MMQCI
MMQCI

WE HAVE MOVED!

Subscribe to MMQCI E-Announcements
Email:

logo-rule
    Xpert BCR-ABL IS Panel C130:
 
Product Name

INTENDED USE:

The Xpert BCR-ABL IS Panel C130 is intended for use as a reference material to monitor the performance of the in vitro quantitative detection of the BCR-ABL1 translocation mRNA e13a2/b2a2 or e14a2/b3a2 transcripts and the ABL1 endogenous control mRNA transcript when analyzed using the GeneXpert® BCR-ABL V2 assay, or the Xpert® BCR-ABL Ultra assay on the Cepheid GeneXpert® Instrument Systems.

The Philadelphia chromosome, a translocation between the ABL1 gene on chromosome 9 and the BCR gene on chromosome 22, designated as t(9;22), generates the fusion gene BCR-ABL1 which is present in most chronic myelogenous leukemia patients. Quantitative monitoring of BCR-ABL1 transcripts in patient blood is an important tool for measuring response to therapy. In 2009, the World Health Organization (WHO) developed a panel of four BCR-ABL1 primary standards to establish an international scale (IS), a standardized method for reporting assay results as a ratio of fusion transcripts to control gene transcripts (%IS), useful to the harmonization of patient care across laboratories worldwide.1,2 The Xpert BCR-ABL IS Panel C130 is designed for use with the GeneXpert® BCR-ABL V2 and Xpert® BCR-ABL Ultra assays which report on the international scale.

STORAGE and STABILITY:

Xpert BCR-ABL IS Panel C130 should be stored at -20oC. Unopened Xpert BCR-ABL IS Panel C130 material is stable through the expiration date printed on the kit label when continuously stored frozen. Xpert BCR-ABL IS Panel C130 components are for single use. Discard after use according to your local and federal regulations.

PRODUCT SUMMARY and PRINCIPLE:

Xpert BCR-ABL IS Panel C130 is composed of six %IS levels:

Xpert BCR-ABL 0%IS
Xpert BCR-ABL 0.0032%IS
Xpert BCR-ABL 0.01%IS
Xpert BCR-ABL 0.1%IS
Xpert BCR-ABL 1%IS
Xpert BCR-ABL 10%IS

Xpert BCR-ABL IS Panel C130 is a set of reference materials which contain synthetic RNA transcripts of BCR-ABL1 (e14a2/b3a2) at six concentrations, each mixed with synthetic RNA transcripts of the ABL1 control gene at one concentration. The panel is designed to represent a range of BCR-ABL1/ABL1 ratios to generate %IS values. The six levels, each containing fusion and control transcripts, were produced to yield approximately 0.0%IS, 0.0032%IS, 0.01%IS, 0.1%IS, 1%IS and 10%IS when analyzed on the GeneXpert® Instrument Systems with the GeneXpert® BCR-ABL V2 or Xpert® BCR-ABL Ultra assay.

Figure 1 illustrates data generated from the Xpert BCR-ABL IS Panel C130 analyzed using one lot of GeneXpert BCR-ABL cartridges on a GeneXpert Instrument to demonstrate a linear dynamic range.

Routine use of reference materials that are consistent lot to lot assists the laboratory in identifying shifts, trends, and increased frequency of random errors caused by variations in the test system, such as failing reagents. Early investigation can prevent failed assay runs.

Figure 1.  Xpert BCR-ABL IS Panel C130 analyzed with one lot of GeneXpert® BCR-ABL V2 Assay

COMPOSITION:

Xpert BCR-ABL IS Panel C130 contains 12 single use bottles, 2 bottles of each %IS level consisting of synthetic BCR-ABL1 transcript and synthetic ABL1 control gene transcript suspended in a stabilizing matrix with a non-infectious solution of buffers and preservatives.

Xpert BCR-ABL IS Panel C130 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

INSTRUCTIONS FOR USE:

  1. Allow the Xpert BCR-ABL IS Panel C130 component to be tested to come completely to room temperature (18oC-25oC), approximately 30 minutes until bottles are warm to the touch.
  2. Immediately before use, mix the panel component by 5-10 inversions followed by brief vortexing (10-15 sec) at medium speed.
  3. Add 4mL of the panel component to 100µL of Proteinase K in a conical tube, as you would a blood specimen.
  4. Continue with the assay procedure according to manufacturer’s instructions.
  5. Discard after use according to local and federal regulations.

PRECAUTIONS and WARNINGS:

  • Do not dilute, re-freeze or transfer to another storage tube.
  • For Research Use Only. The performance characteristics of this product have not been established.
  • Use Xpert BCR-ABL IS Panel C130 with GeneXpert® BCR-ABL V2 or Xpert® BCR-ABL Ultra assays only
  • This product is cloudy in appearance.
  • This product does not contain any biological material of human or animal origin. Universal Precautions are NOT required when handling this product.

EXPECTED VALUES:

An example of results generated when one set of Xpert BCR-ABL IS Panel C130 is analyzed in singleton on a GeneXpert® Instrument System is listed in Table 1.

Table 1: Example of Xpert BCR-ABL IS Panel C130 Test Report

Xpert BCR-ABL IS Panel C130

Component

Test Result

Xpert BCR-ABL 0%IS

BCR-ABL was not detected at a detection limit of 0.00029% (IS)

Xpert BCR-ABL 0.0032%IS

BCR-ABL has been detected at a level of 0.0065% (IS)

Xpert BCR-ABL 0.01%IS

BCR-ABL has been detected at a level of 0.017% (IS)

Xpert BCR-ABL 0.1%IS

BCR-ABL has been detected at a level of 0.2% (IS)

Xpert BCR-ABL 1%IS

BCR-ABL has been detected at a level of 1.2% (IS)

Xpert BCR-ABL 10%IS

BCR-ABL has been detected at a level of 8.6% (IS)

Analyte Results

Analyte Name

Ct

EndPt

Analyte Result

Probe Check

Result

Target Delta Ct

Xpert BCR-ABL 0%IS

BCR-ABL

0.0

2

NEG

PASS

 

ABL

11.4

412

PASS

PASS

Xpert BCR-ABL 0.0032%IS

BCR-ABL

26.7

461

POS

PASS

-15.6

ABL

11.1

413

PASS

PASS

Xpert BCR-ABL 0.01%IS

BCR-ABL

25.2

549

POS

PASS

-14.0

ABL

11.2

418

PASS

PASS

Xpert BCR-ABL 0.1%IS

BCR-ABL

21.0

662

POS

PASS

-10.1

ABL

11.0

372

PASS

PASS

Xpert BCR-ABL 1%IS

BCR-ABL

18.4

689

POS

PASS

-7.1

ABL

11.3

418

PASS

PASS

Xpert BCR-ABL 10%IS

BCR-ABL

14.3

727

POS

PASS

-4.0

ABL

10.3

422

PASS

PASS

1Branford S et al. Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials. Blood 2008, 112:3330-38

2White HE et al. Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. Blood 2010, 116:e111-117

ORDERING INFORMATION:

Xpert BCR-ABL IS Panel C130

Part Number: C130

Kit Contains:
12 bottles x 4mL
2 each of 6 %IS levels

Safety Data Sheet

 


Maine Molecular Quality Controls Inc. | Telephone: 207.885.1072 | Fax: 207.885.1079 | Email
| 17 years of quality commitment

© 2017 Maine Molecular Quality Controls, INC.