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WARNING
Hazard component in cartridge
(binding buffer RB-BB-34a)
Guanidinium chloride; guanidine hydrochloride
Hazard statements
H302
H315
H319
Precautionary statements
P264
P280
P302+P352
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
P337+P313
P501
Table 1 – Limit of Detection (LoD)
Norovirus GII*
*Determined by using quantified clinical isolates for a spiking approach in
eNAT® (COPAN) supplemented with approximately 1000 Human Bronchial/
Tracheal Epithelial Cells (hPBTEC) and 6% (v/v) Stool Matrix Negative Con-
trol (artificial simulated matrix). Norovirus GI was confirmed at the 3x LoD
(as determined for Norovirus GII) using artificial nucleic acid constructs.
Table 2 – Inclusivity
Norovirus GI/GII
Strains validated for inclusivity via BLAST alignment
Table 3 – Exclusivity
Abiotrophia defective
Acinetobacter baumannii
Acinetobacter lwoffii
Adenovirus
Aeromonas caviae
Aeromonas hydrophila
Alcaligenes faecalis
Anaerococcus tetradius
Arcobacter butzleri
Arcobacter cryaerophilus
Ascaris lumbricoides
Astrovirus
Bacillus cereus
Harmful if swallowed.
Causes skin irritation.
Causes serious eye irritation.
Wash hands thoroughly after handling.
Wear protective gloves and eye/face protection.
IF ON SKIN: Wash with plenty of water and soap.
minutes. Remove contact lenses, if present and easy to
do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.
Dispose of contents/container in accordance with local/
regional/ national/ international regulation
168700 copies /mL
Vivalytic Norovirus
Enterococcus faecium
Enterococcus gallinarum
Enterococcus hirae
Enterococcus raffinosus
Enterovirus
Escherichia blattae
Escherichia coli
(Shiga toxin producing) (STEC)
Escherichia coli (Enteroaggregative)
(EAEC)
Escherichia coli (Enteroinvasive)
(EIEC)
Escherichia coli (Enteropathogenic)
(EPEC)
Escherichia coli (Enterotoxigenic)
(ETEC)
Escherichia coli (non-pathogenic)
(K-12 MG1655)
Escherichia coli
(Enterohemorrhagic) (EHEC)
140
– Annex
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