EINFACHE CORONA-TEST

POTENTIELLE EIGENTESTS
SCHNELL & SICHER DURCH ANTIGEN-ERFASSUNG



English Introduction GO》




COVID-19 Antigen Test Kit (Lateral Chromatography)
■ INTENDED USE
COVID-19 Antigen Test Kit (Lateral Chromatography) is an immunochromatographic assay for rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by 
their healthcare provider. Testing is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating 
under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for the identification of SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of 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. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results should be treated as presumptive, 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 considered in the context of a patient’ s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.
COVID-19 Antigen Test Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.
■ SUMMARY AND EXPLANATION
The novel coronaviruses belong to the 3 genus. COVID-19 is an acute respiratory infectious disease. People are generally 
susceptible. Currently, the patients infected by the novel coronavirus (SARS-CoV-2) are the main source of infection; 
asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
COVID-19 Antigen Test Kit (Lateral Chromatography) is for the direct detection of the presence or absence SARS-CoV-2 
antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of CO VD-19. The test is to be interpreted visually by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.
■ PRINCIPLE
COVID-19 Antigen Test Kit (Lateral Chromatography) is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19. When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies labeled by colloidal gold in the test strip. The antigen-antibody complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane.
A positive result is determined when antigen-antibody complexes are deposited at the Test "T" position and the Control "C" position on the assay device to forming colored lines.
A negative result is determined when only Control "C" position to form a colored line, but no visible colored line appears on Test "T" position.
For quality control to ensure the validity of the test result, a colored line should always appear on Control "C" position, no matter whether the result for Test "T" position is showing positive or negative. If there is no visible line at Control "C" position, the test kit result is invalid, and a new test must be performed.
Der Corona-Schnelltest NASOCHECKcomfort zeichnet sich besonders durch seine einfache und sichere Anwendung aus. Ein kurzer steriler Tupfer wird lediglich 2 cm tief in beiden Nasenlöchern gerollt, in die Testkarte gesteckt und anschließend werden 6 Tropfen der Testflüssigkeit darauf gegeben. Nach nur 15 Minuten zeigt der Test über Farbstreifen ein positives oder negatives Ergebnis an.
Auch aufgrund dieser einfachen Durchführung setzt bereits die österreichische Regierung bei umfangreichen, wöchentlichen Selbsttests bei Millionen von Schülern auf dieses Produkt: https://www.bmbwf.gv.at/Themen/schule/beratung/corona/selbsttest.html

COVID-19 Antigen Test Kit (Lateral Chromatography)■ INTENDED USECOVID-19 Antigen Test Kit (Lateral Chromatography) is an immunochromatographic assay for rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for the identification of SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of 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. Positive results do not rule out bacterial infection or co-infection with other viruses.Negative results should be treated as presumptive, 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 considered in the context of a patient’ s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.COVID-19 Antigen Test Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.■ SUMMARY AND EXPLANATIONThe novel coronaviruses belong to the 3 genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus (SARS-CoV-2) are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.COVID-19 Antigen Test Kit (Lateral Chromatography) is for the direct detection of the presence or absence SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of CO VD-19. The test is to be interpreted visually by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.■ PRINCIPLECOVID-19 Antigen Test Kit (Lateral Chromatography) is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19. When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies labeled by colloidal gold in the test strip. The antigen-antibody complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane.A positive result is determined when antigen-antibody complexes are deposited at the Test "T" position and the Control "C" position on the assay device to forming colored lines.A negative result is determined when only Control "C" position to form a colored line, but no visible colored line appears on Test "T" position.For quality control to ensure the validity of the test result, a colored line should always appear on Control "C" position, no matter whether the result for Test "T" position is showing positive or negative. If there is no visible line at Control "C" position, the test kit result is invalid, and a new test must be performed.

E igenschaften

Herstellerzertifizierung

TÜV E N 13485:2016

 

Art der Probe

Abstrich vorderer

Nasenbereich

(anterior nasal)

