Morphine (MOP) Saliva Drug Screening CassetteInstruction of Use

Morphine (MOP) Saliva Drug Screening Cassette

Instruction of Use

CY-SDS-0101

For Employment and Insurance Use Only

iClean® Morphine (MOP) Saliva Drug Screening Cassette offers qualitative detection of Morphine abuse and its principal metabolites in human oral fluid at specified cut-off levels.

Intended Use                                                                       

The MOP Saliva Drug Screening Cassette is rapid saliva screening test. The test is a lateral flow, immunoassay for the qualitative detection of specific drug and its metabolites in human saliva at the following cut-off concentrations:

This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.

The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are the preferred confirmatory methods. Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Summary                                                                          

The MOP Saliva Drug Screening Cassette is a rapid saliva screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in saliva.

Morphine(MOP)：Morphine is a popular marketed drug (Serax) for treatment of moderate to severe pain. It is also a common metabolite of opiates [morphine, codeine (methyl-morphine), and heroin (semi-synthetic derivatives of morphine)]. The opiates are administered either by smoking, intravenous injection, intramuscular injection or oral ingestion. Adverse or toxic effects of opiates usage include papillary constriction, constipation, urinary retention, nausea, vomiting, hypothermia,drowsiness, dizziness, apathy, confusion, respiratory depression, hypotension, cold and clammy skin, coma,and pulmonary edema. Death may occur following an over dosage.

The duration of effect of morphine is 3-6 hours. Morphine is metabolized extensively, with only 2-12% excreted as unchanged morphine in the urine.Heroin is rapidly metabolized to morphine in the body; the pattern of urinary excretion of heroin is similar to that of morphine.Codeine is also extensively metabolized, 10-15% of the dose is demethylated to form morphine and norcodeine. It has been reported that the unchanged morphine may remain detectable in urine for up to one week, which make morphine a marker of opiates abuse.

Principle                                                                           

During testing, a saliva specimen migrates upward by capillary action. A drug, if present in the Saliva 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 region of the specific drug dipstick. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test region. A drug-positive saliva specimen will not generate a colored line in the specific test region of the dipstick because of drug competition, while a drug-negative saliva specimen will generate a line in the test region because of the absence of drug competition.

To serve as a procedural control, a colored line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Precautions                                                                        

1. Do not swallow.
2. Discard after first use.The test cannot be used more than once.
3. Do not use the test kit beyond expiration date.
4. Do not use the test if the pouch is punctured or not sealed.
5. Keep out of the reach of children.
6. Do not read results after 5 minutes.
7. The used collector and cube should be discarded according to local regulations.

Materials                                                                          

Materials Provided

• Test Cubes
• Sponge Collectors
• Additional Sponge Collectors
• Package
• Insert
• Procedure Card

Material Required but Not Provided

• Timer

Storage and Stability                                                                 

1.Store at 4°C-30°C(39℉-86℉) in the sealed pouch up to the expiration date.

2.Keep away from direct sunlight, moisture and heat.

3.DO NOT FREEZE.

4.Preferably open the pouch only shortly before collection and testing.

Specimen Collection and Preparation

1. Collect the oral fluid sample using the sponge collector provided.
2. Oral-fluid collected at any time of the day may be used.
3. No other collection devices should be used with this assay.
4. Do not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.

Test Procedure                                                                       

Allow the kit and saliva specimen to reach room temperature (65°F-86°F/18ºC-30ºC) prior to testing.

AVOID PLACING ANYTHING IN THE MOUTH 10 MINUTES PRIOR TO TESTING.

1. Remove the test cube and the sponge collector from the foil pouch by tearing at the notch. Place the test cube upright on a level surface.
2. Put the sponge end of the collector on your tongue or near cheek to collect oral fluid for about 3 minutes until the sponge is completely saturated.
3. Open the test cube and place the fully saturated sponge collector inside the test cube. Press the sponge collector down firmly until it reaches the bottom of the test cube, then close the cube lid tightly while compressing the collector. Keep test cube upright on flat surface.
4. Interpreting Drug Test Results：Read results at 5 minutes. Do not read after 5 minutes.

