Test Information

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Candida Real-time PCR Panel

Test Code: 2900

Cpt Code:

87481 (x3)

Clinical Utility

Real-time PCR detection of Candida DNA in blood samples may aid in diagnosis of invasive candidiasis (IC) in high risk populations. This assay's ability to discriminate between C. albicans and non-C. albicans species, including C. glabrata, C. krusei, and C. parapsilosis, may allow for implementation of species-specific therapies, when necessary. 

Procedure

Extraction of Candida spp. DNA from specimen followed by amplification and detection using real-time, qualitative PCR. A full-process internal control is added to each clinical specimen in order to ensure proper extraction and to ensure the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

These multiplex reactions are designed to be specific for C. albicans and/or C. tropicalis; C. glabrata and/or C. krusei and C. parapsilosis complex sp. Several fungal and non-fungal pathogens were tested with the Candida spp. Real-time PCR panel assays. An 'Indeterminate' detection result was determined by the C. glabrata/C. krusei assay with Trichosporon cutaneum, a cutaneous pathogen not known to cause invasive disease. A 'Detected' result was determined by the C. glabrata/C. krusei and C. parapsilosis complex sp. assays with Candida rugosa, a rare but azole-resistant pathogen.

Assay Range

Detected/Not Detected/Indeterminate for C. albicans and/or C. tropicalis. Detected/Not Detected/Indeterminate for the C. parapsilosis complex (C. parapsilosis, C. metapsilosis and C. orthopsilosis). Detected/Not Detected/Indeterminate for C. glabrata and/or C. krusei).

Causes For Rejection

Plasma or serum received not frozen, whole blood, or specimen types other than those listed.

Turnaround Time

Same day as specimen received. Monday through Saturday.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

2901 plasma - Collect 4-5 mL whole blood in plasma separator tube, centrifuge, and freeze. Ship on dry ice Monday through Friday. Plasma may be stored up to 7 days at 2 to 8°C or plasma may be frozen up to 14 days at -20 to -80°C.
2910 serum - Collect 4-5 mL whole blood in serum separator tube, centrifuge, and freeze. Ship on dry ice Monday through Friday. Serum may be stored up to 7 days at 2 to 8°C or serum may be frozen up to 14 days at -20 to -80°C.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.

 

References

Avni T, Leibovici L, Paul M. PCR diagnosis of invasive candidiasis: systematic review and meta-analysis. J Clin Microbiol. 2011Feb;49(2):665–70. Epub 2010 Nov 24.

McMullan R,Metwally L, Coyle PV, et al. A prospective clinical trial of a real-time polymerase chain reaction assay for the diagnosis of candidemia in nonneutropenic, critically ill adults. Clin Infect Dis. 2008 Mar 15;46(6):890-6.

Nguyen MH, Wissel M, Shields RK, et al. Performance of Candida Real-time Polymerase Chain Reaction, ß-D-Glucan Assay, and Blood Cultures in the Diagnosis of Invasive Candidiasis. Clin Infect Dis. 2012 May 01;54(9): 1240-48.

Alonso-Valle H, Acha O, Garcia-Palomo JD, et al. Candidemia in a tertiary care hospital: epidemiology and factors influencing mortality. Eur J Clin Microbiol Infect Dis. 2003 Apr;22(4):254–7. Epub 2003 Mar 22.

Pappas PG, Rex JH, Lee J, et al. A prospective observational study of candidemia: epidemiology, therapy, and influences on mortality in hospitalized adult and pediatric patients. Clin Infect Dis. 2003 Sep 1;37(5):634–43.

Edmond MB, Wallace SE, McClish DK, et al. Nosocomial bloodstream infections in United States hospitals: a three-year analysis. ClinInfect Dis. 1999 Aug;29(2):239–44.

Wisplinghoff H, Bischoff T, Tallen SM, et al. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309–17.

Horn DL, Neofytos D, Anaissie EJ, et al. Epidemiology and outcomes of candidemia in 2019 patients: data from the prospective antifungal therapy alliance registry. Clin Infect Dis. 2009 Jun 15;48(2):1695–703.

De Pauw B, Walsh TJ, Donnelly JP, et al. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813–21.

Chandrasekar PH, Weinmann A, and Shearer C. Autopsy-identified infections among bone marrow transplant recipients: a clinico-pathologic study of 56 patients. Bone Marrow Transplantation Team. Bone Marrow Transplant. 1995 Nov;16(5):675–81.0.

Ellepola AN, and Morrison CJ. Laboratory diagnosis of invasive candidiasis. J Microbiol. 2005 Feb;43 Spec No:65–84.

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