Auswertungsdauer

15 Min.

Klinische Sensitivität

92,00%

Klinische Spezifität

99,26%

CI 95% Sensitivität

83,63%-96,28%

CI 95% Spezifität

95,92%-99,87%

VPE

1 Stk. oder 25 Stk.


COVID-19 Antigen Test Kit (Lateral Chromatography)■ INTENDED USECOVID-19 Antigen Test Kit (Lateral Chromatography) is an immunochromatographic assay for rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for the identification of SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of 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. Positive results do not rule out bacterial infection or co-infection with other viruses.Negative results should be treated as presumptive, 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 considered in the context of a patient’ s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.COVID-19 Antigen Test Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.■ SUMMARY AND EXPLANATIONThe novel coronaviruses belong to the 3 genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus (SARS-CoV-2) are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.COVID-19 Antigen Test Kit (Lateral Chromatography) is for the direct detection of the presence or absence SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of CO VD-19. The test is to be interpreted visually by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.■ PRINCIPLECOVID-19 Antigen Test Kit (Lateral Chromatography) is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19. When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies labeled by colloidal gold in the test strip. The antigen-antibody complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane.A positive result is determined when antigen-antibody complexes are deposited at the Test "T" position and the Control "C" position on the assay device to forming colored lines.A negative result is determined when only Control "C" position to form a colored line, but no visible colored line appears on Test "T" position.For quality control to ensure the validity of the test result, a colored line should always appear on Control "C" position, no matter whether the result for Test "T" position is showing positive or negative. If there is no visible line at Control "C" position, the test kit result is invalid, and a new test must be performed.

COVID-19 Antigen Test Kit (Lateral Chromatography)■ INTENDED USECOVID-19 Antigen Test Kit (Lateral Chromatography) is an immunochromatographic assay for rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for the identification of SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of 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. Positive results do not rule out bacterial infection or co-infection with other viruses.Negative results should be treated as presumptive, 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 considered in the context of a patient’ s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.COVID-19 Antigen Test Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.■ SUMMARY AND EXPLANATIONThe novel coronaviruses belong to the 3 genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus (SARS-CoV-2) are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.COVID-19 Antigen Test Kit (Lateral Chromatography) is for the direct detection of the presence or absence SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of CO VD-19. The test is to be interpreted visually by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.■ PRINCIPLECOVID-19 Antigen Test Kit (Lateral Chromatography) is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19. When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies labeled by colloidal gold in the test strip. The antigen-antibody complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane.A positive result is determined when antigen-antibody complexes are deposited at the Test "T" position and the Control "C" position on the assay device to forming colored lines.A negative result is determined when only Control "C" position to form a colored line, but no visible colored line appears on Test "T" position.For quality control to ensure the validity of the test result, a colored line should always appear on Control "C" position, no matter whether the result for Test "T" position is showing positive or negative. If there is no visible line at Control "C" position, the test kit result is invalid, and a new test must be performed.
COVID-19 Antigen Test Kit (Lateral Chromatography)■ INTENDED USECOVID-19 Antigen Test Kit (Lateral Chromatography) is an immunochromatographic assay for rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for the identification of SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of 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. Positive results do not rule out bacterial infection or co-infection with other viruses.Negative results should be treated as presumptive, 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 considered in the context of a patient’ s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.COVID-19 Antigen Test Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.■ SUMMARY AND EXPLANATIONThe novel coronaviruses belong to the 3 genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus (SARS-CoV-2) are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.COVID-19 Antigen Test Kit (Lateral Chromatography) is for the direct detection of the presence or absence SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of CO VD-19. The test is to be interpreted visually by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.■ PRINCIPLECOVID-19 Antigen Test Kit (Lateral Chromatography) is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19. When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies labeled by colloidal gold in the test strip. The antigen-antibody complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane.A positive result is determined when antigen-antibody complexes are deposited at the Test "T" position and the Control "C" position on the assay device to forming colored lines.A negative result is determined when only Control "C" position to form a colored line, but no visible colored line appears on Test "T" position.For quality control to ensure the validity of the test result, a colored line should always appear on Control "C" position, no matter whether the result for Test "T" position is showing positive or negative. If there is no visible line at Control "C" position, the test kit result is invalid, and a new test must be performed.


COVID-19 Antigen Test Kit (Lateral Chromatography)■ INTENDED USECOVID-19 Antigen Test Kit (Lateral Chromatography) is an immunochromatographic assay for rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for the identification of SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of 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. Positive results do not rule out bacterial infection or co-infection with other viruses.Negative results should be treated as presumptive, 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 considered in the context of a patient’ s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.COVID-19 Antigen Test Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.■ SUMMARY AND EXPLANATIONThe novel coronaviruses belong to the 3 genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus (SARS-CoV-2) are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.COVID-19 Antigen Test Kit (Lateral Chromatography) is for the direct detection of the presence or absence SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of CO VD-19. The test is to be interpreted visually by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.■ PRINCIPLECOVID-19 Antigen Test Kit (Lateral Chromatography) is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19. When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies labeled by colloidal gold in the test strip. The antigen-antibody complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane.A positive result is determined when antigen-antibody complexes are deposited at the Test "T" position and the Control "C" position on the assay device to forming colored lines.A negative result is determined when only Control "C" position to form a colored line, but no visible colored line appears on Test "T" position.For quality control to ensure the validity of the test result, a colored line should always appear on Control "C" position, no matter whether the result for Test "T" position is showing positive or negative. If there is no visible line at Control "C" position, the test kit result is invalid, and a new test must be performed.


English Introduction GO》