Note: Make sure the sponge collector is inserted vertically and the handle of collector is put into the clamp.

Step 1                        Step 2                       Step 3

Interpretation of Results                                                               

                          Negative               Positive                 Invalid

Negative (-)

A colored band is visible in the Control Region (C) and the appropriate Test Region (T). It indicates that the concentration of the corresponding drug of that specific test zone is zero or below the detection limit of the test.

Positive (+)

A colored band is visible in the Control Region (C). No colored band appears in the appropriate test region. It indicates a positive result for the corresponding drug of that specific Test Region (T).

Invalid

If a colored band is not visible in the Control Region (C), the test is invalid. Another test should be run to re-evaluate the specimen. If test still fails, please contact the distributor with the lot number.

Note: There is no meaning attributed to line color intensity or width.

Quality Control                                                                     

Though there is an internal procedural control line in the test device of Control Region (C), the use of external controls is strongly recommended as good laboratory testing practice to confirm the test procedure and to verify proper test performance. Positive and negative control should give the expected results. When testing the positive and negative control,the same assay procedure should be adopted.

Limitations of Procedure                                                             

1.The test provides only a qualitative, preliminary result. A secondary analytical method must be used to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods.

2. A positive test result does not indicate the concentration of drug in the specimen or the route of administration.

3. A negative result may not necessarily indicate a drug-free specimen. Drug may be present in the specimen below the cutoff level of the assay.

Performance Characteristic                                                           

1. Analytical Sensitivity

Standard drugs were spiked into negative PBS pool to the concentration of 0% Cut-off, -50% Cut-off，-25% Cut-off,Cut-off,+25% Cut-off and +50% Cut-off.The results were summarized below.

• Analytical Specificity

• Cross-Reactivity

Considering the complexity of clinical saliva specimens and the possibility that various saliva specimens contain potentially interfering substances, we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with iClean® MOP Saliva Drug Screening Cassette at a concentration of 100 ug/mL.

From the results above, it is clear that iClean® MOP Saliva Drug Screening Cassette resists well against interference from these substances.

Bibliography                                                                       

• Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.
• Stewart DJ, Inaba T, Lucassen M, Kalow W. Clin. Pharmacol. Ther. April 1979; 25 ed: 464, 264-8.
• Winger, Gail, A Handbook of Drug and Alcohol Abuse, Third Edition, Oxford Press, 1992, page 146.
• Robert DeCresce. Drug Testing in the workplace, 1989 page 114.
• Glass, IB. The International Handbook of Addiction Behavior. Routledge Publishing, New York, NY. 1991; 216.
• B. Cody, J.T., Specimen Adulteration in drug urinalysis. Forensic Sci. Rev., 1990, 2:63.
• Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 6th Ed. Biomedical Publ., Foster City, CA 2002.
• Hardman JG, Limbird LE. Goodman and Gilman’s: The Pharmacological Basis for Therapeutics. 10th Edition. McGraw Hill Medical Publishing, 2001; 208-209.

Index of Symbols                                                                   

	Temperature limit		Consult instructions for use
	Do not re–use		Batch code
	Contains sufficient for <n> tests		Keep away from sunlight
	Use-by date		Manufacturer
	Catalogue number		Do not use if package is damaged and consult instructions for use
	In vitro Diagnostic medical device

Manufacturer                                                                      

Huachenyang (Shenzhen) Technology Co., Ltd.

8F, Building 4, 128# Shangnan East Rd, Huangpu Community, Xinqiao St, Bao’an, Shenzhen, Guangdong, China

Website: www.chenyanglobal.com

Tel: 86-755-27393226 Fax: 86-755-27381080

Effective Date                                                                      

November 11, 2023