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    FilmArray® BCID Control Panel M235v1.1:
 
Product Name

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 provided.  DO NOT DILUTE.
  3. Prepare and hydrate a pouch according to FilmArray® Instructions.
  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 cap.
  5. Aspirate the control using the FilmArray® transfer pipette.
  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 regulations.

PRECAUTIONS and WARNINGS:

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

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

 

Assay

M23618

Call

M23718

Call

Antimicrobial Resistance Genes

KPC – carbapenem-resistance gene

Detected

N/A

mecA – methicillin-resistance gene

Detected

N/A

vanA/B – vancomycin-resistance genes

Detected

N/A

Gram Positive Bacteria

Enterococcus

Detected

Not Detected

Listeria monocytogenes

Detected

Not Detected

Staphylococcus

Detected

Not Detected

Staphylococcus aureus

Detected

Not Detected

Streptococcus

Detected

Not Detected

Streptococcus agalactiae

Detected

Not Detected

Streptococcus pneumoniae

Detected

Not Detected

Streptococcus pyogenes

Detected

Not Detected

Gram Negative Bacteria

Acinetobacter baumannii

Detected

Not Detected

Enterobacteriaceae

Detected

Not Detected

Enterobacter cloacae complex

Detected

Not Detected

Escherichia coli

Detected

Not Detected

Klebsiella oxytoca

Detected

Not Detected

Klebsiella pneumoniae

Detected

Not Detected

Proteus

Detected

Not Detected

Serratia marcescens

Detected

Not Detected

Haemophilus influenzae

Detected

Not Detected

Neisseria meningitidis

Detected

Not Detected

Pseudomonas aeruginosa

Detected

Not Detected

Yeast

Candida albicans

Detected

Not Detected

Candida glabrata

Detected

Not Detected

Candida krusei

Detected

Not Detected

Candida parapsilosis

Detected

Not Detected

Candida tropicalis

Detected

Not Detected

 

ORDERING INFORMATION:

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

 

Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco, Maine 04072 USA

Phone: 207-885-1072, FAX: 207-885-1079

Web:  www.mmqci.com, Email: info@mmqci.com

1. ISO 15189: Medical laboratories – Particular requirements for quality and competence.

2. CAP Molecular Pathology Checklist; Commission on Laboratory Accreditation, Laboratory Accreditation Program, Mol.20000


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.