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| 1-Panel - BZO |
| One Step Benzodiazepines Test Device (Page 2) |
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| Page
1 |
| A side-by-side comparison was conducted using the BZO One Step
Benzodiazepines Test Device and a leading commercially available BZO
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 BZO Rapid Test |
Total
Results |
BZO
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
130 |
5 |
135 |
| Negative |
14 |
149 |
163 |
| Total Results |
144 |
154 |
298 |
% Agreement With
This Commercial Kit |
90% |
97% |
94% |
|
| When compared to GC/MS at 300 ng/mL cut-off of Benzodiazepines,
the following results were tabulated: |
|
| Method |
GC/MS |
Total
Results |
BZO
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
130 |
6 |
136 |
| Negative |
5 |
159 |
164 |
| Total Results |
135 |
165 |
300 |
% Agreement With
GC/MS Analysis |
96% |
96% |
96% |
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| Eighty (84) of these samples were also run using the BZO One Step
Benzodiazepines 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 Oxazepam at the following
concentrations: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL
and 450 ng/mL. The result demonstrates 100% accuracy at 50% above
and 50% below the cut-off concentration. The data are summarized
below: |
|
Oxazepam
Concentration
(ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 150 |
-50% |
30 |
30 |
0 |
| 225 |
-25% |
30 |
26 |
4 |
| 300 |
Cutoff |
30 |
12 |
18 |
| 375 |
+25% |
30 |
3 |
27 |
| 450 |
+50% |
30 |
0 |
30 |
| A study was conducted at 3 physicians' 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, according to GC/MS, no
Oxazepam, 25% Oxazepam above and below the cut-off and 50% Oxazepam
above and below the 300ng/mL cut-off was provided to each site. The
following results were tabulated |
|
Oxazepam
Concentration
(ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 150 |
15 |
14 |
1 |
14 |
1 |
15 |
0 |
| 225 |
15 |
11 |
4 |
14 |
1 |
14 |
1 |
| 375 |
15 |
0 |
15 |
1 |
14 |
3 |
12 |
| 450 |
15 |
0 |
15 |
0 |
15 |
0 |
15 |
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| Effect of Urinary Specific Gravity |
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| Fifteen (15) urine samples of normal, high, and low specific
gravity ranges were spiked with 150 ng/mL and 450 ng/mL of Oxazepam
respectively. The BZO One Step Benzodiazepines 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 Oxazepam to
150 ng/mL and 450 ng/mL. The spiked, pH-adjusted urine was tested
with the BZO One Step Benzodiazepines 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. |
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| Specificity and Cross-reactivity:
See Page 1. |
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