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Chicago, Rockford, Edwardsville 312-573-8248 815-965-1106 618-656-7672 PROCEDURE TITLE: Test Information - Test Methods Laboratory testing falls into three general categories. The following is a brief description to provide a basic understanding of the limitations of each category. In general, testing for drugs of abuse does not measure the actual drug present in the body. The human body will break down drugs into various smaller compounds called metabolites. Most of the metabolites are excreted into the urine, where they can be readily detected. Some will also be present in the saliva, sweat and eventually the hair. See table below illustrating the differences in sample types. PRINCIPLE: Qualitative Tests: These are basic, almost "fool-proof" test devices, which yield simply a positive or negative result. Such tests are useful when results are required as soon as possible. The manufacturer of such tests designs them for use by individuals who are not trained in laboratory procedures. A common example is the home pregnancy test. The "dipstick" provides a positive reading only when the HCG hormone reaches a certain level, which indicates the pregnancy. According to a 1999 Government study, these tests are at best about 85% accurate for the drugs of abuse. There are several problems with qualitative tests. Accuracy levels will vary with the various manufacturers, so some dipsticks may actually read lower than the customary cutoff, while others may be a little higher. The amphetamine and opiate cut-off levels are higher on the dipsticks than testing by TASCLabs. The Federal Department of Transportation established the higher levels to allow greater compliance of transportation workers to random drug screens. (See Test Information Interpretation - Cut off Values) Thus, there will be more negative results seen as compared to TASCLabs. Qualitative tests, like semi-quantitative tests, are subject to interference by certain other substances. Some over the counter medications contain drugs that are similar to the drugs of abuse. Certain herbal products or foods might also yield a false-positive result. Careless collection or performance of the dipstick test can cause negative results. Semi-Quantitative Tests: Semi-quantitative tests are more specific than the qualitative assays. They are performed in the laboratory under controlled conditions. Test Instruments are calibrated with known standards and checked with known controls, to ensure the results are accurate. Generally, the tests are about 95% accurate. The term "semi-quantitative" is somewhat misleading, as numeric values are obtained, which can be used to monitor the compliance of a client. Semi-quantitative tests, like the qualitative tests work on the basis of an antibody - antigen reaction. The antigen (drug metabolite) attaches itself to the antibody (test reagent) to produce a color. The intensity level of the color is equal to the concentration of the drug metabolite. Usually all the metabolites from a drug are detected as a group. 874019097 Eff: 04/30/04 Doc. No. 09.007 Page 1 of 3 TASC Laboratories The tests are subject to similar interference as are the dipstick tests. TASCLabs maintains a listing of known substances that can or cannot affect the various tests. This listing is called the "Test Effects Table" and is found in the TASCLabs Field Manual. Quantitative Tests: A quantitative assay is very specific and accurate for a given test. In the medical world, they are used to adjust treatments and make life & death judgements of a patient. In the substance abuse world, they can make the difference in deciding if a client is truly following their program or attempting to abuse the system. For Drugs Assays, this quantitative "gold standard" is the GC/MS (Gas Chromatography / Mass Spectroscopy). This assay is capable of measuring each of the individual metabolites of a specific group of drugs. (As compared to semi-quantitative, which measures all the metabolites.) TASCLabs refers samples for confirmation to a Reference Laboratory for the quantitative GC/MS test. The semi-quantitative screening tests are always performed before requesting the confirmation test, because the GC/MS assay uses solvents to extract the specific drug group metabolites. GC/MS cannot be used as a screening system, because each drug group requires a different extraction process, which is costly. Adulterants typically do not interfere with these assays. INVALID TEST: Occasionally a confirmation test may be reported as invalid by the Reference Laboratory. The laboratory may have protocols for certain drugs, as to which metabolites are to be detected before designating the sample as positive. For example, the most likely to have such a protocol is cocaine, as it is tested for three metabolites. If one metabolite is below the cut-off level, the assay may be called invalid, because something is interfering with the confirmation. If two of the three metabolites are below the cut-off, the confirmation may be called negative. This does not apply to all drug groups as most have only one or two major metabolites measured to be called positive. 874019097 Eff: 04/30/04 Doc. No. 09.007 Page 2 of 3 TASC Laboratories Illustration of Sample Types: Specimen Type: Urine Detection Time Usually drug use within 1-3 days Notes Pro: Oldest and most common testing. Most accepted by the court system. Saliva Detects usage earlier than urine by about 4-6 hours. Con: Sample collection issues or concerns A person abstaining long enough can cause a negative result. Pro: Easiest sample collection. Results equivalent to urine, but lower values. Hair Drug use over longer period. One inch of hair is about 60 days Con: Detection times are shorter than urine Pro: Shows chronic use over longer period. Sample easy to collect, store and ship. Sweat Eye Sample gathered using a sweat patch over a week or more to evaluate usage. Con: Testing takes longer and more expensive Black hair shows higher concentration than gray hair. Pro: Detects usage over a longer period User may have hard time abstaining for a long period of time. Eye movements are measured, which is associated with drug usage. Con: Reports of external contamination being absorbed into the patch giving false positives. Pro: Quick evaluation, especially when large number of persons to be tested. Equipment relatively low cost. Con: Not recommended for persons under age 16 or over age 50 Fatigue can give false positives. RELATED DOCUMENTS: Test Information - General Test Information - Result Interpretation Test Information - Reporting DOCUMENT APPROVAL: Revision History: Date Rev. No. 11/15/02 0 04/30/04 1 874019097 William J. Salas BS, MT (ASCP), NM (ASCP) - Laboratory Director (Original signed document maintained in Master Laboratory Manual) Change Description: Original Document created Removed section from General Info and added table illustrating sample types. Eff: 04/30/04 Doc. No. 09.007 Author: Bill Salas Bill Salas Page 3 of 3