Drug Abuse Test Kit PGB(Pregabalin) Rapid Test 4mm card , cut-off
1000ng/ml, urine drug test
PGB Rapid Diagnostic Test/ Pregabalin Rapid Diagnostic Test
The PGB Rapid Test Strip (Urine) is a rapid visual immunoassay for
the qualitative presumptive detection of PGB in human urine
specimens at the cut-off concentrations listed below:
The PGB Rapid Test Strip (Urine) has been designed to detect PGB
through visual interpretation of color development in the Device.
The membrane was immobilized with PGB conjugates on the test
region, and the sample pad was pre-coated with colored anti- PGB
antibodies colloidal gold conjugates. After specimens were added,
the gold-conjugates move along the membrane chromatographically by
capillary action and antibodies get to the test region. If there is
no drug molecule in the urine the antibody gold conjugate would
attach to the drug conjugate to form a visible line. Therefore, the
formation of a visible precipitant in the test region occurs when
the urine is negative for the drug. If PGB are present in the
urine, the drug antigen competes with the immobilized drug
conjugate on the test region for limited antibody sites. In case of
sufficient concentration of the drug, it fills the limited antibody
binding sites. This will prevent attachment of the colored
antibody-colloidal gold conjugate to the drug conjugate zone on the
test region. Therefore, absence of the colored band on the test
region indicates a positive result. Appearance of a colored band at
the control region serves as a procedural control. This indicates
that proper volume of specimen has been added and membrane wicking
DIRECTIONS FOR USE
Remove the test from its sealed pouch, or remove one strip from the
canister, and use it as soon as possible. For best results, the
assay should be performed within one hour. Canisters should be
closed tightly after removing strips.
Hold the strip by the end, where the product name is printed. To
avoid contamination, do not touch the strip membrane.
Holding the strip vertically, dip the test strip in the urine
specimen for at least 10-15 seconds. Do not immerse past the
maximum line (MAX) on the test strip. After the test has finished
running, remove the strip from the specimen and place it on a
non-absorbent flat surface. Start the timer and wait for the
colored band(s) to appear. The result should be read at 5 minutes.
Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
NEGATIVE:* A colored line appears in the Control region (C) and colored lines
appears in the Test region (T). This negative result means that the
concentrations in the urine sample are below the designated cut-off
levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may
vary. The result should be considered negative whenever there is
even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line
appears in the Test region (T). The positive result means that the
drug concentration in the urine sample is greater than the
designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen
volume or incorrect procedural techniques are the most likely
reasons for Control line failure. Read the directions again and
repeat the test with a new test card. If the result is still
invalid, contact your manufacturer.
A procedural control is included in the test. A colored line
appearing in the control line region (C) is considered an internal
procedural control. It confirms sufficient specimen volume,
adequate membrane wicking and correct procedural technique.
- Analytical Sensitivity A drug-free urine pool was spiked with
Pregabalin at the following concentrations: 0ng/mL, 500ng/mL,
750ng/mL, 1000ng/mL, 1250ng/mL, 1500ng/mL and 2000ng/mL. The result
demonstrates >99% accuracy at 50% above and 50% below the
|PGB||Percent of||Visual Result|
C. Reproducibility The reproducibility of the PGB Rapid Test Strip
(Urine) was verified by blind tests performed at four different
locations. Samples with PGB concentrations at 50% of the cut-off
were all determined to be negative, while samples with PGB
concentrations at 200% of the cut-off were all determined to be
|ORIENT NEW LIFE MEDICAL CO., LTD.|
|Email:||Jerry @ newlifebiotest .com|