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Respiratory Supplemental Panel TEM-PCR™

Test Code: 220300P

Cpt Code:

87798 (x8) 87541 (x8) 87641 (x1) 87651 (x1)

Clinical Utility

The Respiratory Supplemental Panel detects thirteen viral and bacterial pathogens using TEM-PCRTM (Target Enriched Multiplex Polymerase Chain Reaction) technology - a multiplex PCR amplification technology to detect multiple targets simultaneously. Multiple target panel testing helps identify co-infections, provides physicians with valuable diagnostic insight into unknown causes of infection, reduces unnecessary antibiotic administration and hospital acquired infections, allows for molecular testing in patients with concurrent therapy, and more targeted therapy for better patient management and overall reduced hospital costs.

Procedure

Target Enriched Multiplex PCRTMdiagnostic 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.

Assay Range

Qualitative. Positive, Not Detected.

Causes For Rejection

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

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), 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

220309P BAL

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220326P bronch wash

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220331P nasal asp

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220330P nasal swab

NY approved. Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube. Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220313P nasal wash

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220324P NP aspirate

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220325P NP swab

NY approved. Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube. Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220347P NP wash

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220323P throat gargle

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220319P trach asp

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

220348P trach wash

NY approved. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

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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