BIOHIT Healthcare is now distributing test kits for the diagnosis of current and past SARS-CoV-2 infections to help in the fight against coronavirus in the UK. The new product line includes the MutaPLEX Coronavirus kit from Immundiagnostik (IDK) – a real-time RT-PCR assay to screen for infected individuals – and Epitope Diagnostics (EDI) immunodiagnostic tests for IgM and IgG SARS-CoV-2 antibodies, to detect past infections.
The IDK MutaPLEX coronavirus screening assay allows the detection of SARS-CoV-2 viral RNA in a variety of biological specimens, especially nasal/throat swabs. This real-time RT-PCR kit contains all the reagents, primers and dual-labelled probes required for the amplification and simultaneous differentiation of RNA from SARS-CoV-2 and other betacoronaviruses, as well as house-keeping genes designed to prevent false-negative results due to insufficient sample collection or transport problems.
The EDI enzyme-linked immunosorbent assay (ELISA) kits provide qualitative detection of antibodies in patient serum, indicating a past SARS-CoV-2 infection. The IgM assay provides the earliest immunodiagnostic indication of an infection, while the IgG test can be used to aid detection and provide an indication of long-term immunological response, making it particularly useful in cases where clustering is suspected or differential diagnosis is required.
These tests extend and complement BIOHIT's repertoire of diagnostic kits for gastroenterology, aiding the evaluation of patients with both gastrointestinal (GI) and upper respiratory complaints, as COVID-19 may include GI symptoms in some cases. Inflammatory bowel disease patients being treated with immunosuppressive agents should also be considered at high risk for COVID-19, making differential diagnosis essential.
Graham Johnson (Managing Director, BIOHIT Healthcare) commented: "Access to diagnostic testing is vital to coordinate an effective response to this global pandemic. By distributing these kits, we hope to streamline and simplify the UK supply chain, allowing more people to be tested sooner. This is just one piece of the puzzle, but it is important that we all do our small part both in protecting individuals and the NHS, and, ultimately, saving lives."