CE-marked Sensitivity: 93.10% Specificity: 100% Specimen type: nasopharyngeal swabs

CE –marked ﹒BfArM Test-ID: AT981/21 ﹒Specimen: Nasopharyngeal/nasal specimen ﹒Sensitivity(NP): 96.3% ﹒Specificity(NP): 100% ﹒Sensitivity(N): 95.5% ﹒Specificity(N): 99.6%

﹒Sensitivity: 95.5% ﹒Specificity: 99.6% ﹒Specimen: Nasal specimen ﹒ISO13485

New coronavirus Antigen test is used for the qualitative detection of novel coronavirus (COVD-19) antigen in human throat swab and nasal swab samples.

The SARS-CoV-2 Antigen Rapid Qualitative Test is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasal swabs, throat swabs, and sputum from individuals who are suspected of COVID-19 by their healthcare provider. within the first five days of the onset of symptoms.

Helicobacter Pylori (H. Pylori)Antigen Test Kit is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in serum or plasma as an aid in the diagnosis of H. pylori infection.

Sensitivity: 100% Specificity: 99.70% ISO 13485

CE-marked Sensitivity: The Rapid Troponin l Test can detect cTnl in whole blood, serum or plasma with concentration of 0.5ng/ml or greater.

CE-marked Sensitivity: 94.4% Specificity: 98% ISO:13485

1 test/Rapid Antigen Test Kit (Sandwich Saliva version)

The Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test is intended to qualify the SARS-CoV-2 IgG and IgM antibody in human plasma, serum or whole blood by colloidal gold immunochromatography assay. The test can be used as an aid detection to SARS-CoV-2 infection and thus caused COVID-19 disease.

CE-marked Sensitivity: 99.6% Specificity: 99.7%

Positive coincidence rate: 95.4% Negative coincidence rate: 98.7% Total coincidence rate: 98.2%

Positive coincidence rate: 95.0% Negative coincidence rate: 99.3% Total coincidence rate: 98.6%

WHO Pre-qualified CE-marked Sensitivity: 99.7% Specificity: 99.8%

Positive coincidence rate: 95.9% Negative coincidence rate: 98.8% Total coincidence rate: 98.3%

CE-marked Sensitivity of Flu A: 93.10% Specificity of Flu A: 97.30% Sensitivity of Flu B: 93.28% Specificity of Flu B: 97.76%

Sensitivity＞99.0% Specificity＞98.5% ISO 13485