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One-step Drug Of Abuse Test Kits

PRECAUTIONS

● For professional in vitro diagnostic use only.
● Do not use after the expiration date indicated on the package. Do not use the test if the
foil pouch is damaged. Do not reuse tests.
● This kit contains products of animal origin. Certified knowledge of the origin and/or
sanitary state of the animals does not completely guarantee the absence of transmissible
pathogenic agents. It is therefore, recommended that these products be treated as
potentially infectious, and handled by observing usual safety precautions (e.g., do not
ingest or inhale).
● Avoid cross-contamination of specimens by using a new specimen collection container
for each specimen obtained.
● Read the entire procedure carefully prior to testing.
● Do not eat, drink or smoke in the area where specimens and kits are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions
against microbiological hazards throughout the procedure and follow standard
procedures for the proper disposal of specimens. Wear protective clothing such as
laboratory coats, disposable gloves and eye protection when specimens are assayed.
● Humidity and temperature can adversely affect results.
● Discard used testing materials in accordance with local regulations.

INSTRUCTIONS

Bring tests, specimens, and/or controls to room temperature (15-30°C or 59-86°F) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the
test with patient or control identification. For best results, the assay should be
performed within one hour.
2. Take off the cap outside of the test end. With arrows pointing toward the urine
specimen, immerse the test panel vertically into the urine specimen for at least 10-15
seconds. Immerse the test panel to at least the level of the wavy lines on the strip(s),
do not pass the arrows on the test panel when immersing the panel.
3. Place the test panel on a non-absorbent flat surface, start the timer and wait for the red
line(s) to appear. The results should be read at 5 minutes. Do not interpret results after
10 minutes.

Result：

NOTE

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed
substances present in the specimen. Therefore, any shade of color in the test region should be
considered negative. Besides, the concentration level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

PERFORMANCE CHARACTERISTICS

Accuracy
The accuracy of the Rapid Response Drugs of Abuse Test Device was compared and checked
against commercially available tests with a threshold value at the same cut-off levels. Urine
samples taken from volunteers claiming to be non-users were examined under both tests. The
results were >99.9% in agreement.
Reproducibility
The reproducibility of the Rapid Response Drugs of Abuse Test Device was verified by
blind tests performed at four different locations. Samples with drug/metabolite
concentrations at 50% of the cut-off were all determined to be negative, while samples
with drug/metabolite concentrations at 200% of the cut-off were all determined to be
positive.
Precision
Test precision was determined by blind tests with control solutions. Controls with
drug/metabolite concentrations at 50% of the cut-off yielded negative results, and controlswith drug/metabolite concentrations at 150% of the cut-off yielded positive results.