Produkte/Schnellteste human/Drog-o-test Multiline 5

Drog-o-test Multiline 5 Testkarte

KGST129-10 

Drog-o-test Schnelltest

 

INTENDED USE
The Drog-o-test (2 panel-test to 12 panel-test) is a simple one step immunochromatographic assay tor the rapid, qualitative detection of any combination of the following drugs: Cocaine (COC) Amphetamines (AMP), Methamphetamines (NIET), Opiates (OPI), and Tetrahydrocannabinol (THC), PCP, Barbiturates (BAR), Methadone (MTD), Benzodiazepines (BZD), Tricyclic anti-depressants. (TCA), MDMA ,Oxycodone in urine. The cutoff of the test is 300 ng/ml of COC, 1000 ng/ml of AMP, 1000ng/ml of MET, 300 ng/ml of OPI, and 50 ng/ml of THC, 25 ng/ml of PCP, 300 ng/ml of BAR, 300 ng/ml of MTD, 300 ng/ml of BZD, 1000 ng/ml of TCA, 500 ng/ml of MDMA, 100 ng/ml of Oxycodone as The SAMHSA recommended cutoff for these test are assays cutoff.

The Drog-o-test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Drog-o-test is based on the principle of the highly specific immunochemical reactions between antigens and antibodies, which are used for the analysis of specific substances in urine.

The Drog-o-test cassette has a letter T and C as ''Test Line" and "Control Line' on the surface of the case. Both the "Test Line" and "Control Line" in the result window are not visible before applying any samples. The "Control Line" is used for procedural control. Control line should always appear  if the test procedure is performed properly and the test reagents of control line are working.

 

MATERIALS PROVIDED
The Drog-o-test kit contains the following items to perform the assay:

  1. Multi-Drug test device.
  2. Instructions for use.

 

MATERIALS REOUIRED BUT NOT PROVIDED

  1. Specimen collection container
  2. Clock or timer

 

PRECAUTIONS

  1. For professional in vitro diagnostic use only.
  2. Avoid cross contamination of urine samples by using a new urine specimen container.
  3. Urine specimens are potentially infectious. Proper handling and disposal methods should be established according to good laboratory practices.
  4. Do not eat or smoke while handling specimen in the laboratory.
  5. The Multi-Drug device should remain in its original sealed pouch until ready for use.
  6. Do not use the test if the pouch is damaged or the seal is broken.
  7. Do not use the test kit after the expiration date.

 

STORAGE AND STABILITY
The Drog-o-test kit should be stored at room temperature or 2-30°C (36-86°F). If test kit is refrigerated, it should be brought to room temperature before use. The expiration date given was determined under normal laboratory conditions.

 

SPECIMEN COLLECTION AND REPARATION

  1. Specimens should be collected in a clean glass or plastic container.
  2. If testing will not be performed immediately, specimens should be refrigerated.
  3. Specimens should be brought to room temperature before using.
  4. Specimens containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to assaying.

 

PHOCEDURE OF THE TEST

  1. Remove the test disk from the foil pouch, and remove the cap off the disk.
  2. Dip the disk into the urine. Sample should not be over the Maxline. Or add sample with droppers.
  3. Interpret the test result at 5 minutes.

 

INTERPRETATION OF RESULTS

  1. As the test kit begins to work, a purple band will appear at the result window to show that the Control Line (indicated as letter "C" on the cassette) is working properly.
  2. The lower section of the result window indicates the test results. If another purple band appears at the result window. This band is Test Band (indicated as letter "T" on the cassette).

Negative: Two Color Bands
The appearance of two purple bands within the result window indicates a negative test result. No drug above the cut-off level has been detected. The color of the Test band may be Iighter or darker than that of the Control Band.
Note: A purple band in the T row of the result window (no matter a faint or obvious band), visible at 5 minutes, indicates that the test result is negative.

Durchführung des Drogen-Schnelltests

 

Positive: One Color band
The appearance of only one purple band within either result window indicates the result is positive, i.e. the specimen contains a drug at a concentration above the cut-off level of the indicated drug on the label.

Invalid: No band
A distinct purple band should always appear in the result window. The test is invalid if no color band forms in the C row of the result window.

Auswertung des Drogen-Schnelltest



USER QUALITY CONTROL
Control standards are not supplied with this kit; however, it is recommended that a control be tested as good laboratory testing practice. For information on how to obtain controls, contact Technical Service. Before using a new kit with patient specimens, positive (cutoff and 25% more than cutoff level) and negative (25% below cutoff level) controls should be tested to confirm the test procedure, and to verify the tests procedure the expected Q.C. results.  
 

LIMITATIONS

  1. The test is designed for use with unadulterated human urine only
  2. There is a possibility that factors such as technical or procedural errors, as well as other substances in the urine sampIes may interfere with the test and cause erroneous results.
  3. Adulterants, such as bleach and/or alum in urine specimens may produce erroneous results regardless of the method of analysis. If adulteration is suspected, the test should be repeated with a new sample.
  4. A positive test result does not provide any indication of the level of intoxication or urinary concentration.
  5. The test result read after 5 minutes may not be consistent with the original reading obtained within the 5-minute reading period. The test must be read within 5 minutes of sample application.


EXPECTED VALUES
The Drog-o-test is a qualitative assay. The amount of drugs and metabolites present in the urine cannot be estimated by the assay. The assay results distinguish positive from negative samples. A positive result indicates the sample contains COC, AMP, MET, OPI, THC, BAR, BZD, MTD, PCP, TCA, MDMA, OXY above the cut-off concentrations.


REFERENCES

  1. Urine Testing for Drugs of Abuse, National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.
  2. Ambre, J.J. Anal. Toxicol. 9: 241-51,1985.
  3. Norbert W, Tietz, Textbook or Clinical Chemistry, W.B. Saunders Company, p. 1735, 1986.
  4. R.C. Baselt, Disposition of Toxic Drugs and Chemicals in Man, 2 and ED. Biomedical Publ, Davis, CA., p. 488,1982

Qualitätssicherung und Vorkommnisse
Sollten Sie den Eindruck eines Qualitätsmangels haben oder unklare oder ihrerseits falsch-positive oder falsch-negative Ergebnisse erhalten, bitten wir Sie, die betreffende Patientenprobe zurückzustellen und für einen Abruf für uns bereitzuhalten.
Bitte informieren Sie uns umgehend. Sie helfen uns dadurch die Sicherheit der Produkte und damit die Qualität zu gewährleisten.

 

img/page/needfull/Tabelle-unten1.jpg

img/page/needfull/ce-zeichen.gif Hersteller:

Guenter Keul GmbH
Günter Keul GmbH
Von-Langen-Weg 10
D-48565 Steinfurt
Tel.: 02551/2097  Fax.: 02551/80883
Web: www.keul.de

 

 



 
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