Fully automated detection and differentiation of pandemic and endemic coronaviruses (NL63, 229E, HKU1, OC43 and SARS-CoV-2) on the Hologic Panther Fusion
| Autor: | Benno Wölk, William M. Rehrauer, Anne Katrin Cordes, Birgitta Hilfrich, Albert Heim, Molly A. Accola |
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| Rok vydání: | 2020 |
| Předmět: |
Transcription-mediated amplification
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Respiratory System Biology medicine.disease_cause Alphacoronavirus Coronavirus OC43 Human 03 medical and health sciences 0302 clinical medicine Diagnostic specimens Coronavirus 229E Human Virology medicine Proficiency testing Single specimen Humans 030212 general & internal medicine Coronavirus Reverse Transcriptase Polymerase Chain Reaction SARS-CoV-2 COVID-19 virus diseases Nucleic acid amplification technique biology.organism_classification Coronavirus NL63 Human Infectious Diseases Real-time polymerase chain reaction Fully automated 030211 gastroenterology & hepatology Nucleic Acid Amplification Techniques |
| Zdroj: | Journal of Medical Virology |
| DOI: | 10.1101/2020.08.31.20185074 |
| Popis: | The hologic panther fusion (PF) platform provides fully automated CE marked diagnostics for respiratory viruses, including the recently discovered severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) by a transcription mediated amplification (TMA) assay, but not for the endemic human coronaviruses (hCoV). Therefore, a laboratory developed test (LDT) comprising a multiplexed reverse transcription polymerase chain reaction (RT-PCR) protocol that detects and differentiates the four hCoV NL63, 229E, HKU1, and OC43 was adapted on the PF. The novel CE marked Aptima SARS-CoV-2 TMA and the LDT for hCoV were validated with 321 diagnostic specimens from the upper and lower respiratory tract in comparison to two SARS-CoV-2 RT-PCRs (PF E-gene RT-PCR and genesig RT-PCR, 157 specimens) or the R-GENE hCoV/hParaFlu RT-PCR (164 specimens), respectively. For the endemic hCoV, results were 96.3% concordant with two specimens discordantly positive in the PF and four specimens discordantly positive in the R-GENE assay. All discordantly positive samples had Ct values between 33 and 39. The PF hCoV LDT identified 23 hCoV positive specimens as NL63, 15 as 229E, 15 as HKU1, and 25 as OC43. The Aptima SARS-CoV-2 TMA gave 99.4% concordant results compared to the consensus results with a single specimen discordantly positive. Moreover, 36 samples from proficiency testing panels were detected and typed correctly by both novel methods. In conclusion, the SARS-CoV-2 TMA and the LDT for hCoV enhanced the diagnostic spectrum of the PF for all coronaviruses circulating globally for a multitude of diagnostic materials from the upper and lower respiratory tract. |
| Databáze: | OpenAIRE |
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