Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 1 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries Prepared by QA Committee

Issued by: Laboratory Manager Revision Date: 9/30/2017

Approved by Laboratory Director:

Microbiologist-in-Chief

Annual Review Date: 11/1/2018

Uncontrolled When Printed

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Introduction

The ARIES® C. difficile Assay uses Multi-Code

® real-time PCR chemistry in

combination with ARIES® Systems. ARIES

® Systems are capable of automated nucleic

acid extraction and purification, real-time PCR detection of nucleic acid sequences, and

data analysis. The ARIES® C. difficile Assay detects the C. difficile toxin A gene (tcdA)

and toxin B gene (tcdB).

Specimen Collection and Transport

Collect unformed stool specimen in a clean Starplex container

Stool collected in Enteric Transport Medium, or in SAF is not suitable for this assay.

Specimens can be stored at 15°C to 30°C (room temperature) for up to 8 hours or 2°C to

8°C (refrigerated) for up to 15 days. If the specimen cannot be tested within the indicated

durations at the specified temperatures, then the specimen can be stored at ≤ -70°C for up

to three months.

Reagents/Materials/Media

The ARIES® C. difficile Assay Complete Kit includes 24 assay cassettes and the

ARIES® Stool Resuspension Kit.

The assay protocol file, package insert, and ARIES®Quick Guide ship separately

on a USB as part of the ARIES® C. difficile Assay Protocol File Kit

Luminex® ARIES

® Systems and accessories

ARIES® magazines

ARIES® Sample Prep Tray

Hand-held barcode reader

Appropriately sized pipettor

Microcentrifuge

Variable volume Ranin Pipette: 1000uL

Aerosol Resistant Tips (ART)

Powder free gloves

Biological Safety Cabinet

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 2 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Vortex mixer

NOTE: If the ARIES® Stool Resuspension Buffer is frozen on receipt, thaw to room

temperature, invert the bottle to re-suspend, and continue testing. ARIES® C. difficile

Assay cassettes are shipped refrigerated and should be stored at room temperature

(15°C to 30°C) after receipt. The ARIES® Stool Resuspension Buffer ships at an

ambient temperature and is stored at room temperature.

ARIES® Cassette

1. Assay type 7. Side cassette

2. Cassette barcode (top) 8. Cassette expiration date

3. Cassette barcode (side) 9. Cassette lot number

4. PCR tube 10. Cassette part number

5. Cassette serial number 11. Back seal

6. Cassette sample chamber 12. Cassette cap

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 3 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 4 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Procedure

1. Label the ARIES®

Stool Resuspension Tube with the Sample ID.

2. Use an appropriately sized pipettor and aerosol barrier pipette tip, aspirate 800 μL of

ARIES® Stool Resuspension Buffer to the ARIES® Stool Resuspension Tube.

3. Observe the consistency of the stool specimen. Collect the appropriate stool specimen

using the provided ARIES® Stool Resuspension Swab, according to the specimen’s

consistency:

A. Soft Stool Specimen

Insert the ARIES® Stool Resuspension Swab into the stool specimen and

roll the swab over the specimen to fully coat.

Once the ARIES® Stool Resuspension Swab is fully coated, roll the swab

on the inside wall of the specimen collection container to remove excess

stool specimen.

NOTE: There should be a thin coating around the entire ARIES® Stool

Resuspension Swab.

Appropriate amount of soft specimen:

Inappropriate amount of soft specimen:

B. Liquid Stool Specimen:

Vortex the stool specimen for 5 seconds until well mixed.

Swirl the ARIES® Stool Resuspension Swab in the stool specimen for

approximately 5 seconds to saturate the swab.

Tap the ARIES® Stool Resuspension Swab on the inside wall of the

specimen collection container to remove excess specimen.

NOTE: The ARIES® Stool Resuspension Swab should not drip liquid.

