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One Step Drug Test: Buprenorphine (Page 2)
- 1-Panel - BUP
- One Step Buprenorphine Test Device
Accuracy
Two hundred twenty-six (226) urine samples were obtained and tested with the BUP One Step Buprenorphine Test Device andy by LC/MS. The results are summarized below:
| Method | LC/MS | ||||||
|---|---|---|---|---|---|---|---|
| Neg.* | Neg. (<-25% Cutoff) | Near Cutoff Neg. (-25% Cutoff to Cutoff) | Near Cutoff Pos. (Cutoff to +25% Cutoff) | Pos. (>+25% Cutoff) | Agreement with LC/MS | ||
| BUP One Step Test Device | Pos. | 0 | 0 | 0 | 5 | 50 | 98% (55/56) |
| Neg. | 150 | 15 | 5 | 1 | 0 | >99% (170/170) | |
Total agreement with LC/MS: 225/226 = >99%
* Negative samples were confirmed using LC/MS by pooling these samples into groups of 15.
Sensitivity
Top of PageA drug-free urine pool was spiked with Buprenorphine at the following concentrations: 0 ng/ml, 5 ng/ml, 7.5 ng/ml, 10 ng/ml, 12.5 ng/ml, 15 ng/ml and 20 ng/ml. The assay cutoff level of 10 ng/ml was selected to correlate with the LC/MS analysis cutoff for Buprenorphine. The result demonstrates 99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:
| Buprenorphine Concentration (ng/ml) | Percent of Cutoff | n | Visual Result | |
|---|---|---|---|---|
| Negative | Positive | |||
| 0 | 0% | 90 | 30 | 0 |
| 5 | -50% | 90 | 30 | 0 |
| 7.5 | -25% | 90 | 27 | 3 |
| 10 | Cutoff | 90 | 22 | 8 |
| 12.5 | +25% | 90 | 7 | 23 |
| 15 | +50% | 90 | 2 | 28 |
| 20 | +100% | 90 | 0 | 30 |
Precision
Top of PageA study was conducted at 3 physician's offices by untrained operators using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens containing no Buprenorphine, 25% Buprenorphine above and below the cutoff and 50% Buprenorphine above and below the 10 ng/ml cutoff was provided to each site. The following results were tabulated:
| Buprenorphine Concentration (ng/ml) | n | Site A | Site B | Site C | |||
|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 5 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 7.5 | 15 | 8 | 7 | 10 | 5 | 9 | 6 |
| 12.5 | 15 | 0 | 15 | 1 | 14 | 0 | 15 |
| 15 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
Effect of Urinary Specific Gravity
Top of PageFifteen (15) urine samples with specific gravity ranges from 1.004 to 1.034 were spiked with Buprenorphine to the concentrations of 5 ng/ml, 15 ng/ml and 20 ng/ml. The BUP One Step Buprenorphine 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 Buprenorphine to the concentrations of 5 ng/ml, 15 ng/ml and 20 ng/ml. The spiked, pH-adjusted urine was tested with the BUP One Step Buprenorphine Test Device in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.
Related Links
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- Specifications, Beginning (Page 1):
- Specificity and Cross-Reactivity
