The INTROL 2C19 Panel P105 is designed for in vitro use as quality control to monitor the analytical performance of the extraction, amplification, and detection steps of the test systems used in the qualitative measurement of the 10 most common cytochrome P450 mutations. 2C19 (CYP2C19) affecting drug metabolism. This product is designed to be routinely extracted and analyzed with each CYP2C19 test run.
INTROL 2C19 Panel P105 is proprietary and cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.
PRODUCT SUMMARY and PRINCIPLE:
INTROL Panel is synthetic DNA of cytochrome P450 2C19 (CYP2C19) suspended in a non-infectious matrix with preservatives and stabilizers. DNA must be extracted and purified from its matrix prior to analysis.
The best practice is to establish a quality control program for each assay performed by the laboratory.1, 2 Routine use of quality controls that are consistent batch-to-batch and monitoring the entire assay helps the laboratory identify changes, trends, and higher frequency of random analyzes. Errors caused by variations in the test system, such as faulty reagents. Early investigation can prevent failed trial runs.
The INTROL 2C19 Panel P105 consists of three bottles of CYP2C19 synthetic DNA suspended in a non-infectious matrix with preservatives and stabilizers. Each bottle contains the genotypes listed in the Table of Expected Results.
STORAGE and STABILITY:
INTROL 2C19 Panel P105 should be stored refrigerated (2 ° – 8 ° C). It is acceptable for this material to come to room temperature. However, upon receipt, the material must be refrigerated (2 ° – 8 ° C) immediately.
Unopened INTROL 2C19 Panel P105 material is stable until 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:
Allow INTROL 2C19 Panel P105 to reach room temperature (18 ° – 25 ° C). Mix the controls well before opening by inverting the bottles several times immediately before use or by placing them in an automatic device.
Draw INTROL 2C19 Panel P105 in the same way as a whole blood sample. Use the same volume that would be used for a patient sample in your laboratory.
Analyze the extracted DNA as you would genomic DNA. If dilutions or other preparations of the extracted DNA are required as part of the test procedure, handle the INTROL 2C19 Panel P105 DNA in the same way as in the clinical case.
Recap each control bottle tightly after use and store refrigerated (2 ° – 8 ° C).
Note: INTROL ™ 2C19 Panel P105 DNA extracts cannot be quantified by spectrophotometric methods.
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PRECAUTIONS and WARNINGS:
This product is designed 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 can be kept away from open flames. This product does not contain any biological material of human origin. INTROL 2C19 Panel P105 is not designed to freeze and is shipped with a DO NOT FREEZE label. This product has been tested in various extraction and testing methods, but please do not contact MMQCI for information on their analysis system.
The laboratory must follow Good Laboratory Practices (GLP) and establish its own performance characteristics for INTROL 2C19 Panel P105 to demonstrate adequate system performance. Recoveries may vary based on the extraction method, instrumentation, cycle time/temperature, reagents, method variation, and systematic or random errors. The genotypes expected when the control is tested are listed in Table 1 of Expected Results.