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One Step Drug Test:  Opiates (Page 2)

1-Panel - OPI
One Step Opiate Test Device

Page 1

Accuracy

A side-by-side comparison was conducted using the OPI One Step Opiate Test Device and a leading commercially available OPI 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 OPI Rapid Test Total Results
OPI One Step Test Device Results Positive Negative
Positive 150 0 150
Negative 0 150 150
Total Results 150 150 300
% Agreement With Commercial Kit >99% >99% >99%

When compared to the GC/MS lab testing method at the cutoff concentration of 2,000 ng/ml, the following results were tabulated:

Method GC/MS Total Results
OPI One Step Test Device Results Positive Negative
Positive 134 16 150
Negative 0 150 150
Total Results 134 166 300
% Agreement With GC/MS Analysis >99% 90% 95%

Eighty (80) of these samples were also run using the OPI One Step Opiate 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.

Sensitivity

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A drug-free urine pool was spiked with Morphine at the following concentrations: 0 ng/ml, 1,000 ng/ml, 1,500 ng/ml, 2,000 ng/ml, 2,500 ng/ml and 3,000 ng/ml. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Morphine Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
1,000 -50% 30 30 0
1,500 -25% 30 30 0
2,000 Cutoff 30 13 17
2,500 +25% 30 4 26
3,000 +50% 30 0 30

Precision

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A study was conducted at 3 physician's 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 were blind labeled and tested at each site. The results are given below:

Morphine Concentration (ng/ml) n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
1,000 15 15 0 15 0 14 1
1,500 15 13 2 11 4 7 8
2,500 15 4 11 1 14 2 13
3,000 15 0 15 0 15 2 13

Effect of Urinary Specific Gravity

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Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 1,000 ng/ml and 3,000 ng/ml of Morphine respectively. The OPI One Step Opiate 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.

Effect of Urinary pH

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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 Morphine to 1,000 ng/ml and 3,000 ng/ml. The spiked, pH-adjusted urine was tested with the OPI One Step Opiate 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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