IN THE NAME OF GOD وزارت بهداشت درمان و آموزش پزشكي اداره كل آزمايشگاه مرجع سالمت سید علی ناظری کارشناس ارشد سم شناس.

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Transcript IN THE NAME OF GOD وزارت بهداشت درمان و آموزش پزشكي اداره كل آزمايشگاه مرجع سالمت سید علی ناظری کارشناس ارشد سم شناس.

Slide 1

IN THE NAME OF GOD


Slide 2

‫وزارت بهداشت درمان و آموزش پزشكي‬
‫اداره كل آزمايشگاه مرجع سالمت‬
‫سید علی ناظری‬
‫کارشناس ارشد سم شناس ی‬
‫‪Seyed Ali Nazeri , Toxicology M.S.‬‬
‫‪[email protected]‬‬
‫‪021-81452381‬‬
‫‪021-66752515‬‬
‫‪09121960690‬‬


Slide 3

‫كارگاه‬
‫آزمایشهای تشخیص مواد مخدر و روان گردان‬
‫‪ 31‬اردیبهشت ‪94‬‬
‫دانشگاه علوم پزشکی شهید صدوقی یزد‬


Slide 4

‫عناوین مورد بحث‬
‫‪ ‬رویکرد جدید آزمایشهای تشخیص مواد مخدر و روانگردان‬
‫‪ ‬بررس ي انواع نمونه های بیولوژیکی ( ادرار‪،‬عرق‪،‬بززاق‪ ،‬وزون و ‪ )...‬مزورد اسزاداده بزرای آزمزایا مزواد مخزدرو روان‬
‫گردان‬
‫‪ ‬مدت زمان تشخيص مواد مخدرو روان گردان درنمونه ادرار‬
‫‪ ‬بررس ی ‪( Cross-reactivity‬واکنشهای ماقاطع ‪ ،‬تداوالت دارویی)‬
‫‪ ‬اصول نمونه گیری و شناسایی انواع مواد مداوله گر در آزمایشهای تشخیص مصرف مواد مخدر و روان گردان‬
‫‪ ‬روشهای تشخیص مواد مخدر و روان گردان‬
‫‪‬‬

‫‪ -‬روش غربالی‬

‫‪‬‬

‫‪ -‬کروماتو گرافی الیه نازک )‪(TLC‬‬

‫‪‬‬

‫‪TLC Troubleshooting -‬‬

‫ تدسیر ناايج آزمايشهاي تشخيص مواد مخدر و روان گردان ( ناایج مثبت آمداامین و مت آمداامین )‬‫‪‬‬
‫‪ ‬کنترل کیدی و اعابار بخش ی روش آزمایا‬


Slide 5

RECOMMENDED METHODS FOR THE IDENTIFICATION AND ANALYSIS OF
AMPHETAMINE, METHAMPHETAMINE and ...

United Nations Office on Drugs and Crime ,Vienna
UNITED NATIONS

New York, 2006
Clarck `s Analysis of Drug and Poison
Pharmaceutical Press , Third Edition , Published 2004
RAPID ON-SITE SCREENING OF DRUGS OF ABUSE
A summary of commercially available products and their applications:
guidance for the selection of suitable products
United Nations Office on Drugs and Crime


Slide 6

‫مقدمه‬
‫ها ت س‬
‫هدیدس ته‬
‫هاس یه‬
‫هاد س‪ 23‬الیحه‬
‫هاستن ه مادس ه‬
‫‪ ‬به‬
‫ر کبینستهرتم س هدتدس رهدرسدسردتماهردتنسدس‬
‫قدتمینس صدبس ت عس یریصس صلح سمظا سدسنهایرس‬
‫صدبا ستلنا سن ادس بار سسبهاس هدتدس رهدرس‬
‫ریان ست هدریسصددرسگهدتی سدهد ستد یهادسبهاسس‬
‫ههدتدس رههدرسسدسردتنسگههردتنسسبههاسس مظههدرس‬
‫تن ردت ‪،‬سکنبسدکهار‪،‬ست ددت‪ ،،‬نهررسبهاسرهار‪،‬س‬
‫ت کیدر‪،‬سترذپردتماسکنب‪،‬س یاغلسآ تد‪،‬سس ه ینس‬
‫د‪ ...‬باسدهد سد تر سبهدتی سگذتی اسید ستن ‪.‬‬
‫‪ ‬مظار سبرسد لکردسآ اییاایهایستمتا سدیمهد س‬
‫تینسآ اییها‪،‬سسیا لس‪ :‬آ اییهاایهایسیهبکاس‬
‫بهدتیهه سدتمیههاایهاوسدلههد سپ یهه‪ ،‬سسکیههدر‪،‬س‬
‫آ اییاایهایسمیردیستم ظا ‪،‬سدس‪ ....‬باسدهد س‬
‫تینسد تر راماسگذتی اسید ستن س‪.‬‬


Slide 7

‫دن درستلع ل فرتیمدیای آ اییاا س یریصس دتدس‬
‫ردرسدسردتنسگردتن‬
‫‪‬‬

‫‪‬‬

‫دسززاوراللمل آزمززایا مززواد مخززدر و روان گززردان بززر اسززاس بنززد ‪ 5‬مصززوبات جلسززه ‪126‬‬
‫سززااد مبززارزه بززا مززواد مخززدر ریاسززت جمهززوری کززه بززه توشززی ریاسززت محتززرم جمهززوری در‬
‫تززاری ‪ 90/2/6‬بززا امءززا وزیززر محتززرم کشززور و دبیززر کززل محتززرم سززااد مبززارزه بززا مززواد مخززدر‬
‫به کلیه دساگاههای ذیربط ازجمله وزارت بهداشت ابالغ شده است‪:‬‬
‫ب ززر اس ززاس ای ززن دس ززاوراللمل ابالش ززی ‪ ،‬انف ززام آزم ززایا تش ززخیص مص ززرف م ززواد مخ ززدر و‬
‫روانگردان توسزط آزمایشزگاههای مربوطزه بزه صزورت یز تکلیزق نزانونی در آمزده اسزت و‬
‫دس ز ززاگاههای اجرای ز ززی موظدن ز ززد نس ز ززبت ب ز ززه جم ز ززع آوری و ارس ز ززال والص ز ززه آم ز ززاری نا ز ززایج‬
‫آزمایشززها‪ ،‬هززر ‪ 3‬مززاه یز بززار بززه دبیززر وانززه سززااد مبززارزه بززا مززواد مخززدر ریاسززت جمهززوری‬
‫اندام نمایند‪.‬‬


