5 Panel Drug Test Instructions

INTRODUCTION

Drugs of Abuse (DOA) Multi-Test Panel is a visual one-step immunoassay for the simultaneous, qualitative detection of multiple drugs and metabolites in human urine. This product is used to obtain qualitative results by visually detecting presence or absence of drugs in urine.

INTENDED USE

The Drugs of Abuse Multi-Test is lateral flow, one-step panel immunoassay for the qualitative detection of morphine (opiate), amphetamine, methamphetamine, benzolecgonine (cocaine metabolite) and 11-nor-.9 tetrahydrocannabinol-carboxylic acid (THC) in human urine at the following cut-off concentrations.

MOR - Morphine 300ng/mL
AMP - Amphetamine 1000ng/mL
MET - Methamphetamine 1000ng/mL
COC - Benzoylecgonine 300ng/mL
THC - 11-nor- 9-THC-9-COOH 50ng/mL

This assay provides only preliminary analytical test results and is usually used for prescreening purposes. A more specific chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GS/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

PRINCIPLE OF THE TEST

The One Step Test for Drugs of Abuse Multi-Test Panel is based on the principle of a competitive inhibition immunoassay, in which a drug conjugate competes with the drug which may be present in urine, for limited antibody binding sites. The test device consists of a membrane strip, which is pre-coated with MOR-BSA, AMP-BSA, MET-BSA, COC-BSA and THC-BSA conjugate on each test band region, and a colored anti-relative monoclonal antibody-colloid gold conjugate pad, which is placed at the end of the membrane.

In the absence of drug in the urine, the colored colloidal gold conjugated antibody moves with the sample by capillary action along the membrane until it reaches the immobilized drug conjugate in the test band region. At this point, the colloidal gold conjugated antibody reacts with the pre-coated drug conjugate and forms a visible red colored line as the antibodies form complexes with the drug conjugate. Therefore, the formation of a visible color line on the test band region shows the negative result of the urine.

When drug is present in the urine, the drug/metabolite antigen competes with drug conjugate on the test band region for limited antibody to for an antigen-antibody complex, preventing the attachment of the colloidal gold conjugate to the test band region. As a consequence, the absence of the color band on the test region indicates a positive result.

A control band with a different antigen/antibody reaction is also added to membrane strip to indicate that the test is performed properly. This control line should always be seen. A negative urine sample produces two distinct color bands, and a positive sample produces only one color band in the control zone.

SPECIMEN COLLECTION

A fresh urine specimen should be used, no special pre-treatment is necessary. The specimen may be refrigerated (2-8oC) and stored up to 2 days, or frozen (-20oC or below) prior to assaying. If samples are refrigerated they should be brought to room temperature before testing.

TEST PROCEDURE

1. Remove the test device from the protective pouch (bring the device to room temperature) before opening the pouch to avoid condensation of moisture on the membrane. Label the device with patient or control identification.
2. Using the sample pipette (provided), withdraw the urine sample from the specimen cup.
3. Separately add 4 drops into each sample well. Make sure that the sample pipette is held vertically, and the complete number of drops is added to the sample wells.
4. Read results in 20 minutes. Results obtained after more than 30 minutes are not considered valid.

INTERPRETATION OF RESULTS

Negative (-): Five sets of 2 lines - These 10 colored lines should be observed in the viewing window. The line on the control region is control line, and the other five lines on test region are the test lines (drug probe lines).

Positive (+): The appearance of control lines and the missing of test line for a specific drug on test region indicate a positive test result for that particular drug.

Invalid: No line appears in the control zone. An invalid result may be due to improper testing procedures or deterioration of the kit components. Repeat the assay sequence using a new device.

Note: A faint line on the test region indicates the drug in sample is near the cut-off level for the test. These samples should be re-tested or confirmed with a more specific method before a clinical determination is made

STORAGE AND STABILITY

The test kit can be stored at temperatures between 2 to 30°C in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.

PRECAUTION

1. For in vitro diagnostic use only.
2. Do not use test kit beyond the expiry date.
3. The test device should not be reused.
4. Urine specimens may be infectious; insure proper handling and dispose of all used reaction devices into a biohazard container.