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CLINITEST Rapid COVID-19 Antigen Test​ Clinical Performance​

Nasal Swab Performance

Method

PCR
(Nasopharyngeal Swab)

Total
Results

CLINITEST® Rapid COVID-19 Antigen Test​ Clinical
(Nasal Swab)

Result

Positive

Negative

Total

Positive

106

3

109

Negative

0

128

128

  

106

131

237

Relative Sensitivity: 97.25% (95% Cl* : 92.17% to 99.43%)

Relative Specificity: 100% (95% Cl* : 97.16% to 100%)

Accuracy: 98.73% (95% Cl* : 96.35% to 99.74%)

*Confidence intervals

Nasopharyngeal Swab Performance

Method

PCR
(Nasopharyngeal Swab)

Total
Results

CLINITEST® Rapid COVID-19 Antigen Test​ Clinical
(Nasopharyngeal Swab)

Result

Positive

Negative

Total

Positive

117

2

119

Negative

3

743

746

  

120

745

865

Relative Sensitivity: 98.32% (95% Cl* : 94.06% to 99.80%)

Relative Specificity: 99.60% (95% Cl* : 98.83% to 99.92%)

Accuracy: 99.42% (95% Cl* : 98.66% to 99.81%)

*Confidence intervals

Page one of the product information document, showing a masked man protected from covid-19 particles, the test cassette, and information about the test

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Product is under FDA review for Emergency Use Authorization (EUA) and not available for sale in the U.S. Product availability may vary by country. Distributed by Siemens Healthineers.