Skin and Soft Tissue Infection Panel TEM-PCR™

Test Code: 220798P

 

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Clinical and Procedure
Clinical Utility

The Skin and Soft Tissue Infection Panel detects 19 bacterial targets using TEM-PCRTM (Target Enriched Multiplex Polymerase Chain Reaction) technology - a multiplex PCR amplification technology to detect multiple targets simultaneously. It is intended to aid in the identification of bacterial pathogens commonly found in skin and soft tissue.

Procedure

Target Enriched Multiplex PCRTM diagnostic panel testing consists of three major steps: extraction, amplification and detection. The key to making TEM-PCRTM occur successfully lies in these primer mixes and how they allow the enrichment of multiple targets. The use of target-specific nested primers at low concentrations at the initial enrichment step allows high specificity of multiplexing amplification. After initial target enrichment is complete, Super Primers within the reaction carry out the exponential amplification and produce tagged PCR products for subsequent detection. The detection phase of the process is accomplished by measuring the fluorescence of special tags that are bound to the target sequences, which have been attached during amplification. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

At high concentrations, cross reactivity is observed between Proteus mirabilis and Proteus vulgaris.

Turnaround Time

2-3 days from sample receipt. Testing performed at Diatherix-Eurofins.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
Abscess Fluid 220798P 87641, 87651, 87798 x17 No

1 mL (min. 0.5 mL)

Qualitative (Positive/Not Detected)
  • The surface of the wound/abscess should be carefully cleansed and debrided using sterile gauze and saline before attempting to aspirate the specimen.
  • Syringe aspiration of purulent material from a loculated, palpable lesion is preferred.
  • Aspirate the specimen and place 0.5 to 1.0 mL of the aspirate directly a tube containing an equal amount of Aimes media and screw the top on tightly.
  • Stability: 7 days ambient, 7 days refrigerated, 30 days frozen.

 
Synovial Fluid 220798P 87641, 87651, 87798 x17 No

1 mL (min. 0.5 mL)

Qualitative (Positive/Not Detected).
  • Collect synovial fluid following established procedure.
  • Place 0.5 to 1.0 mL of the aspirate directly into tube containing an equal amount of Aimes media and screw the top on tightly.
  • Stability: 7 days ambient, 7 days refrigerated, 30 days frozen.
Wound Swab 220798P 87641, 87651, 87798 x17 No

1 mL (min 0.5 mL)

Qualitative (Positive/Not Detected)
  • Cleanse and debride the wound with sterile gauze and saline.
  • Exudate and brushings of the wound base (including advancing margins) should be collected using a regular flocked swab.
  • Without contaminating the swab, place the swab into a tube containing 1-2 mL of Aimes media, ensuring the swab is immersed in liquid. You may either break the swab at the scored breakpoint indication line or rotate the swab 5 times in the solution and discard the swab. Screw the top tightly on the tube.
  • Stability: 7 days ambient, 7 days refrigerated, 30 days frozen.
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 Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10, Lenexa, KS 66219.

Causes for Rejection

Wood shafted swab, calcium alginate swab, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

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. 

References

TEM-PCR, Diatherix Laboratories, LLC

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