The collaboration between colleagues at Public Health England Porton Down (PHE), the University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust and the University of Oxford including support from the NIHR Oxford Biomedical Research Centre, evaluated the performance of LamPORE against RT-PCR - the most commonly-used laboratory test for Covid-19. They used RNA extracted from two types of samples. Initially, mock samples formed of saliva from people without infection that had a known quantity of virus added to it, and subsequently nose and throat swabs from real Covid-19 patients collected during routine care at two UK hospitals - Oxford University Hospitals NHS Foundation Trust and Sheffield Teaching Hospitals NHS Foundation Trust.
The positive clinical specimens came mostly from patients with symptomatic infection, and among these LamPORE had a diagnostic sensitivity of 99.1% (i.e. it was positive in 226 of 228 samples positive by RT-PCR). Among negative clinical specimens, including 153 with other respiratory pathogens detected, LamPORE had a diagnostic specificity of 99.6% (i.e. it was negative in 278 of 279 samples negative by RT-PCR). Overall, 1.4% of samples produced an indeterminate result on first testing, and repeat LamPORE testing on the same RNA extract had a reproducibility of 96.8%.
These results indicate that LamPORE has a similar performance to RT-PCR for the diagnosis of SARS-CoV-2 infection in symptomatic patients.