Propoxyphene (PPX) Drug Abuse Test Kit PPX Rapid Test 4mm dipcard , cut-off 300ng/Ml
Product Name
Propoxyphene (PPX) Drug Abuse Test Kit
Specimen: Urine
Intended Use
The Propoxyphene Assay is intended for qualitative determination of
propoxyphene in human urine.
This assay provides only a preliminary analytical test result. A
more specific alternative chemical method must be used in order to
obtain a confirmed analytical result. Gas chromatography/mass
spectrometry (GC/MS) is the preferred confirmatory method. Clinical
consideration and professional judgment should be applied to any
drug of abuse test result, particularly when preliminary positive
results are used.
| Parameter | Calibrator | Cut-off (ng/mL) |
| PPX | Propoxyphene | 300 |
Test Principle
Reagent Preparation and Storage The reagents are ready for use. No
reagent preparation is required. All assay components, when stored
properly at 2-8°C, are stable until the expiration date indicated
on the label.
In the case of accidental spill, clean and dispose of material
according to your laboratory’s SOP, local, and state regulations.
In the case of damaged packaging on arrival, contact your technical
support representative (refer to back page of this PI).
DIRECTIONS FOR USE
Collect urine specimens in clean glass or plastic containers.
Testing fresh urine specimens is suggested.
The Mandatory Guidelines for Federal Workplace Drug Testing
Programs recommends that specimens that do not receive an initial
test within 7 days of arrival at the laboratory should be placed
into secure refrigeration units.
Samples within a pH range of 3 to 11 are suitable for testing with
this assay.
An effort should be made to keep pipetted samples free of gross
debris. It is recommended that highly turbid specimens be
centrifuged before analysis. Adulteration of the urine sample may
cause erroneous results. If adulteration is suspected, obtain
another sample and forward both specimens to the laboratory for
testing.
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.
QUALITY CONTROL
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.
performance characteristics
A side-by-side comparison was conducted using the PPX Rapid Test
Cassette (Urine) and GC/MS. The following results were tabulated:
Table 1: Specimen Correlation
| Level | Low Control | Cutoff Cal | High Control |
| | | |
| Mean (mA/min) | 324.4 | 379.7 | 422.5 |
| | | |
| Within-run SD (mA/min) | 2.3 | 2.6 | 1.9 |
| | | |
| Within-run CV% | 0.7 | 0.7 | 0.4 |
| | | |
| Total-run SD (mA/min) | 5.3 | 5.4 | 5.4 |
| | | |
| Total-run CV% | 1.6 | 1.4 | 1.3 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
