The BioFire RP2.1 / RP2.1plus M441 Control Panel is designed for use as an M quality control tested positive and negative to monitor the performance of in vitro Laboratory nucleic acid analysis procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus / Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East respiratory syndrome Coronavirus, parainfluenza virus, respiratory syncytial virus, severe acute Respiratory syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumonia and Mycoplasma pneumonia in BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) Assay Performed on the BioFire FilmArray® systems. The BioFire RP2.1 / RP2.1plus Positive Control consists of Synthetic RNA transcripts specifically designed and intended to be used only with the BioFire RP2.1, BioFire RP2.1plus, and BioFire RP2.1-EZ assay.
This The product is not designed to replace the manufacturer’s controls provided with the device. PRODUCT SUMMARY and PRINCIPLE: The BioFire RP2.1 / RP2.1plus M441 control panel consists of 2 controls, BioFire RP2.1 / RP2.1plus Positive and BioFire RP2.1 / RP2.1plus Negative. BioFire RP2.1 / RP2.1plus Positive contains substitute control material consisting of Synthetic RNA transcripts corresponding to the genome segments of the pathogens listed in Table 1. BioFire RP2.1 / RP2.1plus Negative does not contain RNA. Routine use of consistent quality controls between batches helps the laboratory in identifying changes, trends and a higher frequency of random errors caused by
variations in the test system, such as faulty reagents. Early research can prevent failed trial runs.
COMPOSITION:
The BioFire RP2.1 / RP2.1plus M441 control panel consists of 12 tubes, 6 tubes of BioFire RP2.1 / RP2.1plus Positive and 6 tubes of BioFire
Negative RP2.1 / RP2.1plus, 300µL each. BioFire RP2.1 / RP2.1plus Positive the control contains synthetic RNA suspended in a non-infectious buffer solution, preservatives and stabilizers. The BioFire RP2.1 / RP2.1plus Negative Control contains buffers and preservatives. Tables 1 and 2 list the pathogens that are monitored by the BioFire RP2.1 / RP2.1plus M441 Control Panel.
INSTRUCTIONS FOR USE:
Allow the control under test to fully come to room temperature.
(18 ° -25 ° C).
Use control as provided. DO NOT THIN.
Immediately before use, mix the control well by first inverting several times followed by vortexing the tube for 3-5 seconds. Tap the tube several times
on the bench to remove any controls caught in the cap before opening the tube.
Prepare and run a BioFire RP2.1 bag or a BioFire RP2.1plus or BioFire bag RP2.1-EZ Pouch, using the control as you would use a patient sample, according to BioFire RP2.1 or BioFire RP2.1plus or BioFire RP2.1-EZ Quick Guide or instructions for use.
Dispose of the control tube after use in accordance with local and federal regulations.
PRECAUTIONS, WARNINGS and LIMITATIONS:
Do not dilute. Use control as provided. This product is designed for in vitro analytical testing. This product is only for use with BioFire RP2.1 or BioFire RP2.1plus or BioFire RP2.1-EZ in BioFire FilmArray Systems. Does not contain the entire genome of the respiratory pathogens listed in Tables 1 and 2.
The product is not compatible with the FilmArray Respiratory Panel (RP) assay. This product is not designed to be used as a substitute for internal controls. provided in BioFire RP2.1 or BioFire RP2.1plus or BioFire RP2.1-EZ
test.
Appearance: the positive control is slightly cloudy and the negative control is clear.
This product does not contain any biological material of human or animal origin. source. NO universal precautions are required when handling this product.
Quality control materials must be used in accordance with local, state, and federal regulations. regulations and accreditation requirements.
The BioFire RP2.1 / RP2.1plus M441 Control Panel cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.
STORAGE and STABILITY:
The BioFire RP2.1 / RP2.1plus M441 Control Panel should be stored frozen (-25 ° C to -15 ° C). M441 unopened BioFire RP2.1 / RP2.1plus control panel material is stable until the expiration date printed on the kit label when constantly stored frozen. BioFire RP2.1 / RP2.1plus positive and BioFire RP2.1 / RP2.1plus negative are for single use only. Dispose of after use in accordance with local regulations and fede