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Vivalytic C. difficile
WARNING
Hazard component in cartridge
(F09G300919; 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)
C. difficile (tcdA/tcdB)*
*Determined by using Vircell material (surrogate strain R20291 Ribotype 027
(toxin A + B positive) for a spiking approach in eNAT® (COPAN) supplement-
ed with approximately 1000 Human Bronchial/Tracheal Epithelial Cells
(hPBTEC) and 6% (v/v) Stool Matrix Negative Control (artificial simulated
matrix).
Table 2 – Inclusivity
Clostridioides difficile toxin A gene
Clostridioides difficile toxin B gene
Strains validated for inclusivity via BLAST alignment
Table 3 – Exclusivity
Abiotrophia defectiva
Acinetobacter baumannii
Acinetobacter lwoffii
Adenovirus
Aeromonas caviae
Aeromonas hydrophila
Alcaligenes faecalis
Anaerococcus tetradius
Arcobacter butzleri
Arcobacter cryaerophilus
Ascaris lumbricoides
Astrovirus
– Annex
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
10000 copies /mL
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)
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