Alere Drug Screening

Drug Screening Overview

Dot 5 Panel Description And Cutoff Rates

(10 PANEL) (INCLUDES THE ABOVE 5 PANEL)

(12 PANEL) EXPANDED OPIATE PANEL (ADDITIONAL COST)

The Question Of Quantitative Levels

The quantitative (‘quant’) level of a positive drug screen specifically indicates whether a drug or a drug indicator was detected in the donor’s system at the time of collection.

A drug can be detected in a donor’s sample and still be reported as negative.

A laboratory has what is called, “cutoff levels”. These levels are designed to screen out some over‐the‐counter pharmaceuticals or vitamins, certain foods that may show as drug indicators, as well as ambient absorption, such as walking past a smoke‐filled room.

Many factors influence the level of a drug in a donor’s system.

Metabolism, physical condition, fluid balance, frequency of drug ingestion and the last time the drug was consumed are all contributing factors to quantitative levels. The ‘number’ you may see does not provide valid information outside the entire review process conducted by a licensed Medical Review Officer.

The Department of Transportation (DOT) 49 CFR Part 40.163(f) says the MRO cannot provide quantitative levels to Employer or other drug screening company.

“You must not provide quantitative values to the DER or C/TPA for drug or validity test results. However, you must provide the test information in your possession to a SAP… [Substance Abuse Professional]…who consults with you (see Sec. 40.293(g)).”

Why does the DOT discourage quantitative level reporting and what does that have to do with Non DOT drug screening?

A. The ‘numbers’ associated with quant levels require interpretation and context. This process should be handled by a medical doctor.

B. There can be liability issues with the pre‐judgment that may occur if a quant level is available.

C. The DOT is the single standard for drug screening. A regulation within this standard is always a consideration for non DOT drug screening. A non DOT quant level has the same repercussions a DOT quant level has – misinterpretation and liability.

While it may seem that providing quant levels for a drug screen is a good idea, the opposite is true. Providing unambiguous and comprehensible information is helpful to our clients; providing confusing or potentially misinterpreted information is not so helpful. As a DER or C/TPA, we must consider the ramifications of the information we provide: for ourselves, a client, and for a donor (or an employee). Quantitative levels are just a part of the medical professional’s resources for interpreting a drug screening result. In a medical or SAP context, these levels assist with the overall interpretation of a positive drug screen. Outside of that context, quantitative levels provoke far more misinterpretation than they provide any meaningful information.

Specimen Validity Testing*

Specimen validity testing refers to the tests conducted by laboratories to determine if a urine specimen is dilute or has been adulterated or substituted. An adulterated specimen is a urine specimen containing a substance that is not a normal constituent or containing an endogenous substance at a concentration that is not a normal physiological concentration. A dilute specimen is a urine specimen with creatinine and specific gravity values that are lower than expected for human urine. A substituted specimen is a urine specimen with creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal human urine.
To report a specimen as dilute, adulterated, or substituted, the laboratory must conduct an initial validity test (the first test used to determine if a urine specimen is adulterated, dilute, or substituted) and a confirmatory validity test (a second test performed on a different aliquot of the original urine specimen to further support a validity test result).

Adulterants detected in urine specimens include: acids, bases, nitrite, chromium (VI), halogens, glutaraldehyde, pyridine, and surfactants.

Adulterated

The following criteria have been established to report a specimen as adulterated:

(1) The pH is less than 3 or greater than or equal to 11 using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot;
(2) The nitrite concentration is greater than or equal to 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (e.g., multi‐wavelength spectrophotometry, ion chromatography, capillary electrophoresis) on the second aliquot;
(3) The presence of chromium (VI) is verified using either a general oxidant colorimetric test (with a greater than or equal to 50 mcg/mL chromium (VI)‐equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration greater than or equal to 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (e.g., multi‐wavelength spectrophotometry, ion chromatography, atomic absorption spectrophotometry, capillary electrophoresis, inductively coupled plasma‐mass spectrometry) with the chromium (VI) concentration greater than or equal to the LOD of the confirmatory test on the second aliquot;
(4) The presence of halogen (e.g., bleach, iodine, fluoride) is verified using either a general oxidant colorimetric test (with a greater than or equal to 200 mcg/mL nitrite‐equivalent cutoff or a greater than or equal to 50 mcg/mL chromium (VI)‐equivalent cutoff) or halogen colorimetric test (halogen concentration greater than or equal to the LOD) for the initial test on the first aliquot and a different confirmatory test (e.g., multi‐wavelength spectrophotometry, ion chromatography, inductively coupled plasma‐mass spectrometry) with a specific halogen concentration greater than or equal to the LOD of the confirmatory test on the second aliquot
(5) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and GC/MS for the confirmatory test with the glutaraldehyde concentration greater than or equal to the LOD of the analysis on the second aliquot;
(6) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with a greater than or equal to 200 mcg/mL nitrite‐equivalent cutoff or a greater than or equal to 50 mcg/mL chromium (VI)‐equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration greater than or equal to 50 mcg/mL) for the initial test on the first aliquot and GC/MSfor the confirmatory test with the pyridine concentration greater than or equal to the LOD of the analysis on the second aliquot;
(7) The presence of a surfactant is verified by using a surfactant colorimetric test with a greater than or equal to 100 mcg/mL dodecylbenzene sulfonate‐equivalent cutoff for the initial test on the first aliquot and a different confirmatory test (e.g., multi‐wavelengthspectrophotometry) with a greater than or equal to 100 mcg/mL dodecylbenzene sulfonate‐equivalent cutoff on the second aliquot; or
(8) The presence of any other adulterant not specified in 3 through 7 is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.

