EZER™ COVID-19 Antigen Rapid Test Device CE
€0.00
In stock
SKU
P211134
INTENDED USE
The EZER™ COVID-19 Antigen Rapid Test Device is an in vitro diagnostic test based on the principle of immunochromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swab or nasopharyngeal swab. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of 2019 Novel Coronavirus. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Patients with negative result should be treated as presumptive. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be confirmed with a molecular assay, if necessary, for patient management.
SPECIMEN: Nasal Swabbing, Nasopharyngeal Swabbing
TIME TO RESULTS
Allow the samples to react according to the procedure and read the lines that appear in the reading area. Read results at 15 minutes and no more than 30 minutes.
STORAGE CONDITIONS
Test devices must be stored at 2~30°C. DO NOT FREEZE. Devices must be at ambient room temperature at time of testing.
CONTENTS
- Test device
- Sterilized swab
- Extraction tube (with 0.5mL extraction buffer)
- Nozzle
- Tube Stand
- Package insert
The EZER™ COVID-19 Antigen Rapid Test Device is an in vitro diagnostic test based on the principle of immunochromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swab or nasopharyngeal swab. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of 2019 Novel Coronavirus. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Patients with negative result should be treated as presumptive. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be confirmed with a molecular assay, if necessary, for patient management.
SPECIMEN: Nasal Swabbing, Nasopharyngeal Swabbing
TIME TO RESULTS
Allow the samples to react according to the procedure and read the lines that appear in the reading area. Read results at 15 minutes and no more than 30 minutes.
STORAGE CONDITIONS
Test devices must be stored at 2~30°C. DO NOT FREEZE. Devices must be at ambient room temperature at time of testing.
CONTENTS
- Test device
- Sterilized swab
- Extraction tube (with 0.5mL extraction buffer)
- Nozzle
- Tube Stand
- Package insert
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