|
mAMP |
Methamphetamine |
|
MDMA |
D,L Methylenedioxyamphetamine |
|
OPI |
Morphine, Codeine |
|
PCP |
Phencyclidine |
|
TCA |
Nortriptyline |
The following results are tabulated from these clinical studies:
%Agreement with Commercial Kit
| AMP |
BAR |
BZO |
COC |
THC |
MTD |
|
|
Positive Agreement |
97% |
>99% |
90% |
95% |
98% |
99% |
|
Negative Agreement |
100% |
>99% |
97% |
>99% |
100% |
>99% |
|
Total Results |
98% |
99% |
94% |
98% |
99% |
>99% |
| mAMP |
MDMA |
MOP |
OPI |
PCP |
TCA* |
|
|
Positive Agreement |
98% |
100% |
100% |
>99% |
98% |
95% |
|
Negative Agreement |
100% |
99% |
100% |
>99% |
100% |
>99% |
|
Total Results |
99% |
99% |
100% |
>99% |
99% |
99% |
%Agreement with GC/MS
|
AMP |
BAR |
BZO |
COC |
THC |
MTD |
|||
|
Positive Agreement |
97% |
>99% |
96% |
96% |
97% |
99% |
||
|
Negative Agreement |
95% |
>99% |
96% |
>90% |
88% |
>94% |
||
|
Total Results |
96% |
99% |
96% |
93% |
91% |
>96% |
||
|
mAMP |
MDMA |
MOP |
OPI |
PCP |
TCA* |
|||
|
Positive Agreement |
99% |
96% |
100% |
>99% |
100% |
>99% |
||
|
Negative Agreement |
94% |
98% |
94% |
>90% |
97% |
89% |
||
|
Total Results/p> |
96% |
97% |
97% |
>95% |
98% |
91% |
||
Forty (40) clinical samples for each drug were run using each of the Split-Specimen Cup by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel. *Note: TCA was based on HPLC data.
A study was conducted at three physician 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. containing drugs at the concentration of + 50% and ± 25% cut-off level, was labeled, blinded and tested at each site. The results are given below:
|
Amphetamine conc. (ng/mL) |
n per site |
Site A |
SiteB |
SiteC |
|||
|
- |
+ |
- |
+ |
- |
+ |
||
|
0 |
5 |
5 |
0 |
5 |
0 |
5 |
0 |
|
500 |
5 |
5 |
0 |
4 |
1 |
5 |
: |
|
750 |
5 |
5 |
0 |
1 |
4 |
1 |
- |
|
1,250 |
5 |
0 |
5 |
0 |
5 |
0 |
5 |
|
1,500 |
5 |
0 |
5 |
0 |
5 |
0 |
5 |
BARBITURATES (BAR)
|
Secobarbital conc. (ng/mL) |
n per site |
Site A |
Site B |
SiteC |
|||
|
- |
+ |
- |
+ |
- |
+ |
||
|
0 |
5 |
5 |
0 |
5 |
0 |
5 |
0 |
|
150 |
5 |
4 |
1 |
5 |
0 |
5 |
0 |
|
225 |
5 |
1 |
4 |
4 |
1 |
5 |
0 |
|
375 |
5 |
0 |
5 |
0 |
5 |
2 |
3 |
|
450 |
5 |
0 |
5 |
0 |
5 |
1 |
4 |
BENZODIAZEPINES (BZO)
|
Oxazepam conc. (ng/mL) |
n per site |
Site A |
SiteB |
SiteC |
|||
|
- |
+ |
- |
+ |
- |
+ |
||
|
0 |
5 |
5 |
0 |
5 |
0 |
5 |
0 |
|
150 |
5 |
4 |
1 |
3 |
2 |
4 |
1 |
|
225 |
5 |
2 |
3 |
4 |
1 |
2 |
3 |
|
375 |
5 |
0 |
5 |
0 |
5 |
3 |
2 |
|
450 |
5 |
0 |
5 |
0 |
5 |
1 |
4 |