HC HOLY CROSS HOSPITAL The test

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HC

HOLY CROSS HOSPITAL

Memo

1500 Forest Glen Road

Silver Spring, MD

20910-1484

Phone: (301) 754-7000 www.holycrosshealth.org

TO: All Holy Cross Hospital Affiliated Physicians

FROM: Pablo Gutman, M D \ ^ '

Medical Director, Microbiology Laboratory > ^

DATE: February 15, 2012 ^~~~-^<\

SUBJECT: Clostridium difficile Disease (CDI) Panel

Effective March 19, 2012 the Microbiology laboratory will implement a new algorithm for Clostridium difficile disease testing (See attachment). The laboratory will perform antigen detection testing on all stools submitted for CDI to determine the presence or absence of Clostridium difficile in the stool.

Reflexive toxin testing will be performed on all specimens with a positive antigen result using enzyme immunoassay (EIA) and/or real time polymerase chain reaction

(RT-PCR) methods. in addition, a fecal lactoferrin test will be performed to determine the presence or absence of inflammation t o assist in the differentiation of carrier states and active infection.

The t e s t parameters are as follows:

Test

Normal value

C. difficile Antigen variable

Test

Results positive c. difficile antigen detected

Negative C. difficile antigen NOT detected invalid The presence or absence of C. difficile antigen cannot be determined

C. difficile Toxin

Negative

Toxigenic C. difficile detected

Toxigenic C. difficile

NOT detected

The presence or absence of toxigenic C.

difficile cannot be determined

Fecal Lactoferrin

Negative

Fecal lactoferrin detected

Fecal lactoferrin

NOT detected

The presence or absence of fecal lactoferrin cannot be determined

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Holy C r o s s . E x p e r t s in M e d i c i n e , S p e c i a l i s t s in C a r i n g .

HC

HOLY CROSS HOSPITAL

1500 Forest Glen Road

Silver Spring, MD

20910-1484

Phone: (301) 754-7000 www.hoiycrossheaith.org

Critical Testing Notes:

• Testing should be limited to patients with _> 3 diarrheal (unformed) stools in a 24 hour period, unless ileus (obstruction) is suspected.

• Patients may carry toxigenic Clostridium difficile months after a positive test with clinical cure. Test of cure is not recommended.

• Repeat testing after a positive test is recommended only in instances of improvement with therapy followed by clinical relapse after the completion of treatment.

• Repeat testing during the same episode of diarrhea will not be performed.

• Neonates may be colonized with toxigenic Clostridium difficile. Consultation with an infectious Disease physician is recommended prior to requesting this testing for this patient population.

• if c. difficile disease is strongly suspected after a negative test result, performance of toxin detection assays after toxigenic culture may be required. At present culture methods are available through outside reference laboratories.

Thank you for allowing us to help you serve your patients. Please contact the laboratory director, Jay Marchwinski (301-754-7321), or myself if you have any questions or concerns regarding our laboratory's practices or service to your patients.

References:

1. Cohen SH, Gerding DN, Johnson s, Kelly CP, LOO VG, McDonald LC, Pepin J, Wilcox M H .

Clinical practice guidelines for Clostridium difficile infection in adults:

2010 update by the society for Healthcare Epidemiology of America (SHEA) and the

infectious Diseases society of America (IDSA), infection Control and Hospital

Epidemiology. 2010 31(5):43155.

2. Swindells J, Brenwald N, Reading N, Oppenheim B., "Evaluation of diagnostic tests for Clostridium difficile infection", Journal of Clinical Microbiology. 2010

February48(2):6068.

cc: S. Mitchell, MD

B. Eig, MD j . Marchwinski

M. Mohyla, RN, CIC

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Holy C r o s s . E x p e r t s in M e d i c i n e , S p e c i a l i s t s in C a r i n g .

HC

HOLY CROSS HOSPITAL

Holy Cross Hospital

Microbiology Laboratory

C. difficile Disease

Test Algorithm

C. difficile Antigen

Screen

Positive

1500 Forest Glen Road

Silver Spring, MD

20910-1484

Phone:(301)754-7000 www.holycrosshealth.org

C. difficile"

NOT detected

Fecal Lactoferin

Toxigenic

C difficile

NOT detected

( Possible carrier A f Inflammatory \

I state ) ^diarrheal disease/

Holy C r o s s . E x p e r t s in M e d i c i n e , S p e c i a l i s t s in C a r i n g .

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