DRUG TESTING IN THE
LABORATORY
Drug Testing
• Facilities
• Screening: at least 20 sq.m. floor area with a 10
sq.m. working area
• Confirmatory: at least 60 sq.m. floor area with a 30
sq.m. working area
• can accommodate at least 5 patients at one time
• handwashing area, toilet stalls
Specimen Collection
• Must be at a permanent drug testing facility except for
remote collection which is allowed in the following:
• Workplace/school/jail or prison/rehabilitation center for:
• Random
• Follow-up
• Reasonable suspicion/cause
• Crime scene and post-accident
• Persons who are critically-ill or disabled
• In these cases, sample validity tests must be performed
Parameters for Validity Test
• Color
• Appearance: clear
• Odor: aromatic
• Volume: 30-60 mL
• Temperature: 32-38 degrees C
• pH: 4.0-9.0
• Specific Gravity: 1.003-1.030
Tampering of Specimens
• ADULTERATION
• with a substance not normally present in the test
specimen
• Addition of juice, illicit drugs
• Taking of drug screens like aspirin, niacin, and zinc sulfate
which interfere with drug analysis
• ‘doping samples’: adding chemicals to urine
• e.g. bleach, ammonia/liquid soap/table salt, hydrogen peroxide,
vinegar
Tampering of Specimens
• DILUTION
• less than normal physiological constituents
• Internal dilution: plenty of water, diuretics
• External dilution: adding water to specimen
• SUBSTITUTION: submission of switched or replaced sample
Personnel
• HEAD OF THE LAB (Screening)
• Clinical Pathologist or any licensed physician w/ certification
in Clinical Laboratory Management by the DOH
• 10: maximum screening labs a physician can handle (within
5 km radius)
• HEAD OF THE LAB (Confirmatory)
• physician/pathologist with 2 years experience in analytical
toxicology
• chemist with a master's degree and 2 years experience in
analytical chemistry
Personnel
• ANALYST (Screening)
• either a chemist, med tech, pharmacist, or chemical engineer with
training
• ANALYST (Confirmatory)
• Required: full-time chemist with training in chromatography and mass
spectroscopy and either a med tech, pharmacist, or chemical engineer
with training in screening
• The personnel verify chain of custody, perform test, certify results,
perform QA
• AUTHORIZED SPECIMEN COLLECTOR: instructs, assists, and
receives/inspects specimens
Documents
• Custody and Control Form • Chain of Custody Document
• A BHFS-approved form • The form/s used to document the
security of the specimen and all
used to document the aliquots of the specimen during
collection, transport, testing and storage
security, and test results of • Includes the names and signatures
the specimen of all individuals who handled the
• donor's info specimen and the date and purpose
of access
• CoC document
• status of specimen:
temperature, appearance
• drug test requested
• result of test
Drug Testing Specimens
• URINE: most common
• 60 mL is needed
• prolonged storage at (-20 degrees C)
• collected in a 30-60 mL polyethylene specimen container
• Saliva
• 2 mL of saliva collected in a 30 mL polyethylene specimen
container
Drug Testing Specimens
• Blood
• most expensive, most accurate
• plain test tube, 10 mL (sample: minimum of 5 mL)
• No standardized procedure available
• Sweat
• FDA-approved sweat patch (worn 1-2 weeks)
• Hair
• 100 mg hair in 200 mg capacity self-sealing transparent plastic bag
• expensive and tedious
• detects chronic substance abuse
Specimen Handling
• Observed specimen collection
• Ensure the integrity of urine specimen
• Coloring agents in toilet bowl
• Removal of unnecessary outer garments, body search
• Washing and drying of hands prior to urination
• Checking urine volume, temperature, color, and appearance
• Labeling of the specimen
• Date/time of collection, signature of client and ASC, and specimen
ID number
Specimen Retention
• Negative: 5 days after receipt of result
• Positive, adulterated, substituted, or invalid: minimum of 15
days upon receipt of result; may be extended for up to a year
upon request
Analytical Methods
• Screening test: presence or absence of a drug
• Presumptive positive (at or above the cutoff level)
• Presumptive negative (below cutoff level, drug may be
absent or present)
• TAT: 30 minutes
• Confirmatory test: presence or absence, identity of
the metabolite, concentration of the drug
• TAT: 15 days
• RESULTS ARE VALID FOR ONE YEAR
Analytical Methods
• Screening
• FDA-DOH-approved testing kits using
immunoassay
• Instrumented screening method
• Immunoassay: ELISA, fluorescence
polarization immunoassay
• Chromatographic: TLC, HPLC
Analytical Methods
• Confirmatory
• Gold standard: gas chromatography-mass spectrometry (GC-MS)
• Qualitative chemical characterization
• Quantitation and determination of concentration of analyte
Drug Testing
• Re-test
• lab satisfaction for quality validation
• replicate test to check the initial test result of same sample
• Challenge test
• replicate test when confirmatory results are legally questioned
• complainant will pay the test fee
Drug Testing
Drug Testing
• Lab Records
• training records
• custody and control form
• info on the specimen, date/time of collection, name of lab, chain of custody form
• QA records
• reports
• calculations in test results
• License validity
• Screening Lab: 1 year
• Confirmatory Lab: 2 years