Slide 8

‫دن درستلع ل فرتیمدیای آ اییاا س یریصس دتدس‬
‫ردرسدسردتنسگردتن‬

‫در اين دساور اللمل‪:‬‬
‫‪ ‬آزمایشگاه ‪ :‬به عنوان آزمایشگاه تشخیص مواد مخدر و روانگردان شناواه می شود‪.‬‬
‫‪ ‬س ززو مص ززرف م ززواد‪ :‬ش ززامل مص ززرف کلی ززه م ززواد مخ ززدر و روانگردان ززی وواه ززد ب ززود ک ززه در‬
‫نانون ممنوع می باشد‪.‬‬
‫‪ ‬نمون ززه مناس ززا ب ززرای آزم ززایا‪ :‬درآزمایشز ززگاههای تش ززخیص م ززواد مخ ززدر و روانگ ززردان بز ززه‬
‫منظ ززور ازدواا ‪ ،‬اس ززاخدام‪ ،‬پوش ززه وري و‪ ...‬فق ززط نمون ززه ادرار )‪ )Urine‬وواه ززد ب ززود و از‬
‫اوذ سایر نمونه های بیولوژی مثل وون‪ ،‬عرق‪ ،‬مو و‪ ...‬وود داری شود‪.‬‬


Slide 9

‫نحوه انفام آزمایشهای تشخیص مواد مخدر و روانگردان‬
‫مطززابا ایززن دسززاوراللمل کززه نجیفززه مصززوبات کمیاززه فمززی سززااد مبززارزه بززا مززواد مخززدر و‬
‫نیز مطابا با اساانداردهای بین املللزی مزی باشزد روش حزبی بزرای تشزخیص مزواد مخزدر‬

‫و روان گززردان بززه ایززن ترت ززا اسززت کززه اباززدا بززا رعایززت کلیززه نکززات مربززو بززه هیزه نمونززه‬
‫حززبی‬

‫(جلززوگیری از تقلبهززای رایززج)‪ ،‬اباززدا ایززن آزمایشززها بززا روش هززای غربززالگری س زریع‬

‫(روشززهای مطلززوق و نابززل نبززول از نظززر کنتززرل کیدززی کززه بززه تاییززد وزارت بهداشززت رسززیده‬

‫باشززد) انفززام شززده سز‬
‫درهمان آزمایشگاه‪).‬‬

‫ناززایج مثبززت بززا روش کرومززاتو گرافززی تاییززد شززوند‪( .‬ترجیحززا‬


Slide 10

‫گرچز ز ززه روش مرجز ز ززع بز ز ززرای تشز ز ززخیص مز ز ززواد مخز ز ززدر روش ‪ GC/MS‬مز ز ززی باشز ز ززد ولز ز ززی‬
‫محز ز ززدودی های ایز ز ززن روش اسز ز ززاداده از آن را محز ز ززدود مز ز ززی کنز ز ززد و در ز ز ززال ا ز ز ززر از‬
‫روشز ززهای کرومز ززاتوگرافی سز ززاده تز ززر مثز ززل کرومز ززاتو گرافز ززی الیز ززه نز ززازک )‪ (TLC‬بز ززرای‬

‫آزمایشززهای روزانززه اسززاداده م ززی شززود‪( .‬الباززه ب ززا رعایززت کلیززه نک ززات فمززی مرب زو ب ززه‬
‫مرا ل انفام آزمایا و نکات مربو به تدسیر ناایج)‪.‬‬


Slide 11

‫برخی از محدودی های روشهایی نظیر ‪ GC/MS,GC‬به شرح زیر است‪:‬‬
‫‪ ‬این س سامها ویلی گران هسجند ‪.‬‬
‫‪ ‬اساداده از مواد مشاا ساز و مزواد شزیمیایی بزا درجزه ولزو بزاال هزینزه آزمایشزها را بزاال‬
‫می برد‪.‬‬
‫‪ -3 ‬نیاز به افراد ماخصص داشاه تا توانایی کار با این دساگاهها و تدسیر طیدهای بدست‬
‫آمده را داشاه باشد‪.‬‬
‫‪ ‬نیازمند ودمات پ ازفروش نوی می باشد‪.‬‬
‫‪ ‬عدم دسترس ی و امکان پذیر نبودن اساداده آنها در نقا دور دست‪.‬‬


Slide 12

‫نگهداري سوابق و مستندات انجام آزمايشها‬
‫سوابا انفام آزمایشها بصورت حبی بایگانی و نگه داري شود ‪:‬‬

‫‪ ‬عرف سما اسیاسدسدرردتنه هاوسآ های س هدتدس‬
‫ردرسدسردتنسگردتنسباس د سددسنال‪.‬‬
‫‪ ‬دف رسثب سم ایجس مر سآ های س هدتدس رهدرسدس‬
‫ردتنسگردتنسباس د سناسنال‪.‬‬
‫‪ ‬دف رثب سم ایج سآ اییهاو س اییهدو( ‪،‬رد ها دس‬
‫گرتف ) دتدس ردرسدسردتنسگردتن باس هد سد س‬
‫نال‪.‬‬
‫هایجس مره سدس ثبه س‬
‫هاسم ه‬
‫هدتباستل‪ ،‬ردمی‪،‬ه س(‪،‬لیه‬
‫‪ ‬نه‬
‫آ‬
‫)‬
‫‪‬‬

‫اییهاوس ذ‪،‬درسدسدرصدر ست ‪،‬انستن‪،‬نس عرف سما اسیهاس‬

‫ادت ستلع رماهدتروسیدد‪.‬‬
‫پلی هاو ‪ TLC‬ربدطسباسم یتاسآ اییهاس د سیكس‬
‫نالسباسصدر س مظ سدسبرچنبس د سید سبهاسذ‪،‬هرس‬


Slide 13

Specimen (matrix)


Slide 14

Specimen (matrix)




There are a variety of biological specimens suitable for
drug screening, including urine, sweat and saliva, blood and
hair/nails. The choice of a specimen for analysis depends on :
the purpose of the testing,
and may be affected by :
concerns about sample collection, transport, handling, and
assurance of sample integrity between the collection site and
point of analysis.
Most commonly, focus on the detection of illicit drugs in
urine.


