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      2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma)

      Short Description:

      The 2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma)?is a rapid

      chromatographic immunoassay for the qualitative detection of IgG & IgM antibody of

      Coronavirus Disease 2019 in human whole blood, serum, or plasma as an aid in the diagnosis of

      COVID-19 infections.


      Product Detail

      FAQ

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      Sensitivity and Specificity

      For IgG testing:

      Method RT-PCR Total Results
      2019-nCOV IgG/IgM Rapid Test Device?(Whole blood/Serum/Plasma) Results Positive Negative
      Positive 233 2 235
      Negative 25 287 312
      Total Results 258 289 547

      Relative Sensitivity:233/258=90.31%(95%CI*:86.04%-93.40%)

      Relative Specificity:287/289=99.31% (95%CI*:97.34%-99.98%)

      Accuracy:520/547=95.06% (95%CI*: 92.89%-96.61%)

      *Confidence Interval

      For IgM testing

      Method RT-PCR Total Results
      2019-nCOV IgG/IgM Rapid Test Device?(Whole blood/Serum/Plasma) Results Positive Negative
      Positive 223 7 230
      Negative 35 282 317
      Total Results 258 289 547

      Relative Sensitivity:223/258=86.43% (95%CI*:81.68%-90.11%)

      Relative Specificity:282/289=97.58% (95%CI*: 94.99%-98.92%)

      Accuracy:505/547=92.32% (95%CI*: 89.76%-94.29%)

      *Confidence Interval

      DIRECTIONS FOR USE

      safd

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