STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual page 60

Table 2. Summary of Positive Agreement, Negative Agreement for Reproducibility Testing
Concentration
3xLoD
1xLoD
Negative
* Note: detection rate applies for both targets, Influenza A and H1.
Concentration
3xLoD
1xLoD
Negative
60 DiagCORE Respiratory Panel 2 Instructions for Use
Pathogen
Influenza A H1 *
Cor HKU1
PIV2
RSVB
Influenza A H1 *
Cor HKU1
PIV2
RSVB
Influenza A H1 *
Cor HKU1
PIV2
RSVB
Pathogen
Influenza B
Cor 229E
PIV4a
Enterovirus D68
hMPV B2
B. pertussis
Influenza B
Cor 229E
PIV4a
Enterovirus D68
hMPV B2
B. pertussis
Influenza B
Cor 229E
PIV4a
Enterovirus D68
hMPV B2
B. pertussis
Expected Detection
Result Rate
Positive 20/20
Positive 20/20
Positive 20/20
Positive 20/20
Positive 20/20
Positive 19/20
Positive 19/20
Positive 20/20
Negative 80/80
Negative
80/80
Negative
80/80
Negative
80/80
Expected Detection
Result Rate
Positive 20/20
Positive 20/20
Positive 20/20
Positive 20/20
Positive 20/20
Positive 20/20
Positive 19/20
Positive 20/20
Positive 20/20
Positive 19/20
Positive 19/20
Positive 20/20
Negative 80/80
Negative 80/80
Negative 80/80
Negative 80/80
Negative 80/80
Negative 80/80
% Agreement with
Expected Result
100%
100%
100%
100%
100%
95%
95%
100%
100%
100%
100%
100%
% Agreement with
Expected Result
100%
100%
100%
100%
100%
100%
95%
100%
100%
95%
95%
100%
100%
100%
100%
100%
100%
100%