Fully automated detection and differentiation of pandemic and endemic coronaviruses (NL63, 229E, HKU1, OC43 and SARS‐CoV‐2) on the hologic panther fusion

The hologic panther fusion (PF) platform provides fully automated CE marked diagnostics for respiratory viruses, including the recently discovered severe acute syndrome-coronavirus 2 (SARS-CoV-2) by a transcription mediated amplification (TMA) assay, but not endemic human coronaviruses (hCoV). Therefore, laboratory developed test (LDT) comprising multiplexed reverse polymerase chain reaction (RT-PCR) protocol that detects and differentiates four hCoV NL63, 229E, HKU1, OC43 was adapted on PF. novel Aptima SARS-CoV-2 TMA LDT were validated with 321 diagnostic specimens from upper lower tract in comparison to two RT-PCRs (PF E-gene RT-PCR genesig RT-PCR, 157 specimens) or R-GENE hCoV/hParaFlu (164 specimens), respectively. For hCoV, results 96.3% concordant discordantly positive PF assay. All samples had Ct values between 33 39. identified 23 as 15 25 OC43. gave 99.4% compared consensus single specimen positive. Moreover, 36 proficiency testing panels detected typed correctly both methods. In conclusion, enhanced spectrum of all circulating globally multitude materials tract.