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    FilmArray RP2/RP2plus Control Panel M315:
 
Product Name

INTENDED USE:

FilmArray RP2/RP2plus Control Panel is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3,  Influenza A subtype H1-2009, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus,  Respiratory Syncytial Virus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the FilmArray® RP2 and FilmArray® RP2plus assay performed on the FilmArray® systems. FilmArray RP2/RP2plus Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray® RP2 assay and FilmArray® RP2plus assay. This product is not intended to replace manufacturer controls provided with the device.

PRODUCT SUMMARY and PRINCIPLE:

FilmArray RP2/RP2plus Control Panel is composed of 2 controls, FilmArray RP2/RP2plus Positive and FilmArray RP2/RP2plus Negative. FilmArray RP2/RP2plus Positive contains surrogate control material composed of synthetic RNA transcripts corresponding to genome segments of pathogens listed in Table 1. FilmArray RP2/RP2plus Negative contains non-target RNA.

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. At a minimum, controls should be run at the frequency recommended by the FilmArray® RP2/RP2plus manufacturer’s recommendations for external quality control testing.

STORAGE and STABILITY:

FilmArray RP2/RP2plus Control Panel should be stored frozen (–20°C or colder). Unopened FilmArray RP2/RP2plus Control Panel material is stable through the expiration date printed on the kit label when continuously stored frozen. FilmArray RP2/RP2plus Positive and FilmArray RP2/RP2plus Negative are for single use. Discard after use according to your local and federal regulations.

COMPOSITION:

The FilmArray RP2/RP2plus Control Panel is comprised of 12 tubes, 300µL 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 RP2/RP2plus Control Panel when tested by the FilmArray® RP2 assay and FilmArray® RP2plus on the FilmArray instrument.

INSTRUCTIONS FOR USE:

Note: Use one FilmArray® RP2 assay Pouch or FilmArray® RP2plus Pouch to perform the negative control test, and another FilmArray® RP2 assay Pouch or FilmArray® RP2plus Pouch to perform the positive control test.

  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. Immediately before use, mix the control thoroughly by first inverting several times followed by briefly vortexing the tube for 3-5 seconds. Tap the tube several times on the bench to remove any control caught in the cap before opening the tube.
  4. Prepare and run a FilmArray® RP2 Pouch or FilmArray® RP2plus Pouch, using the control as you would use a patient specimen, according to FilmArray® RP2 or FilmArray® RP2plus Quick Guide or Instruction Booklet.
  5. Discard control tube after use according to your local and federal regulations.

PRECAUTIONS, WARNINGS and LIMITATIONS:

  • Do not dilute.
  • This product is intended for in vitro analytical testing and is provided for Research Use Only (RUO), not for use in diagnostic procedures.
  • This product is only for use with FilmArray® Respiratory Panel 2 (RP2) or FilmArray® Respiratory Panel 2 plus (RP2plus) on the FilmArray® 2.0 or FilmArray® Torch systems. It does not contain the entire genome of the respiratory pathogens listed in Table 1. This product is not compatible with the FilmArray Respiratory Panel (RP) assay.
  • This product is not intended for use as a substitute for the internal controls provided in the FilmArray® RP2 assay or FilmArray® RP2plus assay.
  • This product is slightly cloudy in appearance.
  • This product does not contain any biological material of human or animal origin.  Universal Precautions are NOT required when handling this product.
  • Quality control materials should be used in accordance with local, state, federal regulations and accreditation requirements.
  • FilmArray RP2/RP2plus Control Panel cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

EXPECTED VALUES:

The expected results when the controls are analyzed are listed in Tables 1 and 2.

Table 1: FilmArray RP2/RP2plus Positive FilmArray Result Summary

Results Summary

Detected

Not Detected

Viruses

  • Adenovirus
  • Coronavirus 229E
  • Coronavirus HKU1
  • Coronavirus NL63
  • Coronavirus OC43
  • Human Metapneumovirus
  • Human Rhinovirus/ Enterovirus
  • Influenza A H1-2009
  • Influenza A H3
  • Influenza B
  • Middle East Respiratory Syndrome Coronavirus*
  • Parainfluenza Virus 1
  • Parainfluneza Virus 2
  • Parainfluenza Virus 3
  • Parainfluenza Virus 4
  • Respiratory Syncytial Virus

 

Bacteria

  • Bordetella  parapertussis (IS1001)
  • Bordetella pertussis (ptxP)
  • Chlamydia pneumonia
  • Mycoplasma pneumoniae

 

* Middle East Respiratory Syndrome Coronavirus is reported on RP2plus only

 

Table 2: FilmArray RP2/RP2plus Negative FilmArray Result Summary

Results Summary

Detected

Not Detected

Viruses

 

  • Adenovirus
  • Coronavirus 229E
  • Coronavirus HKU1
  • Coronavirus NL63
  • Coronavirus OC43
  • Human Metapneumovirus
  • Human Rhinovirus/ Enterovirus
  • Influenza A
  • Influenza B
  • Middle East Respiratory Syndrome Coronavirus*
  • Parainfluenza Virus 1
  • Parainfluneza Virus 2
  • Parainfluenza Virus 3
  • Parainfluenza Virus 4
  • Respiratory Syncytial Virus

Bacteria

 

  • Bordetella parapertussis (IS1001)
  • Bordetella pertussis (ptxP)
  • Chlamydia pneumoniae
  • Mycoplasma pneumoniae

* Middle East Respiratory Syndrome Coronavirus is reported on RP2plus only

ORDERING INFORMATION:

FilmArray RP2/RP2plus Control Panel
Part Number:        M315
Kit Contains:          12 tubes x 300µL, 6 Positive controls and 6 Negative controls

Maine Molecular Quality Controls, Inc.
23 Mill Brook Road, Saco, ME 04072 USA
Phone: 207-885-1072, FAX: 207-885-1079

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

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.