Instructions for Use

General Purpose Reagents: Controls
For use as qualitative PCR controls.

Catalog Number

Product Name

Quantity

40880008

IGH SHM Pos (+)

1 Tube - 45 µL

40880010

IVS-0001 Clonal Control DNA

1 Tube - 100 µL

40880190

IVS-0004 Clonal Control DNA

1 Tube - 100 µL

40880370

IVS-0007 Clonal Control DNA

1 Tube - 100 µL

40880430

IVS-0008 Clonal Control DNA

1 Tube - 100 µL

40880490

IVS-0009 Clonal Control DNA

1 Tube - 100 µL

40880550

IVS-0010 Clonal Control DNA

1 Tube - 100 µL

40880730

IVS-0013 Clonal Control DNA

1 Tube - 100 µL

40881090

IVS-0019 Clonal Control DNA

1 Tube - 100 µL

40881210

IVS-0021 Clonal Control DNA

1 Tube - 100 µL

40881390

IVS-0024 Clonal Control DNA

1 Tube - 100 µL

40881690

IVS-0029 Clonal Control DNA

1 Tube - 100 µL

40881750

IVS-0030 Clonal Control DNA

1 Tube - 100 µL

40881810

IVS-0031 Clonal Control DNA

1 Tube - 100 µL

40883320

5% TCRG Positive Control DNA

1 Tube - 50 µL

40920020

TCRG Negative Control DNA

1 Tube - 50 µL

40920010

IVS-0000 Polyclonal Control DNA

1 Tube - 100 µL

R0880230

FLT3 ITD Positive DNA

1 Tube - 100 µL

R0880240

FLT3 TKD Positive DNA

1 Tube - 100 µL

R0880250

FLT3 Extraction Control

1 Tube - 1800 µL

40890100

IVS-0002 Clonal Control RNA

1 Tube - 100 µL

40890190

IVS-0003 Clonal Control RNA

1 Tube - 100 µL

40890910

IVS-0011 Clonal Control RNA

1 Tube - 100 µL

40891270

IVS-0015 Clonal Control RNA

1 Tube - 100 µL

40891720

IVS-0020 Clonal Control RNA

1 Tube - 100 µL

40892800

IVS-0032 Clonal Control RNA

1 Tube - 100 µL

40893070

IVS-0035 Clonal Control RNA

1 Tube - 100 µL

Page 2 of 7

Table of Contents
1.

PROPRIETARY NAME .................................................................................................................................................................................... 3

2.

INTENDED USE .............................................................................................................................................................................................. 3

3.

REAGENTS ..................................................................................................................................................................................................... 44.

Tissue DNA Controls .............................................................................................................................................................................................................. 4
Cell Line DNA Controls ......................................................................................................................................................................................................... 4
RNA Controls ............................................................................................................................................................................................................................ 5
Warnings and Precautions .................................................................................................................................................................................................. 6
Storage and Stability.............................................................................................................................................................................................................. 6

PROCEDURE .................................................................................................................................................................................................. 65.

INTERPRETATION OF RESULTS ..................................................................................................................................................................... 66.

SYMBOLS ....................................................................................................................................................................................................... 6

7.

TECHNICAL AND CUSTOMER SERVICE .......................................................................................................................................................... 7

8.

LEGAL NOTICE .............................................................................................................................................................................................. 7

General Purpose Reagents: Controls

280307 Rev. D | April 2020
FOR LABORATORY USEPage 3 of 7

1.

Proprietary Name

Table 1. Proprietary Product Names and Unique Device Identification (UDI)

2.

Catalog Number

Product Name

UDI

Volume40880008

IGH SHM Pos (+)

