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    ePlex BCID-FP Control M320:
 
Product Name

INTENDED USE:
The ePlex BCID-FP Control M320 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 Candida albicans, Candida auris, Candida dubliniensis, Candida famata, Candida glabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Cryptococcus gattii, Cryptococcus neoformans, Fusarium, and Rhodotorula on the ePlex® Blood Culture Identification Fungal Pathogen (BCID-FP) Panel performed on the ePlex System (GenMark Diagnostics, Inc.). The ePlex BCID-FP Control M320 is composed of synthetic DNA specifically designed for and intended to be used solely with the ePlex BCID-FP Panel assay. This product is not intended to replace manufacturer controls provided with the device.

PRODUCT SUMMARY and PRINCIPLE:
ePlex BCID-FP Control M320 is composed of 3 controls, ePlex BCID-FP Positive A, ePlex BCID-FP Positive B, and ePlex BCID-FP Negative. The ePlex BCID-FP Control M320 positive controls contain surrogate control material composed of synthetic DNA corresponding to genome segments of pathogens listed in Table 1. ePlex BCID-FP Negative contains no 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-FP Control M320 is comprised of 12 tubes, 4 tubes of each positive control, A and B, and 4 tubes of negative control, 50μL each. The ePlex BCID-FP Positive controls contain synthetic DNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. Table 1 lists the fungal pathogens that are monitored by the ePlex BCID-FP Control M320 when tested by the ePlex BCID-FP Panel on the ePlex System.

STORAGE and STABILITY:
ePlex BCID-FP Control M320 should be stored refrigerated at 2-8°C. Unopened ePlex BCID-FP Control M320 material is stable through the expiration date printed on the kit label when continuously stored refrigerated. ePlex BCID-FP Control M320 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.
  • This product is intended for in vitro analytical testing and is provided for Research Use Only, not for use in diagnostic procedures.
  • ePlex BCID-FP Control M320 is only for use with ePlex BCID-FP Panel on the ePlex System. It does not contain the entire genome of the fungal pathogens listed in Table 1.
  • This product is not intended for use as a substitute for the internal controls provided in ePlex BCID-FP Panel.
  • This product does not contain any biological material of human or animal origin. Universal Precautions are NOT required when handling this product.
  • Due to the sensitivity of the ePlex BCID-FP Panel test, it is important when handling the ePlex BCID-FP Control M320 to adhere to all precautions to prevent contamination.
  • ePlex BCID-FP Control M320 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

INSTRUCTIONS FOR USE:
For complete ePlex BCID-FP Panel instructions, refer to the ePlex BCID-FP 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 50μL of control and transfer into the cartridge sample port chamber.
  4. Continue to process and analyze the control with the ePlex BCID-FP 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-FP 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:
Table 1 lists the expected results when the controls are tested with ePlex BCID-FP Panel on the ePlex system.

The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for ePlex BCID-FP Control M320 in demonstrating adequate system performance.

Table 1. Expected Results: ePlex BCID-FP Control M320

Control Name
ePlex
BCID-FP Positive A
ePlex
BCID-FP Positive B
ePlex
BCID-FP Negative
Part Number
M32117
M32217
M50117
Fungal Pathogen
Result
Candida albicans
Detected
Not Detected
Not Detected
Candida auris
Not Detected
Detected
Not Detected
Candida dubliniensis
Detected
Not Detected
Not Detected
Candida famata
Detected
Not Detected
Not Detected
Candida glabrata
Detected
Not Detected
Not Detected
Candida guilliermondii
Not Detected
Detected
Not Detected
Candida kefyr
Detected
Not Detected
Not Detected
Candida krusei
Not Detected
Detected
Not Detected
Candida lusitaniae
Not Detected
Detected
Not Detected
Candida parapsilosis
Not Detected
Detected
Not Detected
Candida tropicalis
Not Detected
Detected
Not Detected
Cryptococcus gattii
Detected
Not Detected
Not Detected
Cryptococcus neoformans
Not Detected
Detected
Not Detected
Fusarium
Not Detected
Detected
Not Detected
Rhodotorula
Not Detected
Detected
Not Detected

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

ORDERING INFORMATION:
ePlex BCID-FP Control M320
Part Number:          M320
Kit Contains:            12 tubes x 50μL
4 each Positive A, Positive B & Negative

Safety Data Sheet

 


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