FilmArray Pneumonia/Pneumonia plus Control

FilmArray Pneumonia/Pneumoniaplus Control

Part Number: M340

Kit Contains: 12 tubes x 120µL

6 Positive controls and 6 Negative controls

FilmArray Pneumonia/Pneumonia plus Control DataSheet

INTENDED USE:

FilmArray Pneumonia/Pneumoniaplus Control 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 bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assay performed on the FilmArray systems. FilmArray Pneumonia/Pneumoniaplus Control is composed of synthetic RNA and DNA specifically designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer controls provided with the device.

PRODUCT SUMMARY and PRINCIPLE:

FilmArray Pneumonia/Pneumoniaplus Control is composed of 2 controls, FilmArray Pneumonia/Pneumoniaplus POSITIVE and FilmArray Pneumonia/Pneumoniaplus NEGATIVE. FilmArray Pneumonia/Pneumoniaplus POSITIVE contains surrogate control material composed of synthetic nucleic acid corresponding to genome segments of pathogens listed in Table 1. FilmArray Pneumonia/Pneumoniaplus NEGATIVE contains no RNA or DNA.

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 Pneumonia/Pneumoniaplus Control is comprised of 12 tubes, 6 tubes of positive control and 6 tubes of negative control, 120µL each. FilmArray Pneumonia/Pneumoniaplus POSITIVE contains synthetic RNA and DNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. FilmArray Pneumonia/Pneumoniaplus NEGATIVE contains buffers and preservatives. Table 1 lists the pathogens that are monitored by the FilmArray Pneumonia/Pneumoniaplus Control when tested by the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays on the FilmArray systems.

INSTRUCTIONS FOR USE:

1. Allow the control to be tested to come completely to room temperature (18° – 25°C).
2. Use the control as DO NOT DILUTE.
3. Prepare and hydrate a FilmArray Pneumonia Panel pouch or FilmArray Pneumonia Panel plus pouch according to the FilmArray Instructions for Use or Quick
4. Prepare the Sample Injection Vial according to the FilmArray Instructions for Use or Quick
5. Immediately before use, mix the control thoroughly 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 control caught in the cap before opening the
   • Open the swab packet and place the flocked tip inside the control tube so that it touches the bottom of the tube.
   • Tilt the tube slightly and gently mix/stir the swab for about 10 seconds, keeping the tip fully immersed in the control liquid to saturate the entire swab. Note: When removing the saturated swab from the tube, be careful not to touch the side of the control tube to ensure that all the liquid remains on the
   • Place the swab end into the Sample Injection Vial, then break off the swab handle. Discard the remaining swab handle and close the Sample Injection Vial lid
   • The controls are single use only. Discard control tube after use according to your local and federal
6. Continue to process the control according to FilmArray Pneumonia Panel or FilmArray Pneumonia Panel

plus Instructions for Use or Quick Guide.

PRECAUTIONS, WARNINGS and LIMITATIONS:

• Do not Use the control as provided.
• This product is intended for in vitro diagnostic use
• This product is only for use with FilmArray Pneumonia Panel or FilmArray Pneumonia Panel plus on the FilmArray systems. It does not contain the entire genome of the respiratory pathogens listed in Table
• This product is not intended for use as a substitute for the internal controls provided in the FilmArray Pneumonia Panel or FilmArray Pneumonia Panel plus
• This product is slightly cloudy 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 Pneumonia/Pneumoniaplus Control cannot be cloned, sold, or transferred without the explicit written consent of

STORAGE and STABILITY:

FilmArray Pneumonia/Pneumoniaplus Control should be stored frozen (-25°C to -15°C). Unopened FilmArray Pneumonia/Pneumoniaplus Control material is stable through the expiration date printed on the kit label when continuously stored frozen. FilmArray Pneumonia/Pneumoniaplus POSITIVE and FilmArray Pneumonia/Pneumoniaplus NEGATIVE are for single use only. Discard after use according to your local and federal regulations.

EXPECTED VALUES:

Table 1 lists the expected results when the controls are analyzed by FilmArray Pneumonia Panel or FilmArray Pneumonia Panel plus. Note that the reported Bins (copies/ mL) are approximate and may vary run to run.

The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for FilmArray Pneumonia/Pneumoniaplus Control in demonstrating adequate system performance.

Table 1: FilmArray Pneumonia/Pneumoniaplus POSITIVE M342 & NEGATIVE M341 Result Summary

† Bins (copies/ mL) are approximate and may vary run to run.

‡ Middle East Respiratory Syndrome Coronavirus is reported on FilmArray Pneumonia Panel

plus assay only.

REPRESENTATIVE PERFORMANCE DATA:

Three lots of FilmArray Pneumonia/Pneumoniaplus POSITIVE and three lots of FilmArray Pneumonia/Pneumoniaplus NEGATIVE were tested using the FilmArray Pneumonia/Pneumoniaplus Panel assay on FilmArray^® systems at 3 external clinical laboratory sites, incorporating 3 unique pouch lots and multiple operators. A total of 185 external controls were tested over 10 days at each site. Two Negative Controls gave initial false positive results and three Positive controls gave initial false negative results. All produced the correct results upon a single retest for an overall correct result rate of 97.3%.