810022731642

45 µL

40880010

IVS-0001 Clonal Control DNA

810022731666

100 µL40880190

IVS-0004 Clonal Control DNA

810022731710

100 µL40880370

IVS-0007 Clonal Control DNA

810022731727

100 µL40880430

IVS-0008 Clonal Control DNA

810022731734

100 µL40880490

IVS-0009 Clonal Control DNA

810022731741

100 µL40880550

IVS-0010 Clonal Control DNA

810022731758

100 µL40880730

IVS-0013 Clonal Control DNA

810022731765

100 µL

40881090

IVS-0019 Clonal Control DNA

810022731789

100 µL

40881210

IVS-0021 Clonal Control DNA

810022731796

100 µL

40881390

IVS-0024 Clonal Control DNA

810022731802

100 µL

40881690

IVS-0029 Clonal Control DNA

810022731819

100 µL

40881750

IVS-0030 Clonal Control DNA

810022731826

100 µL

40881810

IVS-0031 Clonal Control DNA

810022731833

100 µL

40883320

5% TCRG Positive Control DNA

810022731857

50 µL

40920020

TCRG Negative Control DNA

810022732076

50 µL

40920010

IVS-0000 Polyclonal Control DNA

810022732052

100 µL

R0880230

FLT3 ITD Positive DNA

810022732373

100 µL

R0880240

FLT3 TKD Positive DNA

810022732380

100 µL

R0880250

FLT3 Extraction Control

810022732472

1800 µL

40890100

IVS-0002 Clonal Control RNA

810022731949

100 µL40890190

IVS-0003 Clonal Control RNA

810022731956

100 µL40890910

IVS-0011 Clonal Control RNA

810022731963

100 µL40891270

IVS-0015 Clonal Control RNA

810022731970

100 µL40891720

IVS-0020 Clonal Control RNA

810022731987

100 µL

40892800

IVS-0032 Clonal Control RNA

810022731994

100 µL

40893070

IVS-0035 Clonal Control RNA

810022731642

100 µL

Intended Use

Invivoscribe’s General Purpose Reagents (GPR) are intended for validation by the end user for use in molecular assays. These controls
are specific to gene rearrangements, mutations, and/or translocations from human DNA or RNA indicated in section 3: Reagents.
These products are General Purpose Reagents and are for Laboratory Use.

General Purpose Reagents: Controls

280307 Rev. D | April 2020
FOR LABORATORY USEPage 4 of 73.

Reagents
Tissue DNA Controls
Tissue DNA controls are extracted from normal, disease-free tissue and are tested extensively to ensure quality and reproducibilityof your test results.
Tissue DNA Controls are adjusted to the final concentration specified in Table 2 with 1/10 TE (1 mM Tris-HCl (pH8.0), 0.1 mM EDTA), which provides sufficient buffering capacity and EDTA to protect the DNA controls without
interfering with the Mg2+ concentrations required for robust amplification reactions.

Table 2. Tissue DNA Controls

Catalog
NumberDescription

40920010

IVS-0000 Polyclonal Control DNA

Storage
Conditions

Concentration

Characteristics

200 µg/mL genomic DNA isolated from the tissue ofnormal human tonsils
 negative control for gene rearrangements,
chromosome translocations, and mutation tests**Minimize the number of freeze-thaw cycles.

Cell Line DNA Controls
Cell Line DNA Controls are extracted from established cell lines grown under standard cell culture conditions and extensively
tested to ensure quality and reproducibility.
DNA Clonal Controls are adjusted to the final concentration specified in Table 3 with 1/10th TE (1 mM Tris-HCl(pH 8.0), 0.1 mM EDTA), which provides sufficient buffering capacity and EDTA to protect the DNA controls
without interfering with the Mg2+ concentrations required for robust amplification reactions.

