INTROL® PGx 1 Control

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SKU:
P102-1
Size:
3 x 1 mL
DataSheet:
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€540.00
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Description

MMQCI INTROL PGx 1 Control

P/N P102-1 contains: 1 mL per bottle 3 bottles, P101b-1, P101c-1, P101d-1

INTROL® PGx 1 Control DataSheet

INTENDED USE

The INTROL PGx 1 Control is intended for in vitro use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of test systems used in the qualitative measurement of nucleotide variants of Cytochrome P450 2C9 (CYP2C9) that may affect an individual’s response to warfarin. This product is intended to be extracted and analyzed routinely with each CYP2C9 test run.

INTROL PGx 1 Control cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

SUMMARY AND PRINCIPLE

INTROL PGx 1 Control is synthetic Cytochrome P450 2C9 (CYP2C9), Cytochrome P450 4F2 (CYP4F2), and Vitamin K Epoxide Reductase Complex, Subunit 1 (VKORC1) DNA suspended in a non-infectious matrix with preservatives and stabilizers. The DNA should be extracted and purified from its matrix before analysis.

Specific nucleotide polymorphisms found in INTROL PGx 1 Control that may be associated with wafarin (Coumadin®) sensitivity are listed in the Variants Table 1.

KIT COMPONENTS

The INTROL PGx 1 Control kit consists of three bottles of synthetic CYP2C9/CYP4F2/VKORC1 DNA suspended in a non- infectious matrix with preservatives and stabilizers. Each bottle contains the genotypes listed in the Variants Table 1.

STORAGE AND STABILITY

INTROL PGx 1 Control should be stored refrigerated (2° – 8°C). It is acceptable for this material to arrive at room temperature. However, upon receipt, material should be refrigerated (2° – 8°C) immediately.

Unopened INTROL PGx 1 Control material is stable through the expiration date printed on each bottle when stored refrigerated (2° – 8°C). Opened material returned to the refrigerator (2° – 8°C) immediately after use is stable for thirty (30) days from the date of opening.

INSTRUCTIONS FOR USE

  1. Allow INTROL PGx 1 Control to come to room temperature (18° – 25°C).
  2. Thoroughly mix the controls prior to opening by inverting the bottles several times immediately before use, or by placing on an automated
  3. Extract INTROL PGx 1 Control in the same manner as a whole blood Use the same volume that would be used for a patient sample in your lab.
  4. Analyze the extracted DNA as you would genomic DNA according to test manufacturers’ instructions.
  5. Tightly recap each control bottle after use and store refrigerated (2° - 8°C).

Note: INTROL PGx 1 Control DNA extracts cannot be quantified by spectrophotometric methods.

PRECAUTIONS AND WARNINGS

  • This product is intended for in vitro analytical testing and is provided for Research Use Only, not for use in diagnostic procedures
  • This product contains 23% ethanol (v/v) and could be Keep away from open flames.
  • This product does not contain any biological material of human origin.
  • INTROL PGx 1 products are not intended to be frozen and are shipped with a DO NOT FREEZE label.

EXPECTED VALUES

The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for INTROL PGx 1 in demonstrating adequate system performance. Recoveries may vary depending on extraction method, instrumentation, cycle time / temperature, reagents, method variation, and systematic or random errors. Nucleotide variants found in INTROL PGx 1 are listed in the Variants Table 1.

INTROL PGx 1 Control Variants Table 1.

Polymorphism (Allele)

Bottle b

Bottle c

Bottle d

CYP2C9

430C>T (*2)

C/T

C/C

T/T

1075A>C (*3)

A/C

C/C

A/A

1080C>G (*5)

C/G

C/C

G/G

818delA (*6)

A/delA

A/A

delA/delA

1003C>T (*11)

C/T

C/C

T/T

374G>A (*14)

G/A

A/A

G/G

485C>A (*15)

C/A

C/C

A/A

895A>G (*16)

A/G

A/A

G/G

VKORC1 Promoter

-1639G>A

G/A

G/G

A/A

5808 (497T>G)

T/G

T/T

G/G

6009 (698C>T)

C/T

T/T

C/C

6484 (1173C>T)

C/T

C/C

T/T

6853 (1542G>C)

G/C

G/G

C/C

7566 (2255C>T)

C/T

C/C

T/T

9041 (3730G>A)

G/A

A/A

G/G

CYP4F2

1347G>A

G/A

G/G

A/A

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1 Review

  • 5
    INTROL® PGx 1 Control

    Posted by MMQC on 11th Jun 2021

    The INTROL PGx 1 Control is intended for in vitro use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of test systems used in the qualitative measurement of nucleotide variants of Cytochrome P450 2C9 (CYP2C9) that may affect an individual’s response to warfarin. This product is intended to be extracted and analyzed routinely with each CYP2C9 test run.

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