Singclean OEM CE Approved Wholesale Rapid Medical Ivd Diagnostic Urine Drug Test Cup for Home and Self Testing

• Type: IVD Reagent
• Certificates: ISO13485//Cfda
• Principle: Colloidal Gold Method
• Specimen: Urine
• Form: Strip/Cassette/Uncut Sheet/Device/Midstream/Canist
• Strip: 2.5mm/3.0mm/3.5mm
• Storage: Room Temperature
• Packing: 1test/Pouch
• Sellf Life: 2 Years
• Transport Package: Cartons
• Specification: 5 in 1; 6 in 1; 10 in 1; 12 in 1;14 in 1 panel/cup
• Trademark: Singclean or OEM brand
• Origin: China
• HS Code: 3302100090
• Production Capacity: 10000/Day

Product Description

Intended Use

Singclean Multi-Drug One Step Test Kit is used to qualitatively detect whether there are drugs or drug metabolites in the urine of target people, and conduct preliminary screening for target drug users with the colloidal gold method. lt is for the deleclion of 23 drugs like cOC.AMP,MOP,THC.MET-OPI,BAR,BZO,MTD.MDMA,TCA, OxY,BUP,PCP,EDDP.

 

Application
The test is used to obtain visual qualitative result and is intended for healthcare professionals use including professionals at point of care sites toassist in the determination of drug compliance

Singclean Advantages
Accurate results:
More than 99% accurate,according to international drug abuse monitoring standards;
Good specificity:
Select monoclonal antibody with high specificity to minimize possible crossover;
Easy to operate:
Do not need any equipment and additional testing; Samples are easy to collect and canbe tested on site;
Fast detection:
5 minutes to interpret the results,saving time;
Joint testing:
Multiple drugs can be screened at once.

Specification
 

Format	cassette, panel, and cup
Cassette Format	Customized, up to 6 panelspanel format: up to 16 panels
Cup Format	up to 18 panels

 

How much sample do I need?
 

Cassette Format: Need 3 drops of urine sample[about 10ouL).
Panel Format: immerse the test panel vertically into the urine specimen for at least 10-15 seconds or until migration occurs. Immerse the strip(sy at least the level of the wavy lines, but not above the arrow (s) on the test card.
Cup Format: Fill the Drug Test Cup with urine to at least the minimum fill level line. Customization is available. A special format for testing special types of drugs according to clients" requirements can be provided.

 

 

 

Test Procedure
 

For Test Cassette
· Place the Test Cassette on a clean and level surface.Hold the dropper vertically and transfer 3 ful rops ofurine (apprax,10OL) to the specimen well (s).Avoid trapping air bubbles in the specimen well (S).
· Start the time and wait for the colored line to appear.
· Read the test results at 5 minutes. Do not read the results after 10minutes.

 

For Test Panel
· Remove the cap from the end of the test card. With arrows pointing toward the urine specimen, immerse the test panel vertically into the urine specimen for at least 10-15 seconds or until migration occurs. Immerse the strip(s) at least the level of the wavy lines, but not above the arrow(s) on the test card.
· Place the test panel on a flat dry surface, start the time, and wait for the colored line(s) to appear. 
· Read the test results for 5 minutes. Do not read the results after 10 minutes.

For Test Cup
· Collect the specimen in the cup and secure the cap tightly. · If the temperature strip is included with Drug Test Cup, please read urine temperature between 2-4 minutes after voiding to verify the temperature ranges between 32-38"c.
· Place the cup on a flat surface.
· Date and initial the security seal, and place the security seal on the cap.
· Peel off the label on the cup to view the results.
· Read the test results for 5 minutes. Do not read the results after 10 minutes.

Interpretation of Results:
POSITIVE
Only one colored band appears in the control region (C). No apparent colored band appears in the test region(T). The absence of a line in the test region (T) indicates a positive result. The positive result indicates that the drug concentration in the urine specimen is above the designated cut-off level for that specific drug.
Note: The samples with positive results should be confirmed with a more specific method.

NEGATIVE
Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). The negative result indicates that the drug concentration in the urine specimen is below the designated cut-off level for that specific drug.

INVALID
The control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat it with a new test. if the problem persists, discontinue using the kit immediately and contact your local distributor.


Test Limitations
1. Failure to use this kit as directed may result in an insufficient sample or an inaccurate screening result.
2. The possibility exists that substances and factors not described in this instruction may interfere with the test, causing false results (e.g. technical or procedural error).
3. This test provides a screening result t is not designed to determine the actual concentration of a drug or the level of intoxication.