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drug abuse test kit PGB rapid test reliable and high sensitivity for oral fluid

Brand Name:	ALLTEST
Model Number:	DPG-802
MOQ:	N/A
Price:	negotiation
Payment Terms:	Ex works
Supply Ability:	2000mg/month

Detail Information

Product Description

Detail Information

Test Time:

3-10 Minutes

Format:

Cassette

Shelf Time:

24 Months

Sample Type:

Oral Fluid

Usage:

For In Vitro Diagnostic Use Only

Storage Temperature:

2-30°C

Packaging Details:

0.5mg/tube 1mg/tube, 2mg/tube、5mg/tube、10mg/tube、20mg/tube、30mg/tube

Supply Ability:

2000mg/month

Highlight:

recombinant antigen

Recombinant Proteins

Product Description

The PGB Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative

detection of Pregabalin in human oral fluid at a cut-off concentration of 500ng/mL.

This assay provides only a preliminary test result. A more specific alternate chemical method

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

spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and

professional judgment should be applied to any drug of abuse test result, particularly when

preliminary positive results are used.

【SUMMARY】

Pregabalin, also known as β-isobutyl-γ-amino butyric acid (beta-isobutyl-GABA), is a medication

used to treat epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder.1

Common side effects include: sleepiness, confusion, trouble with memory, poor coordination, dry

mouth, problem with vision, and weight gain. Potentially serious side effects include angioedema,

drug misuse, and an increased suicide risk.2

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged

drug. The Pregabalin is predominantly excreted unchanged in urine (≥ 98%).3 Pregabalin mean

elimination half-life is 6.3 hours.4 50% would be expected to have negative urine specimens

within 3 days and a total of 5 days would be needed to achieve negative urine specimens in the

subject with the maximum urinary concentration measured.5

【ASSAY PRINCIPLE】

The PGB Rapid Test (Oral Fluid) is an immunoassay based on the principle of competitive

binding. Drugs that may be present in the oral fluid specimen compete against their respective

drug conjugate for binding sites on their specific antibody.

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

colored line will show up in the test line region of the specific drug strip. The presence of drug

above the cut-off concentration in the oral fluid specimen will saturate all the binding sites of the

antibody. Therefore, the colored line will not form in the test line region.

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

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

line in the test line region because of the absence of drug competition.

To serve as a procedural control, a colored line will always appear at the control line region,

indicating that proper volume of specimen has been added and membrane wicking has occurred.

【REAGENTS】

The test contains membrane strip coated with PGB-protein conjugates (purified bovine albumin)

on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and

a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody

specific to Pregabalin.

【PRECAUTIONS】

• Do not use after the expiration date.

• The test should remain in the sealed pouch until use.

• Oral fluid is not classified as biological hazard unless derived from a dental procedure.

• The used collector and cassette should be discarded according to local regulations.

【STORAGE AND STABILITY】

Store as packaged in the sealed pouch at 2-30°C. The test is stable through the expiration date

printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO

NOT FREEZE. Do not use beyond the expiration date.

【SPECIMEN COLLECTION AND PREPARATION】

The oral fluid specimen should be collected using the collector provided with the kit. Follow the

detailed Directions for Use below. No other collection cassettes should be used with this assay.

Oral fluid collected at any time of the day may be used.

【MATERIALS】

Materials Provided

• Test cassettes

• Collectors

• Collection tubes

• Package insert

• Security seals

Materials Required but Not Provided

• Timer

【DIRECTIONS FOR USE】

Allow the test cassette, specimen and/or controls to reach room temperature (15-30ºC)

prior to testing. Instruct the donor to not place anything in the mouth including food, drink,

gum or tobacco products for at least 10 minutes prior to collection.

1. Bring the pouch to room temperature before opening it. Remove the test from the sealed

pouch and use it within one hour.

2. Remove the collector from the sealed pouch and collect oral fluid specimen as follows:

Important: Place the tongue against the upper and lower jaws and roots to enrich the oral fluid

before oral fluid collection.

Insert the sponge end into the mouth, actively swab around the gums on both sides of the

mouth and under the tongue and chew the sponge tenderly, place the sponge end under the

tongue for a total of 2-3 minutes until the sponge becomes fully saturated.

Gently pressing the sponge between the tongue and teeth will assist saturation. No hard spots

should be felt on the sponge when saturated.

3. Remove the collector from the mouth. Place saturated oral fluid collector into collection tube

and press sponge fully against the strainer to collect oral fluid. Discard the collector. Snap the

cap shut on the Collection tube.

4. Place the test cassette on a clean and level surface. Unscrew cap cover from the Collection

tube. Invert the Collection tube and transfer 3 drops of oral fluid (approximately 120 µL) into

specimen well of the test cassette. Avoid trapping air bubbles in the specimen well. Place

screw cap on the collection tube. Wait for the flow to appear in the test windows and start the

timer.

5. Read the test results at 3-10 minutes.

If all lines are clearly visible at 3 minutes or sooner,then the test can be interpreted as negative

and discarded. If any lines not visible at 3 minutes, then the test should be re-read at 10

minutes.

6. Apply the security seal over screw cap and send to the laboratory for confirmation if necessary.

Tags:

Custom Monoclonal Antibody

Drug Abuse Test Kit

Rapid Test Kit

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Convenient Oncology Rapid Diagnostic Test kits

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Fluorescence Immunoassay Analyzer

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Veterinary Rapid Test Kits

Flourescence Immunoassay Test Kits

Urine Chemistry Analyzer

Nucleic Acid PCR

Rapid Test Reader

Chemiluminescence Immunoassay Test

Blood Biochemistry Analyzer

Custom Monoclonal Antibody

Drug Abuse Test Kit

Rapid Test Kit

Infectious Disease Testing

Accuate Cardiac Marker Rapid Test kits

Convenient Oncology Rapid Diagnostic Test kits

Rapid Diagnostic Test Kits

Fluorescence Immunoassay Analyzer

Glucose Monitoring Device

Veterinary Rapid Test Kits

Flourescence Immunoassay Test Kits

Urine Chemistry Analyzer

Nucleic Acid PCR

Rapid Test Reader

Chemiluminescence Immunoassay Test

Blood Biochemistry Analyzer

products details

drug abuse test kit PGB rapid test reliable and high sensitivity for oral fluid

drug abuse test kit PGB rapid test reliable and high sensitivity for oral fluid

recombinant antigen

Recombinant Proteins