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Qiagen QIAREACH User Manual
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Qiagen QIAREACH Antigen And Antibody Tests: Fighting The Covid19 Pandemic
User Manual - Page 52
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5 A-EUA202424 Qiagen IFU-05-11-2021
For in vitro diagnostic use
For Emergency Use Authorization Only
Rx Only
Intended Use
Summary and Explanation of the Test
Principles of the assay
Time required for performing the assay
Pipet use
Kit Contents
Materials Required but not Provided
Equipment required but not provided
Storage and Handling
Kit reagents
Stability
Warnings
Precautions
Hazard statements
Further information
Procedures
Preparing samples
Detection assay
Materials required
Important points before starting
Procedure
Results Analysis and Test Interpretation
Quality control of test
Interpretation of results
Limitations
Conditions of Authorization for the Laboratory
Performance Characteristics
Clinical performance
Positive Percent Agreement (PPA)/Sensitivity
Negative Percent Agreement/Specificity
Independent evaluation of clinical performance
Cross-reactivity
Interference
Matrix equivalency
Technical Information
Clotted plasma samples
eHub display icons
Error codes
Troubleshooting Guide
QIAreach Anti-SARS-CoV-2 Total Test troubleshooting
Additional user warnings
Contact Information
References
Symbols
Ordering Information
Document Revision History
5 B-EUA202424.Qiagen Instrument User Manual 05-11-2021
For in vitro diagnostic use
For Emergency Use Authorization Only
Rx Only
1 Introduction
1.1 About this user manual
1.2 General Information
1.2.1 Technical assistance
1.2.2 Policy statement
1.3 Intended use of the QIAreach⢠eHub
1.3.1 Limitations of use
1.4 Symbols on the QIAreach⢠eHub
2 Safety Information
2.1 Proper use
2.2 Electrical safety
2.3 Chemical safety
2.4 Biological safety
2.5 Waste disposal
3 General Description
3.1 System description
3.2 QIAreach⢠eHub description
4 Installation Procedures
4.1 Site requirements
4.2 QIAreach⢠eHub delivery and components
4.3 Unpacking and installing the QIAreach⢠eHub
5 Operating the QIAreach⢠eHub
5.1 Setting up the QIAreach⢠eHub for use
5.2 Running a test on the QIAreach⢠eHub
5.3 Shutting down the QIAreach⢠eHub
6 QIAreach⢠eHub Functions
6.1 Display screen icons
6.2 Battery LED indicator
7 Maintenance
7.1 Cleaning the QIAreach⢠eHub after use
8 Troubleshooting
8.1 General information
8.2 Contacting QIAGEN Technical Services
8.3 QIAreach⢠eHub error codes
9 Technical Specifications
9.1 Electromagnetic compatibility (EMC)
9.2 Electrical Safety
9.3 Cybersecurity
9.4 Software Validation
10 Appendix A â Technical Data
10.1 FCC Compliance: Supplierâs Declaration of Conformity
10.2 Waste Electrical and Electronic Equipment (WEEE)
10.3 Disclaimer of warranties
11 Ordering Information
12 Document Revision History
5 C-EUA202424 Qiagen Product Information Card 05-11-2021
5 D-EUA202424 Qiagen QRI 05-11-2021
5 E-EUA202424 Qiagen Controls IFU 05-11-2021
Intended use
Summary and explanation
Principles of the procedure
Kit contents
Warnings and Precautions
Procedure
Expected results
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Contents
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52
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File type: PDF
File name: 24037784_qiareach.pdf
File size: 3.1 MB
File Language: English
Pages: 97
Author: Qiagen
File created: 2021-05-11
Published: 2021-10-08
Updated: 2023-05-21
Download File
Table of Contents
×
5 A-EUA202424 Qiagen IFU-05-11-2021
1
For in vitro diagnostic use
1
For Emergency Use Authorization Only
1
Rx Only
1
Intended Use
4
Summary and Explanation of the Test
5
Principles of the assay
5
Time required for performing the assay
7
Pipet use
7
Kit Contents
8
Materials Required but not Provided
9
Equipment required but not provided
9
Storage and Handling
9
Kit reagents
9
Stability
9
Warnings
11
Precautions
11
Hazard statements
12
Further information
13
Procedures
14
Preparing samples
14
Detection assay
15
Materials required
15
Important points before starting
15
Procedure
18
Results Analysis and Test Interpretation
22
Quality control of test
22
Interpretation of results
24
Limitations
24
Conditions of Authorization for the Laboratory
26
Performance Characteristics
29
Clinical performance
29
Positive Percent Agreement (PPA)/Sensitivity
29
Negative Percent Agreement/Specificity
30
Independent evaluation of clinical performance
30
Cross-reactivity
32
Interference
34
Matrix equivalency
34
Technical Information
35
Clotted plasma samples
35
eHub display icons
36
Error codes
37
Troubleshooting Guide
43
QIAreach Anti-SARS-CoV-2 Total Test troubleshooting
43
Additional user warnings
43
Contact Information
44
References
45
Symbols
48
Ordering Information
49
Document Revision History
50
5 B-EUA202424.Qiagen Instrument User Manual 05-11-2021
53
For in vitro diagnostic use
53
For Emergency Use Authorization Only
53
Rx Only
53
1 Introduction
57
1.1 About this user manual
57
1.2 General Information
58
1.2.1 Technical assistance
58
1.2.2 Policy statement
59
1.3 Intended use of the QIAreach⢠eHub
59
1.3.1 Limitations of use
59
1.4 Symbols on the QIAreach⢠eHub
60
2 Safety Information
62
2.1 Proper use
63
2.2 Electrical safety
63
2.3 Chemical safety
63
2.4 Biological safety
63
2.5 Waste disposal
64
3 General Description
65
3.1 System description
65
3.2 QIAreach⢠eHub description
65
4 Installation Procedures
67
4.1 Site requirements
67
4.2 QIAreach⢠eHub delivery and components
68
4.3 Unpacking and installing the QIAreach⢠eHub
70
5 Operating the QIAreach⢠eHub
71
5.1 Setting up the QIAreach⢠eHub for use
71
5.2 Running a test on the QIAreach⢠eHub
73
5.3 Shutting down the QIAreach⢠eHub
74
6 QIAreach⢠eHub Functions
75
6.1 Display screen icons
75
6.2 Battery LED indicator
76
7 Maintenance
77
7.1 Cleaning the QIAreach⢠eHub after use
77
8 Troubleshooting
78
8.1 General information
78
8.2 Contacting QIAGEN Technical Services
78
8.3 QIAreach⢠eHub error codes
78
9 Technical Specifications
80
9.1 Electromagnetic compatibility (EMC)
81
9.2 Electrical Safety
81
9.3 Cybersecurity
81
9.4 Software Validation
81
10 Appendix A â Technical Data
82
10.1 FCC Compliance: Supplierâs Declaration of Conformity
82
10.2 Waste Electrical and Electronic Equipment (WEEE)
84
10.3 Disclaimer of warranties
84
11 Ordering Information
85
12 Document Revision History
86
5 C-EUA202424 Qiagen Product Information Card 05-11-2021
90
5 D-EUA202424 Qiagen QRI 05-11-2021
91
5 E-EUA202424 Qiagen Controls IFU 05-11-2021
93
Intended use
93
Summary and explanation
93
Principles of the procedure
93
Kit contents
94
Warnings and Precautions
94
Procedure
95
Expected results
95
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