FilmArray BCID2 Control Panel M416

Part Number: M416

Kit Contains: 12 tubes x 200μL

6 Positive controls and 6 Negative controls

FilmArray BCID2 Control Panel M416 DataSheet

INTENDED USE:

The FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like,

vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire^® Blood Culture Identification 2 (BCID2) Panel on the BioFire FilmArray^® systems. This product is not intended to replace manufacturer controls provided with the device.

PRODUCT SUMMARY and PRINCIPLE:

FilmArray BCID2 Control Panel M416 is comprised of 2 controls, FilmArray BCID2 Positive Control and FilmArray BCID2 Negative Control. FilmArray BCID2 Positive Control contains surrogate control material composed of synthetic nucleic acid corresponding to genome segments of the pathogens and antimicrobial resistance markers listed in Table 1. FilmArray BCID2 Negative Control contains no nucleic acid.

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:

FilmArray BCID2 Control Panel M416 is comprised of 12 tubes, 6 tubes of positive control and 6 tubes of negative control, 200μL each. FilmArray BCID2 Positive Control contains synthetic DNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. FilmArray BCID2 Negative Control contains buffers and preservatives. Table 1 lists the antimicrobial resistance markers and pathogens that are monitored by the FilmArray BCID2 Control Panel M416 when tested by the BioFire BCID2 Panel on the BioFire FilmArray systems.

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
3. Immediately before use, mix the control thoroughly by first inverting several times followed by vortexing the tube for 3-5 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 BioFire BCID2 Pouch using the control as you would use a patient specimen, according to BioFire BCID2 Panel Quick Guide or Instructions for
5. Discard after use according to your local and federal

PRECAUTIONS, WARNINGS and LIMITATIONS:

• Use the control as provided. Do not dilute or transfer to another
• This product is intended for in vitro diagnostic use
• This product is only for use with BioFire BCID2 Panel on the BioFire FilmArray It does not contain the entire genome of the pathogens listed in Table 1.
• This product is not intended for use as a substitute for the internal controls provided in the BioFire BCID2 Panel assay.
• This product is red in
• This product does not contain any biological material of human or animal Universal Precautions are NOT required when handling this product.
• Quality control materials should be used in accordance with local, state, federal regulations and accreditation
• FilmArray BCID2 Control Panel M416 cannot be cloned, sold, or transferred without the explicit written consent of

STORAGE and STABILITY:

FilmArray BCID2 Control Panel M416 should be stored at 2 - 8°C. Unopened FilmArray BCID2 Control Panel M416 is stable through the expiration date printed on the kit label when consistently stored refrigerated (2° – 8°C). FilmArray BCID2 Positive Control and FilmArray BCID2 Negative Control are for single use. Discard after use according to your local and federal regulations.

EXPECTED VALUES:

Table 1 lists the expected results when the controls are analyzed by BioFire BCID2 Panel. The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for FilmArray BCID2 Control Panel M416 in demonstrating adequate system performance.

Table 1: FilmArray BCID2 Positive & Negative Control Result Summary

 REPRESENTATIVE PERFORMANCE DATA:

Three lots of FilmArray BCID2 Positive Control and three lots of FilmArray BCID2 Negative Control were tested using the BioFire BCID2 Panel assay on BioFire FilmArray systems at 3 external clinical laboratory sites, incorporating 3 unique pouch lots and multiple operators and instruments. A total of 185 external controls were tested over 10 days at each site. Two Controls gave initial Invalid results and three Positive controls gave 1 or more initial false negative results. All produced the correct results upon retesting for an overall correct result rate of 98.4%.

* Invalid results were not included in percent correct.