Instructions for Use

RNA Controls and Sensitivity Panels

For use as qualitative PCR controls.
These products are for Research Use Only; not intended for diagnostic procedures.

Storage Conditions: -85°C to -65ºC
RNA Controls and Sensitivity Panels

280532 Rev. B | September 2023
For Research Use Only (RUO). Not intended for diagnostic purposes.

Page 2 of 6

Table of Contents
1.

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

2.

PRODUCT USE .................................................................................................................................................................................................... 3

3.

REAGENTS........................................................................................................................................................................................................... 4

4.

3.1.
3.2.
3.3.
3.4.

PROCEDURE ........................................................................................................................................................................................................ 5

5.

INTERPRETATION OF RESULTS.......................................................................................................................................................................... 56.

SYMBOLS ............................................................................................................................................................................................................. 67.

TECHNICAL AND CUSTOMER SERVICE ............................................................................................................................................................... 6

8.

LEGAL NOTICE .................................................................................................................................................................................................... 6

RNA Sensitivity Panels ................................................................................................................................................................................................................ 4
RNA Controls.................................................................................................................................................................................................................................... 4Warnings and Precautions ........................................................................................................................................................................................................ 5
Storage and Stability .................................................................................................................................................................................................................... 5

RNA Controls and Sensitivity Panels

For Research Use Only (RUO). Not intended for diagnostic purposes.

280532 Rev. B | September 2023

Page 3 of 6

1.

Proprietary Name

Table 1. Proprietary Product Names

Catalog Number
40870030
40870110
40870150
40870200
40870320
40890200
40890210
4089022040890230
40890240
40890920
40890930
40890940
40890950
40890960
40892810
40892820
40892830
40892840
408928502.

Product Name
Sensitivity Panel - IVS-0003 Clonal Control RNA
Sensitivity Panel - IVS-0011 Clonal Control RNA
Sensitivity Panel - IVS-0015 Clonal Control RNA
Sensitivity Panel - IVS-0020 Clonal Control RNA
Sensitivity Panel - IVS-0032 Clonal Control RNA
10-1 IVS-0003 Clonal Control RNA
10-2 IVS-0003 Clonal Control RNA
10-3 IVS-0003 Clonal Control RNA
10-4 IVS-0003 Clonal Control RNA
10-5 IVS-0003 Clonal Control RNA
10-1 IVS-0011 Clonal Control RNA
10-2 IVS-0011 Clonal Control RNA
10-3 IVS-0011 Clonal Control RNA
10-4 IVS-0011 Clonal Control RNA
10-5 IVS-0011 Clonal Control RNA
10-1 IVS-0032 Clonal Control RNA
10-2 IVS-0032 Clonal Control RNA
10-3 IVS-0032 Clonal Control RNA
10-4 IVS-0032 Clonal Control RNA
10-5 IVS-0032 Clonal Control RNA

Quantity
1 Panel – 7 Tubes - 100 µL each
1 Panel – 7 Tubes - 100 µL each
1 Panel – 7 Tubes - 100 µL each
1 Panel – 7 Tubes - 100 µL each
1 Panel – 7 Tubes - 100 µL each
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL
1 Tube - 100 µL

Product Use

Invivoscribe’s RNA Controls and Panels are intended for validation by the end user for use in molecular assays. These controls arespecific to gene rearrangements, mutations, and/or translocations from human RNA, indicated in section 3. Reagents.
These products are for Research Use Only. Not intended for diagnostic purposes.

RNA Controls and Sensitivity Panels

For Research Use Only (RUO). Not intended for diagnostic purposes.

280532 Rev. B | September 2023

Page 4 of 6

3.

Reagents
3.1.

RNA Sensitivity Panels

Invivoscribe RNA Sensitivity Panels are seven (7) member panels that consist of 100% clonal RNA extracted from a positive
control cell line and 10-1, 10-2, 10-3, 10-4, 10-5, and 10-6 dilutions of the positive clonal RNA diluted (v/v) into our standard negative
control RNA, IVS-0035 Clonal Control RNA.
Controls are adjusted to the final concentration specified in Table 2 with molecular grade water.

Table 2. RNA Sensitivity Panels

Catalog Number

Description

Concentration

Target40870030

Sensitivity Panel - IVS-0003 Clonal Control RNA

400 µg/mL

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

40870110

Sensitivity Panel - IVS-0011 Clonal Control RNA

400 µg/mL

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

40870150

Sensitivity Panel - IVS-0015 Clonal Control RNA

400 µg/mL

CBFB-MYH11 inv(16)40870200

Sensitivity Panel - IVS-0020 Clonal Control RNA

400 µg/mL

PML-RARα t(15;17)(q22;q11)

40870320

Sensitivity Panel - IVS-0032 Clonal Control RNA

400 µg/mL

BCR-ABL1 t(9;22) p190 e1a2

StorageConditions**Minimize the number of freeze-thaw cycles.

