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DiagCORE Respiratory Panel 2
STAT-Dx DiagCORE Respiratory Panel 2 Manuals
Manuals and User Guides for STAT-Dx DiagCORE Respiratory Panel 2. We have
1
STAT-Dx DiagCORE Respiratory Panel 2 manual available for free PDF download: Instructions For Use Manual
STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual (67 pages)
Brand:
STAT-Dx
| Category:
Medical Equipment
| Size: 3.58 MB
Table of Contents
Customer and Technical Support
2
Table of Contents
3
Contents
3
Table of Symbols
5
1 Information about the Diagcore ® Respiratory Panel 2
6
Product Name and Intended Use
6
Package Contents
7
Storage and Expiration Date
7
2 Safety Information
8
3 General Background
9
Diagcore ® Respiratory Panel 2 Cartridge Description
9
Detected Pathogens
10
Description of the Procedure
12
Sample Collection and Cartridge Loading
13
Sample Preparation, Nucleic Acid Amplification, and Detection
13
4 Required Materials and Equipment that Are Not Provided
15
5 Procedure for Dry Swab Samples
16
Sample Collection, Transport, and Storage
16
Loading a Sample into the Diagcore ® Respiratory Panel 2 Cartridge
16
Starting the Diagcore ® Analyzer
19
Running a Test
19
6 Procedure for Transport Medium Liquid Samples
25
Sample Collection, Transport, and Storage
25
Loading a Sample into the Diagcore ® Respiratory Panel 2 Cartridge
25
Starting the Diagcore Analyzer
28
Running a Test
29
7 Internal Control
34
8 Interpretation of Results
35
Viewing Results
35
Result Interpretation
40
Internal Control Interpretation
41
9 Installing the Assay Definition File
42
10 Limitations of the Procedure
44
11 Performance Characteristics. Clinical Performance
46
12 Performance Characteristics. Analytical Performance
51
Sensitivity (Limit of Detection)
51
Assay Robustness
52
Exclusivity (Analytical Specificity)
52
Inclusivity (Analytical Reactivity)
54
Co-Infections
57
Interfering Substances
58
Carryover
59
Reproducibility
59
Sample Stability
62
13 References
63
14 Appendices
64
Disposal Information
64
Declaration of Conformity
64
Glossary
64
Trademarks and Copyright
65
Copyright, Disclaimer, and Warranty
65
Patent Statement
65
Software License Agreement
65
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