2. MT
Professional
Service
âĒ Clinical
Microscopy
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
âĒ Clinical
Chemistry
âĒ Clinical
Microbiology
âĒ Molecular
Biology
âĒ Toxicology
âĒ TDM
âĒ Drug of abuse
: DOAs
The main goals of MT professional
service is to providing accurate
laboratory results that enhance care
while minimizing risk and support
decisions.
âĒ Hematology
âĒ Transfusion
Science
âĒ Legal
âĒ Criminal
âĒ Justice
âĒ Medicare
2
25. Confirmatory methods: Gas liquid chromatography,
High performance liquid chromatography and
Gas chromatography/mass spectrometry (GC/MS)
(the gold standard for drug detection
Qualitative and Semi quantitative screening method for drug detection:
Homogeneous competitive immunoassay
in solution is a screening test used with most substances.
DRI, KIMS, CEDIA, EMIT, FPIA
Qualitative screening method for drug detection:
Lateral flow immuno-assay (LFIA) or rapid diagnostic test (RDT),
Thin-layer chromatography (TLC)
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
āļāļēāļĢāļ§āļīāđāļāļĢāļēāļ°āļŦāđ/āļāļĢāļ§āļ
āļŠāļēāļĢāđāļŠāļāļāļīāļ
(Drug abuse
determination)
25
31. DRITM Technology
Enzyme-labelled Molecules of
the compound to be measured
âENZ-CONJUGATEâ
Diagnostic Reagent Incorporate Enzyme Immunoassay (DRITM) is based
on the competition between a drug or drug enzyme conjugate (glucose-6-
phosphate dehydrogenase:G6PDH) and free drug from the sample for a
fixed amount of specific antibody binding sites.
G6PDH in the presence of Cofactor and Substrate forms NADH.
The NADH absorbs light at 340 nm.
Cofactor
âNADâ
SUBSTRATE
âG6Pâ
NADH
Monoclonal antibody
specific for molecules
of target analyte
âspecific-Abâ
āļĄāļĩāļŠāļēāļĢāđāļāđāļēāļŦāļĄāļēāļĒāđāļĒāļāļ°...āđāļāļāđāļāļĒāđāļĄ āļĒāļīāđāļāļāļēāļāļēāļāļāļĩ
āđāļāļ·āđāļāļāļāļēāļāļŠāļēāļĢāđāļāđāļēāļŦāļĄāļēāļĒāđāļĒāđāļāļāļąāļāļāļąāļāđāļāļāļāļĩāļāļāļāļĩ
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
31
33. DRITM Technology, features and benefits
1. Liquid ready-to-use homogeneous competitive enzyme immunoassay.
2. High analytical accuracy while eliminating time-consuming steps in
reagent preparation.
3. The assay uses bio-engineered specific monoclonal antibodies, not
interfere by endogenous enzyme.
4. Minimal cross-reactivity to various over the counter structurally
unrelated compounds, add excellent sensitivity, linearity, specificity,
precision and accuracy to the mix.
5. Give excellent result acceptance of analyte levels through excellent
correlation to GC/MS.
6. Provide excellent open vial stability via guaranteed consistency: kit to
kit, lot to lot, and year to year
7. All of excellent that has been proven to reduce costs and increase
laboratory productivity without sacrificing quality (close to zero
false positive).
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ 33
35. Amp + Methamp =
Amphetamine assay
âĒ Both methamphetamine and amphetamines are potent
stimulants by release dopamine surges into the brain, quickly
elevating your blood pressure and heart rate to increase so
speed up the bodyâs metabolism and raise body
temperature.
âĒ Methamphetamine can release five times more dopamine
than amphetamine this might contribute to the greater
addictiveness and largely abuse than amphetamine.
âĒ More prescription medications, like Adderall, contain
amphetamine and dextroamphetamine, has an important
place as a prescription drug that treats attention deficit
hyperactivity disorder (ADHD).
âĒ These substances have many similarities, methamphetamine
was derived from amphetamines in 1919.
âĒ The European Monitoring Centre for Drugs and Drug
Addiction (EMCDDA) states that there are so many
similarities between the two that, for monitoring purposes,
they are often lumped into one term: amphetamines.
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ 35
36. DRITM Amphetamine Assay
âĒ Between 30-54% of an oral dose is excreted in urine
as unchanged meth and 10-23% as unchanged
amphetamine.
âĒ Following an intravenous dose, 45% is excreted as
unchanged meth and 7% amphetamine.
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
The National Highway Traffic Safety Administration (NHTSA) 36
38. DRITM Amphetamine Assay
âĒ Amphetamine are synthetic derivatives of ephedrine.
âĒ The most common amphetamines include
d-amphetamine, d-methamphetamine, and
d,l-amphetamine.
âĒ When amphetamine ingested, it is either rapidly
deactivated in the liver or excreted unchanged into
the urine.
âĒ Other ephedrine derivatives such as,
methamphetamine can be metabolized and excreted
in urine as amphetamine.
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ 38
39. āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
https://www.practicalpainmanagement.com/treatments/pharmacological/non-opioids/methamphetamine-urine-toxicology-depth-review
âĒThe challenge for the laboratory is to differentiate
between the d and the l isomer forms of
methamphetamine. The clinician needs this critical
information because without the d:l-isomer ratio,
the clinician is unable to narrow down the potential
sources of the methamphetamine.