Slide 15

Specimen (matrix)
Urine:
However,urine samples can be relatively easily
substituted, or adulterated.
 Among the most popular manipulations is dilution of
the sample, for example, by excessive drinking or use
of diuretics, or simply by adding water.
 Furthermore, the patterns of drug excretion are
dependent on the pH value of the urine and are thus
influenced by diet. Deliberate changes of the pH of the
urine can be effected by the addition of pH-modifying
agents (e.g.,vinegar,ascorbic acid, lemon juice).


Slide 16

Specimen (matrix)




Similarly, addition of oxidizing (sodium hypochlorite)
and surface-active (e.g.,detergents,soap) agents, certain
medicaments , and even sweeteners (saccharin) or table
salt (sodium chloride), may also lead to false results.
Therefore, to ensure the integrity of the sample it may
be necessary to observe directly the collection of urine,
i.e., urine testing can be invasive of privacy.


Slide 17

Specimen (matrix)



There is no clear relationship between dose and urine
concentration.
If the purpose of drug testing is to relate concentrations
to impairment or other toxicological / pharmacological
responses, blood is generally the specimen of choice, as
blood drug concentrations are most closely related to
concentrations at receptor sites.


Slide 18

Comparison of biological specimens for
drug testing
Table 1:

Comparison of biological specimens for drug testing with on-site screening devices

Note that this comparison does not consider applications of the specimen in other than ON-SITE situations. It does,
therefore, not consider sweat testing in the form of sweat patches, which (because worn for several days) are a cumulative
measure of drug excretion, thus allowing to monitor drug intake for a period of days to weeks

Criteria for

Urine

Comparison
History of use/

Long history of use;

experiences

Uniform testing criteria

with specimens

established

Sweat
Relatively new approach;

Relatively new approach;

performance testing under

performance testing under

development; more R&D

development; more R&D

required

required

Easy;

Sample acquisition (note:
practicalities of sampling
depend on the facilities at

Saliva

Easy

Easy,

but existing collection

(but less practical, for

but sensitivity might

devices may still need

example, at the roasided)

be a problem

improving for practical use in

the sampling sites)

on-site situations

Privacy

Invasive

Target analyte

Metabolite(s)

Analyte concentration

High

Non-invasive

Non-invasive

Parent drug

Parent drug

(and metabolites)

(and metabolites)

Low

Low


Slide 19

Comparison of biological specimens for
drug testing
Table 1:

Comparison of biological specimens for drug testing with on-site screening devices

Note that this comparison does not consider applications of the specimen in other than ON-SITE situations. It does,
therefore, not consider sweat testing in the form of sweat patches, which (because worn for several days) are a cumulative
measure of drug excretion, thus allowing to monitor drug intake for a period of days to weeks

Criteria for

Comparison
Detection time

Urine
Relatively long

Adulteration,
Substitution and

Easily adulterated /
substituted

Contamination
Result

Sweat
Relatively short
Adulteration possible but
difficult; external
contamination possible

Saliva
Relatively short

Adulteration possible, but
difficult

Indicates prior exposure in

“Current-status” / “real

“Current-status” / “real

past few days

time”results

time”results


Slide 20

DRUG DETECTION TIMES IN
URINE


Slide 21

DRUG DETECTION TIMES IN URINE
DRUG DETECTION TIMES IN URINE
Table 2: The following table should be used as a guide only (individual differences in the metabolism and
excretion of drugs and their metabolites may affect specific detection times).

DRUG type *

INFREQUENT

FREQUENT

CHRONIC

USER

USER

USER

Amphetamine

1-3 days

2-6 days

Several weeks

Methamphetamine

1-3 days

2-6 days

Several weeks

Morphine

12-48 hours

2-6 days

Up to several weeks

Codeine

1-3 days

2-5 days

Up to several weeks

Cannabis products

2-5 days

4-14 days

Up to 2-3 months

Cocaine

12-48 hours

1-4 days

Up to several weeks

Methadone

1-4 days

2-10 days

Up to several weeks

Note: Drug detection times actually refer to the urinary metabolites of most of the drugs listed.
Source: 1-Step Detect Associates


Slide 22

Amphetamine
Racemic Desoxynorephedrin:
After a larg dos in urine for several days.
30%
90%
74%
1-4%

dose extracted unchange in urine after 24 h.
dose extracted in urine after 3-4 days.
increased in urinary pH acidic (unchange).
decreased in urinary pH alkalin.
Hypuric acid,Benzoic acid,Hydroxyamphetamin,
Benzoylglocoronid, 4- Hydroxyamphetamine,norephedrine,...

Half life in plasma : 4-8 h.


Slide 23

Metamphetamine
Desoxyephedrine,Crank,Crystal,Ice,Meth,Speed,
Norodine ,‫ شیشه‬.
%70 dose extracted in urine in 24h.
43 % extracted in urine unchange.
15 % 4- Hydroxymetamphetamine .
5 % Amphetamine. (20-30%)
Urinary pH alkalin reduced 2% dose.

