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| 1-Panel - BAR |
| One Step Barbiturates Test Device (Page 2) |
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1 |
| A side-by-side comparison was conducted using the BAR One Step
Barbiturates Test Device and a commercially available BAR 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 BAR Rapid Test |
Total
Results |
BAR One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
126 |
1 |
127 |
| Negative |
0 |
165 |
165 |
| Total Results |
126 |
166 |
292 |
% Agreement With
This Commercial Kit |
>99% |
99% |
99% |
|
| When compared to GC/MS at the cut-off concentration of 300 ng/mL,
the following results were tabulated: |
|
| Method |
GC/MS |
Total
Results |
BAR One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
122 |
4 |
126 |
| Negative |
10 |
156 |
166 |
| Total Results |
132 |
160 |
292 |
% Agreement With
GC/MS Analysis |
92% |
98% |
95% |
|
| Eighty (80) of these samples were also run using the BAR One Step
Barbiturates 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 Secobarbital 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 >99% accuracy at
50% above and 50% below the cut-off concentration. The data are
summarized below: |
|
Secobarbital
Concentration
(ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 150 |
-50% |
30 |
30 |
0 |
| 225 |
-25% |
30 |
20 |
10 |
| 300 |
Cutoff |
30 |
13 |
17 |
| 375 |
+25% |
30 |
8 |
22 |
| 450 |
+50% |
30 |
0 |
30 |
| 600 |
+100% |
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 no Secobarbital, 25%
Secobarbital above and below the cut-off and 50% Secobarbital above
and below the 300 ng/mL cut-off was provided to each site. The
following results were tabulated: |
|
Secobarbital
Concentration
(ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 150 |
15 |
13 |
2 |
15 |
0 |
15 |
0 |
| 225 |
15 |
2 |
13 |
8 |
7 |
6 |
9 |
| 375 |
15 |
2 |
13 |
1 |
14 |
2 |
13 |
| 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 with specific gravity ranges from 1.000
to 1.037 were spiked with 150 ng/mL and 450 ng/mL of Secobarbital
respectively. The BAR One Step Barbiturates 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 Secobarbital
to 150 ng/mL and 450 ng/mL. The spiked, pH-adjusted urine was tested
with the BAR One Step Barbiturates 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:
See Page 1. |
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