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    ePlex RP Control M306:
 
Product Name

INTENDED USE:

The ePlex RP Control M306 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 the pathogens listed in Tables 1 & 2 on the ePlex® Respiratory Pathogen (RP) Panel performed on the ePlex System (GenMark Diagnostics, Inc.). The ePlex RP Control M306 is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the ePlex RP Panel on the ePlex System. This product is not intended to replace manufacturer internal ePlex RP Panel controls provided with the device. ePlex RP Control M306 is processed like a patient sample.

PRODUCT SUMMARY and PRINCIPLE:

ePlex RP Control M306 is composed of 5 controls, ePlex RP Positive A, ePlex RP Positive B, ePlex RP Positive C, ePlex RP Positive D and ePlex RP Negative. The ePlex RP Control M306 positive controls contain surrogate control material composed of synthetic DNA and RNA corresponding to genome segments of pathogens listed as detected in Tables 1 & 2. ePlex RP Negative contains non-target DNA and RNA.

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 RP Control M306 is comprised of 10 tubes, 2 tubes of each positive control, A, B, C, and D, and 2 tubes of negative control, 200 µL each. The controls are composed of synthetic DNA and RNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. Tables 1 & 2 list the pathogens that are detected in the ePlex RP Control when tested by ePlex RP Panel on the ePlex System.

STORAGE and STABILITY:

ePlex RP Control M306 should be stored frozen  (–20°C or colder). Unopened ePlex RP Control M306 material is stable through the expiration date printed on the kit label when continuously stored frozen. ePlex RP Control M306 components are for single use. Discard after use according to your local and federal regulations.

PRECAUTIONS and WARNINGS:

  • Do not dilute, re-freeze or transfer to another storage tube.
  • For Research Use Only.
  • This product is only for use with ePlex RP Panel on the ePlex System. It does not contain the entire genome of the pathogens listed in Tables 1 & 2.
  • This product is not intended for use as a substitute for the internal controls provided in the ePlex RP Panel.
  • This product does not contain any biological material and is not biohazardous.
  • Due to the sensitivity of the ePlex RP Panel test, it is important when handling the ePlex RP Control M306 to adhere to all precautions to prevent contamination.
  • ePlex RP Control M306 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

INSTRUCTIONS FOR USE:

For complete ePlex RP Panel instructions, refer to the ePlex RP Panel package insert provided by GenMark Diagnostics, Inc.

  1. Allow the control to be tested to come to room temperature (18° – 25°C).
  2. Immediately before use, thoroughly mix the control by flicking the tube several times. Follow by a quick vortex for 3-5 seconds, then shake down or tap on bench to remove any droplets remaining on cap.
  3. Gently tap the ePlex Sample Delivery Device on the counter or benchtop surface to collect liquid that may have adhered to the sides of the vial.
  4. Unscrew the purple cap from the Sample Delivery Device.
  5. Use a calibrated pipette to aspirate 200 µL of control and transfer into the Sample Delivery Device.
  6. Replace purple cap on Sample Delivery Device. Ensure that cap is securely fastened on the Sample Delivery Device. Vortex for 10 seconds immediately before loading onto the cartridge.
  7. Continue to process and analyze the control with the ePlex RP Panel test on the ePlex System as you would a patient sample.
    Note: Sample can be pre-defined as External Control to generate an RP Panel External Control Report. Refer to ePlex Operator Manual for more information on defining external controls on ePlex System.
  8. Discard after use according to your local and federal regulations.

EXPECTED VALUES:

The expected results when the controls are tested with ePlex RP Panel test are listed in Tables 1 & 2.

Table 1. US customers Expected Results: ePlex RP Control M306

Control Name

ePlex RP Positive A

ePlex RP Positive B

ePlex RP Positive C

ePlex RP Positive D

ePlex RP Negative

Part Number

M30718

M30818

M30918

M31018

M31118

Viral Analytes

Adenovirus

Detected

Detected

Detected

Not Detected

Not Detected

Coronavirus

Detected

Detected

Detected

Detected

Not Detected

Human Metapneumovirus

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Human Rhinovirus/ Enterovirus

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Influenza A

Detected

Detected

Detected

Not Detected

Not Detected

Influenza A H1

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Influenza A H1-2009

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Influenza A H3

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Influenza B

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Parainfluenza Virus 1

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Parainfluenza Virus 2

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Parainfluenza Virus 3

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Parainfluenza Virus 4

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Respiratory Syncytial Virus A

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Respiratory Syncytial Virus B

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Bacterial Analytes

Chlamydia pneumoniae

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Mycoplasma pneumoniae

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Table 2: NON-US customers Expected Results: ePlex RP Control M306

Control Name

ePlex RP Positive A

ePlex RP Positive B

ePlex RP Positive C

ePlex RP Positive D

ePlex RP Negative

Part Number

M30718

M30818

M30918

M31018

M31118

Viral Analytes

Adenovirus

Detected

Detected

Detected

Not Detected

Not Detected

Coronavirus 229E

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Coronavirus HKU1

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Coronavirus NL63

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Coronavirus OC43

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Middle East Respiratory Syndrome Coronavirus

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Human Bocavirus

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Human Metapneumovirus

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Human Rhinovirus/ Enterovirus

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Influenza A

Detected

Detected

Detected

Not Detected

Not Detected

Influenza A H1

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Influenza A H1-2009

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Influenza A H3

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Influenza B

Not Detected

Not Detected

Not Detected

Detected

Not Detected

Parainfluenza Virus 1

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Parainfluenza Virus 2

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Parainfluenza Virus 3

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Parainfluenza Virus 4

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Respiratory Syncytial Virus A

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Respiratory Syncytial Virus B

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Bacterial Analytes

Bordetella pertussis

Not Detected

Not Detected

Detected

Not Detected

Not Detected

Chlamydia pneumoniae

Detected

Not Detected

Not Detected

Not Detected

Not Detected

Legionella pneumophila

Not Detected

Detected

Not Detected

Not Detected

Not Detected

Mycoplasma pneumoniae

Not Detected

Not Detected

Not Detected

Detected

Not Detected

ORDERING INFORMATION:

ePlex RP Control M306
Part Number: M306
Kit Contains:          10 tubes x 200µL
2 each of Pos A, Pos B, Pos C, Pos D & Negative

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

Safety Data Sheet

 


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