in vitro diagnostic devices

the eternal covidual covid-19 igm/igg rapid test is a lateral flow immunoassay intended for the qualitative detection and differentiation of igm and igg antibodies to sars-cov-2 in fingerstick whole blood, venous whole blood, serum, or plasma (containing sodium heparin, sodium citrate, or edta) specimens from patients suspected of sars-cov-2 infection by a healthcare provider. the covidual covid-19 igm/igg rapid test is an aid in the diagnosis of patients with suspected sars-cov-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
the eternal covidual covid-19 igm/igg rapid test, which has a specificity greater than 93.9% and sensitivity of 99.4% (>14 days form symptom onset to blood collection), can contribute to evaluate patients’ immune response to the virus. the combined accuracy of 98.9% of this product can provide reliable test result if a person has been exposed to the virus and developed antibodies.

covidual covid-19 igm/igg rapid test

item name characteristics applications data sheets pdf
ncov-019-mm060300 for the qualitative detection and differentiation of igm and igg antibodies to sars-cov-2 in blood serology test