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13-PANEL ORAL FLUID DRUG SCREEN WITH REFLEX TO CONFIRMATION AND MEDICATIONS (OFDS)

Presumptive oral fluid drug screen covering the most commonly prescribed and abused drug classes, with automatic reflex to definitive LC-MS/MS confirmation on any positive result, plus medication monitoring to verify compliance with prescribed therapy.

LIS PANEL CODE: (MID) 13-Panel Oral Fluid Drug Screen with Reflex to Confirmation & Meds (OFDS)

INDIVIDUAL LIS TEST CODES INCLUDED WITHIN PANEL: OFDS-6AM, OFDS-Amphetamine, OFDS-Benzodiazepines, OFDS-Buprenorphine, OFDS-Cocaine, OFDS-EDDP, OFDS-Fentanyl, OFDS-Marijuana (THC), OFDS-Methamphetamine, OFDS-Opiates, OFDS-Oxycodone, Oral Fluid Specimen Validity: OFDS-Volume Adequacy Indicator, OFDS-pH, OFDS-Oral Fluid Biomarker

CPT CODE: 80307 (Presumptive Screen); G0481 (Definitive Confirmation, Reflex Only, billed for 8 – 14 drug classes)

ALIASES: OFDS, Saliva Drug Screen, Oral Fluid Tox Panel, 13-Panel Oral Tox

METHODOLOGIES: Homogeneous Enzyme Immunoassay (CEDIA/EMIT-type, run on Beckman Coulter AU series); Liquid Chromatography–Tandem Mass Spectrometry, LC-MS/MS (Confirmation, Reflex Only)

SPECIMEN:

- Type: Oral Fluid (Saliva)

- Container: Oral fluid collection device (e.g., Quantisal-type pad/swab with built-in volume-adequacy indicator, sealed into a buffer transport tube); tamper-evident, chain-of-custody packaging required if legally defensible testing is needed.

- Minimum Volume Required: Full saturation of collection pad (device indicator confirms adequate volume, typically ~ 1 mL neat oral fluid absorbed into buffer)

- Storage/Handling: Cap and seal the buffer tube immediately after collection. Collection should be directly observed by the collector (this is a built-in advantage of oral fluid, as this reduces adulteration/substitution risk vs. urine). Refrigerate if testing will be delayed more than a few hours; do not specimen let sit at room temperature for extended periods prior to screen.

- Stability:

Room Temperature (20-25 °C): 3 - 5 days (device-dependent)

Refrigerated (2-8 °C): 14 days

Frozen (-20 °C or below): 6 months (required for Reflex Confirmation Retention)

- Turnaround Time: 24 hours from receipt for oral fluid drug screen; Reflex confirmation (LC-MS/MS) requires an additional 2 – 4 business days.

Special Instructions: Any presumptive positive result automatically reflexes to LC-MS/MS confirmation at no additional draw required. Testing is performed from the retained buffer aliquot. Oral fluid detects recent use (typically within the past 1 – 3 days depending on drug class), making it well suited for recent-use/current-impairment testing rather than longer-window monitoring. Because collection is observed, oral fluid specimens submitted with a signed CoC form are inherently harder to adulterate or substitute than urine; specimens without a CoC form will be processed as medical/clinical (non-forensic) diagnostic testing only.

For patients on prescribed controlled substances (e.g., opioids, benzodiazepines, buprenorphine, amphetamine-based stimulants), the screen also reflexes to medication compliance confirmation by LC-MS/MS whenever the prescribed medication or its expected metabolite is detected, even if the immunoassay screen reads negative or below cutoff. This is billed and reported separately from the standard drug-of-abuse reflex, since the goal is verifying therapeutic presence/absence rather than confirming an illicit positive.

REJECTION REASONS: QNS (Insufficient Oral Fluid Volume; device adequacy indicator not activated), Evidence of Oral Contamination (food, gum, mouthwash, or eating/drinking within 10 minutes of collection), Damaged/Leaking Collection Device, Device Buffer Seal Broken, Unlabeled/Mislabeled Specimen, Expired Collection Device, Missing Chain-of-Custody Form (CoC orders only)

REFERENCE RANGES:

Oral Fluid Drug Screen results are reported qualitatively, Positive or Negative, against manufacturer/SAMHSA (OFMG) cutoff concentrations per drug class (see Table below).

Confirmed positives are reported quantitatively in ng/mL.

Medication monitoring results are reported as one of the following:

Consistent = prescribed medication and expected metabolite(s) are present at appropriate levels for recent use.

Inconsistent: Not Detected = prescribed medication not found (possible non-compliance or reflects oral fluid's short detection window; a negative may simply mean the dose wasn't taken recently, not that it was never taken. Interpret with caution relative to last-dose timing).

Inconsistent: Unexpected Substance Detected = a non-prescribed drug or substance is present in addition to, or instead of, expected medications.