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C DIFF DNA AND TOXIN B GENE, QL REAL TIME PCR

Test Code

16739

CPT Code(s)

87493
87798

Preferred Specimen(s)

1 G FROZEN STOOL

Minimum Volume

0.5 G

Transport Container

CLEAN PLASTIC SCREW-CAP, LEAK-PROOF CONTAINER

Transport Temperature

FROZEN

Specimen Stability

ROOM TEMPERATURE: UNACCEPTABLE
REFRIGERATED: UNACCEPTABLE
FROZEN: 30 DAYS

Reject Criteria

RECEIVED ROOM TEMPERATURE; RECEIVED REFRIGERATED

Methodology

REAL TIME POLYMERASE CHAIN REACTION (RT-PCR)

LABORATORY DEVELOPED TEST (LDT)
THIS TEST WAS DEVELOPED AND ITS PERFORMANCE CHARACTERISTICS
HAVE BEEN DETERMINED BY FOCUS DIAGNOSTICS. PERFORMANCE
CHARACTERISTICS REFER TO THE ANALYTICAL PERFORMANCE OF THE
TEST. THIS TEST IS PERFORMED PURSUANT TO A LICENSE AGREEMENT
WITH ROCHE MOLECULAR SYSTEMS, INC.

Performing Laboratory

FOCUS DIAGNOSTICS
33608 ORTEGA HIGHWAY
BUILDING B-WEST WING
SAN JUAN CAPISTRANO CA 92675-2042

Setup Days

DAILY

Clinical Significance

CLOSTRIDIUM DIFFICILE STRAINS PRODUCING TOXIN A AND/OR B
ARE ASSOCIATED WITH DIARRHEAL DISEASE, WHEREAS STRAINS
THAT PRODUCE NEITHER TOXIN ARE NOT. MOST C. DIFFICILE
STRAINS ASSOCIATED WITH DIARRHEAL DISEASE PRODUCE BOTH
TOXIN A AND B. THUS, THIS QUALITATIVE REAL-TIME PCR ASSAY
IS USEFUL FOR THE DIAGNOSIS OF TOXIGENIC C. DIFFICILE
ASSOCIATED WITH DIARRHEAL DISEASE.

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

LOINC assignment is based on a combination of test attributes, including the method used by the performing laboratory. For tests not performed by Quest Diagnostics, codes are assigned by the performing laboratory.

* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.