Multi-drug One Step Test Kit 

(Colloidal Gold Method)
 

Product List

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

Special condition for use statement(s)

Configurations of multi-drug test kit come with any combination of the above listed drug analytes with or without specimen validity test (S.V.T.). 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. 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.

Pack formats

Cassette: 25 tests/box

Panel: 25 tests/box

Cup: 20 tests/box

Principle

The multi-drug test kit is a competitive binding immunoassay in which drugs and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. During testing, a urine specimen migrates through the test device by capillary action. If the drug or drug metabolite concentration in the specimen is below the cut-off level, the anti-drug antibodies in colloidal gold particles will bind to the drug antigens coated in the test line of the nitrocellulose membrane to form a T line which indicates a negative result. If the concentration of drug in the urine specimen is above the cut-off level, it will bind with antibodies conjugated with colloidal gold particles, so that no T line will be developed in the test region, which indicates a positive result. A control band with a different antigen/antibody reaction is added to the immune-chrom atographic membranestrip at the control region(C) to indicate that the test has performed properly. This control line should always appear regardless of the presence of drug or drug metabolite. If the control line does not appear the test device should be discarded.

Procedure

Equilibrate the tests, urine specimens, and/or controls to room temperature (15-25ºC) prior to testing.

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

For Test Cassette

• Place the Test Cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx.100L) 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. Immerse the strip(s) at least the level of the wary 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 at 5 minutes. Do not read the results after 10minutes.

For Test Cup

•Collect 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 32-38ºC.

•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 at 5 minutes. Do not read the results after 10minutes. 

Note:

•If adulteration test is included, read the adulteration strip between 3 and 5 minutes. 

See the color chart for interpretation. If the result indicates adulteration, do no interpret the drug test result and either retest the urine or collect another specimen.
 

Interpretation of results

Negative

Two distinct colored lines appear. One line should be in the control line region (C) and another line should be in the test line region (T). It indicates that the drug concentration in the urine specimen is below the designated cut-off level for the specific drug. 

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.

Invalid

The result is invalid if no colored line appears in the control line region (C), even if a line appears in the test line region (T). You should repeat the test with a new test. Ifthe problem persists, discontinue using the lot immediately and contact your local distributor.

Adulteration interpretation

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

NOTE: 

1.The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. If the color in test region (T) is very weak, indicating that the drug concentration in the urine specimen is close to the cut-off concentration, then the specimen needs to be detected repeatedly or confirmed by other more accurate method.

2.Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

Quality control

• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique. 

• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

Storage and stability

• Store in the sealed pouch at 2ºC to 30ºC.

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

• The test must remain in the sealed pouch until use. 

• After opening the sealed pouch, use the test as soon as possible within 60 minutes.

• Do not freeze.

• Do not use beyond the expiration date.