Half life in plasma : 9 h


Slide 24

Amph, Meth, MDMA


Slide 25

Morphine
Opium: 10-12 % Morphine
0.5 % Codeine
90 % dose extracted in urine in 24h.
10 % Free.
65-70 % Conjogate ; M3G, M6G
Normorphine,...

increased in urinary pH acidic. (Free)
decreased in urinary pH alkalin.(Conjogate)


Slide 26



Methadone
2-ethylidene 1,5,dimethyl 3,3 diphenylpyrrolin (EDDP)
2- (ethyl-5-dimethyl-3,3 diphenyl -1-pyrrolin (EMDP)

60% after 24h urine
33% unchange , 43% EDDP , EMDP
Half life: 10-25h (15h) , 13-55h (30h)


Slide 27



Tramadol
O-monodesmethyltramadol
90% after 3 days Urine
30% Unchange
Half life : 6 h (6-7)



Buprenorphine
Buprenorphine
Norbuprenorphine
Half life : 1.2 – 7.2 h

N-O-didesmethyltamadol


Slide 28

Cross-reactivity


Slide 29

Cross-reactivity


Drugs and
drug metabolites with significant
structural similarities to the target analyte may crossreact with target
analyte-specific antibodies,
producing false positive results.
 It is important to know that some immunoassays are
class-specific only.
They cannot be used therefore to identify,
specifically, individual drugs within a class.
Examples
are
tests
for
amphetamines,
benzodiazepines, barbiturates, and opiates.


Slide 30

Cross-reactivity
Manufacturers test for cross-reactivity by spiking test
samples and documenting test results. This is the
information that is found in package inserts.
However, the cross-reactivity lists provided by most
manufacturers have been found to be far from
cmplete.
Moreover, since these data are not obtained from
actual ingestion of drug, the reported concentrations
are not necessarily physiologic and may not give
information about possible interference of drug
metabolites.


Slide 31

Cross-reactivity
It is also highly possible that some crossreacting
compounds may not have been tested, and are therefore
not listed.
Lists of compounds, which have been tested and found
not to cross-react, are therefore equally informative
to obtain a more comprehensive picture of possible
interferences.


Slide 32

Cross-reactivity
Aamphetamine-type Stimulants (ATS):


Because of the large number of closely related
substances, including ecstasy-type analogues (such
as MDMA,MDA,MDE,etc.
 Although amphetamine class tests(Amphetamine
and Metamphetamine ) are usually designed to
cross-react with ecstasy and other illicit ATS.


Slide 33

Cross-reactivity


degrees of cross-reactivity may vary considerably
from one substance to another. Because of direct
cross-reactivity of some of their ingredients, or
because their main urinary metabolites are the target
drugs tested.
 For amphetamine tests, examples include certain
nasal decongestants and anorectics
e.g.,ephedrine,phenylpropanolamine,
phentermine),and the anti-parkinsonian drug
selegiline, which is metabolized to amphetamine.
 Benzphetamin...


Slide 34

Cross-reactivity











Amphetamin Test:
Methylenedioxyamphetamine (MDMA)
Phentermine
Benzphetamin
Ephedrine
Pseudoephedrine
Selegiline
Deprenyl
Methamphetamine
L-Methamphethamine (Vick’s inhaler)


Slide 35



Phenylpropanolamine
 Phenylephrine
 Ranitidine
 Tyramine , ….
 Metamphetamine Test:
 Methylenedioxymethamphetamine (MDMA)
 Amphetamine
 Ephedrine
 Phenyletylamine
 Chloroquine
 …


Slide 36

Cross-reactivity
Opiate-type tests:
Most opiate assays are designed to detect morphine.
Heroin use causes a positive opiate test result
because its predominant urinary metabolite is
morphine.

A number of cough suppressants, such as codeine,
some analgesics, and morphine agonists and
antagonists cross-react to a high extent with opiatetype tests.


Slide 37

Cross-reactivity
False positive results may also be produced from the
ingestion of food containing poppy seeds.
In contrast, the ability to detect the use of synthetic
opioids, such as hydromorphone, hydrocodone,
oxycodone and oxymorphone varies among
immunoassays from different manufacturers.


Slide 38

Cross-reactivity



Opiate,Opioids tests:

Morphine
 Codeine
 Poppy seed
 Dextromethorphn
 Diphenhidramine
 Hydrocodone
 Hydromorphon
 Nalorphine
 Procaine
 Tebaine
 Naloxane


Slide 39

Regulatory Process


Slide 40

Evolution of Workplace testing
Mandatory Guideline For Drug Testing:

Health and Human Services (HHS)
Which became known as the:

National Institute For Drug Abuse (NIDA)
Today sa The:

Substance Abuse and Mental Health Services
Administration (SAMHSA)
and

United Nation on Drug and Crim (UNODC)
1994 Cannabioids, 1999 Morphine


Slide 41

Cut-off value / Concentration


The cut-off value of an assay is the specific
concentration of a drug , or drug metabolite, in the
sample that is chosen as a limit to distinguish a
presumptive positive from a negative test result.
 Samples with concentrations at or above the cut-off
level are considered presumptive positive and
results below are considered negative.
 In this connection, it should be remembered that a
clear correlation between the cut-off concentration
and the level of impairment has not been
established for any of the sample specimens.


Slide 42

Cut-off value / concentration
Moreover, any attempt to correlate test results with
impairment has to carefully consider these
pharmacokinetic / metabolic aspects for individual
drugs and how they are reflected in concentration
profiles in different sample specimens.
Usually established based on epidemiological
information, i.e., they reflect, to a certain extent, the
prevalence of, and the importance attached to the
abuse of certain drugs or drug classes in different
countries.


Slide 43

Workplace drug screening cut-off in urine
(ng/ml)
Table 3:

Workplace drug screening cut-offs in urine (ng/m(

Drug type

Cut-off in urine (ng/mL)

Amphetamines

500

Metamphetamine ***

500

Opiate

300

Methadone or metabolites

300

Cocaine metabolites

300

Cannabis metabolites

50


Slide 44

Methods

Immunochromatography
Chromatography


Slide 45

‫مرور روشهاي متداول آزمايشگاهي تشخيص مواد مخدر و روان گردان‬

‫‪Drug Screening Tests - A‬‬
‫•‬

‫ایمونوکروماتوگرافی )‪(Immonochromatography‬‬

‫•‬

‫ایمونواسي )‪(Immonoassay‬‬

‫•‬

‫ایمونوفلورسانت )‪(Immonofloresent‬‬

‫•‬

‫رادیوایمونواسي)‪(RIA‬‬

‫•‬

‫االیزا )‪(EIA‬‬

‫•‬

‫‪EMIT‬‬

‫•‬

‫روشهاي شیمیایي ‪ :‬ماركي – فرود ‪…,‬‬


Slide 46

Principles of on-site immunoassay devices





Direct competition technology****
Displacement technology
Trapping technology


Slide 47

Principles of on-site immunoassay devices
Immunochromatographic methods
Most of these tests are based on competitive technology. In
these assays, drug (or drug metabolite) that may be present in
the test sample competes with a drug conjugate for antibody
binding sites.


