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 — More product information about the CLINITEST Rapid COVID-19 Antigen Test is available for download

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CLINITEST® Rapid COVID-19 Antigen Test

Scalable COVID-19 antigen testing in minutes for any setting

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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.

CLINITEST Rapid COVID-19 Antigen Test​ Clinical Performance​