Performance Data - Bosch Randox Vivalytic VRI Test Instructions For Use Manual

Performance Data

Table 1 – Limit of Detection (per Test)
SARS-CoV-2
Table 2 – Inclusivity
SARS-CoV-2: BetaCoV/Germany/BavPatI/2020 (EVAg)
SARS-CoV-2: Culture from 2nd positive sample received in the UK (PHE)
SARS-CoV-2: 2019-nCoV E gene stabilized RNA (encapsulated RNA for SARS-CoV-2 /
2019-nCoV; EVAg)
SARS-CoV-2: Wuhan / COVID-19 construct (Qnostics)
SARS-CoV-2: 2019-nCoV/Italy INMI (EVAg)
Table 3 – Exclusivity
Bordetella pertussis
Candida albicans
Haemophilus influenzae
Human adenovirus E
Human coronavirus 229E
Influenza A virus
Influenza B virus
Legionella pneumophila
Mycoplasma pneumoniae
Neisseria meningitidis
Parainfluenzavirus 1
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 % (v/v)
Table 5 – Clinical Sensitivity [1] and Specificity [2] (95 % Confidence
Interval)
SARS-CoV-2
[1] 100 % (91.6 – 100.0 %)*
[2] 100 % (66.4 – 100.0 %)
* Two out of 51 specimens were tested as "valid negative". Upon dilution with eNAT™
medium (COPAN Italia S.P.A.) repetition of these specimens gave "valid positive" re-
sults which were considered. Without retesting sensitivity was 95.2 % (83.4 – 99.4 %).
Vivalytic VRI Test
6 000 RNA copies
Parainfluenzavirus 2
Parainfluenzavirus 3
Parainfluenzavirus 4
Pseudomonas aeruginosa
Respiratory syncytial virus A
Respiratory syncytial virus B
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus pyogenes
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– Annex