Interpretation Of Doa Results: Saliva Drug Test printable pdf download

 Wear protective clothing such as laboratory coats, disposable gloves and eye protection when

NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes

specimens are assayed.

Saliva Drug Test

present in the specimen. Therefore, any shade of color in the test region (T) should be considered

STORAGE AND STABILITY

negative. Please note that this is a qualitative test only, and cannot determine the concentration of



The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

INTENDED USE

analytes in the specimen.



The test must remain in the sealed pouch until use.

2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely

The Oral Express Saliva Drug Test is a rapid visual immunoassay for the qualitative detection of drugs



Do not freeze.

reasons for control band failure.

of abuse in human oral fluid specimens. The test system consists of up to 16 membrane strips mounted



Kits should be kept out of direct sunlight.

QUALITY CONTROL

in a plastic device. This test detects combinations of the following drugs at the concentrations listed



Care should be taken to protect the components of the kit from contamination. Do not use if



below. Specific combinations will vary according to the test in question:

Internal procedural controls are included in the test. A colored band appearing in the control region (C)

there is evidence of microbial contamination or precipitation. Biological contamination of

Test

Calibrator

Cut-off (ng/ml)

is considered an internal positive procedural control, confirming sufficient specimen volume and correct

dispensing equipment, containers or reagents can lead to false results.

Amphetamine (AMP)

D-Amphetamine

procedural technique.

SPECIMEN COLLECTION AND STORAGE



Barbiturate(BAR)

Barbiturate

External controls are not supplied with this kit. It is recommended that positive and negative controls be



Benzodiazepine (BZO)

Oxazepam

The Oral Express Saliva Drug Test is intended for use with human oral fluid specimens only.

tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.



Oral fluid specimens must be collected according to the directions in the Procedure section of this

Buprenorphine(BUP)

Buprenorphine

LIMITATIONS OF THE TEST

Cocaine (COC)

Cocaine

package insert.



The Oral Express Saliva Drug Test is for professional in vitro diagnostic use, and should be only

Cotinine(COT)

Cotinine

Perform testing immediately after specimen collection.



used for the qualitative detection of drugs of abuse in oral fluid.

EDDP(EDDP)

2-Ethyliden-1,5-Dimethyl-3,3-Diphenylpyrrolidine

If specimens are to be shipped, pack them in compliance with all applicable regulations for

This assay provides a preliminary analytical test result only. A more specific alternative chemical

Ketamine（KET）

Ketamine

transportation of etiological agents.

method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass

Methadone (MTD)

Methadone

PROCEDURE

spectrometry (GC/MS) has been established as the preferred confirmatory method by the National

Methamphetamine (MET)

D-Methamphetamine

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use. Donors should

Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be

Ecstasy（MDMA）

3,4-Methylenedioxymethamphetamine

avoid placing anything (including food, drink, gum and tobacco products) in their mouth for at

applied to any test result, particularly when preliminary positive results are indicated.

6-MAM

6-Monoacetylmorphine

least 10 minutes prior to specimen collection.

There is a possibility that technical or procedural errors as well as other substances and factors may

Opiates (OPI)

Morphine



The oral fluid specimen should be collected using the collector provided with the kit. No other

interfere with the test and cause false results.

Opiates (OPI)

Morphine

collection devices should be used with this assay.

A positive result indicates the presence of a drug/metabolite only, and does not indicate or measure

Oxycodone(OXY)

Oxycodone



Instruct the donor to not place anything in the mouth including food, drink, gum, or tobacco

intoxication.

Phencyclidine (PCP)

Phencyclidine

products for at least 10 minutes prior to collection.

A negative result does not at any time rule out the presence of drugs/metabolites in saliva, as they

Propoxyphene(PPX)

Propoxyphene



Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

may be present below the minimum detection level of the test.

Marijuana (THC)

11-nor-Δ

-THC-9-COOH



Using the provided collection swab, have donor sweep inside of mouth (cheek, gums, and tongue)

This test does not distinguish between drugs of abuse and certain medications.

Marijuana (THC)

-THC

several times, and then hold swab in mouth until color on the saturation indicator strip appears in the

PERFORMANCE CHARACTERISTICS

PRINCIPLE

indicator window of collection swab. Important: Do not bite, suck, or chew on the sponge.