Table 3. Cell Line DNA Controls

Catalog
NumberCharacteristics
Description

Concentration

Gene
Rearrangement40880008

IGH SHM Pos (+)‡

15 µg/mL

IGH, IGK

40880010

IVS-0001 Clonal Control DNA

200 µg/mL

n/c40880190

IVS-0004 Clonal Control DNA

200 µg/mL

TRB, TRG

40880370

IVS-0007 Clonal Control DNA

200 µg/mL

IGH, IGK, IGL

40880430

IVS-0008 Clonal Control DNA†

200 µg/mL

IGH DH-JH, TRB,TRG

n/cn/c40880490

IVS-0009 Clonal Control DNA200 µg/mL

TRB, TRGn/cn/c40880550

IVS-0010 Clonal Control DNA

200 µg/mL

IGH, IGK, IGL

40880730

IVS-0013 Clonal Control DNA

200 µg/mL

IGH, IGK, IGL

n/cn/c40881090

IVS-0019 Clonal Control DNA

200 µg/mL

IGH, IGKn/cn/c40881210

IVS-0021 Clonal Control DNA

200 µg/mL

TRG, TRB, TRD

n/cn/c40881390

IVS-0024 Clonal Control DNA

200 µg/mL

IGH, IGKn/cn/c40881690

IVS-0029 Clonal Control DNA

200 µg/mL

IGH, IGK, IGL

n/cn/cGeneral Purpose Reagents: Controls

ChromosomeTranslocation

IGH-BCL2t(14;18) Mbr

IGH-BCL2t(14;18) mcrn/c

IGH-BCL2t(14;18) Mbr

IGH-BCL1t(11;14)§

GeneMutation

Storage
Conditionsn/cn/cn/cn/cn/c280307 Rev. D | April 2020
FOR LABORATORY USEPage 5 of 7
Table 3. Cell Line DNA Controls

Characteristics

Catalog
NumberDescription

Concentration

Gene
Rearrangement40881750

IVS-0030 Clonal Control DNA‡

200 µg/mL

IGH, IGK

40881810

IVS-0031 Clonal Control DNA

200 µg/mL

IGH, IGK

40883320

5% TCRG Positive Control DNA

50 µg/mLTRG

n/cn/c40920020

TCRG Negative Control DNA

50 µg/mL

negative control
for TRG generearrangements

n/cn/cR0880230

FLT3 ITD Positive DNA

10 µg/mLn/cn/cFLT3 ITD

R0880240

FLT3 TKD Positive DNA

10 µg/mLn/cn/cFLT3 TKD

R0880250

FLT3 Extraction Control

50 µg/mLn/cn/c

Chromosome
Translocation

Gene
Mutation

IGH-BCL2

Storage
Conditions

n/ct(14;18) Mbr

IGH-BCL2n/ct(14;18) mcr*FLT3
negativeNote:n/c is used to indicate that the control has not been fully characterized; there may be additional rearrangements, translocations or mutations
associated with the control.
*Minimize the number of freeze-thaw cycles.

†This control does not contain a complete IGH VH-JH rearrangement and may only be suitable for IGH DH-JH rearrangements.

§IGH-BCL1 was previously referred to as BCL1/JH‡

These controls can be used as SHM positive controls with ≥2% mutational rates compared to the germline sequence.

RNA Controls
Invivoscribe RNA Controls are extracted from established cell lines grown under standard cell culture conditions and extensively
tested to ensure quality and reproducibility.RNA

Controls are adjusted to the final concentration specified in Table 4.

with molecular grade water.

Table 4. RNA Controls

Catalog
NumberStorage
Conditions

Description

Concentration

Target40890100

IVS-0002 Clonal Control RNA

400 µg/mL

E2A-PBX1 t(1;19)(q23;p13)40890190

IVS-0003 Clonal Control RNA

400 µg/mL

BCR-ABL1 t(9;22) p210 e13a2 (b2a2)

40890910

IVS-0011 Clonal Control RNA

400 µg/mL

BCR-ABL1 t(9;22) p210 e14a2 (b3a2)

40891270

IVS-0015 Clonal Control RNA

400 µg/mL

CBFB-MYH11 inv(16)40891720

IVS-0020 Clonal Control RNA

400 µg/mL

PML-RARα t(15;17)(q22;q11)

40892800

IVS-0032 Clonal Control RNA

400 µg/mL

BCR-ABL1 t(9;22) p190 e1a2

40893070

IVS-0035 Clonal Control RNA

400 µg/mL

negative for BCR-ABL and PML-RARα
chromosome translocations**Minimize the number of freeze-thaw cycles.

General Purpose Reagents: Controls

280307 Rev. D | April 2020
FOR LABORATORY USEPage 6 of 7Warnings and PrecautionsInvivoscribe’s GPRs are for Laboratory Use.
Invivoscribe’s GPR Controls are not intended for use as a substitute for the internal controls provided by in vitro
diagnostic kit manufacturers.
Establish standard operating procedures and instructions for using the Invivoscribe GPR DNA and RNA controls inmolecular assays.
Reagents are stable until the labeled expiration date when stored and handled as directed. Do not use reagents
beyond their expiration date.
Perform all quality control requirements in conformance with local, state and/or federal regulations or accreditation
requirements.
Wear appropriate personal protective equipment and follow good laboratory practices and universal precautions
when working with specimens.
Handle specimens in approved biological safety containment facilities and open only in certified biological safetycabinets.
Use extreme care to avoid the contamination of reagents with samples, controls or amplified materials. Closely
monitor all reagents for signs of contamination (e.g., negative controls giving positive signals). Discard reagents
suspected of contamination.
To minimize contamination, wear clean gloves when handling samples and reagents and routinely clean work areasand pipettes prior to doing PCR.
Autoclaving does not eliminate DNA contamination.
Follow uni-directional workflow in the PCR laboratory; begin with master mix preparation, move to specimen
preparation, then to amplification, and finally to detection. Do not bring amplified DNA into the areas designatedfor master mix or specimen preparation.
Dedicate all pipettes, pipette tips, and any equipment used in a particular area to that area of the laboratory.
Use sterile, disposable plastic ware whenever possible to avoid RNase, DNase, or cross-contamination.

