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SUGENTECH, INC.

SGTi-flex COVID-19 IgG Antibody Test

  • 10 min for result

  • Test Cassette x 25

  • Sample Buffer Tube 1 (4.5mL/tube)

  • SGTi-flex COVID-19 IgG has no cross-reactivity with samples containing antibodies to other viruses, bacteria as well as autoantibodies

  • Clinical Performance Analysis: Sensitivity (Positive percent agreement): 92.43%
    (171/185, 95% CI: 87.70%~95.44%)

  • Clinical Performance Analysis: Specificity (Negative percent agreement): 99.15%
    (232/234, 95% CI: 96.94%~99.77%)

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FDA INSTRUCTIONS & DOCUMENTS

SGTI-FLEX IFU

SGTI-FLEX FACT SHEET FOR HEALTHCARE PROVIDERS

SGTI-FLEX FACT SHEET FOR PATIENTS

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