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Rapid test for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human whole blood, serum or plasma specimens. For professional in-vitro diagnostic use only
COVID-19 serological tests allow to identify the presence of antibodies (IgG and/or IgM targeting the Nucleocapsid protein) produced by the immune system in response to SARS-CoV-2 virus and to take precautionary measures, waiting for a molecular test.
read moreRecent studies have shown that in people infected with the virus, IgM and/or IgG antibodies appear within 19 days after the onset of symptoms (in 60% of cases within the first week and in 90% within the second week) and, while IgM levels decrease at the end of the infection, those of IgG remain high and therefore detectable.
Easy to use
Results in 10 minutes
COVID-19 emergency support
Track any asymptomatic subjects
Seroprevalence detection
Serological tests are a fundamental tool for both controlling asymptomatic individuals, possibly exposed to the virus in the last two weeks, and for seroprevalence investigations.
read moreIn the first case, these tests can be considered tools to support molecular tests, as they would allow to know the prevalence of the virus in a specific place, letting to adopt isolation measures and thus reducing any asymptomatic spread. The seroprevalence studies, on the other hand, are surveys in which a representative sample of the population is subjected to the test in question. Thanks to these analyzes it is possible to know the real lethality of the disease, the geographical spread and the spread within the different age groups.
COVID-19 IgG/IgM RAPID TEST is a lateral flow immunochromatographic device for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human whole blood, serum or plasma samples. This test consists of two components, an IgG component and an IgM component. During testing, the sample reacts with SARS-CoV-2 antigen coated particles in the test cassette.
| Test format | rapid immunochromatographic lateral-flow assay |
| Results reading time | 10 minutes |
| Sample | whole blood, serum and plasma |
| Antigen | Nucleocapsid |
| Specificity | 97.8% |
| Sensitivity | 95.7% |
| Accuracy | 97.3% |
| Negative | anti-Nucleocapsid IgG and IgM levels are not present in the sample or they are present in very low concentrations, which are not detectable by the device. |
| Positive | IgG and/or IgM antibodies have been detected in the blood sample. |
1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011; 81:85-164. PMID:22094080 DOI: 10.1016/B978-0-12-385885-6.00009-2
2. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016; 24:490-502. PMID:27012512 DOI:10.1016/j.tim.2016.03.003
3. Valenti L et al. SARS-CoV-2 seroprevalence trends in healthy blood donors during the COVID-19 Milan outbreak”. Submitted to Eurosurveillance, 2020, medRxiv preprint doi: https://doi.org/10.1101/2020.05.11.20098442
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).
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