MMQCI FilmArray^® BCID Control Panel M235 v1.1

Part Number: M235v1.1

Kit Contains:         12 tubes x 200 µL

6 each of M23618v1.1 & M23718v1.1

FilmArray® BCID Control Panel M235 v1.1 DataSheet

INTENDED USE:

The FilmArray^® BCID Control Panel M235 v1.1 is intended for in vitro use as a quality control to monitor the detection and identification of multiple pathogens and antibiotic resistance genes associated with blood stream infections when tested by the FilmArray^® Blood Culture Identification Panel on the FilmArray^® instrument.

FilmArray^® BCID Control Panel M235 v1.1 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

PRODUCT SUMMARY and PRINCIPLE:

FilmArray^® BCID Control Panel M235 v1.1 is comprised of synthetic DNA suspended in a non-infectious solution of buffers, preservatives and stabilizers.

Best practice is to establish a quality control program for every assay performed by the laboratory.^{1, 2} Routine use of quality controls 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.

COMPOSITION:

The FilmArray^® BCID Control Panel M235 v1.1 is comprised of 12 tubes, 200µL each, of synthetic DNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. Table 1 lists the pathogens that are monitored by the FilmArray^® BCID Control Panel M235 v1.1 when tested by the FilmArray^® Blood Culture Identification Panel on the FilmArray^® instrument.

STORAGE and STABILITY:

FilmArray^® BCID Control Panel M235 v1.1 should be stored at 2 - 8°C. Unopened FilmArray^® BCID Control Panel M235 v1.1 is stable through the expiration date printed on the kit label when stored refrigerated (2° – 8°C). FilmArray^® BCID Positive Control and FilmArray^® BCID Negative Control are for single use. Discard after use according to your local and federal regulations.

INSTRUCTIONS FOR USE:

1. Allow the control to be tested to come to room temperature (18° – 25°C).
2. Use the control as DO NOT DILUTE.
3. Prepare and hydrate a pouch according to FilmArray^®
4. Immediately before use, mix the control by briefly vortexing the tube for 3 – 5 seconds and then shake the tube down firmly to remove any droplets caught in the
5. Aspirate the control using the FilmArray^® transfer
6. Analyze the control as you would a patient sample by adding the control to the FilmArray^® Sample Buffer.
7. Discard after use according to your local and federal

PRECAUTIONS and WARNINGS:

• Do not
• This product is intended for in vitro analytical testing and is provided for Research Use Only, not for use in diagnostic
• This product does not contain any biological material of human

EXPECTED VALUES:

The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for FilmArray^® BCID Control Panel M235 v1.1 in demonstrating adequate system performance. Recoveries may vary depending on instrumentation, reagents and systematic or random errors. The expected results when the controls are analyzed are listed in Table 1.

Table 1: FilmArray^® Result Summary Interpretation

1. ISO 15189: Medical laboratories – Particular requirements for quality and
2. CAP Molecular Pathology Checklist; Commission on Laboratory Accreditation, Laboratory Accreditation Program, 20000