Microbiologics has introduced a SARS-CoV-2 quality control product for use with antigen point-of-care Covid-19 diagnostics. The inactivated Whole Virus Antigen Control can act as a non-viable, external, positive control to assess the assay’s performance, lowering the risk of false-negative or false-positive results. The product consists of wholly intact genomic and viral proteins, allowing its use with antigen tests as well as nucleic acid amplification tests.
Beroni Group has reported that its SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) showed an overall sensitivity of 95% and 100% specificity in a new clinical study, which involved 70 subjects with 105 true-positive samples and true-negative samples each. With nasal specimens, the test kit demonstrated 92% sensitivity, while nasopharyngeal and oropharyngeal sampling led to a sensitivity of 97% and 95%, respectively. Specificity was 100% with all sampling methods.
Consumer genetic testing firm DnaNudge has raised $60m in a Series A investment round to fast-track the global rollout of its CovidNudge RT-PCR Covid-19 test that can be performed outside of a laboratory. The portable, point-of-care test provides results in just over an hour. The test will be supplied through wholesale agreements with healthcare companies and medical groups. DnaNudge intends to primarily offer the test in the US, Japan, Europe and additional major territories.