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List of mutations identified in Dec 20, 2020 COG-UK report and BioFire RP2.1 assay reactivity summary

          Mutation                            BioFire RP2.1                     BioFire RP2.1
          Nucleotide       Amino Acid         SARSCoV2-2 Assay:   SARSCoV2-1 Assay:   Overall Result
                                              M-gene (Membrane)  S-gene (Spike)  Expected
          ORF1ab
          ACT3263ATT       T1001I
          GCT5384GAT       A1708D                                               Detection
                                              Not targeted     Not targeted
          ATA6950ACA       I2230T                                               Unaffected
          TCTGGTTTT11284   Δ3675-7 SGF
          Spike
          ACATGT21763      Δ69-70
          TTA21991         Δ145
          AAT23063TAT      N501Y                               Primers unaffected
                                                               (Assay located in a
          AAT23063TAT      N501Y
                                                               different area of
          CCT23602CAT      P681H                               the gene)        Detection
                                              Not targeted
          ACA23707ATA      T716I                                                Unaffected
          TCA24505GCA      S982A
                                                               Located in 5' end of one
          GAC24913CAC       D1118H                             primer; no effect on
                                                               performance expected.

          ORF8
          CAA27969TAA      Q27 stop
                                                                                Detection
          AGA28044ATA      R52I               Not targeted     Not targeted
                                                                                Unaffected
          TAC28107TGC      Y73C
          N
          GAT28277CTA      D3L                                                  Detection
                                              Not targeted     Not targeted
          TCT28973TTT      S235F                                                Unaffected
          주의: BioFire RP2.1 Panel (제품번호: 423738)의 사용 목적은 새로운 돌연변이를 모니터링하기 위한 것이 아니며, 변종에 감염된 실제 환자 검
          체를 이용한 검증이 아님


            RESPIRATORY 2.1 PANEL (EUA): 1 Test, 22 Targets, ~45Minutes.
            Overall 97.1% sensitivity and 99.3% specificity (prospective specimens)
            SARS-CoV-2 98.0% sensitivity and 100% specificity (archived specimens)
            SARS-CoV-2 100% PPA and 100% NPA (contrived specimens)
            Sample Type: Nasopharyngeal swab in transport media
            VIRUSES:                        BACTERIA:
             •Adenovirus                     •Bordetella parapertussis
             •Coronavirus HKU1               •Bordetella pertussis
             •Coronavirus NL63               •Chlamydia pneumonia
             •Coronavirus 229E               •Mycoplasma pneumoniae
             •Coronavirus OC43
             •Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
             •Human Metapneumovirus
             •Human Rhinovirus/Enterovirus
             •Influenza A
             •Influenza A/H1
             •Influenza A/H3
             •Influenza A/H1-2009
             •Influenza B
             •Parainfluenza Virus 1
             •Parainfluenza Virus 2
             •Parainfluenza Virus 3
                                                                      코로나바이러스감염증-19 [핵산증폭법] 응급용 선별검사 Ⅲ
             •Parainfluenza Virus 4
             •Respiratory Syncytial Virus                                (COVID-19를 포함한 호흡기 바이러스, 폐렴원인균)
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