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Test 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.


Useful 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).

Method Name

Competitive Chemiluminescent Immunoassay

Reporting Name

Controlled Substance Panel, OF

Specimen Type

Fluid

Specimen 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;  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).

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 days

Performing 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