3.2.

RNA Controls

Invivoscribe RNA Controls are extracted from established cell lines grown under standard cell culture conditions. These controls
are available as several ready-to-use dilutions into a standard negative control, IVS-0035 Clonal Control RNA, as listed in thetable below.
Controls are adjusted to the final concentration specified in Table 3 with molecular grade water.

Table 3. RNA Controls

Catalog Number

Description

Concentration

40890200

10-1 IVS-0003 Clonal Control RNA

400 µg/mL

4089021010-2 IVS-0003 Clonal Control RNA

400 µg/mL

4089022010-3 IVS-0003 Clonal Control RNA

400 µg/mL

40890230

10-4 IVS-0003 Clonal Control RNA

400 µg/mL

40890240

10-5 IVS-0003 Clonal Control RNA

400 µg/mL

40890920

10-1 IVS-0011 Clonal Control RNA

400 µg/mL

40890930

10-2 IVS-0011 Clonal Control RNA

400 µg/mL

40890940

10-3 IVS-0011 Clonal Control RNA

400 µg/mL

40890950

10-4 IVS-0011 Clonal Control RNA

400 µg/mL40890960

10-5 IVS-0011 Clonal Control RNA

400 µg/mL

4089281010-1 IVS-0032 Clonal Control RNA

400 µg/mL

40892820

10-2 IVS-0032 Clonal Control RNA

400 µg/mL

40892830

10-3 IVS-0032 Clonal Control RNA

400 µg/mL

40892840

10-4 IVS-0032 Clonal Control RNA

400 µg/mL

40892850

10-5 IVS-0032 Clonal Control RNA

400 µg/mL

StorageConditions*TargetBCR-ABL1 t(9;22) p210 e13a2 (b2a2)

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

BCR-ABL1 t(9;22) p190 e1a2

*Minimize the number of freeze-thaw cycles.

RNA Controls and Sensitivity Panels

For Research Use Only (RUO). Not intended for diagnostic purposes.

280532 Rev. B | September 2023

Page 5 of 6

3.3.

Warnings and Precautions







3.4.

Storage and Stability4.

5.

Invivoscribe’s RNA Controls and Panels are for Research Use Only. Not intended for diagnostic purposes.
Establish standard operating procedures and instructions for using the Invivoscribe RNA Controls or Panels 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 oraccreditation 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 nucleic acid 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 nucleic acid into the areas
designated for 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 plasticware whenever possible to avoid RNase, DNase, and cross-contamination.

When stored at the intended storage conditions, Invivoscribe’s RNA Controls and Panels are stable until theexpiration date indicated on the vial label.

Procedure
4.1.

Allow the RNA Control or Panel to equilibrate to room temperature.

4.2.

Vortex gently, then pulse-spin in a centrifuge (4 to 6 seconds) to collect the contents at the bottom of the tube.

4.3.

Introduce the RNA Control or Panel as an independent sample at the template addition step in the workflow.

4.4.

Handle the RNA Control or Panel similarly to nucleic acids extracted from routine samples and run in parallel withroutine samples.

Interpretation of Results
5.1.

Results generated by Invivoscribe’s RNA Controls and Panels may differ according to the molecular test method.

5.2.

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.

5.3.

Once the validated size range is ascertained, the expected size range can be used to verify each subsequent run resultof the RNA Control or Panel.

RNA Controls and Sensitivity Panels

For Research Use Only (RUO). Not intended for diagnostic purposes.

280532 Rev. B | September 2023

Page 6 of 66.

Symbols

The following symbols are used in labeling for Invivoscribe products.

7.

Catalog Number

Expiration Date

Reagent Volume

Manufacturer

Lot Number

Consult Instructions for Use

Storage Conditions

Research Use Only

Technical and Customer ServiceTechnical 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.
Contact Information
Invivoscribe, Inc
10222 Barnes Canyon Road | Building 1 | San Diego | California 92121-2711 | USA
Phone: +1 858 224-6600 | Fax: +1 858 224-6601 | Business Hours: 7:00AM - 5:00 PM PST/PDT
Technical Service: support@invivoscribe.com | Customer Service: sales@invivoscribe.com | Website: www.invivoscribe.com

8.

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 notlimited to testing of internally validated positive, negative, and blank controls every time a sample is tested. Ordering, acceptanceand use of product constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement
to the limitation of liability set forth in this paragraph.
This product is for Research Use Only; not for use in diagnostic procedures.
©2023 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.

RNA Controls and Sensitivity Panels

For Research Use Only (RUO). Not intended for diagnostic purposes.

280532 Rev. B | September 2023