5 IN 1 (Opiates including Heroin, Amphetamine, MDMA, Cocaine, Cannabis)

Anonymous listing

INTRODUCTION

The Cassette Style Drug test is a rapid test based on the principle of immunoassay combined with conjugated colloid gold technology. The tests are designed to obtain a visual, qualitative result.

The Drug Test provides only preliminary analytical data , A more specific ,alternative method is required to obtain a confirmed analytical result . Clinical considerations and professional judgment should be applied to any drug of abuse test result ,particularly when preliminary positive Results are indicated.

PRINCIPLE OF THE PROCEDURE

The Drug Test is a competitive ,IVD,immunochromatographic ,urinary assay in which a chemically modified and bound drug conjugate competes with urinary MED for limited ,specific drug antibody binding sites. The one step Cassette Style Drug Test have eight strips ,Each test strip contains a sample reaction unit , a pink-colored , antibody-colloidal gold conjugate unit pre-labeled with specific antibody ,and a chromatographic membrane pre-coated with drug conjugate in the device test region .

The free drug is absent from urine or at concentration lower than the urinary detection cut-off level,the pink-colored ,antibody-collidial gold conjugate is free to bind to the immobilized drug conjugate pre-coated on the chromatographic membrane test region .Consequently ,a pink-colored band will form in the test region indicating a negative result .When drug is present in urine at concentrations at or exceeding the detection cut-off level,it will bind to limited epitopes on the pink-colored,antibody-colloidal gold conjugate , completely competing with drug conjugate in the test region .In such cases , no band forms in the test region ,indicating a positive result.

The one step Cassette Style Drug test also provide a built-in process control . A pink-colored band should always appear in the control region ,regardless of the presence of any urinary MED . This pink-colored control band verifies that :1) sufficient urine volume was added,and 2) proper flow was obtained. If the control band is missing ,the test was not performed correctly or  failed to function correctly. In summary ,negative urine will produce two pink-colored bands, one in the control region and one in the test region .Positive urine will produce one pink-colored band in the control region only .

MATERIALS REQUIRED BUT NOT PROVIDED

1. Urine sample collection containers   2. Timer or clock

SAMPLE COLLECTION AND PREPATION

The fresh urine samples should be collected in a clean ,dry container such that same-day testing may be preformed . Urine specimens may be refrigerated at 2-8℃  for 48 hours,or frozen at -20℃  for assaying at a later date .Specimens that have been refrigerated or frozen must be equilibrated to room temperature before testing.Urine samples exhibiting visible precipitates should be filtered,centrifuged or allowed to settle so that clear aliquots can be obtained for testing.

ASSAY PROCEDURE

1.      Review “ Specimen collection ” instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30 ℃) prior to testing. Do not open pouches until ready to perform the assay.

2.      Remove the test device from its protective pouch (bring the device to room temperature before open the pouch to avoid condensation of moisture on the membrane ). Label the device with patient or control number.

3.       Immerse the strips into the sample with the arrow end pointing towards the sample. Do not immerse past the MAX (maximum) line. Take the cassette out after 10 seconds and lay the cassette flat on a clean, dry, nonabsorbent surface.

4.      Read the test result at five minutes.

IMPORTANT:

In order to prevent an incorrect reading,do not read the test results after more than 8 minutes.After 8 minutes,the intensity of the colored lines may change or a new line may appear.To avoid confusion,discard the test device after interpreting the result.

INTERPRETATION OF RESULTS

Negative:Two pink-colored bands appear,one in the control region and one in the test region. A negative result indicates free drug is absent from urine or at concentrations lower than the detection cut-off level of the test.

Positive:One pink-colored band appears in the control region with no apparent band appearing in the test region. A positive result indicates free drug is present in urine at concentrations at or exceeding the detection cut-off  level of the test.

Invalid:No band appears in the control region,or a pink-colored band appears in the test region only. An invalid test result may be due to improper assay procedures or damage to the device. If results are invalid, the assay is inconclusive and the specimen should be re-tested using a new test device.

Note:The band intensity may be weaker or stronger than that of the control band.

CUT OFF LEVEL:

 Opiate (OPI) 300ng/ml, COC 300ng/ml, THC 50ng/ml, AMP 1000ng/ml, BZO 300ng/ml, BAR 300ng/ml, MDMA 500ng/ml

WARNINGS AND PRECAUTIONS

1.       For in vitro diagnostic use.

2.       Avoid cross contamination of urine samples by a new sample collection container and pipette for each urine sample.

3.       Urine specimens may be potentially infectious. Avoid contact with skin by wearing gloves and proper laboratory attire. Properly handle and dispose of all used test devices in an approved  biohazard container.

4.       Do not ues a test device beyond the expiration date imprinted on the outside of the foil pouch.

STORAGE AND STABILITY

1.       The test devices supplied can be stored at room temperature or refrigerated (2-30℃) and will remain stable until the expiration date.

2.       Do Not Freeze.