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HelpTest Code CSMOF Controlled Substance Monitoring Panel, 11 Drug Classes, Screen Only, Immunoassay, Oral Fluid
Ordering Guidance
This oral fluid test only offers presumptive positive screening results without confirmatory testing. If specific drug identification is required, urine testing is recommended. Order CSMPU / Controlled Substance Monitoring Panel, Random, Urine, which uses high-resolution accurate mass spectrometry-based targeted testing.
Specimen Required
Patient Preparation:
1. For 15 to 60 minutes before specimen collection, the patient should abstain from eating food.
2. If the patient has recently taken an oral medication or used an inhaled medication, wait 2 hours before collecting the specimen.
3. Patient must empty mouth of any gum, food, or tobacco prior to oral fluid collection. If patient's mouth is not empty immediately before collection, have them rinse their mouth with water (up to 4 oz) and wait 10 minutes before collection. The patient may discard or drink the water after rinsing.
Supplies: Quantisal Oral Fluid Collection Device (T980)
Note: Check expiration date on Quantisal packaging
Container/Tube: Quantisal collection device
Specimen Volume: 1 mL
Collection Instructions:
1. For complete instructions, see Oral Fluid Specimen Collection Instructions for Controlled Substance Monitoring.
2. Peel open package and remove collector by the handle. Do not touch the collection pad with fingers before or after specimen collection. To expedite the collection process, move tongue side to side to accumulate saliva in mouth before starting. Keep the tip of the device pointed down.
3. Position collector under tongue and close mouth. Keep head down to allow gravity to help with saliva collection.
Important: Do not chew on pad, talk, or remove collector from mouth until indicator turns BLUE, or until 10 minutes has passed, whichever occurs first.
4. Hold transport tube in an upright position and uncap by pushing up with thumbs. Do not stand tube on table. Do not spill or empty the liquid from tube.
5. Insert collector into the uncapped transport tube and replace cap. Do not place collector back in mouth after it has been placed in the transport tube.
6. Snap cap firmly for transport. Place center of specimen seal on top of tube and press down both sides.
7. Complete paperwork and send sample to laboratory.
8. Send in original tube. Do not aliquot.
Secondary ID
621483Useful For
Monitoring acute (ie, short-term) drug use in addiction treatment or pain management settings as part of a rotational drug testing strategy
Presumptive screening for amphetamine, methamphetamine, opioids/opiates (targeting morphine, oxymorphone, oxycodone, hydrocodone, 6-monoacetylmorphine, tramadol, buprenorphine, fentanyl, and methadone), PCP (phencyclidine), cocaine metabolite (targeting benzoylecgonine), benzodiazepines (targeting oxazepam, lorazepam, and clonazepam), zolpidem, barbiturates (targeting phenobarbital), methylphenidate, and THC-COOH (marijuana metabolite) in oral fluid specimens
This test is not intended for forensic or medico-legal purposes (ie, employee drug testing or settings where chain-of-custody is required).
Highlights
The oral fluid sample, collected with the Quantisal device, is screened using a competitive immunoassay.
Special Instructions
Method Name
Competitive Chemiluminescent Immunoassay
Reporting Name
Controlled Substance Panel, OFSpecimen Type
FluidSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Fluid | Ambient (preferred) | 7 days | |
| Frozen | 28 days | ||
| Refrigerated | 7 days |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
Drug abuse is a major social and medical issue and usually requires costly interventions for the treatment and rehabilitation of abusers. This qualitative test screens for commonly prescribed and/or abused drugs/drug classes in human oral fluid specimens. It uses a noninvasive specimen collection method, which can be observed. This test may be used for screening samples for compliance monitoring of prescription drugs in a point of care setting.
Reference Values
Not detected
Positives are reported with a qualitative result.
Cutoff concentrations by competitive chemiluminescent immunoassay:
Opioids:
6-Acetylmorphine: 5 ng/mL
Morphine: 10 ng/mL
Hydrocodone: 10 ng/mL
Oxycodone: 10 ng/mL
Oxymorphone: 10 ng/mL
Methadone: 10 ng/mL
Fentanyl: 1 ng/mL
Tramadol: 5 ng/mL
Buprenorphine: 1 ng/mL
Benzodiazepines:
Oxazepam: 10 ng/mL
Clonazepam: 10 ng/mL
Lorazepam: 10 ng/mL
Non-Benzodiazepine: Zolpidem: 10 ng/mL
Stimulants:
Amphetamine: 20 ng/mL
Methamphetamine: 10 ng/mL
Methylphenidate: 100 ng/mL
Cocaine Metabolite (BE): 30 ng/mL
PCP, Phencyclidine: 5 ng/mL
Marijuana metabolite (THC-COOH): 10 ng/mL
Barbiturates, Phenobarbital: 50 ng/mL
Interpretation
This test is intended to screen for amphetamine, methamphetamine, opioids/opiates (targeting morphine, oxymorphone, oxycodone, hydrocodone, 6-monoacetylmorphine, tramadol, buprenorphine, fentanyl, and methadone), PCP (phencyclidine), cocaine metabolite (targeting benzoylecgonine), benzodiazepines (targeting oxazepam, lorazepam, and clonazepam), zolpidem, barbiturates (targeting phenobarbital), methylphenidate, and THC-COOH (marijuana metabolite) in oral fluid specimens. The limit of detection for each of these drug groups varies (see Reference Values). A positive finding for one of these drugs or metabolites is an indication for the presence of the drug of abuse or cross reactivity with other structurally similar commonly prescribed drugs.