Appropriate amount of liquid specimen:

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 5 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Inappropriate amount of liquid specimen:

4. Place the ARIES®

Stool Resuspension Swab into the ARIES® Stool Resuspension

Tube that contains 800 μL of ARIES® Stool Resuspension Buffer.

a. Line up the breakpoint of the swab shaft with the rim of the tube and break

the ARIES® Stool Resuspension Swab from the shaft by applying firm but

gentle force to the swab shaft against the ARIES® Stool Resuspension

Tube rim.

b. With the ARIES® Stool Resuspension Swab remaining in the ARIES

®

Stool Resuspension Tube, re-cap the tube. NOTE: Gripping the ARIES®

Stool Resuspension Swab shaft closer to the breakpoint and rotating while

bending, makes breaking the shaft off easier. Gently twirl the ARIES®

Stool Resuspension Swab if the shaft and swab remain slightly attached

after breaking.

CAUTION: If gloves become contaminated with stool specimen during

transfer to the ARIES® Stool Resuspension Tube, change

gloves to avoid specimen contamination.

5. Vortex the ARIES® Stool Resuspension Tube at the highest setting for 15 seconds.

Ensure full vortex is formed during mixing.

6. Centrifuge the ARIES® Stool Resuspension Tube at a minimum of 2,000 x g (4643

rpm) or 13,200 rcf for a minimum of 30 seconds.

Adding Samples to the Cassettes

1. Remove the assay cassette from its packaging and visually inspect the cassette for any

damage. Ensure the PCR tube is intact and cassette is dry.

a. CAUTION: If the cassette(s) or its packaging appears damaged in any way or

if you see any leaks, DO NOT USE THE CASSETTE. Immediately contact

Luminex Technical Support to report the damage.

2. Close the cassette cap to seal the cassette sample chamber.

3. Place the ARIES®

Stool Resuspension Tube in the Sample Prep Tray.

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 6 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

4. Pull the tab to remove the foil seal from the cassette. Add Samples to the Cassettes.

Be careful to remove all foil and any remaining clear plastic. Ensure that the wax

under the foils is flush with the cassette and not indented.

CAUTION: Use caution when pulling the back seal off the cassettes.

The foil is sharp and may cause injury.

5. Add sample to the Cassettes

6. Place the cassette in the Sample Prep Tray next to the sample.

7. Label the cassette with small barcode label according to the ARIES® Stool

Resuspension Tube

8. Using an appropriately sized pipettor and aerosol barrier pipette tip, aspirate 200 μL

of processed stool sample from the ARIES® Stool Resuspension Tube. Pipette from

the top of the processed stool sample to avoid disturbing any beads that settled to the

bottom of the ARIES® Stool Resuspension Tube.

a. CAUTION: Verify that the pipette is correctly set to aspirate 200 μL.

Adding a higher volume of processed stool sample to the cassette may result

in assay inhibition.

b. CAUTION: Avoid disturbing the beads contained in the ARIES® Stool

Resuspension Tube or transferring the beads to the cassette. Use care to

avoid contamination of the pipettor during transfer of the processed stool

sample from the ARIES®

Stool Resuspension Tube to the cassette.

c. CAUTION: If the sediment layer is disturbed, recap and centrifuge the

ARIES® Stool Resuspension Tube at a minimum of 2,000 x g (4643 rpm)

for a minimum of 30 seconds and pipette 200 μL of processed stool sample.

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 7 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

9. Open the cassette cap and place the processed stool sample in the cassette sample

chamber by inserting the pipette tip near the bottom of the chamber before expelling

the processed stool sample.

10. Close the cassette cap to seal the cassette sample chamber.

WARNING: Failure to ensure the cassette cap is fully closed may

cause a delay or failure in results and expose you to biohazards.

CAUTION: Do not vortex or shake the cassette.

Entering Orders on ARIES® Systems

When entering orders, the Sample ID and Assay are required for an order to be valid.

NOTE: The order should be created prior to placing the cassette in the magazine. If you

scan the cassette while the cassette is in the magazine, it is possible to scan the incorrect

cassette barcode.

1. Select in the upper left-hand corner of the screen and navigate to Order

Management > Sample Orders.

2. Select from the Page Action bar. The New Order dialog box displays.

3. Pick up and scan the barcode on the top (or side) of the cassette with the hand-held

barcode reader. A touch screen keyboard or a drop-down menu displays.

