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    FilmArray® RP Control Panel M210 v1.1:
 
Product Name

The FilmArray® RP Control Panel M210 v1.1 is intended for in vitro use as a quality control to monitor the detection and identification of multiple respiratory viral and bacterial targets in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections when tested by the FilmArray® Respiratory Panel on the FilmArray® instrument.

FilmArray® RP Control Panel M210 v1.1 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

PRODUCT SUMMARY and PRINCIPLE:
FilmArray® RP Control Panel M210 v1.1 is 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® RP Control Panel M210 v1.1 is comprised of 12 tubes 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® RP Control Panel M210 v1.1 when tested by the FilmArray® Respiratory Panel on the FilmArray® instrument.

STORAGE and STABILITY:

FilmArray® RP Control Panel M210 v1.1 should be stored frozen (–20°C or colder). Unopened FilmArray® RP Control Panel M210 v1.1 material is stable through the expiration date printed on the kit label when continuously stored frozen. FilmArray® RP Control M211 v1.1 and FilmArray® RP Control M212 v1.1 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. Prepare and hydrate a pouch according to FilmArray® Instructions.
  3. Immediately before use, mix the control by flicking the tube several times and then shake the tube down firmly to remove any control caught in the cap.
  4. Aspirate the control using the FilmArray® transfer pipette.
  5. Analyze the FilmArray® RP Control M211 v1.1 and FilmArray® RP Control M212 v1.1 as you would a patient sample.
  6. Discard after use according to your local and federal regulations.

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 is cloudy in appearance.
  • This product contains 10% ethanol (v/v) and could be flammable. Keep away from open flames.
  • 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® RP Control Panel M210 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.

FilmArray® Result Details Table 1

Assay

M211v1.1

Call

M212v1.1

Call

Adenovirus                             Adeno

Positive

Negative

Adeno2

Positive

Negative

Coronavirus 229E

Negative

Positive

Coronavirus HKU1

Negative

Positive

Coronavirus NL63

Negative

Positive

Coronavirus OC43

Negative

Positive

Human Metapneumovirus

Positive

Negative

Human Rhinovirus/ Enterovirus

Entero 1

Positive

Negative

Entero 2

Positive

Negative

HRV1

Positive

Negative

HRV2

Positive

Negative

HRV3

Positive

Negative

HRV4

Positive

Negative

Influenza A H1-2009

FluA-H1-2009

Positive

Negative

Influenza A H3

FluA-H1-pan

Positive

Positive

 

FluA-H3

Positive

Negative

 

FluA-pan1

Negative

Positive

 

FluA-pan2

Positive

Negative

Influenza B

Negative

Positive

Parainfluenza Virus 1

Positive

Negative

Parainfluenza Virus 2

Negative

Positive

Parainfluenza Virus 3

Negative

Positive

Parainfluenza Virus 4

Positive

Negative

Respiratory Syncytial Virus

Negative

Positive

Bordetella pertussis

Negative

Positive

Chlamydophila pneumoniae

Negative

Positive

Mycoplasma pneumoniae

Negative

Positive

ORDERING INFORMATION:
FilmArray® RP Control Panel M210 v1.1
Part Number:      M210v1.1
Kit Contains:        12 tubes x 300uL (6 each of M2115513v1.1 & M2126713v1.1)

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

 


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