Slide 48

Purpose and intended use of on-site drug
screening








Currently, on-site testing for drugs of abuse is being carried
out, to varying extents, in the following applications:
• Workplace surveillance programmes (including preemployment, random /periodic, “reasonable suspicion”, postaccident, and return-to-duty/follow-up testing), including
testing of military and personnel in other safety-sensitive jobs.
• Roadside drug testing programmes,
• Crime investigations and legal proceedings,
• Drug treatment and rehabilitation programmes,
• Parole/probation programmes (including so-called “drug
courts”),
• Hospital emergency.


Slide 49

Analytical performance characteristics of onsite screening devices
The performance of on-site screening devices is usually
assessed in terms of sensitivity, which is the
percentage of true positive, and specificity or
percentage of true negative results.
These analytical measures therefore indicate the ability
of the on-site device to identify, at a given cut-off
concentration, those samples that truly contain the
target analyte (sensitivity) or are truly drug-free
(specificity )


Slide 50

Analytical performance characteristics of onsite screening devices
In analytical performance studies, sensitivity and
specificity are expressed as percentage of results
confirmed by another method such as gas
chromatography-mass spectrometry (GC/MS).
The specimens identified as positive by the on-site
screening device but later confirmed as negative are
called false positive.
And specimens identified as negative by the device but
confirmed positive are called false negative.


Slide 51

Analytical performance characteristics of
on-site screening devices
The overall performance of a test is often expressed by
the term efficiency (sometimes called accuracy),
which is defined as the percentage of all true (correct)
results, whether positive or negative (equation 3).
High efficiency is desired when both false positives and
false negatives can have equally serious consequences
for the tested individual.


Slide 52

Analytical performance characteristics of onsite screening devices
Sensitivity = TP (TP + FN )x 100
Specificity = TN (TN + FP)x 100
Efficiency = (TP + TN) N x 100

The following analytical criteria are
recommended for a good screening test.
Sensitivity ≥ 90%
 Specificity ≥ 90%
 Efficiency ≥ 95%



Slide 53

Other considerations







Temperature / Humidity (Stability)
Shelf life (length of storage)
Range of drugs /classes
Time requirements to perform a test
Documentation / storage of results
Costs & Time


Slide 54

Validation protocol
Sensitivity ≥ 90%
Specificity ≥ 90%
Efficiency ≥ 95%
Accuracy (Control-Comparison method- Recovery- St.add.)
Precision
Intera assay ) ‫( درون سنجی‬
Inter assay )‫)برون سنجی‬
Cross - reactivity
Cut - off
Stability
(Accel, Real, in use)


Slide 55



Precision
Precision is a measure of the reproducibility of the whole
analytical method (including sampling, sample preparation
and analysis) under normal operating circumstances.
Precision is determined by using the method to assay a sample
for a sufficient number of times to obtain statistically valid
results .The precision is then expressed as the relative standard
deviation.

%RSD = std dev x 100% / mean


Slide 56



Accuracy
Accuracy is a measure of the closeness of test results obtained
by a method to the true value.

Re-Co-Comp...


Slide 57

(Chromatography Methods) Confirmatoryt Tests -B
، ‫ تفكيك مرفين و كدئين – حساسيت كم‬:

Paper Chromatography



‫زمان طوالني‬

‫تفكيك مناسبتر‬

: Thin layer Chromatography (TLC)
‫ زمان كوتاهتر‬، ‫ حساسيت بيشتر‬، ‫ كدئين‬،‫مرفين‬




Slide 58

‫•‬

‫‪Chromatography (GC) ,GC/MS‬‬

‫‪ : Gas‬تفكيك بسيار خوب‬

‫مرفين وكدئين ‪ ،‬و ساير آناليتها ‪،‬حساسيت بسيار باال‪ ،‬گران قيمت ‪ ،‬نيازمند تخصص ويژه است‪.‬‬

‫• ‪MS/MS, LC/MS, HPLC‬‬


Slide 59

Chromatography Methods
:‫رتحلسدستت تء‬

)Exteraction(‫س اد س دردسآمالی سس‬،‫تن ررت‬
)Mobile Phas) ‫فا س حرکس‬
(Stationary Phase) ‫فا سثاب سس‬
(Detecore) ‫ظایرسکممد‬








Slide 60

Liquid liquid extraction (LLE)


Slide 61

Solid phase Extraction (SPE)


Slide 62


Slide 63

Introduction






Thin layer chromatography (TLC) has become one of
the most commonly used techniques for the separation
and identification of illicitly manufactured drugs .
TLC is a widely-used chromatography technique used
to separate chemical compounds.
It is a technique used to separate and identify individual
components in a mixture.
It can be used to determine the pigments a plant
contains, to detect drugs , pesticides or insecticides in
food , in forensics to analyze or to identify compounds
present in a given substance. ....


Slide 64

Introduction





TLC is rapid, sensitive (sub-milligram quantities of analyte
required), enormously flexible in both the stationary and the
mobile phase, and thus amenable to a wide variety of
substances, in base and salt form, ranging from the most polar
to the most non-polar materials.
It is also amenable to a variety of visualization techniques.
TLC is one of the easiest of the many chromatographic
techniques, and it is inexpensive.


Slide 65

TLC Theory
It involves :
 A stationary phase consisting of a thin layer of adsorbent
material, usually silicagel, alumina, cellulose immobilised
onto a flat, inert carrier sheet.
 A mobile Phase (solvent )(eluent) travels up the matrix by
capillarity, moving the components of the samples at various
rates because of their different degrees of interaction with the
matrix (stationary phase) and solubility in the developing
solvent.


