|
|
|
| 1-Panel - THC |
| One Step Marijuana Test Device (Page 2) |
|
| Page
1 |
| A three-way side-by-side comparison was conducted using the THC
One Step Marijuana Test Device and a leading commercially available
THC 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 THC Rapid Test |
Total
Results |
THC
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
143 |
0 |
143 |
| Negative |
0 |
157 |
157 |
| Total Results |
143 |
157 |
300 |
% Agreement With
This Commercial Kit |
100% |
100% |
100% |
|
| When compared to GC/MS at 50 ng/mL, the following results were
tabulated: |
|
| Method |
GC/MS |
Total
Results |
THC
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
119 |
24 |
143 |
| Negative |
3 |
154 |
157 |
| Total Results |
122 |
178 |
300 |
% Agreement With
GC/MS Analysis |
98% |
87% |
91% |
|
| When compared to GC/MS at 25 ng/mL, the following results were
tabulated: |
|
| Method |
GC/MS |
Total
Results |
THC
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
137 |
6 |
143 |
| Negative |
4 |
153 |
157 |
| Total Results |
141 |
159 |
300 |
% Agreement With
GC/MS Analysis |
97% |
96% |
97% |
| A study was conducted using the same clinical specimens with ten
percent (10%) distribution at 25% above and below the 50ng/mL
cut-off at three geographically distinct point of care sites to
determine the accuracy of the THC One Step Marijuana Test Device in
the hands of a point of care user. Forty (40) positive specimens and
forty (40) negative specimens were tested on three (3) different
lots of each product. The difference in sensitivity and specificity
results obtained by the laboratory professional for the same
clinical specimens compared to the results obtained by the point of
care (untrained) user was insignificant. At a ninety-five percent
(95%) confidence interval, the odds ratio for the point of care user
versus the laboratory professional was 1 to 1 for sensitivity and
specificity. |
| A drug-free urine pool was spiked with 11-nor-D9-THC-9 COOH at the
following concentrations: 75 ng/mL, 62.5 ng/mL, 37.5 ng/mL, 25
ng/mL, and 0 ng/mL. The result demonstrates 100% accuracy at 50%
above and 50% below the cut-off concentration. The data are
summarized below: |
|
THC
Concentration
(ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 25 |
-50% |
30 |
30 |
0 |
| 37.5 |
-25% |
30 |
10 |
20 |
| 50 |
Cutoff |
30 |
4 |
26 |
| 62.5 |
+25% |
30 |
3 |
27 |
| 75 |
+50% |
30 |
0 |
30 |
| A study was conducted at 3 geographically distinct 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 THC, 25% THC above and below the cut-off and
50% THC above and below the 50 ng/mL cut-off was provided to each
site. For the specimens below the -25 % cut-off concentration, the 3
sites demonstrated 98% agreement with each other. For the -25% to
+25% cut-off specimens, the 3 sites demonstrated 83% agreement with
each other. For specimens above the +25% cut-off concentration, the
3 sites demonstrated 100% agreement with each other. For all
results, the 3 sites were found to have a 92% agreement with each
other. |
|
| Effect of Urinary Specific Gravity |
|
|
|
| Twenty-six (26) urine samples of normal, high, and low specific
gravity ranges were spiked with 25 ng/mL and 75 ng/mL of
11-nor-D9-THC-9 COOH, respectively. The THC One Step Marijuana Test
Device was tested in duplicate using the twenty-six 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
11-nor-D9-THC-9 COOH to 25 ng/mL and 75 ng/mL. The spiked,
pH-adjusted urine was tested with the THC One Step Marijuana 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. |
|
| Specificity and Cross-reactivity:
See Page 1. |
|
