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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.


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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

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