Slide 66

TLC Theory


Non-polar solvents will force non-polar compounds to the top
of the plate, because the compounds dissolve well and do not
interact with the polar stationary phase.


Slide 67

Thin Layer Chromatography


Slide 68

Technique (Operation involved)


Choice of adsorbent (stationary phase,plate)
 Preparation of plate
 Preparation & application of sample (spotting)
 Choice of solvent (mobile phase)
 Development of chromatogram
 Drying of chromatogram
 Location of spot (visualization)
 Quantitative estimation.


Slide 69

Choice of adsorbent




Two general properties decides the selection are
Particle size and homogeniscity.
Factor affecting selection:
There should not be any reaction with substance to be
separated. It should be insoluble with mobile phase and
solvent used for elution. It should not catalyses or
decompose off substance. It should be colour less.


Slide 70

Classification of adsorbents used
Classification according to bonding strength:
 Weak adsorbent; eg. Sucrose, starch, talc ,cellulose.
Intermediate adsorbent eg. Silica gel, calcium
carbonate, calcium phosphate, magnesia
 Strong adsorbent: alumina ,charcoals


Slide 71

Stationary Phase (adsorbents)
 A special finely, ground matrix (silicagel,alumina,or

similar material) is coated on a glass plate,a metal or a
plastic film as a thin layer (~0.25 mm).


In addition a binder like gypsum is mixed into the
stationary phase to make it stick better to the slide.
 In many cases, a fluorescent powder is mixed into the
stationary phase to simplify the visualization later on (e.g.
bright green when you expose it to 254 nm UV light).


Slide 72

Sample Application (spotting)


Dissolve solid sample in MeOH. Use TLC
capillary to transfer and spot dissolved
sample.


Slide 73

Plate preparation (spotting)




The plate is dried and activated by heating in an oven for
thirty minutes at 80-110 C. (90)(120)
Spotting must be done carefully, without damaging the
plate’s surface.
The starting point of the run, i.e., the “spotting line, ”
should be 1-2 cm from the bottom of the plate. The
solvent level has to be below the starting line of the TLC,
otherwise the spots will dissolve away.


Slide 74

Plate preparation (spotting)




The spacing between applications of sample (spotting
points) should be at least 1 cm, and spots should not be
placed closer than 1.5 cm to the side edge of the plate.
To avoid diffuse spots during development, the size of the
sample spot should be as small as possible ( 2 mm).


Slide 75

Spotting and developing





Remove plate from the development tank as soon as the
solvent reaches the development line marked beforehand; until
~1 cm from the top. otherwise, diffuse spots will occur.
Do not allow the solvent to run over the edge of the plate.
Next, let the solvent evaporate completely .


Slide 76

Choice of solvent




Selection of M.P. depends on:
nature of substance to be separated ,Viscosity & Polarity of
S.P. The solvent used may be a single or double phase
system.
N-hexane, cyclohexane, carbon tetra chloride, benzene,
toluene, trichloro ethylene, chloroform, diethyl ether, ethyl
acetate, n-butanol, acetone, ethanol, methanol and water.


Slide 77

Choice of solvent
Solvent systems (mobile phases)


System A:

Methanol 100 : Concentrated ammonia 1.5
 System B:
Ethyl acetate 85: Methanol 10 : Concentrated ammonia 5


System C:

Cyclohexane 75: Toluene 15: Diethylamine 10


Slide 78

Visualization/detection


Plates must be dried prior to visualization: The solvent can be
allowed to evaporate at room temperature, or removed with a
hot air blower.
 If hot air is used,care must be taken because of the volatility of
the ATS free bases.
 It is important for proper colour development that all traces of
ammonia be removed from the plate.


Slide 79

Visualization of TLC Results
There are various techniques to visualize the compounds.
Iodine , Sulforic ,…., RF, UV, long wavelength (background
green, spots dark), short wavelength (plate dark, compounds
glow)
Be sure not to use the UV lamp outside of the cabinet and
wear the safety glasses at all times while viewing.


Slide 80

Using Silica plates impregnated with methanolic
KOH (0.1 mol/l).
 Detection time ( 1-1.5 h)
 Dark
 Temperature
 Moisture
 Experienced & Expert person



Slide 81

Interpretation
After visualization, mark spots (e.g., by pencil), and calculate
retardation factor (Rf) values:
Rf =
Migration distance: from origin to centre of analyte zone (spot)/
Development distance: from origin to solvent front
It is very common to express retention factors as Rf x 100,


Slide 82

Thin Layer Chromatography (TLC)


Slide 83

Thin Layer Chromatography (TLC)


Slide 84


Slide 85

Troubleshooting TLC


About the first time you run a TLC, and see spots
everywhere and blurred , streaked spots?

Run the TLC again after diluting your sample.
Or, your sample might just contain many components,
creating many spots which run together and appear as a
streak.


Slide 86

Troubleshooting TLC


The sample runs as a downward crescent.
The adsorbent was disturbed during the spotting,
causing the crescent shape.


Slide 87

Troubleshooting TLC


The plate solvent front runs crookedly.
Either the adsorbent has flaked off the sides of the plate
Or ; the sides of the plate are touching the sides of the container
as the plate develops.
(Or ; the paper used to saturate the container 30-45 min)
Crookedly run plates make it harder
to measure Rf values accurately.


Slide 88

Interpretation of Results


Slide 89

Interpretation of Opiate Positive Results
Confirmation of Codein and Morphine by GC/MS.
Use of 300ng/ml criterion resulted in a large number of
positive results that drived from ether poppy- seed
ingestion or therapeutic doses for codeine.
Where there was a prescription for codeine or
morphine….
However,in the absence of a prescription for codeine or
morphine , “ clinical signs of opiate use “ befor reporting
verified opiatepositive result back to the employer.


Slide 90

Interpretation of Amphetamine &
Metamphetamine Positive Results


A laboratory report Metamphetamine as positive only if :
its concentration is 500 ng\ml or greater, and if that of
amphetamine is 200 ng\ml or greater by GC\MS.
This reporting criterion was introduced hn 1991 after
several specimens were reported as positive for
methamphetamine when the specimen contained larg amounts
of Pseudoephedrine or Ephedrine .
It was discovered (Hornbeck et al. 1993) that
hydroxylated sympathomimetics (Pseudoephedrine or
Ephedrine) could convert to metamphetamine in either the
extraction or chromatographic stage of analysis. None of
these specimens contained amphetamine when tested. and
therfor; false–positive.


