Bosch Vivalytic SARS-CoV-2 Guia De Inicio Rapido página 70

Table 1 – Limit of Detection (per Test)
SARS-CoV-2
Table 2 – Inclusivity (SARS-CoV-2)
SARS-CoV-2: Chemically inactivated virus particles (Zeptometrix)
SARS-CoV-2: Specimen of ring trial
Table 3 – Exclusivity
SARS coronavirus
(without SARS-CoV-2)
Human coronavirus 229E
Human coronavirus OC43
Human coronavirus NL63
Human adenovirus
Human metapneumovirus
Parainfluenza virus
Influenza A virus
Influenza B virus
Table 4 – Tested Substances for Interference
Nasivin® spray (0.5 mg/ml oxymetyzoline-hydrochloride); 5 % (v/v)
Rhinomer® (9 g/l NaCl); 10 % (v/v)
Weleda Heuschnupfenspray; 10 % (v/v)
Turixin® 2 % Mupirocin; 2.5 mg/ml
TobraZid® (80 mg Tobramycin / 2 ml ampoule); 4 µg/mL
Simulated nasal matrix [(2.5 % (w/v) porcine mucin, 1 % (v/v) human whole
blood in 0.85 % sodium chloride (NaCl), in 1x PBS with 15 % glycerol];
2.0 % (v/v)
Salbutamol-ratiopharm®; 5 % (v/v)
Neosynephrin-POS® 10 % eye drops; 5% (v/v)
Otri-Allergie Spray Fluticason; 5 % (v/v)
Table 5 – Clinical Sensitivity [1] and Specificity [2]
(95 % Confidence Interval)
SARS-CoV-2
[1] 97.6 % (87.4 – 99.9 %)
[2] 100 % (87.2 – 100.0 %)*
* (1) specimen was tested as "false positive" and was re-tested. Repetition
of this specimen with a third reference assay yielded a positive result and
the specimen was considered as "true positive" in this table. Without
retesting specificity was 96.4 % (81.7 – 99.9 %).
Vivalytic SARS-CoV-2
750 virus particles
Human enterovirus
Respiratory syncytial virus A
Human rhinovirus
Chlamydia pneumoniae
Legionella pneumophila
Streptococcus pyogenes
Bordetella pertussis
Mycoplasma pneumoniae
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– Annex