japanese)
      • Flyer:
      • Download flyer
      • Datasheet:
      • PDF DownloadDownload
      • Video:
      • Applications
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • Result Zone of the COVID-19 Antigen Testing Strip indicates Test line (T line) Control line (C line). C line must appear to ensure the quality of sample processing.Note: Report all positive results to the appropriate public health authorities. For invalid results, review the procedure and repeat the procedure with a new test. If the problem persists, discontinue using the test kit and contact local distributors and Abnova.
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • PPA: 100% (C.I. 84%-100%) NPA: 95% (C.I. 87%-98%) OPA: 96% (C.I. 90%-99%)81 direct nasal swabs were prospectively collected and enrolled from individual symptomatic patients (within12 days of onset) who were suspected of COVID-19. The performance of the Abnova COVID-19 Viral Antigen Rapid Test wascomparedtoresults of a nasopharyngeal swab testedwith an Emergency Use Authorized molecular (RT-PCR) test for detection of SARS-CoV-2.
      • Application Image
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • enlarge
      • Lateral Flow Immunoassay
      • Lateral Flow Immunoassay
      • enlarge
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