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Bacteria
Bordetella pertussis
Mycoplasma
pneumoniae
*Note: There were 7 Chlamydophila pneumoniae pathogens found by the comparator methods
in the study samples. These were all correctly detected by the DiagCORE Respiartory Panel 2 but
are not subject to this CE mark and the sensitivity performance is therefore not reported. The 7
results were however incuded in the specificity calculation for the indiviual panel pathogens.
Note: there were no evaluable results available for Legionella pneumophila, both because this
pathogen was found in a low number in the study (2 detections), and because of the absence of
comparator method results.
Note: the sensitivity and specificity performance results for Parainfluenza Virus 1 (17 of 19 results)
and for Bordetella Pertussis (24 of 29 results) include results from a previous study (DiagCORE
Respiratory Panel assay study). This is a true reflection of the performance for these pathogens
because no design or other changes were made for these pathogens between these 2 assays.
Except for the sensitivity and specificity calculation of these respective organisms, these 44 results
are not part of the 698 results used to calculate the specificity performance for the remaining
(DiagCORE Respiratory Panel 2 assay pathogens.
The DiagCORE Respiratory Panel 2 assay detected multiple organisms in 101 samples, for a total of
228 organism results. This represents 26.3 % of the total positive specimens (101/ 385). Eighty-two
samples were double infections, 15 were triple infections, and the remaining coinfection samples
had 4 (3) or more pathogens (1 sample had 7 pathogens).
11.1 Dry swab specimen
To assess the ability and the clinical performance characteristics of the dry swab specimen when
entered directly into the DiagCORE Respiratory Panel 2 cartridge, a total of 448 clinical samples
were tested. This testing was conducted in 2 of the 3 sites that participated in the performance
evaluation of the UTM specimen. The objective was to demonstrate equivalency between
performance characteristics of the dry swab and the UTM specimens.
One clinical site had requested and obtained IRB approval to enroll patients for this part of the
study. Patients consenting to participate in the study provided 2 nasopharyngeal swabs, one from
each nostril. One swab was transferred into UTM and the other swab was directly entered into the
cartridge. Ninety-eight (98) swab samples were enrolled following this approach. To augment the
number of dry swab results and to ensure that all DiagCORE Respiratory Panel 2 pathogens were
represented in the dry swab testing, an additional 350 swabs were dipped in UTM. Because each
swab holds approximately 0.1 ml of liquid after dipping, two swabs were simultaneously dipped in
UTM, and entered into the cartridge. For all SWAB specimen, the simultaneously tested UTM
specimen served as the comparator method.
48
DiagCORE Respiratory Panel 2 Instructions for Use
DiagCORE Respiratory Panel 2
TP/
Sensitivity
/PPA
TP+FN
88.3%-
29/29
100.00%
100.0%
84.5%-
21/21
100.00%
100.0%
TN/
Specificity
95% CI
/NPA
TN+FP
693/693
100.00%
676/677
99.80%
95% CI
99.4%-
100.0%
99.2%-
100.0%
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