|
|
|
| 1-Panel - OXY |
| One Step Oxycodone Test Device (Page 2) |
|
| Page
1 |
| A side-by-side comparison was conducted by laboratory personnel using the OXY One Step Oxycodone Test Device and a commercially available rapid test. Testing was performed on specimens previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following results were tabulated: |
|
| Method |
Other OXY Rapid Test |
Total
Results |
OXY
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
142 |
0 |
142 |
| Negative |
4 |
154 |
158 |
| Total Results |
146 |
154 |
300 |
% Agreement With
This Commercial Kit |
97% |
97% |
97% |
|
| When compared to GC/MS at the cut-off of 100 ng/mL, the
following results were tabulated: |
|
| Method |
GC/MS |
Agreement
with
GC/MS |
OXY
One Step
Test Device |
Results |
Neg. |
Near
Cutoff
Neg. |
Near
Cutoff
Pos. |
Pos. |
| Positive |
0 |
5 |
2 |
135 |
98% |
| Negative |
147 |
8 |
2 |
1 |
97% |
|
| Eighty (80) of these clinical samples were also run using the OXY One Step Oxycodone Test Device by an untrained operator at a different site. Based on GC/MS data, the operator obtained a statistically similar Positive Agreement, Negative Agreement and Overall Agreement rate as the laboratory personnel. |
| A drug-free urine pool was spiked with Oxycodone at the following concentrations: 0 ng/mL, 50 ng/mL, 75 ng/mL, 100 ng/mL, 125 ng/mL, 150 ng/mL and 200 ng/mL. The result demonstrates 100% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below: |
|
Oxycodone
Concentration
(ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 50 |
-50% |
30 |
30 |
0 |
| 75 |
-25% |
30 |
23 |
7 |
| 100 |
Cutoff |
30 |
13 |
17 |
| 125 |
+25% |
30 |
7 |
23 |
| 150 |
+50% |
30 |
0 |
30 |
| 200 |
+100% |
30 |
0 |
30 |
| A study was conducted at three independent physicians’ office sites (A. internal medicine, B. pediatrics, C. general practice) by three independent, untrained, licensed medical assistants using three different lots of product and run in three consecutive days to demonstrate the within-run, between-run and between-operator precision. An identical panel of coded specimens containing no Oxycodone, Oxycodone spiked at levels +/- 25% of the assay cut-off and Oxycodone spiked at levels +/- 50% of the 100 ng/mL assay cut-off was provided to each site. The results are given below: |
|
Oxycodone
Concentration (ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 50 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 75 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 125 |
15 |
13 |
2 |
10 |
5 |
6 |
9 |
| 150 |
15 |
0 |
15 |
0 |
15 |
0 |
15 |
|
| Effect of Urinary Specific Gravity |
|
|
|
| Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 50 ng/mL and 150 ng/mL of Oxycodone respectively. The OXY One Step Oxycodone Test Device was tested in duplicate using the fifteen neat and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results. |
| The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with Oxycodone to 50 ng/mL and 150 ng/mL. The spiked, pH-adjusted urine was tested with the OXY One Step Oxycodone Test Device in duplicate and interpreted according to the package insert. The results demonstrate that varying ranges of pH does not interfere with the performance of the test. |
|
| Specificity and Cross-reactivity:
See Page 1. |
|
