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Sofia® SARS Antigen FIA Fluorescence Immunoassay for use with Sofia and Sofia 2 Instrument #20374

Sofia®

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Sofia® SARS Antigen FIA Fluorescence Immunoassay for use with Sofia and Sofia 2 Instrument #20374
  • Rapid results in 15 minutes to support efficient dispositioning of patients
  • Dual work modes adjust to your volume fluctuations and allow significant throughput and batching of samples in Read Now mode
  • Kit includes 25 individually packaged test cassettes; reagent tubes; ampules of reagent solution; sterile nasal swabs; 120-µl fixed volume pipettes; positive and negative control swabs; package insert; quick reference instructions; QC card
SKU:
1166253
For Use With:
For use with Sofia / Sofia 2 Instrument
QTY Per Sell:
1
Number of Tests:
25 Tests
Reading Type:
Machine Read
Sample Type:
Nasal Swab / Nasopharyngeal Swab Sample
Catalog Number:
20374
Analyte:
SARS‑CoV‑2 nucleocapsid protein
Time to Result:
15 minutes
Regulatory Information:
FDA EUA for use with Sofia and Sofia 2 instruments
Intended Use:
Qualitative detection of SARS‑CoV‑2 antigen; symptomatic ≤5 days; serial testing for asymptomatic use
Specimen Collection:
Nasal swab (anterior nares) — per package insert
Kit Contents:
  • 25 test cassettes
  • 25 reagent tubes & ampules
  • 25 sterile nasal swabs
    • Storage Instructions:
    Store as directed on label; follow package insert for shelf life and temps
    Shelf Life:
    See package insert/label for expiration date (manufacturer‑controlled)
    Clinical Applications:
    Point‑of‑care screening for acute SARS‑CoV‑2 infection
    Packaging Details:
    Kit: 25 tests per box; Case: 12 boxes
    Performance Note:
    Manufacturer reports PPA up to ~96.7% vs PCR in amended EUA data
    Manufacturer Links:
    Quidel/QuidelOrtho product & technical documents pages
    QC & Training:
    Includes QC card; training/certification resources available from manufacturer
    Codes and Identifiers:
    Quidel catalog 20374; distributor SKUs vary by vendor
    SKU:
    1166253
    For Use With:
    For use with Sofia / Sofia 2 Instrument
    QTY Per Sell:
    1
    Number of Tests:
    25 Tests
    Reading Type:
    Machine Read
    Sample Type:
    Nasal Swab / Nasopharyngeal Swab Sample
    ic__sync_id:
    4
    ic__id:
    7900
    Catalog Number:
    20374
    Analyte:
    SARS‑CoV‑2 nucleocapsid protein
    Time to Result:
    15 minutes
    Regulatory Information:
    FDA EUA for use with Sofia and Sofia 2 instruments
    Intended Use:
    Qualitative detection of SARS‑CoV‑2 antigen; symptomatic ≤5 days; serial testing for asymptomatic use
    Specimen Collection:
    Nasal swab (anterior nares) — per package insert
    Kit Contents:
  • 25 test cassettes
  • 25 reagent tubes & ampules
  • 25 sterile nasal swabs
    • Storage Instructions:
    Store as directed on label; follow package insert for shelf life and temps
    Shelf Life:
    See package insert/label for expiration date (manufacturer‑controlled)
    Clinical Applications:
    Point‑of‑care screening for acute SARS‑CoV‑2 infection
    Packaging Details:
    Kit: 25 tests per box; Case: 12 boxes
    Performance Note:
    Manufacturer reports PPA up to ~96.7% vs PCR in amended EUA data
    Manufacturer Links:
    Quidel/QuidelOrtho product & technical documents pages
    QC & Training:
    Includes QC card; training/certification resources available from manufacturer
    Codes and Identifiers:
    Quidel catalog 20374; distributor SKUs vary by vendor