âĒA positive methamphetamine test could be caused
by use of an OTC product, a prescription drug, or
illicit use (Table1). The laboratory may run up to 3
distinct tests to produce a complete amphetamine
profile.
âĒThe first test is an immunoassay (IA) screening test
for the amphetamine class of medications, which
includes both amphetamines and
methamphetamines.
âĒIf the screening test is positive (a reaction greater
than the cutoff), then a mass spectrometry (MS)
confirmation test is performed to determine which
specific compounds, amphetamine and/or
methamphetamine, are present.
âĒOnce methamphetamine is confirmed positive by
MS, a third test may be performed to ascertain the
ratio between the 2 isomers of methamphetamine.
âĒThe d,l-isomer test also is performed by MS.
Understanding each of the 3 testing steps is
essential to clinical decision making related to
patient care.
39
52. āļāļēāļĢāļāļāļŠāļāļāļāļĩāđāđāļŦāđāļāļĢāļīāļāļēāļĢāđāļ
āļāļąāļāļāļļāļāļąāļ
SAMHSA Panel: Analyte
Attributes
Common Name Analytes Detection Window Screening for Abuse
Marijuana (Pot) Metabolite:
THCA (11-nor-
Î
9
-THC-COOH)
Single Use: 3 days
4 times/wk Use: 5-7 days
Daily Use: 10-15 days
Heavy User: 3+ weeks
9
Marijuana is rapidly
metabolized, with little to
none found in the urine.
However, its major metabolite,
THCA, is detectable within
hours after exposure and for
up to 3+ weeks in heavy users.
Therefore, only the metabolite
is required for detection.
16
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ 52
56. Specimen validity tests (SVT)
âĒ Methods used on a urine drug screen specimen to
detect for substitution, adulteration, or dilution.
âĒ Thermo Fisher Scientific provides Specimen Validity
Tests for creatinine, specific gravity, oxidizing agents
(e.g. nitrites) and pH.
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ 56
57. Specimen validity tests (SVT)
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
âĒ Substitution and dilution of the urine samples is done
by using either water or other liquids which have a
color similar to urine, such as tea and/or apple juice.
âĒ SAMHSA recommends several ways to assess for this
type of substitution/dilution by using Creatinine and
Specific Gravity tests.
âĒ Creatinine is a waste product produced by the body
and excreted in the urine at a relatively constant rate.
Fluctuations in creatinine concentration may be an
indication of hydration, dilution or substitution.
âĒ Specific gravity reflects the density of the urine
specimen when compared to water. The lower the
specific gravity, the closer its consistency to water and
therefore possible indication of dilution or
substitution.
57
58. Specimen validity tests (SVT)
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
Indicator SAMHSA Guidelines Thermo Scientific Test
Creatinine
Specific Gravity
< 2 mg/dL
âĪ 1.0010 or âĨ 1.0200
DRI Creatinine-Detect
DRI Gravity-Detect
Monitoring for Substitution
Monitoring for Dilution
Indicator SAMHSA Guidelines* SAMHSA Guidelinesâ Thermo Scientific Test
Creatinine
Specific Gravity
5 mg/dL but < 20 mg/dL
âĨ 1.002 but < 1.003
âĨ 2 mg/mL but < 20 mg/dL
> 1.0010 but < 1.0030
DRI Creatinine-Detect
DRI Gravity-Detect
58
59. Specimen validity tests (SVT)
âĒ Adulterants (Additives āđāļāļ·āļāļāļ) Oxidizing agents can be
purchased commercially and used to adulterate urine samples.
âĒ The most commonly used oxidizing agents are nitrite (KlearâĒ),
chromate (Urine LuckâĒ), iodine, bleach, and horseradish
peroxidase (Stealth).
âĒ These oxidizing agents, when added to urine, do not show any
significant change to the appearance of the urine and may not
be detected by other methods such as pH, specific gravity or
even creatinine concentration.
âĒ Testing the urine for pH gives an indication of whether the
specimen is adulterated with bleach or ammonia (producing a
basic pH >11.0) or adulterated with lemon juice or vinegar
(producing an acidic pH < 4.0).
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ 59
60. Specimen validity tests (SVT)
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
Indicator SAMHSA Guidelines Thermo Scientific Test
pH pH < 4.0 or > 11.0 DRIâĒ pH-Detect
Nitrite âĨ 500 Âĩg/mL DRI General Oxidant-Detect
Chromium âĨ 50 Âĩg/mL DRI General Oxidant-Detect
Halogens
(bleach, iodine, fluoride)
Use either a general
oxidant or halogen
colorimetric test
DRI General Oxidant-Detect
Pyridine Use either a general
oxidant or chromium
colorimetric test
DRI General Oxidant-Detect
60
63. Alcohol Determination in the Clinical Laboratory
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ
American Journal of Clinical Pathology 74(5):747-50 · December 1980
63
67. 1. Performing
professional services
with quality for
taking care of
individual and
population health
2. Mastering novel
and appropriate
technology for
health sciences
application
āļāļĢāļ°āļ āļ āļāđāļēāļāđāļĻāļĢāļĐāļāļāļļāļĨ 67