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    ePlex BCID-GP Control M323:
 
Product Name

INTENDED USE:
The ePlex BCID-GP Control M323 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 the gram-positive pathogens and resistance genes listed in Table 1 by the ePlex® Blood Culture Identification Gram-Positive Panel (ePlex BCID-GP Panel) performed on the ePlex System (GenMark Diagnostics, Inc.). The ePlex BCID-GP Control M323 is composed of synthetic DNA specifically designed for and intended to be used solely with the ePlex BCID-GP Panel performed on the ePlex System. This product is not intended to replace manufacturer controls provided with the device.

PRODUCT SUMMARY and PRINCIPLE:
ePlex BCID-GP Control M323 is composed of 3 controls, ePlex BCID-GP Positive A, ePlex BCID-GP Positive B, and ePlex BCID-GP Negative. The ePlex BCID-GP Control M323 positive controls contain surrogate control material composed of synthetic DNA corresponding to genome segments of pathogens and resistance genes listed as detected in Table 1. ePlex BCID-GP Negative contains non-target 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:
ePlex BCID-GP Control M323 is comprised of 12 tubes, 4 tubes of each positive control, A, and B, and 4 tubes of negative control, 50 μL each. The controls are composed of synthetic DNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. Table 1 lists the gram-positive pathogens and resistance genes that are detected in the ePlex BCID-GP Control M323 when tested by the ePlex BCID-GP Panel on the ePlex System.

STORAGE and STABILITY:
ePlex BCID-GP Control M323 should be stored refrigerated at 2-8°C. Unopened ePlex BCID-GP Control M323 material is stable through the expiration date printed on the kit label when continuously stored refrigerated. ePlex BCID-GP Control M323 components are for single use. Discard after use according to your local and federal regulations.

PRECAUTIONS and WARNINGS:

  • Use the control as provided. Do not dilute or transfer to another tube.
  • For Research Use Only.
  • This product is only for use with ePlex BCID-GP Panel on the ePlex System. It does not contain the entire genome of the gram positive pathogens listed in Table 1.
  • This product is not intended for use as a substitute for the internal controls provided in ePlex BCID-GP Panel.
  • This product does not contain any biological material and is not biohazardous.
  • Due to the sensitivity of the ePlex BCID-GP Panel test, it is important when handling the ePlex BCID-GP Control M323 to adhere to all precautions to prevent contamination.
  • ePlex BCID-GP Control M323 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

ORDERING INFORMATION:

ePlex BCID-GP Control M323
Part Number:  M323
Kit Contains     12 tubes x 50μL
4 each Positive A, Positive B & Negative

INSTRUCTIONS FOR USE:
For complete ePlex BCID-GP Panel instructions, refer to the ePlex BCID-GP Panel package insert provided by GenMark Diagnostics, Inc.

  1. Allow the control to be tested to come completely to room temperature (18° – 25°C).
  2. Immediately before use thoroughly mix the control by flicking the tube several times, followed by vortexing for 5-10 seconds. Shake the tube down or tap it on bench to remove any droplets remaining in the cap.
  3. Use a calibrated pipette to aspirate 50 µL of control and transfer into the cartridge sample port chamber.
  4. Continue to process and analyze the control with the ePlex BCID-GP Panel test on the ePlex System as you would a patient sample.

    Note: Sample can be pre-defined as External Control to generate a BCID-GP External Control Report. Refer to ePlex Operator Manual for more information on defining external controls on ePlex System.
  5. Discard controls after use according to your local and federal regulations.

EXPECTED VALUES:
The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for ePlex BCID-GP Control M323 in demonstrating adequate system performance.

The expected results when the controls are tested with ePlex BCID-GP Panel are listed in Table 1.

Table 1. Expected Results: ePlex BCID-GP Control M323

Control Name
ePlex
BCID-GP
Positive A
ePlex
BCID-GP
Positive B
ePlex
BCID-GP
Negative
Part Number
M32417
M32517
M50217
Bacterial Target
Result
Bacillus cereus group
Detected
Not Detected
Not Detected
Bacillus subtilis group
Detected
Not Detected
Not Detected
Corynebacterium
Detected
Not Detected
Not Detected
Cutibacterium acnes
(P. acnes)
Not Detected
Detected
Not Detected
Enterococcus
Detected
Not Detected
Not Detected
Enterococcus faecalis
Detected
Not Detected
Not Detected
Enterococcus faecium
Detected
Not Detected
Not Detected
Lactobacillus
Not Detected
Detected
Not Detected
Listeria
Not Detected
Detected
Not Detected
Listeria monocytogenes
Not Detected
Detected
Not Detected
Micrococcus
Not Detected
Detected
Not Detected
Staphylococcus
Not Detected
Detected
Not Detected
Staphylococcus aureus
Not Detected
Detected
Not Detected
Staphylococcus epidermidis
Not Detected
Detected
Not Detected
Staphylococcus lugdunensis
Not Detected
Detected
Not Detected
Streptococcus
Detected
Not Detected
Not Detected
Streptococcus agalactiae
Detected
Not Detected
Not Detected
Streptococcus anginosus group
Detected
Not Detected
Not Detected
Streptococcus pneumoniae
Detected
Not Detected
Not Detected
Streptococcus pyogenes
Detected
Not Detected
Not Detected
Pan Targets
Result
Pan Candida
Not Detected
Detected
Not Detected
Pan Gram-Negative
Not Detected
Detected
Not Detected
Resistance Gene Target
Result
mecA
N/A
Detected
N/A
mecC
N/A
Detected
N/A
vanA
Detected
N/A
N/A
vanB
Detected
N/A
N/A

Notice: ePlex is a registered trademark of GenMark Diagnostics, Inc.

Safety Data Sheet

 


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