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Instructions for Use
Analytical specificity
Microbial cross-reactivity was determined by testing a panel of 30 potentially cross-reacting organisms, including common human pathogens encountered in the upper respiratory passage of humans. These pathogens consisted of cultured clinical isolates in the form of cell preparations or nucleic acid extracts. Samples were prepared in VCM transport medium and tested across multiple lots of reaction mix:
Adenovirus
SARS-coronavirus
Human Parainfluenza 4
Chlamydophila pneumoniae
Influenza virus A
MERS-coronavirus
Human coronavirus 229E
Pseudomonas aeruginosa
Respiratory Syncytial Virus A
Enterovirus
Moraxella catarrhalis
Respiratory Syncytial Virus B
Epstein-Barr Virus
Influenza virus B
Staphylococcus epidermidis
Escherichia coli
Mycoplasma pneumoniae
Streptococcus mutans
Haemophilus influenza
Pneumocystis jiroveci
Streptococcus pyogenes
Human coronavirus OC43
Human Parainfluenza 1
Paraechovirus
Human coronavirus NL63
Human Parainfluenza 2
Streptococcus salivarius
Human Rhinovirus
Human Parainfluenza 3
Bordetella pertussis
Amplification was observed for SARS coronavirus. Cross-reactivity with this organism was expected based on homology with several of the assay primers. However, this virus is no longer in circulation as the outbreak in 2003/2004 has been successfully contained [15]. Cross-reactivity from a human upper respiratory sample with COVID19 is highly unlikely.
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