Instructions for Use

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

 

clonoSEQ^® Assay B-cell Reagent Set

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

 

Table of Contents…2

1 INTENDED PURPOSE/INTENDED USE…4

2 SUMMARY AND EXPLANATION OF THE TEST….4

3 LIMITATIONS…4

4 SERIOUS INCIDENT REPORTING….5

5 TEST PRINCIPLE…5

6 DEVICE DESCRIPTION…6

6.1 Sample Preparation….6

6.2 Library Preparation….6

6.3 Sequencing and Data Analysis…6

7 REAGENTS (PROVIDED)…8

7.1 Reagents Overview….8

7.2 Storage and Handling…9

8 INSTRUMENTS AND CONSUMABLES REQUIRED (NOT PROVIDED)…9

8.1 Instruments…9

8.2 Other Equipment….10

8.3 Consumables….11

9 SPECIMEN COLLECTION AND PREPARATION….13

9.1 Precautions….13

9.2 Sample Storage….13

9.3 Sample Requirements and Handling…13

10 ASSAY PROCEDURE….14

10.1 Warnings and Precautions…14

10.2 Procedural Considerations….15

10.3 Workflow….16

10.4 Sample Preparation….16

10.5 Library Preparation: Pre-Amplification….17

10.6 Library Preparation: Exonuclease Treatment….22

10.7 Library Preparation: PCR Amplification….23

10.8 Library Pooling and Cleanup….26

10.9 Quantification of Library Pool….29

10.10 Sequencing….30

11 DATA ANALYSIS….32

11.1 Experiment List Generation….32

11.2 Data Transfer…32

12 CALCULATION OF EXAMINATION RESULTS….32

13 INTERPRETATION AND REPORTING….32

13.1 Clinical Reports…32

14 ANALYTICAL PERFORMANCE CHARACTERISTICS…33

14.1 Specimen Characterization….33

14.2 Precision…34

14.3 Analytical Sensitivity….46

14.4 Analytical Specificity…47

14.5 Linearity….49

14.6 Reagent Stability….54

14.7 Accuracy….55

15 CLINICAL PERFORMANCE….61

16 SUMMARY…75

17 GLOSSARY OF HARMONIZED SYMBOLS….76

19 TECHNICAL AND CUSTOMER SERVICE…77

20 REFERENCES….78