A. Sensitivity

NOTE: If after 7 minutes, color on the saturation indicator has not appeared in the indicator

The Oral Express Saliva Drug Test is an immunoassay based on the principle of competitive binding.

A phosphate-buffered saline (PBS) pool was spiked with drugs to target concentrations of  50% cut-off

Drugs that may be present in the oral fluid specimen compete against their respective drug conjugate for

window, proceed with the test below.

and  25% cut-off and tested with The Oral Express Saliva Drug Test. The results are summarized



binding sites on their specific antibody.

Remove collection swab from mouth and insert it sponge first into the screening device, screw until

below.

the locking flange locks in place in the bottom of the device.

During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if



present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its

Test device upright on flat surface and keep upright while test is running. Wait for the colored bands

Drug Conc.

AMP

BUP

BZO

COC

(Cut-off range)

specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line

to appear in test results area. Read results at 10 minutes.



will show up in the test line region of the specific drug strip. The presence of drug above the cut-off

NOTE: Once the collection swab locks in place, the device is airtight, tamper evident, and ready to

0% Cut-off

concentration in the oral fluid specimen will saturate all the binding sites of the antibody. Therefore, the

be disposed or sent to lab for confirmation (on presumptive positive result).

-50% Cut-off

colored line will not form in the test line region.

-25% Cut-off

A drug-positive oral fluid specimen will not generate a colored line in the specific test line region of the

Cut-off

strip because of drug competition, while a drug-negative oral fluid specimen will generate a line in the

+25% Cut-off

test line region because of the absence of drug competition. To serve as a procedural control, a colored

+50% Cut-off

line will always appear at the control line region, indicating that proper volume of specimen has been

added and membrane wicking has occurred.

Drug Conc.

COT

EDDP

KET

MET

MATERIALS

(Cut-off range)

0% Cut-off

Materials Provided

-50% Cut-off

-25% Cut-off

Individually packed screening devices

Cut-off

Oral fluid collection swabs

+25% Cut-off

Package insert

+50% Cut-off

Drug Conc.

MOR

MTD

OXY

PCP

(Cut-off range)

0% Cut-off

INTERPRETATION OF RESULTS

-50% Cut-off

 INTERPRETATION OF DOA RESULTS:

-25% Cut-off

Cut-off

+25% Cut-off

Materials Required but Not provided

+50% Cut-off

Timer

Positive and negative controls

Drug Conc.

THC

THC parent

BAR

PPX

PRECAUTIONS

(Cut-off range)

 For professional in vitro diagnostic use only.

0% Cut-off

 Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is

-50% Cut-off

damaged. Do not reuse tests.

-25% Cut-off

 This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of

Cut-off

(See previous illustration)

the animals does not completely guarantee the absence of transmissible pathogenic agents. It is

+25% Cut-off

POSITIVE: Only one colored band appears, in the control region (C). No colored band appears in the

therefore, recommended that these products be treated as potentially infectious, and handled by

+50% Cut-off

test region (T) for the drug in question. A positive result indicates that the drug concentration exceeds

observing usual safety precautions (e.g., do not ingest or inhale).

the detectable level.

 Read the entire procedure carefully prior to testing.

Drug Conc.

MDMA

6-MAM

MOR25

 Do not eat, drink or smoke in the area where specimens and kits are handled. Handle all specimens

(Cut-off range)

NEGATIVE: Two colored bands appear on the membrane. One band appears in the control region (C)

as if they contain infectious agents. Observe established precautions against microbiological hazards

0% Cut-off

and another band appears in the test region (T) for the drug in question. A negative result indicates that

throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear

the drug concentration is below the detectable level.

-50% Cut-off

protective clothing such as laboratory coats, disposable gloves and eye protection when specimens

-25% Cut-off

INVALID: Control band fails to appear. Results from any test which has not produced a control band at

are assayed.

Cut-off

 Humidity and temperature can adversely affect results.

the specified read time must be discarded. Please review the procedure and repeat with a new test. If the

+25% Cut-off

 Used testing materials should be discarded in accordance with local regulations.

problem persists, discontinue using the kit immediately and contact your local distributor.

+50% Cut-off

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Interpretation Of Doa Results: Saliva Drug Test

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