Urine Drug Test Kit for Eddp Methadone Metabolite Rapid Detection in Hospital

• Type: IVD Instrument
• Product Name: Testsealabs Eddp Urine Test
• Format: Strip/Cassette
• Test Items: Eddp
• Detection Time: 5min
• Specimen: Urine
• Cassette: 40t
• Storage Time: 4ºC-30ºC
• OEM: Acceptable
• Packaging: Foil Pouch+Bag+Carton
• Accuracy: Over 99%
• Trademark: Testsealabs
• Origin: China
• Production Capacity: 1000000 Pieces/Year

Product Description

Urine Drug Test Kit for EDDP Methadone Metabolite Rapid Detection in Hospital
 

[INTRODUCTION] 
Testsealabs EDDP Methadone Metabolite Test (Urine) is a lateral flow chromatographic immunoassay for the qualitative detection of Methadone Metabolite in urine at the following cut-off concentrations of 100ng/ml..

Product Name	Testsealabs EDDP Urine Test
Format	Strip/Cassette
Test Items	EDDP
Detection time	5min
Specimen	Urine
Cassette	40T
Storage time	4ºC-30ºC, 24months
OEM	Acceptable
Packaging	Foil pouch+Bag+Carton

[PRODUCT FEATURE]
Easy to Use
Fast Result
High Accuracy
Good Quality

[Principle]
The EDDP EDDP Methadone Metabolite Test (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody.
During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine 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 cassette. 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 line region.
A drug-positive urine specimen will not generate a colored line in the specific test line region of the cassette because of drug competition, while a drug-negative urine 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.

[MAIN COMPONENTS]
The test contains a membrane strip coated with Methadone Metabolite -protein conjugates  on the test line, a goat-anti-mouse IgG polyclonal antibody on the control line, and a dye pad which contains colloidal gold-monoclonal antibody specific to Methadone Metabolite.
Each box contains test panels and package insert.
 
[Storage Conditions And Shelf Life]
1.Store as packaged in the sealed pouch at room temperature (2-30ºC or 36-86ºF). The kit is stable within the expiration date printed on the labeling.
2.Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

[Materials Required But Not Provided]          
Ÿ Specimen collection container            
Ÿ Timer           
Ÿ External controls       

[Sample Requirements] 

• The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear supernatant for testing.
• Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.

[Testing Method]
Allow the test and urine samples to equilibrate to room temperature (15-30ºCor 59-86ºF) prior to testing.

1. Remove the test cassette from the sealed pouch.
2. Hold the dropper vertically and transfer 3 full drops (approx. 100ml) of urine to the specimen well of the test cassette, and then begin timing. See the illustration below.
3. Wait for colored lines to appear. Interpret the test results at 3-5 minutes. Do not read results after 10 minutes.

[Results interpretation] 
Negative: *Two lines appear. One red line should be in the control region (C), and another apparent red or pink line adjacent should be in the test region (T). This negative result indicates that the drug concentration is below the detectable level.
 *NOTE: The shade of red in the test line region (T) will vary, but it should be considered negative whenever there is even a faint pink line.
Positive: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the drug concentration is above the detectable level.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your local distributor.

[Quality control]
A procedural control is included in the test.  A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.  
Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

[Accuracy]
A side-by-side comparison was conducted using the EDDP EDDP Methadone Metabolite Test (Urine) and commercially available drug rapid tests. Testing was performed on approximately 300 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested.

Test	Compounds Contributed to the Totals of GC/MS
EDDP	Methadone Metabolite

The following results are tabulated from these clinical studies:

%Agreement with Commercial Kit			%Agreement with GC/MS
	EDDP			EDDP
Positive Agreement	100%		Positive Agreement	98%
Negative Agreement	100%		Negative Agreement	100%
Total Results	100%		Total Results	100%

Forty (40) clinical samples were run using the EDDP EDDP Methadone Metabolite Test (Urine) by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained Laboratory personnel.