Cautions
It is possible that substances other than those investigated may interfere and cause a false-positive screening result. If specific drug identification is required, urine testing is recommended;Â order CSMPU / Controlled Substance Monitoring Panel, Random, Urine, which uses high-resolution accurate mass spectrometry-based targeted testing.
In instances where an oral fluid specimen cannot be collected (eg, dry mouth), providers should consider alternative specimen collection methods (eg, urine).
This test is not appropriate for use in forensic or employment settings (ie, medico-legal, chain-of-custody).
Clinical Reference
1. Jannetto PJ, Bratanow NC, Clark WA, et al. Executive Summary: American Association of Clinical Chemistry Laboratory Medicine Practice Guideline-Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. J Appl Lab Med. 2018;2(4):489-526. doi:10.1373/jalm.2017.023341
2. Bosker WM, Huestis MA. Oral fluid testing for drugs of abuse. Clin Chem. 2009;55(11):1910-31. doi:10.1373/clinchem.2008.108670.
3. Huestis MA, Verstraete A, Kwong TC, Morland J, Vincent MJ, de la Torre R. Oral fluid testing: promises and pitfalls. Clin Chem. 2011;57(6):805-10. doi:10.1373/clinchem.2010.152124
Method Description
The oral fluid sample, collected with the Quantisal device, is screened using a competitive immunoassay to indicate the presence of any of the drugs/drug classes or their cross reactivity with other structurally similar commonly prescribed or abused drugs. Screening for amphetamine, methamphetamine, opioids/opiates (targeting morphine, oxymorphone, oxycodone, hydrocodone, 6-monoacetyl morphine, tramadol, buprenorphine, fentanyl, and methadone), phencyclidine (PCP), cocaine metabolite (targeting benzoylecgonine), benzodiazepines (targeting oxazepam, lorazepam, and clonazepam), zolpidem, barbiturates (targeting phenobarbital), methylphenidate, and THC-COOH (marijuana metabolite) is accomplished using a competitive chemiluminescent immunoassay.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
2 daysSpecimen Retention Time
2 weeksPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
80307
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CSMOF | Controlled Substance Panel, OF | 20787-8 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 621485 | Opioids, 6-acetylmorphine, OF | 32099-4 |
| 621486 | Opioids, Morphine, OF | 32100-0 |
| 621487 | Opioids, Hydrocodone, OF | 32080-4 |
| 621488 | Opioids, Oxycodone, OF | 69356-4 |
| 621489 | Opioids, Oxymorphone, OF | 104692-9 |
| 621490 | Opioids, Methadone, OF | 72626-5 |
| 621491 | Opioids, Fentanyl, OF | 87815-7 |
| 621492 | Opioids, Tramadol, OF | 74110-8 |
| 621493 | Opioids, Buprenorphine, OF | 73942-5 |
| 621494 | Benzodiazepines, Oxazepam, OF | 72614-1 |
| 621495 | Benzodiazepines, Clonazepam, OF | 61039-4 |
| 621496 | Benzodiazepines, Lorazepam, OF | 61044-4 |
| 621497 | Non-Benzodiazepine, Zolpidem, OF | 87820-7 |
| 621498 | Stimulants, Amphetamine, OF | 40799-9 |
| 621499 | Stimulants, Methamphetamine, OF | 40804-7 |
| 621500 | Stimulants, Methylphenidate, OF | 87805-8 |
| 621501 | Stimulants, Cocaine Metabolite (BE), OF | 40802-1 |
| 621502 | PCP, Phencyclidine, OF | 40808-8 |
| 621503 | Marijuana metabolite (THC-COOH), OF | 40801-3 |
| 621504 | Barbiturates, Phenobarbital, OF | 32108-3 |
| 621484 | Controlled Substance Interpretation | 69050-3 |