ePlex RP2 Control M451

MMQCI ePlex RP2 Control M451

Part Number: M451

Kit Contains: 12 tubes x 200μL

4 each of Positive A, Positive B & Negative

ePlex RP2 Control M451 DataSheet

INTENDED USE:

The ePlex RP2 Control M451 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 pathogens: Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), SARS-CoV-2, Middle East Respiratory Syndrome Coronavirus, Human Bocavirus, Human Metapneumovirus, Rhinovirus/Enterovirus, Influenza A, Influenza A H1, Influenza A H1 2009, Influenza A H3, Influenza B, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Chlamydophila pneumoniae, Bordetella pertussis, Legionella pneumophila and Mycoplasma pneumoniae on the ePlex^® Respiratory Pathogen Panel 2 (RP2) performed on the ePlex System (GenMark Diagnostics, Inc.). The ePlex RP2 Control M451 is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the ePlex RP2 Panel on the ePlex System.

PRODUCT SUMMARY and PRINCIPLE:

ePlex RP2 Control M451 is composed of 3 controls, ePlex RP2 Positive A, ePlex RP2 Positive B and ePlex RP2 Negative. The ePlex RP2 Control M451 positive controls contain surrogate control material composed of synthetic DNA and RNA corresponding to genome segments of pathogens listed as detected in Table 1. ePlex RP2 Negative contains no DNA or 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 RP2 Control M451 is comprised of 12 tubes, 4 tubes of each positive control, A and B, and 4 tubes of negative control, 200 μL each. The ePlex RP2 Positive controls are composed of synthetic DNA and RNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. The ePlex RP2 Negative control contains buffer and preservatives. Table 1 lists the pathogens that are detected in the ePlex RP2 Control M451 when tested by ePlex RP2 Panel on the ePlex System.

STORAGE and STABILITY:

ePlex RP2 Control M451 should be stored frozen (–25°C to –15°C). Unopened ePlex RP2 Control M451 material is stable through the expiration date printed on the kit label when consistently stored frozen. ePlex RP2 Control M451 components are for single use. Discard after use according to your local and federal regulations.

PRECAUTIONS and WARNINGS:

Do not Use the control as provided.

This product is intended for in vitro analytical testing and is provided for Research Use Only, not for diagnostic

ePlex RP2 Control M451 is for use with ePlex RP2 Panel on the ePlex It does not contain the entire genome of the pathogens listed in Table 1.

ePlex RP2 Control M451 may also be used with ePlex RP Panel but only when run as a patient sample, not as a pre-defined External Testing of M451 positive controls pre-defined as “External Controls” with ePlex RP Panel will cause Invalid results.

This product is not intended for use as a substitute for the internal controls provided in the RP2

Appearance: Positive controls are cloudy and Negative control is

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

ePlex RP2 Control M451 cannot be cloned, sold, or transferred without the explicit written consent of

INSTRUCTIONS FOR USE:

Allow the control to come completely to room temperature (18° – 25°C).

Use the control as Do Not Dilute.

Immediately before use, thoroughly mix the control by flicking the tube several times, followed by vortexing for 3-5 Shake the tube down or tap it on bench to remove any droplets remaining in the cap.

Use a calibrated pipette to aspirate 200 μL of control and transfer into the

Sample Loading Port of the ePlex RP2 cartridges.

Continue to process and analyze the control with the ePlex RP2 Panel test on the ePlex System as you would a patient

Note: Sample can be pre-defined as External Control to generate an RP2 Panel External Control Report. Refer to ePlex Operator Manual for more information. Do not pre-define M451 controls as External Control when using ePlex RP Panel.

Discard after use according to your local and federal

For complete ePlex RP2 Panel instructions, refer to the appropriate package insert provided by GenMark Diagnostics, Inc.

EXPECTED VALUES:

The expected results when the controls are tested with ePlex RP2 Panel test are listed in Table 1.

Table 1. Expected Results: ePlex RP2 Control M451

*Coronavirus strains (HKU1 and NL63 are detected with ePlex RP2 Positive A, 229E and OC43 are detected with ePlex RP2 Positive B), Middle East Respiratory Syndrome Coronavirus, Human Bocavirus, Bordetella pertussis, and Legionella pneumophila are reported out for NON-US customers only

Chlamydophila pneumoniae is reported out for US customers only

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