STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual page 53

intended test population. Selected organisms are clinically relevant (colonizing the upper
respiratory tract or causing respiratory symptoms), are common skin flora or laboratory
contaminants, or are microorganisms for which much of the population may have been infected.
Samples were prepared by spiking potential cross-reactive organisms into simulated
nasopharyngeal swab sample matrix at the highest concentration possible based on the organism
stock, preferably 10 TCID
5
A certain level of cross-reactivity with Bordetella species was predicted by preliminary sequence
analysis and was observed when high concentrations of Bordetella holmesii were tested. No cross-
reactivity was observed with Bordetella bronchiseptica and Bordetella parapertussis at high
concentrations. Target gene used for Bordetella pertussis detection (insertion element IS481) is a
transposon also present in other Bordetella species. Table 1 below shows the list of pathogens
tested in this study.
Table 1. List of Analytical Specificity pathogens tested.
Type
Bacteria
Viruses
/mL for viral targets and 10
50
Bordetella bronchiseptica
Bordetella holmesii
Bordetella parapertussis
Chlamydia trachomatis
Enterobacter aerogenes
Escherichia coli (0157)
Haemophilus influenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Lactobacillus acidophilus
Moraxella catarrhalis
Mycoplasma genitalium
Mycoplasma hominis
Neisseria elongata
Neisseria gonorrhoeae
Neisseria meningitidis
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Staphylococcus epidermidis
Stenotrophomonas maltophilia
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus salivarus
Cytomegalovirus
Epstein-Barr Virus
Herpes Simplex Virus 1
Herpes Simplex Virus 2
Measles Virus
Mumps
CFU/mL for bacterial targets.
6
Pathogen
DiagCORE Respiratory Panel 2 Instructions for Use 53