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Concentration
Influenza H1N1 (pdm) *
Cor OC43
PIV3
3xLoD
Rhinovirus A16
M. pneumoniae
Influenza H1N1 (pdm) *
Cor OC43
1xLoD
PIV3
Rhinovirus A16
M. pneumoniae
Influenza H1N1 (pdm) *
Cor OC43
Negative
PIV3
Rhinovirus A16
M. pneumoniae
* Note: detection rate applies for both targets, Influenza A and H1/pandemic.
Concentration
Influenza A H3 *
Cor NL63
PIV1
3xLoD
Adenovirus E4
L. pneumophila
Influenza A H3 *
Cor NL63
1xLoD
PIV1
Adenovirus E4
L. pneumophila
Influenza A H3 *
Cor NL63
Negative
PIV1
Adenovirus E4
L. pneumophila
* Note: detection rate applies for both targets, Influenza A and H3.
Concentration
3xLoD
Bocavirus
1xLoD
Bocavirus
Negative
Bocavirus
All samples tested generated the expected result (95-100% agreement) showing reproducible
performance of the DiagCORE
Pathogen
Expected Result
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Negative
Negative
Negative
Negative
Negative
Expected
Pathogen
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Negative
Negative
Negative
Negative
Negative
Expected
Pathogen
Positive
Positive
Negative
®
Respiratory Panel 2.
Detection
Rate
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
80/80
80/80
80/80
80/80
80/80
Detection
Result
Rate
20/20
20/20
20/20
20/20
20/20
19/20
20/20
20/20
20/20
20/20
80/80
80/80
80/80
80/80
80/80
Detection
Result
Rate
20/20
20/20
80/80
DiagCORE Respiratory Panel 2 Instructions for Use
% Agreement with
Expected Result
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
% Agreement with
Expected Result
100%
100%
100%
100%
100%
95%
100%
100%
100%
100%
100%
100%
100%
100%
100%
% Agreement with
Expected Result
100%
100%
100%
61
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