NOTE: If the keyboard does not automatically appear, click the toggle next to the keyboard icon to

Yes. The keyboard will appear when you click in a field.

NOTE: If manually entering the Cassette Lot Expiration, select the calendar icon and choose

the date using the calendar. The date is shown in the YYMMDD format.

a. If applicable, to add a control, choose Control in the Sample Type drop-down menu.

b. In the Control field, click the magnifying glass to select a control from the Controls dialog box.

c. Select the type of control in the Control Type drop-down menu.

NOTE: You can define the controls on the Assay Management > Controls page.

4. From the ARIES® Stool Resuspension Tube, pick up and scan the Sample ID with

the hand-held barcode reader or enter the required information manually.

NOTE: Ensure that the ARIES® cassette is associated with the corresponding sample

by manually verifying the information on the screen.

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 8 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

5. Scan the Data Matrix barcode on the screen next to Save, or manually select Save.

6. Place the cassette into the magazine by lining the cassette up with the first notch (a

tab on the cassette fits into the notch).

NOTE: The PCR tube must face toward the numbers on the magazine.

7. Gently insert the cassette into the magazine.

8. Gently slide the cassette all the way back toward the numbers. Repeat for all other

cassettes.

WARNING: Do not use your index finger to push the cassette into

the magazine. You may indirectly dispense the reagent. Luminex

recommends using the palm of your hand, or holding the cassette

and sliding the cas-sette into proper position.

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 9 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Running an Assay

1. Select in the upper left-hand corner of the screen and navigate to Run > Run.

2. Change the run name to “cdyyyymmddyourinitialrun” number example

cd20170901ZZ1

3. Insert the magazine into the ARIES® instrument. The ARIES® instrument

automatically scans the barcode printed on the top of the ARIES® C. difficile Assay

cassettes, identifies associated orders, and the proper assay protocol files before

starting the run.

4. If there are any errors, the ARIES® instrument displays the specific error (for

example, cassettes that cannot be run together, cassette IDs that have not been read,

or assay files not loaded on to the ARIES® instrument). These errors must be

corrected in order for the run to begin.

If Auto run upon Magazine Insertion is enabled and no errors occur,

the instrument will automatically scan and start the run for you. The

magazine state then indicates PLEASE DO NOT REMOVE THE

MAGAZINE and an orange lock icon displays on the left-hand side of

the magazine state. The Run Status bar, located at the bottom of the

Run page, displays an orange progress bar next to the estimated time to

completion, colored purple

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 10 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Monitoring the Run

From the Run page, select on the Page Action bar to display the status of the

magazine(s), the estimated time to completion, and the customizable name of the

ARIES® instrument. This status screen is intended to be visible from across the room,

allowing you to monitor your runs while you are working on other projects.

Unloading Cassette

1. Once the run is completed, pull out the magazine

Inspect and make sure that the cassettes are not leaking and all PCR tubes are

attached to each cassette

WARNING: In the event that a PCR tube falls off the cassette or a cassette leaks

inside the ARIES® instrument, you should perform appropriate decontamination

procedures to reduce the risk of contamination. Immediately clean all surfaces of

the ARIES® magazine and the surrounding bench top with water. Wipe the

surfaces with a lint-free cloth. Follow that with a fresh 10% bleach solution.

Allow the bleach solution to sit for a minimum of 10 minutes. Thoroughly rinse

bleached surfaces with deionized water. Dispose of all lint-free cloths in the

appropriate waste container. Immediately contact Luminex Technical Support in

order to retrieve the PCR tube from the ARIES® instrument. Do not throw away

the cassette before you contact Technical Support. Do not attempt to retrieve the

tube or put your hands inside the ARIES® instrument at any time. Do not proceed

with additional testing until the PCR tube has been removed from the ARIES®

instrument. Discard the cassette in accordance with the procedures defined by

appropriate biohazard safety guidelines or regulations.

1. Slide out each cassette and seal them into biohazard bag

2. Discard whole bag following good laboratory practices

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 11 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Interpretation of Sample Results

The ARIES®software determines results for the sample and the sample processing

control (SPC) for each sample based on the amplification cycle (Ct) value and the

melting temperature (Tm) value provided in the assay protocol file. All assay outcomes

are described below. C. difficile positivity is based on detection of the tcdA and/or tcdB

target.

