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| 1-Panel - COC |
| One Step Cocaine Test Device (Page 2) |
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| Page
1 |
| A side-by-side comparison was conducted by laboratory personnel
using the COC One Step Cocaine 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 COC Rapid Test |
Total
Results |
COC
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
136 |
0 |
136 |
| Negative |
7 |
157 |
164 |
| Total Results |
143 |
157 |
300 |
% Agreement With
This Commercial Kit |
95% |
>99% |
98% |
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| When compared to GC/MS at the cut-off of 300 ng/mL, the following
results were tabulated: |
|
| Method |
GC/MS |
Total
Results |
COC
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
119 |
17 |
136 |
| Negative |
5 |
159 |
164 |
| Total Results |
124 |
176 |
300 |
% Agreement With
GC/MS Analysis |
96% |
90% |
93% |
|
| Eighty (80) of these clinical samples were also run using the COC
One Step Cocaine 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 Benzoylecgonine 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: |
|
Benzoylecgonine
Concentration (ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 150 |
-50% |
30 |
30 |
0 |
| 225 |
-25% |
30 |
30 |
0 |
| 300 |
Cutoff |
30 |
9 |
21 |
| 375 |
+25% |
30 |
7 |
23 |
| 450 |
+50% |
30 |
0 |
30 |
| A study was conducted at three geographically distinct physicians'
offices by untrained operators using three different lots of product
to demonstrate the within run, between run and between operator
precision. An identical panel of coded specimens was blind labeled
and tested at each site. The results are given below: |
|
Benzoylecgonine
Concentration
(ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 150 |
15 |
10 |
5 |
8* |
6 |
14 |
1 |
| 225 |
15 |
3* |
11 |
4 |
11 |
6 |
9 |
| 375 |
15 |
0 |
15 |
0 |
15 |
1* |
13 |
| 450 |
15 |
0 |
15 |
0 |
15 |
1 |
14 |
| Non Valid |
15 |
16/16 |
15/15 |
15/15 |
|
| *Note: Non-valid results were
obtained in this treatment. Non-valid tests were provided as part of
this study to ensure that readers would accurately identify
non-valid test results. |
|
| 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
Benzoylecgonine respectively. The COC One Step Cocaine 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
Benzoylecgonine to 150 ng/mL and 450 ng/mL. The spiked, pH-adjusted
urine was tested with the COC One Step Cocaine 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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