NICOTINE METABOLITE WITH CONFIRMATION, URINE | |
| This test is a lab developed test. For further information, see the Compliance Remarks section below. |
| SPECIMEN REQUIREMENTS | | | Container Type | Leakproof plastic urine container | | Specimen Type | Random urine | | Preferred Volume | 20 mLs | | Store and Transport | Maintain specimen at room temperature. If arrival at lab will extend beyond seven days, refrigerate. | | Stability | Room Temp 7 days | | CPT Codes | 80307 | | Interface Order Code | 80307.Z153 | | Billing Code | NICCO | | Test Schedule | Mon,Tue,Wed,Thu,Fri,Sat | | Turnaround Time | 1-3 days | | Method | Immunoassay; Confirmation: Mass Spectrometry | | Reference Ranges | | Title | Descriptor | Ranges | Units | | Nicotine | | <300 | ng/mL | | Cotinine | | <300 | ng/mL | | | Please Note: Cotinine level equal to or greater than 300 ng/ml is consistent with the use of tobacco or tobacco cessation product. |
| | Compliance Remarks | PAML LDT/Modified FDA Compliance Statement [PAMLC]: This test was developed and its performance characteristics determined by PAML. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. PAML is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing. | | Notes | Detect use of nicotine products. | | Reflex Testing | | Reflex Condition | Reflex Test Name | Reflex CPT codes | Reflex Billing codes | | Nicotine is positive at >300 ng/mL | Cotinine | 80383 (HCPCS G0480) | NICRFX |
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| Interface Codes | | type | order code | test description | result code | result description | units | decimal places | loinc code | | o | 80307.Z153 | Nicotine Screen with reflex to Cotinine |
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