Substituted

A urine specimen is reported substituted when the creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1.0010 or greater than or equal to 1.0200 on both the initial and confirmatory creatinine tests (i.e., the same colorimetric test may be used to test both aliquots) and on both the initial and confirmatory specific gravity tests (i.e., a refractometer is used to test both aliquots) on two separate aliquots.

Dilute

A urine specimen is reported dilute when the creatinine concentration is greater than or equal to 2 mg/dL but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030 on a single aliquot.

* From the Mandatory Guidelines for Federal Workplace Drug Testing Programs published in the Federal Register on April 13, 2004 (69 FR 19644), effective November 1, 2004.

Random Selection Protocol

How Amerisearch Background Alliance Generates Random Numbers

Selecting pool members is a two-step process:

1) Our system uses a random algorithm, or mathematical equation, to assign an “index number” to everyone in the pool. The employee’s index number is usually different every selection period, though it is possible for the computer to assign the same index number two or more periods in a row. The number of index numbers is always equal to the number of people in the pool for the selection period. The index number becomes the “identity” of each member of the pool group for the selection period. For example, if the pool group has 100 members, then each member in the pool will receive a randomly assigned index number between 1 and 100.

2)Next, using a random algorithm, ASSISTANT PRO generates a series of random numbers equal to the number of tests required for the period. The program then matches these random numbers to the index numbers that are randomly assigned to the pool group members. For example, if ASSISTANT PRO determined that five tests were needed for the period in a pool group of 100 members, it would randomly pick five numbers between 1 and 100. For illustrative purposes, let us assume that the numbers 34, 45, 67, 35, and 10 were picked. ASSISTANT PRO would then search through the 100 index numbers and find out which pool group members were assigned the index numbers of 34, 45, 67, 35, and 10. Those five individuals would be selected for a test.

IMPORTANT: The selection process cannot be undone. Once ASSISTANT PRO has assigned index numbers and made selections, a permanent record for each selection is created. It is also important to know that the random algorithm used by ASSISTANT PRO has been
thoroughly tested and documented. Statistical analysis has also determined that computer algorithms are the best random generators because they are free from physical biases and can thoroughly document the random selection process. ASSISTANT PRO’s random number generator verification is available upon request.

Selection And Notification Procedure

Clients provide updated lists of employees on a monthly or quarterly basis. Lists are imported into the system updating the employee roster with only active employees and coding them for operating administration (FAA, FMCSA, etc). Selections are completed and mailed to clients to immediately begin testing.

Important Information Regarding Random Testing

Each person selected for a random drug test should be issued a chain of custody form. Each person selected for a random alcohol test should be issued an alcohol testing form (these are sent to you with notification or the Breath Alcohol Technician will have the form).

On both the drug testing chain of custody form and the alcohol testing form (BAT) – it is the employer responsibility to complete the sections requesting the employee ID # (employee ID number ID# on the Notification Letter); the reason for test – Random; Testing Authority – DOT; and DOT Agency (i.e. FMCSA, FAA, FRA, FTA, PHMSA,
USCG).

If for some reason an employee is out for an extended period-of-time or not employed with you any longer – please notify us with this information and an alternate selection will be provided.

Key Points To Remember

1. Please complete all testing within monthly or quarterly timeframe. Complete on all forms the employee ID # (employee ID number ID# on the Notification Letter); the reason for the test – Random; Testing Authority – DOT; and DOT Agency (i.e. FMCSA, FAA, FRA, FTA, PHMSA, USCG).

2. Do not notify any employee of their selection until such time as you are ready to send them for the test.

3. If you have more than five employees to test and would like to schedule an on site collection, please call: 1 800-569-6133 and speak with our Collection Site Coordinator.

4. Employees selected for an alcohol test must go to a facility that conducts alcohol testing, Quest and Labcorp facilities do not conduct alcohol testing. Please call and request a location for alcohol testing if you are not sure of where to send your employee for this test.

Scroll to Top