Singclean High Accuracy One Step Lab Urine Drug of Abuse Test Kit for Drug Screen Rapid Test Kit Combo

• Customization: Available
• 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

Multi-drug One Step Test Kit 

(Colloidal Gold Method)
 

 

Product List

	Product Name	Catalog No.	Specimen	Format	Test/Kit	Cut-off (ng/mL)
DOA Single-Drug	AMP Amphetamine	DAM-101/102	Urine	Strip/Device	50T/40T	1000
	BAR Barbiturates	DBA-101/102		Strip/Device	50T/40T	300
	BUP Buprenorphine	DBU-101/102		Strip/Device	50T/40T	10
	BZO Benzodiazepines	DBZ-101/102		Strip/Device	50T/40T	300
	COC Cocaine	DCO-101/102		Strip/Device	50T/40T	300
	COT Cotinine	DCT-101/102		Strip/Device	50T/40T	200
	EDDP	DED-101/102		Strip/Device	50T/40T	300
	FTY Fentanyl	DFT-101/102		Strip/Device	50T/40T	100
	KET Ketamine	DKE-101/102		Strip/Device	50T/40T	1000
	MDMA Ecstasy	DMD-101/102		Strip/Device	50T/40T	500
	MET Methamphetamine (MET/mAMP)	DME-101/102		Strip/Device	50T/40T	1000
	MOP Morphine 300 (OPI300)	DMO-101/102		Strip/Device	50T/40T	300
	MTD Methadone	DMT-101/102		Strip/Device	50T/40T	300
	OPI Opiate 2000	DOP-101/102		Strip/Device	50T/40T	2000
	OXY Oxycodone	DOX-101/102		Strip/Device	50T/40T	100
	PCP Phencyclidine	DPC-101/102		Strip/Device	50T/40T	25
	PPX Propoxyphene	DPX-101/102		Strip/Device	50T/40T	300
	TCA Tricyclic Antidepressants	DTC-101/102		Strip/Device	50T/40T	1000
	THC M-arijuana	DTH-101/102		Strip/Device	50T/40T	50
	TRA Tramadol	DTR-101/102		Strip/Device	50T/40T	300
DOA Multi-Drug Panel/ Device/Cup	Multi-Drug One Step Drug Screen Test Panel	DOA-124 to DOA-1124	Urine	2-12 Drugs	20 Test/ box
		DUD-124 to DUD-1124		2-10 Drugs
	Multi-Drug One Step Multi-Line Drug Screen Test Device	DOA-125 to DOA-1124	Urine	2-12 Drugs
	Multi-Drug Panel withIntegrated E-Z Split KeyTM Cup II	DBO-127 to DBO-1127	Urine	2-12 Drugs
		DBD-127 to DBD-1107		2-15 Drugs
Urine Adulteration Strips (Creatinine/Nitrite/ Glutaraldehyde/ pH/Specificravity/Oxidant)	6 parameter strip	DUC-111	Urine	6 parameter strip

 

Intended use
The Multi-drug One Step Test Kit (Colloidal Gold Method) is a rapid chromatographic immunoassay for the qualitative detection of drugs and drug metabolites in human urine. The detection limits (cut-off concentrations) for this test are listed below.

Special conditions for use

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method, although other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Multi-drug test kits are available in various configurations, including any combination of the drug analytes listed above, with or without a specimen validity test (S.V.T.).

 

Pack formats

Cassette: 25 tests/box

Panel: 25 tests/box

Cup: 20 tests/box

Product superiority

1. Visual interpretation results, no need for instruments
2. High sensitivity, good specificity;
3. Easy to operate, suitable for rapid screening;
4. Sample is stool, non-invasive test
 

Principle

The multi-drug test kit is based on a competitive binding immunoassay. Drugs and drug metabolites in the urine sample compete with immobilized drug conjugates for limited labeled antibody binding sites.

During testing, the urine specimen migrates through the test device via capillary action:

• If the drug or drug metabolite concentration is below the cut-off level, the anti-drug antibodies in colloidal gold particles bind to the drug antigens in the test line (T), forming a visible line that indicates a negative result.

• If the drug concentration is above the cut-off level, it binds with the antibodies conjugated to colloidal gold particles, preventing formation of the T line, which indicates a positive result.

A control band (C) is included to verify proper test performance. This line must always appear; if it does not, the test device should be discarded.

Procedure

1. Bring tests, urine specimens, and/or controls to room temperature (15-25°C) before testing.

2. Remove the test from its sealed pouch and use it as soon as possible.

For Test Cassette

• Place the cassette on a clean, level surface.

• Hold the dropper vertically and dispense 3 full drops of urine (approx. 100 µL) into the specimen well (S), avoiding air bubbles.

• Start timing and wait for colored lines to appear.

• Read results at 5 minutes. Do not interpret after 10 minutes.

For Test Panel

• Remove the cap from the test card.

• Immerse the test panel vertically into the urine specimen for 10-15 seconds, ensuring the strip is submerged to the wavy lines but not above the arrows.

• Place the test panel on a flat, dry surface, start timing, and wait for colored lines to appear.

• Read results at 5 minutes. Do not interpret after 10 minutes.

For Test Cup

• Collect the specimen in the cup and secure the cap tightly.

• If a temperature strip is included, read the urine temperature 2-4 minutes after voiding to ensure it is between 32-38°C.

• Place the cup on a flat surface.

• Date and initial the security seal, then apply it to the cap.

• Peel off the label to view the results.

• Read results at 5 minutes. Do not interpret after 10 minutes.

Note:

• If an adulteration test is included, read the strip between 3 and 5 minutes. Refer to the color chart for interpretation. If adulteration is indicated, do not interpret the drug test result; retest the urine or collect a new specimen.

Interpretation of results

Negative

Two distinct colored lines appear-one in the control region (C) and one in the test region (T). This indicates drug concentration below the cut-off level.

Positive

Only one colored band appears in the control region (C), with no band in the test region (T). This indicates drug concentration above the cut-off level.

Invalid

No colored line appears in the control region (C), even if a test line is present. Repeat the test with a new device. If the issue persists, discontinue use of the lot and contact your local distributor.
Adulteration interpretation

(Refer to the color chart)
Semi-quantitative results are obtained by visually comparing the reacted color blocks on the strip to the printed color indicators. No instrumentation is required.

Note:

1. The color intensity in the test region (T) may vary. A faint T line suggests drug concentration near the cut-off; repeat testing or confirm with a more accurate method.

2. Control band failure may result from insufficient specimen volume, incorrect procedure, or use of expired tests.

 

Quality control

• An internal procedural control is included: a colored band in the control region (C) indicates sufficient specimen volume and correct technique.

• External controls are not supplied. Testing positive and negative controls is recommended as good laboratory practice to verify test performance.

Storage and stability

• Store in the sealed pouch at 2-30°C.

• The test is stable until the expiration date printed on the pouch.

• Keep the test in the sealed pouch until use.

• Use within 60 minutes after opening the pouch.

• Do not freeze.

• Do not use beyond the expiration date.