Slide 91

It was discovered (Hornbeck et al. 1993) that hydroxylated
sympathomimetics (Pseudoephedrine or Ephedrine) could
convert to metamphetamine in either the extraction or
chromatographic stage of analysis. None of these specimens
contained amphetamine when tested. and therfor; false–
positive.
Pre – oxidation step with preiodate to prevent the
possibility of this happening.


Slide 92


Slide 93

Interpretation of Amphetamine Positive
Results


If both amines are present in concentration greater than
500 ng\ml by GC\MS, both are reported as positive and
threre is no confusion.
Dificalty araises when the amphetamine between 200
and 500ng\ml , (Less than the amphethamine
confirmation cut-off).


Slide 94

Interpretation of Amphetamine Positive
Results


Some drugs can metabolise to metamphetamine and
amphetamine ( benzphetamine and selegeline).


Slide 95

Interpretation of Amphetamine Positive
Results


The Confusion in differentiation of ,

D - and L-Metamphetamine:
Vicks Inhaler (decongestant product); It’s use can result
(false positive) in the detection of amphetamine and
metamphetamine in urine. (low concentration and crossreactivity to the L- isomer of
metamphetamine and
amphetamine; a unlikely positive (False Positive) , following
normal use.
In such case can request a GC/MS separation and
isomers. These are usualy analysis and reported as X% disomer and %Y L-isomer. Where the L-Isomer is greater than
80% , the result as negative.


Slide 96

L-methamphetamine isn’t really anything like the
D-methamphetamine isomer that is found in street
drugs. D-methamphetamine is psychoactive,
L-methamphetamine isn’t very
while
psychoactive at all


Slide 97

Thin Layer Chromatography


Slide 98

Thin Layer Chromatography


Slide 99

Thin Layer
Layer Chromatography
Chromatography
Thin


Slide 100

Thin Layer Chromatography


Slide 101

Thin Layer
Layer Chromatography
Chromatography
Thin


Slide 102

Thin Layer
Layer Chromatography
Chromatography
Thin


Slide 103

TLC, Multi Drug



Slide 104

Thin Layer Chromatography


Slide 105

Thin Layer
Layer Chromatography
Chromatography
Thin


Slide 106

TLC, Amphetamine


Slide 107

TLC, Amphetamine


Slide 108

Thin Layer
Layer Chromatography
Chromatography
Thin


Slide 109

Thin Layer Chromatography


Slide 110

Thin Layer Chromatography


Slide 111

Thin Layer Chromatography


Slide 112

Paper chromatography


Slide 113

Paper chromatography


Slide 114

HPTLC analysis
HPTLC analysis is particularly appreciated in the

following fields :
- chemical / medical: detection of illicit substances,
quality controls and pharmaceutical and cosmetic
purity
- Human and animal nutrition: additives; monitoring
composition and stability; quality control
- Environment: pesticides, water and soil pollution,
plant extracts, etc


Slide 115

HPTLC analysis


Slide 116


Slide 117

Thanks for your attention


Slide 118

‫پذیرش و نمونه گیری‬


Slide 119

‫نکاتی در مورد پذیرش و نمونه گیری‬
‫•‬

‫نمونه گیری بایستی ءوری و یا با اساداده از دور بین مدار بساه انفام‬
‫شود‪.‬‬

‫•‬

‫مکان نمونه گیری بایستی از هویه و نور کافی برووردار باشد‪.‬‬

‫•‬

‫در محل نمونه گیری صابون و مواد سدید کننده نابل دسترس ی برای‬
‫مراجله کنندگان موجود نباشد‪.‬‬

‫•‬

‫ارائه كارت شناسايي يا ملرفي نامه عك‬
‫نمونه با نمونه فرد ديگر‪.‬‬

‫جلوگیري از جايگزيمي‬

‫•‬

‫موارد ا افي (كت‪ ،‬كيق و ‪ ) ....‬وارا از محل نمونه گیري تحويل گرفاه‬
‫شود‪ .‬تي بازرس ي بدني در صورت لزوم‪.‬‬

‫دار‬


Slide 120

‫مکا‬

‫سدر دردسپذیر‬

‫دسم دماسگیری‬

‫•‬

‫شستن دس ها نبزل از نمونزه گیزري ‪ :‬زيزر نزاون ‪ ،‬چسزا زوزم ویزا آلزوده كزردن دسزت‬
‫به موادي كه موجا ایفاد اواالل در آزمايا مي شوند‪.‬‬

‫•‬

‫دماي نمونه تزا ‪ 4‬دنيقزه بلزد از نمونزه گیزري انزدازه گیزري شزود‪.‬‬
‫‪ : )33‬موثرترين راهها براي تشخيص رنيا سازي‬

‫•‬

‫نمونه گیر بايد فردي مطمئن ‪ ،‬هوشيار و آگاه باشد‪.‬‬

‫(‪-37 C‬‬


Slide 121

‫بعدست سم دماسگیروس‬

‫‪.1‬‬

‫دماي نمونه تا ‪ 4‬دنيقه بلد از نمونه گیري ‪ 33-37 C‬است‪.‬‬

‫‪.2‬‬

‫رنگ ‪ ،‬شدافيت ‪ ، PH،‬وزن مخصو نمونه بررس ي شود‪ .‬اگر نمونه مشكوك‬
‫به تقلا است دوباره نمونه گیري انفام مي شود‪.‬‬
‫‪‬‬
‫‪‬‬
‫‪‬‬

‫‪.3‬‬

‫كراتي تین كمتر از ‪20mg/dl‬‬

‫مشكوك‬

‫وزن مخصو بايد ‪ 1.002-1.04‬باشد پايین تر نابل نبول نوست‪.‬‬
‫‪ PH‬نمونه ‪ 4.5-8.5‬نابل نبول است‪.‬‬

