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One Step Drug Test: Oxycodone (Page 2)
- 1-Panel - OXY
- One Step Oxycodone Test Device
Accuracy
A side-by-side comparison was conducted using the OXY One Step Oxycodone Test Device and a leading commercially available Oxycodone rapid test. Testing was performed on 300 clinical specimens. Five (5) percent of the positive specimens employed were within 75% or 125% of the assay cutoff concentration of 100 ng/ml oxycodone. 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 Commercial Kit | 97% | >99% | 99% | |
When compared to the GC/MS lab testing method at the cutoff concentration of 100 ng/ml, the following results were tabulated:
| Method | GC/MS | % Agreement With GC/MS Analysis | ||||
|---|---|---|---|---|---|---|
| OXY One Step Test Device | Results | Neg. | Near Cutoff Neg. | Near Cutoff Pos. | Pos. | |
| Positive | 0 | 5 | 2 | 135 | 96% | |
| Negative | 147 | 8 | 2 | 1 | 98% | |
Eighty (80) of these 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 untrained operator obtained a statistically similar Positive Agreement, Negative Agreement and Overall Agreement rate as the laboratory personnel.
Sensitivity
Top of PageA 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% and 150% of the cutoff concentration of the assay. 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 | 8 | 22 |
| 150 | +50% | 30 | 0 | 30 |
| 200 | +100% | 30 | 0 | 30 |
Precision
Top of PageA study was conducted at three independent physician's 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 cutoff and oxycodone spiked at levels +/-50% of the 100 ng/ml assay cutoff were 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 | 14 | 1 |
| 75 | 15 | 15 | 0 | 14 | 1 | 5 | 10 |
| 125 | 15 | 0 | 15 | 3 | 12 | 2 | 13 |
| 150 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
Effect of Urinary Specific Gravity
Top of PageFifteen (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.
Effect of Urinary pH
Top of PageThe 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 at levels of 50 ng/ml and 150 ng/ml. The spiked, pH-adjusted urine was tested with the OXY One Step Oxycodone Test Device in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.
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- Specificity and Cross-Reactivity
