SIZE
50 tests/box
INTENDED USE
SARS-CoV-2 IgM/IgG detection kit is a lateral flow immunoassay which uses europium (III) nanoparticles as the fluorescent marker for the detection and qualitative measurement of IgM and IgG antibodies against the nucleocapsid protein (NP) of SARS-CoV-2 virus in human blood.
The kit is only used as a supplementary test indicator for suspected cases with negative nucleic acid test results of SARS-CoV-2 virus, or used in conjugation with the nucleic acid test in diagnosis of suspected cases of coronavirus disease 19 (COVID-19). It cannot be used as a basis for diagnosis and exclusion of COVID-19, and it is not suitable for screening of general population.
The product is only applicable to medical institutions, and intended for use by professional person.
A positive test result requires further confirmation, and a negative test result cannot rule out the possibility of infection of SARS-CoV-2 virus.
The product is limited to clinical use and emergency storage during the COVID-19 outbreak and cannot be used as a routine in vitro diagnostic reagent for clinical use. The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis based on the clinical manifestations of patients and other laboratory tests.
Laboratory testing of SARS-CoV-2 virus shall be carried out in accordance with local requirements for biosafety.
SUMMARY
The novel coronaviruses belong to the β genus, now officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which caused the outbreak of a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19). COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus 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.
Nucleocapsid protein (NP) is the most abundant protein on the helical nucleocapsid of coronaviruses, which envelopes the entire genomic RNA. NP also interacts with other viral structural proteins to play important roles during host cell entry and virus particle assembly and release. Anti-NP antibodies have been shown to be the earliest and the most predominant antibodies detectable in patient’s blood samples after coronavirus infection.
SIZE
50 tests/box
INTENDED USE
SARS-CoV-2 IgM/IgG detection kit is a lateral flow immunoassay which uses europium (III) nanoparticles as the fluorescent marker for the detection and qualitative measurement of IgM and IgG antibodies against the nucleocapsid protein (NP) of SARS-CoV-2 virus in human blood.
The kit is only used as a supplementary test indicator for suspected cases with negative nucleic acid test results of SARS-CoV-2 virus, or used in conjugation with the nucleic acid test in diagnosis of suspected cases of coronavirus disease 19 (COVID-19). It cannot be used as a basis for diagnosis and exclusion of COVID-19, and it is not suitable for screening of general population.
The product is only applicable to medical institutions, and intended for use by professional person.
A positive test result requires further confirmation, and a negative test result cannot rule out the possibility of infection of SARS-CoV-2 virus.
The product is limited to clinical use and emergency storage during the COVID-19 outbreak and cannot be used as a routine in vitro diagnostic reagent for clinical use. The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis based on the clinical manifestations of patients and other laboratory tests.
Laboratory testing of SARS-CoV-2 virus shall be carried out in accordance with local requirements for biosafety.
SUMMARY
The novel coronaviruses belong to the β genus, now officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which caused the outbreak of a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19). COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus 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.
Nucleocapsid protein (NP) is the most abundant protein on the helical nucleocapsid of coronaviruses, which envelopes the entire genomic RNA. NP also interacts with other viral structural proteins to play important roles during host cell entry and virus particle assembly and release. Anti-NP antibodies have been shown to be the earliest and the most predominant antibodies detectable in patient’s blood samples after coronavirus infection.
