58 DiagCORE Respiratory Panel 2 Instructions for Use
All co-infections tested gave a positive result for the two pathogens combined at low and high
concentrations. No effect in results are observed due to the presence of co-infections in a sample
tested with the DiagCORE
®
Respiratory Panel 2.
12.6
Interfering Substances
The influence of potential interfering substances on the performance of the DiagCORE
®
Respiratory
Panel 2 was evaluated in this study. The interfering substances include endogenous as well as
exogenous substances that are normally found in the nasopharynx or may be introduced into NPS
specimens during specimen collection, respectively.
A set of selected samples which cover all the respiratory pathogens from the panel were used for
the Interfering Substances testing. Interfering substances were spiked into the selected samples at
a level predicted to be above the concentration of the substance likely to be found in an
authentic nasopharyngeal swab specimen. The selected samples were tested with and without
addition of the potential inhibitory substance for direct sample-to-sample comparison. Additionally
pathogen-negative samples were spiked with the potential inhibitory substances.
None of the tested substances showed interference with the Internal Control or the pathogens
included in the combined sample.
Table 1. Concentrations of the interfering substances tested for the DiagCORE
®
Respiratory Panel
2.
Endogenous substances
Concentration tested
Human genomic DNA
50 ng/µL
Human whole Blood
10% v/v
Human Mucin
0.5% v/v
Competitive microorganisms
Concentration tested
Staphylococcus aureus
(ATCC CRM-6538)
1.70E+08 CFU/mL
Streptococcus pneumoniae
(ATCC 6303)
1.25E+07 CFU/mL
Haemophilus influenzae
(ATCC 49766)
6.20E+08 CFU/mL
Candida albicans
(ATCC CRM-10231)
1.00E+06 CFU/mL
Herpes Simplex Virus 1
(ATCC VR-1789)
1.60E+07 TCID
50
/mL
Human Cytomegalovirus
(ATCC NATCMV-0005)
2.0E+04 TCID
50
/mL
Exogenous substances
Concentration tested
Utabon
®
Nasal spray (decongestant)
10% v/v
RHINOmer
®
Nasal spray (salt water solutions)
10% v/v
Tobramycin
6 mg/mL
Mupirocin
2.5% w/v