The BioFire® RP2.1/RP2.1plus M441 Control Panel is designed to be used as an external positive and quality control assayed negative to monitor in vitro laboratory performance nucleic acid test procedures for the qualitative detection of adenovirus, coronavirus, Human metapneumovirus, human rhinovirus/enterovirus, influenza A, influenza A H1 subtype, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Medium Eastern Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumonia and Mycoplasma pneumonia in the BioFire® 2.1 Respiratory Panel (RP2.1), BioFire® 2.1plus Respiratory Panel (RP2.1plus) and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays performed on the BioFire® FilmArray® systems.
BioFire RP2.1/RP2.1plus Positive Control is composed of RNA transcripts specifically designed and intended for use with BioFire only RP2.1, BioFire RP2.1plus and BioFire RP2.1-EZ assays. This product is not intended to replace the manufacturer’s controls provided with the device.
Product Summary and Principle:
The BioFire RP2.1/RP2.1plus M441 Control Panel is comprised of 2 controls, BioFire RP2.1/RP2.1plus Positive and BioFire RP2.1/RP2.1plus Negative. bio fire RP2.1/RP2.1plus Positive contains surrogate control material composed of RNA transcripts corresponding to the genome segments of the pathogen. BioFire RP2.1/RP2.1plus Negative does not contain RNA. The routine use of quality controls that are consistent from lot to lot helps the laboratory to identify changes, trends, and increased frequency of random errors caused by variations in the test system, such as defective reagents. Early investigation can prevent failed trial runs.
The BioFire RP2.1/RP2.1plus M441 Control Panel consists of 12 single-use tubes, 6 BioFire RP2.1/RP2.1plus tubes Positive and 6 BioFire RP2.1/RP2.1plus tubes Negative, 300 µL each. BioFire RP2.1/RP2.1plus Positive Control contains RNA suspended in a non-infectious solution of buffers, preservatives, and stabilizers. BioFire RP2.1/RP2.1plus Negative Control contains buffers and preservatives.
Instructions For Use:
1. Allow the control to be tested to fully come to room temperature (18°–25°C), approximately 30 minutes.
2. Use the control as provided. DO NOT THIN.
3. Immediately prior to use, mix the control thoroughly by first inverting several times followed by vortexing the tube for 3-5 sec. Hit the tube several times on the bench to remove any controls caught in the cap before opening the tube.
4. Prepare the sample mix, invert at least 3 times, load and run a BioFire RP2.1 bag, BioFire RP2.1plus Bag or BioFire RP2.1-EZ Bag, using the control as you would use a patient sample, per BioFire RP2.1, BioFire RP2.1plus or BioFire RP2.1-EZ Quick Guide or Instructions for Use.
5. Discard the control tube after use in accordance with local and federal regulations.
Cautions, Warnings and Limitations:
- Do not dilute. Use the control as provided.
- This product is intended for in vitro diagnostic use only.
- This product is for use only with BioFire RP2.1, BioFire RP2.1plus or BioFire RP2.1-EZ Assays on BioFire FilmArray Systems. does not contain everything genome of the respiratory pathogens. This product is not compatible with the FilmArray Respiratory Panel (RP) assay.
- This product is not intended to be used as a substitute for the internal controls provided in the BioFire RP2.1, BioFire RP2.1plus or BioFire RP2.1-EZ assays.
- Appearance: the positive control is slightly turbid and the negative control is clear.
- 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 must be used in accordance with local, state, and federal regulations and accreditation requirements.
- BioFire RP2.1/RP2.1plus Control Panel M441 may not be cloned, sold or transferred without the explicit written consent of MMQCI.
Storage and Stability:
BioFire RP2.1/RP2.1plus M441 Control Panel should be stored frozen (–25°C to -15°C). Unopened M441 BioFire RP2.1/RP2.1plus control panel material is stable through the expiration date printed on the kit label when stored constantly frozen.