ePlex BCID-FP Control M320 v1.1 Package Insert
Research Use Only
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road, Saco, ME 04072 USA
Phone: 207-885-1072, FAX: 207-885-1079
Web: www.mmqci.com, Email: info@mmqci.com
ePlex BCID-FP Control M320 v1.1
M320v1.1 101519.00
INTENDED USE:
The ePlex BCID-FP Control M320 v1.1 is intended for use as an external
positive and negative 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 v1.1 is composed of synthetic
DNA specifically designed for and intended to be used solely with the
ePlex BCID-FP Panel assay.
PRODUCT SUMMARY and PRINCIPLE:
ePlex BCID-FP Control M320 v1.1 is composed of 3 controls, ePlex
BCID-FP Positive A1, ePlex BCID-FP Positive B1, and ePlex BCID-FP
Negative. The ePlex BCID-FP Control M320 v1.1 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 v1.1 is comprised of 12 tubes, 4 tubes of
each positive control, A1 and B1, 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 v1.1 when tested by the ePlex BCID-FP
Panel on the ePlex System.
STORAGE and STABILITY:
ePlex BCID-FP Control M320 v1.1 should be stored refrigerated at 2-8°C.
Unopened ePlex BCID-FP Control M320 v1.1 material is stable through
the expiration date printed on the kit label when consistently stored
refrigerated. ePlex BCID-FP Control M320 v1.1 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 v1.1 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 the 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.
• Quality control materials should be used in accordance with local, state,
federal regulations and accreditation requirements.
• ePlex BCID-FP Control M320 v1.1 cannot be cloned, sold, or
transferred without the explicit written consent of MMQCI.
INSTRUCTIONS FOR USE:
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 BCIDFP 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.
For complete ePlex BCID-FP Panel instructions, refer to the ePlex BCIDFP Panel package insert provided by GenMark Diagnostics, Inc.
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 v1.1 in demonstrating adequate system performance.
Table 1. Expected Results: ePlex BCID-FP Control M320 v1.1
Control Name
ePlex
BCID-FP
Positive A1
ePlex
BCID-FP
Positive B1
ePlex
BCID-FP
Negative
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 Detected Not Detected Not Detected
Notice: ePlex is a registered trademark of GenMark Diagnostics, Inc
ORDERING INFORMATION:
ePlex BCID-FP Control M320 v1.1
Part Number: M320v1.1
Kit Contains: 12 tubes x 50μL
4 each Positive A1, Positive B1 & Negative