Instructions for Use

For the entire instructions for use (IFU), please email Adaptive at dxsupport@adaptivebiotech.com.

 

clonoSEQ® Assay B-cell Reagent Set

Key to Symbols Used

CE Mark

Consult Instructions for Use

For In Vitro Diagnostic Use

Authorized Representative in the European Community

Caution

Lot Number

Manufacturer

Product of USA

Reference Number

Temperature Limit

Use By Date

Date of Manufacture

 

For professional and laboratory use
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE.

 

1. INTENDED USE….3

2. SUMMARY AND EXPLANATION OF THE TEST….3

3. LIMITATIONS….3

4. TEST PRINCIPLE….4

5. DEVICE DESCRIPTION….5

5.1 Sample Preparation….5

5.2 Library Preparation….5

5.3 Sequencing and Data Analysis….5

5.4 Controls….6

6. REAGENTS (PROVIDED)….7

6.1 Reagents Overview….7

6.2 Storage and Handling….7

7. INSTRUMENTS AND CONSUMMABLES REQUIRED (NOT PROVIDED)….8

7.1 Instruments….8

7.2 Other Equipment….9

7.3 Consumables….9

8. SPECIMEN COLLECTION AND PREPARATION….12

8.1 Precautions….12

8.2 Sample Storage….12

8.3 Sample Requirements and Handling….12

9. ASSAY PROCEDURE….13

9.1 Warnings and Precautions….13

9.2 Procedural Considerations….14

9.3 Workflow….15

9.4 Sample Preparation….15

9.5 Library Preparation: Pre-Amplification….16

9.6 Library Preparation: Exonuclease Treatment….19

9.7 Library Preparation: PCR Amplification….21

9.8 Library Pooling and Cleanup….24

9.9 Quantification of Library Pool….26

9.10 Sequencing….28

10. DATA ANALYSIS….29

10.1 Experiment List Generation….29

10.2 Data Transfer….32

11. CALCULATION OF EXAMINATION RESULTS….33

12. INTERPRETATION AND REPORTING….34

12.1 Batch Reports….34

12.2 Clinical Reports….34

13. ANALYTICAL PERFORMANCE CHARACTERISTICS….35

13.1 Specimen Characterization….35

13.2 Precision….35

13.3 Analytical Sensitivity….40

13.4 Analytical Specificity….41

13.5 Linearity….42

13.6 Reagent Stability….46

13.7 Accuracy….47

14. CLINICAL PERFORMANCE CHARACTERISTICS….52

15. TECHNICAL AND CUSTOMER SERVICE….60

16. REFERENCES….61