In response to the worldwide pandemic due to the SARS-CoV-2 virus, Promoitalia Group Spa, with its Italian manufacturing , has undertaken to manufacture and distribute, as an aid in the diagnosis of infection from the Novel Coronavirus, a SARS-CoV-2 Rapid Antibody Test. This test is designed for the qualitative detection of antibodies produced by the immune system in response to the Covid-19 virus in human whole blood/serum/ plasma.
This rapid antibody test (IGM/IGG) is intended an in vitro diagnostic assay for professional use. It only requires a finger prick drop of blood and 15 minutes for results. In a clinical study, this test has been demonstrated to have Sensitivity (Positive Coincidence Rate) of 98,9% and Specificity (Negative Coincidence Rate) of 97.6% and Repeatability and Accuracy of ≥ 90%. The results obtained from this test are intended to be an aid in diagnosis only.Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.
A negative test result indicates that antibodies to Novel Coronavirus are either not present or at levels undetectable by the test.
The test is for professional in vitro diagnostic use only and is not intended for home-use. The tests contained in the box are not to be sold individually