‫نمونه مهر و موم شده (به روش مناسا نگهداري شود و دسترس ي به نمونه تا زمان‬
‫آزمايا براي افراد مادرنه امكان پذير نباشد)‪.‬‬


Slide 122

‫روشهاي مداوله (تقلا ) در نمونه گیري‬
‫تلويض نمونه )‪(Substituation‬‬
‫•‬
‫جابفايي نمونه با نمونه ديگر ويا اساداده از موادي كه شبيه ادرار باشند مثل چاي‪،‬آق سوا‬
‫و‪...‬‬
‫• رنيا نمودن نمونه )‪(Diluation‬‬
‫• ‪ -‬رنيا سازي توسط آق سبا مي شود كه غلظت دارو به دي كاها يابد كه نابل‬
‫تشخيص نباشد‪.‬‬
‫• ‪ -‬نوشيدن آق و مايلات ديگر سبا مي شود كه غلظت دارو كمتر از غلظت د‬
‫مرزي )‪ (Cut Off‬برسد‪.‬‬
‫• افزايا سرعت دفع ‪ :‬سركه‪ ،‬وياامین ‪ ،C‬آق ليمو‪ ،‬داروهاي ديورتيك‬

‫•‬

‫تزريا آق و مايلا ت ديگر به مثانه (عدونت و آسوا بافتي)‬

‫• اساداده از ادرار ليوفيلیزه كه براي اين منظور به صورت تفارتي ساواه موشود‪.‬‬


Slide 123

‫•افزودن مواد وارجي )‪(Adulteration‬‬
‫آزمايشگاه‬
‫بطور كلي افزودن مواد وارجي به نمونه با هدف به اشجباه انداوتن‬
‫ودريافت پاسخ مندي كاذق ِ‪ Adulteration‬گداه موشود‪.‬اين مواد بطور كلي دو گروه‬
‫هسجند ‪:‬‬
‫• گروه اول مواد وانگي هسجند كه به را تي در دسترس مي باشند‪.‬‬
‫ صابون‪ ،‬پاك كننده هاي وانگي )‪(Detergent‬‬‫ سديد كننده ها )‪(Bleaching agent‬‬‫ جوهر ليمو‬‫ كلريد سديم‬‫ سركه وياامین ‪ C‬و‪...‬‬‫• گروه دوم موادي هسجند كه به را تي در دسترس نبوده و اساداده از آنها نياز به اطالعات‬
‫وتخصص دارد‪ .‬تلدادي از اين مواد به شرح زير هسجند‪:‬‬


Slide 124

‫دتدیسکاسبطدرس ع دلسدرسدن رسسمین مد‬
‫‪ - ‬كلر(‪)Chlorine‬‬
‫‪ - ‬آق اكسیژنه‬
‫‪ - ‬نمكها مثل‪ :‬سديم برومايد ‪ ،‬سد يم نيتريت و ‪...‬‬
‫‪ - ‬نيتريت )‪ (Nitrite‬مثل ‪Whizziez , Klear‬‬
‫‪ - ‬كرومات و پیريدينيوم كرومات )‪(Chromat , Pyridinium chromat‬‬
‫‪ - ‬پراكسيد و پراكسيداز )‪(Peroxid , Peroxidas‬‬
‫مثل موادي با نامهاي تفارتي ‪Clean choce‬‬
‫‪ - ‬گلوتاريك آلدهيد )‪(Glutaric aldehyde‬‬
‫‪ - ‬مثل موادي با نامهاي تفارتي ‪Instant clean‬‬
‫‪ - ‬مصرف موادي تحت عنوان ‪ Golden seal,Guick caps ,Test clean‬و‪...‬‬


Slide 125

‫• سه مورد اویر تحت عنوان كلي ‪ Urine Lock‬نیز نا ميده مي شود‪.‬‬
‫• ‪ : Mixed reagent‬ممكن است تركيا چند مورد از مواد فوق با هم توسط فرد‬
‫مورد آزمايا مورد اساداده نرار گیرد كه در اين الت به آنها ‪ Lock Lab‬گداه مي شود‬
‫‪.‬‬
‫‪Bleaching agent , Detergent‬‬
‫** تاثیر اين مواد روي بلض ي مواد مورد آزمايا بوشتر و در مواردي كمتر است همچنین تاثیر‬
‫اين مواد در روشهاي مخالق باهم فرق ميكند‪.‬‬
‫** ووشبخاانه افزودن اين مواد در مر له نمونه گیري صورت مي گیرد كه با دنت در انفام‬
‫نمونه گیري ءوري مي توان از اين دساه تقلبها جلوگیري كرد‪.‬‬


Slide 126

‫مکان سم عمل موادی که برای تقلا اساداده می شود‬

‫‪ ‬پرستکنیدسدسپرستکنیدت‬
‫ بعمدتنستکنیدتم سد لس سکممدس‪.‬‬‫دت‪،‬م سآم سبادوسدسآم سژن‬

‫رریبسد لسآم ی سدتر اللسدرسس‬

‫‪ ‬کرد ا سدسپیریدسمید سکرد ا‬
‫‪ -‬قابلس قایناسباس دردسباال‬

‫‪ ‬گلد اریکسآلدسیید ) ‪)c-o-c‬‬
‫‪-‬‬

‫ر لسکردنسد لسآم ی سسبرصدصسرد سس‪Emit‬‬

‫‪ ‬نریدسکممد سیاس‬
‫ت سیكسن سباسدتردسبامدس سیدمدس( ینل) دتر اللسدرس‬
‫دت‪،‬م سآم سبادوسدسآم سژن‬
‫‪‬‬

‫‪-‬‬

‫تنیدسدسقلیا‬
‫دتدیس ثلستنیدسیاسدسقلیایاسبهاس یییهرس‪ pH‬باده س‬
‫یییرسنار انسپرد مینسدتر اللسدرسبامهدسیهدنسآم ه س‬
‫بادیسدسآم سژنس سیدمدسدردیهایستی دمدتن سرتس حه س‬
‫اثیرسقرترس یدیمد‪.‬‬


Slide 127

Thanks for your attention