TABLE 1. Interpretation of Sample Results

Legend

+ Value meets acceptance criteria

- Value does not meet acceptance criteria

N/A Not applicable. All outcomes will result in the same call

> Indicates that the Ct is beyond the Ct cutoff

Example SPC tcdA tcdB

Toxigenic C. difficile Call Ct Tm Ct Tm Ct Tm

1 N/A + + + + + Toxigenic C. difficile Positive

2 N/A + N/A N/A + + Toxigenic C. difficile Positive

3 N/A + + + N/A N/A Toxigenic C. difficile Positive

4 + + > N/A > N/A Toxigenic C. difficile

Negative

5 + + - - > N/A Toxigenic C. difficile

Negative

6 + + > N/A - - Toxigenic C. difficile

Negative

7 + + - - - - Toxigenic C. difficile

Negative

8 - + > N/A > N/A Invalid*

9 - + - N/A > N/A Invalid*

10 - + > N/A - N/A Invalid*

11 - + - N/A - N/A Invalid*

12 N/A + - - - + Invalid*

13 N/A + - + - - Invalid*

14 N/A + - + - + Invalid*

15 N/A - N/A N/A N/A N/A Invalid*

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 12 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

*Invalid Results

In case of an “Invalid” result, re-test beginning with the primary sample. Start at “Assay

Procedure and use a new assay cassette. If the problem is unresolved, contact Luminex

Technical Support.

Reporting

LIS report

1. Negative Result:

Negative – No C. difficile toxin A or B gene detected

by Luminex ARIES C. difficile assay. This assay has a negative likelihood ratio of

0.04. A second test does NOT significantly increase the sensitivity or change the

negative likelihood ratio. This is a research test.

2. Invalid Result:

Invalid – Unable to obtain valid test result by Luminex

ARIES C. difficile assay. This is a research test.

*NOTE*: If this is your patient's first episode of C.difficile infection, place orders

using the C.difficile treatment order set in Power Chart at Mount Sinai Hospital or

Electronic Patient Record(EPR) at University Health Network. Follow the "First

Episode Clostridium difficile Infection Management Algorithm" available at

http://tinyurl.com/jox5nmw for best practices associated with the management of

C.difficile infection.

3. Positive Result:

C. difficile toxin gene DETECTED

by Luminex ARIES C. difficile assay. This is a research test.

*NOTE*: If this is your patient's first episode of C.difficile infection, place orders

using the C.difficile treatment order set in Power Chart at Mount Sinai Hospital or

Electronic Patient Record(EPR) at University Health Network. Follow the "First

Episode Clostridium difficile Infection Management Algorithm" available at

http://tinyurl.com/jox5nmw for best practices associated with the management of

C.difficile infection.

Quality Control

Each ARIES® C. difficile Assay cassette contains a sample processing control, which is

processed with the sample and analyzed during the amplification reaction.

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 13 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

All In-house External control materials: C.difficile positive control and negative control

should be run with each new lot or shipment on each instrument or after major

maintenance.

Report all failed QC to senior/ charge technologist

Do not release results pending resolution of QC failure.

Inform charge/senior technologist.

Record in Reagent Log Chart, Instrument Maintenance Log or Incident Report

where appropriate.

If the QC failure was due to a simple matter of position reversal or misplacement,

the run can be released (positive QC material yielded positive result, negative

yielded negative result).

Maintenance

Refer to the maintenance procedure in Influenza A/B & RSV PCR by Luminex Aries

Reference

Luminex Package Insert/RUO Aries ® C.difficile Assay

Department of Microbiology

Quality Manual

Policy # MI_MD_CDAR

Page

Version: 0 CURRENT 14 of 14

Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex

Aries

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked

against the document (titled as above) on the server prior to use.

Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\

Record of Edited Revisions

Manual Section Name: Clostridium difficile PCR by ARIES®

Page Number / Item Date of Revision Signature of

Approval