1001 NW Technology Drive, Lee's Summit, MO 64086 // (800) 305-5198 // (816) 347-0143 Fax // info@viracor-eurofins.com 220398P - Respiratory Supplemental Panel TEM PCR - 3/28/2024 12:27:26 PM Page of Respiratory Supplemental Panel TEM-PCR™ Test Code: 220398P Tests in this Panel Human bocavirus Acinetobacter baumannii Haemophilus influenzae Haemophilus influenzae (Type B) Klebsiella pneumoniae Legionella pneumophila Moraxella catarrhalis MRSA - Meth. resistant S. aureus Panton-Valentine leukocidin gene Pseudomonas aeruginosa Staphylococcus aureus Streptococcus pneumoniae Clinical and Procedure Clinical Utility The Respiratory Supplemental Panel detects thirteen viral and bacterial pathogens using TEM-PCR TM (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 PCR TM diagnostic panel testing consists of three major steps: extraction, amplification and detection. The key to making TEM-PCR TM 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. Turnaround Time Within 24 hours from receipt of specimen, Monday through Saturday. Specimen Information Specimen Type Order Code CPT Code NY Approved Volume Assay Range BAL 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. bronch wash 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. nasal asp 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. nasal swab 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL Positive/Not Detected Special Instructions - Place 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 7 days of collection. nasal wash 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. NP aspirate 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. NP swab 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL Positive/Not Detected Special Instructions - Place 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 7 days of collection. NP wash 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. sputum 220398 87798 (x9), 87541 (x1), 87486 (x1), 87581 (x1), 87632 (x1), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. throat gargle 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. trach asp 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. trach wash 220398 87798 (x8), 87541 (x8), 87641 (x1), 87651 (x1) No 2 mL (min. 0.5 mL) Positive/Not Detected Special Instructions - Collect in a sterile, screw top tube. - Can be shipped at ambient or frozen temperature Monday through Friday. - Specimens shipped at ambient temperature must be received within 7 days of collection. 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 Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 18000 W 99th St. Ste, #10, Lenexa, KS 66219. 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. 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 Eurofins' 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 Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material. References TEM-PCR, Diatherix Laboratories, LLC Error page

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