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    FilmArray® GI Control Panel M238:
 
Product Name

INTENDED USE:

The FilmArray® GI Control Panel M238 is intended for in vitro use as a quality control to monitor the detection and identification of multiple gastrointestinal pathogens as performed by the FilmArray® Gastrointestinal (GI) Panel assay on the FilmArray® instrument. Detection of the viruses, bacteria and protozoa listed in Table 1 is an important aid to the diagnosis of gastrointestinal illness.

FilmArray® GI Control Panel M238 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

PRODUCT SUMMARY and PRINCIPLE:

FilmArray® GI Control Panel M238 is comprised of synthetic RNA 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® GI Control Panel M238 is comprised of 12 tubes, 200µL each, of synthetic RNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. Table 1 lists the pathogens that are monitored by the FilmArray® GI Control Panel M238 when tested by the FilmArray® Gastrointestinal Panel on the FilmArray® instrument.

STORAGE and STABILITY:

FilmArray® GI Control Panel M238 should be stored frozen (–20°C or colder).  Unopened FilmArray® GI Control Panel M238 is stable through the expiration date printed on the kit label when continuously stored frozen. FilmArray® GI Control M239 and FilmArray® GI Control M240 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. Using the FilmArray® transfer pipette, draw up the control to 2nd line.
  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® GI Control Panel M238 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

M2393718

Call

M2402818

Call

Bacteria

Campylobacter

Not Detected

Detected

Clostridium difficile toxin A/B

Detected

Not Detected

Plesiomonas shigelloides

Detected

Not Detected

Salmonella

Not Detected

Detected

Vibrio

Detected

Not Detected

Vibrio cholerae

Detected

Not Detected

Yersinia enterocolitica

Detected

Not Detected

Diarrheagenic E.coli/Shigella

Enteroaggregative E. coli (EAEC)

Detected

Not Detected

Enteropathogenic E. coli (EPEC)

Ø  N/A

Detected

Enterotoxigenic E. coli (ETEC) lt/st

Not Detected

Detected

Shiga-like toxin-producing E. coli (STEC) stx1/stx2

Detected

Not Detected

E. coli O157

Detected

Ø  N/A

Shigella/Enteroinvasive E. coli (EIEC)

Detected

Not Detected

Parasites

Cryptosporidium

Detected

Not Detected

Cyclospora cayetanensis

Not Detected

Detected

Entamoeba histolytica

Not Detected

Detected

Giardia lamblia

Not Detected

Detected

Viruses

Adenovirus F 40/41

Detected

Not Detected

Astrovirus

Not Detected

Detected

Norovirus GI/GII

Not Detected

Detected

Rotavirus A

Not Detected

Detected

Sapovirus

Detected

Not Detected

 

ORDERING INFORMATION:

FilmArray® GI Control Panel M238

Part Number: M238

Kit Contains:           12 tubes x 200 µL

6 each of M2393718 & M2402818


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

M238 052714.001

 


Maine Molecular Quality Controls Inc. | Telephone: 207.885.1072 | Fax: 207.885.1079 | Email
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