NICE does not recommend 3 molecular tests for sepsis

In final diagnostics guidance published NICE has recommended that further research is carried out on 3 promising new blood tests for speeding up the identification of bloodstream bacteria and fungi in people with suspected Sepsis or bloodstream infections. The LightCycler SeptiFast Test MGRADE, from Roche Diagnostics, SepsiTest from Molzym Molecular Diagnostics and IRIDICA BAC BSI assay from Abbott Laboratories, analyse whole blood samples to identify bacterial and fungal DNA. The tests aim to identify the causes of infection much quicker than traditional microbiology techniques which require blood samples to be incubated and cultured before pathogens can be identified.

The LightCycler SeptiFast Test MGRADE is a CE marked, in vitro, diagnostic, real-time polymerase chain reaction (PCR) test that simultaneously detects and identifies DNA from 25 bacterial and fungal pathogens. SepsiTest is a CE marked PCR in vitro test for detecting bacterial and fungal DNA in 1 ml of k-EDTA- or citrate-treated whole blood. The test is able to identify species from more than 200 genera of bacteria and 65 genera of fungi. The IRIDICA BAC BSI assay (Abbott Laboratories) is a CE marked, in vitro, diagnostic test for detecting and identifying DNA from bacteria and candida in 5 ml of whole blood treated with EDTA. The test can also detect the MecA (Staphylococcus- specific methicillin resistance), vanA and vanB (Enterococcus-specific vancomycin resistance), and KPC (gram-negative associated carbapenem resistance) genes, which are associated with antibiotic resistance.