Storage and Stability4.

When stored at the intended storage conditions, Invivoscribe’s GPR controls are stable until the expiration dateindicated on the vial label.

Procedure
Allow the GPR control to equilibrate to room temperature.
Vortex gently, then pulse-spin in a centrifuge (4 to 6 seconds) to collect the contents at the bottom of the tube.
Introduce the GPR control as an independent sample at the template addition step in the workflow.
Handle the GPR control similarly to nucleic acids extracted from routine samples and run in parallel with routinesamples.

5.

Interpretation of Results
Results generated by Invivoscribe’s GPR controls may differ according to the molecular test method.
To establish a baseline performance, incorporate results from multiple runs under different conditions (e.g., operator,run, day) to determine a valid size range specific to the assay used.
Once the validated size range is ascertained, the expected size range can be used to verify each subsequent run result ofthe GPR control.

6.

Symbols

The following symbols are used in labeling for Invivoscribe products.
Storage Conditions

Expiration Date

Catalog NumberAuthorized Representative in theEuropean Community

Reagent Volume

Manufacturer

Lot Number

Consult Instructions for Use

General Purpose Reagents: Controls

280307 Rev. D | April 2020
FOR LABORATORY USEPage 7 of 77.

Technical and Customer Service

Technical and Customer Service Representatives are available Monday through Friday to answer phone, e-mail or website inquiries.
Please do not hesitate to contact sales@invivoscribe.com for assistance evaluating controls to suit your testing needs.

Authorized Representative andEU Technical AssistanceContact Information
Invivoscribe, Inc.
10222 Barnes Canyon Road, Bldg. 1
San Diego, CA 92121-2777
USA

Phone:
Fax:
Technical Service:
Customer Service:
Website:Business Hours:

8.

Invivoscribe Technologies, SARLLe Forum – Bât B
515 Avenue de la Tramontane
ZI Athélia IV
13600 La Ciotat, France+1 858 224-6600+1 858 224-6601
support@invivoscribe.com
sales@invivoscribe.com
www.invivoscribe.com
7:00AM – 5:00PM PST/PDT

Phone:
Fax:
Technical Service:
Customer Service:
Website:Business Hours:+33 (0)4 42 01 78 10+33 (0)4 88 56 22 89
support@invivoscribe.com
sales-eu@invivoscribe.com
www.invivoscribe.com
9:00AM – 5:00PM CET/CEST

Legal Notice

Invivoscribe, Inc. (Invivoscribe®) is committed to providing the highest quality products. Invivoscribe® warrants that the products
meet or exceed the performance standards described in the Instructions For Use, as to products with such an insert. If a product iscovered by product specifications and does not perform as specified, our policy is to replace the product or credit the full purchaseprice. No other warranties of any kind, expressed or implied, are provided by Invivoscribe®. Invivoscribe® liability shall not exceed
the purchase price of the product.Invivoscribe shall have no liability for direct, indirect, consequential or incidental damages arisingfrom the use, results of use, or inability to use its products; product efficacy under purchaser controlled conditions in purchaser’slaboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited
to testing of internally validated positive, negative, and blank controls every time a sample is tested. Ordering, acceptance and use ofproduct constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement to the limitationof liability set forth in this paragraph.
This product is a General Purpose Reagent (GPR).
©2020 Invivoscribe, Inc. All rights reserved. The trademarks mentioned herein are the property of Invivoscribe, Inc. and/or its
affiliates or (as to the trademarks of others used herein) their respective owners.

General Purpose Reagents: Controls

280307 Rev. D | April 2020
FOR LABORATORY USE