4
Sensitivity/Precision
Performance
around the cutoff for MEDTOX Buprenorphine was evaluated by testing standard drug solutions diluted in drug-free urine in triplicate on 5 different intervals by 3
in-house operators. Drug-free urine was also tested on each interval. The results were interpreted at five minutes.
Buprenorphine (Buprenorphine) Cutoff = 10 ng/mL
Conc. (ng/mL)
Number Tested
Positive
Negative
0
45
0
45
2.5
45
0
45
5
45
0
45
7.5
45
17
28
12.5
45
41
4
15
45
45
0
13B. Non-Crossreactive Endogenous Compounds
The endogenous compounds were tested following the study of M.L. Smith, et. al.
4
Drug free urine samples were spiked with buprenorphine to the targeted concentrations of
5 ng/mL (50% of the cutoff) and 15 ng/mL (150% of the cutoff). Most of the compounds were evaluated for interference of the MEDTOX Buprenorphine Test at 100 µg/mL
(albumin was evaluated at 20 mg/mL and bilirubin was evaluated at 200
μ
g/mL). Samples were evaluated in triplicate by in-house operators. None of the endogenous
compounds listed below affected the expected results.
Acetaldehyde
Creatinine
Sodium Chloride
Acetone
Epinephrine
Tetrahydrocortisone
Albumin, Human
β-Estradiol
d,1-Thyroxine
Ascorbic acid
Estriol
Uric Acid
Bilirubin
Glucose Std. Solution
Cholesterol
Hemoglobin, Human
13C. Related and Reactive Compounds
The following metabolites and reacting compounds were evaluated in the MEDTOX
Buprenorphine Test. Reference standards for the various metabolites and compounds
were prepared in negative urine samples. Results are expressed as the minimum concentration expected to produce a positive result in the indicated assay. Compounds that
reacted with the test are listed first, and related compounds that did not react with the highest concentration tested are listed second as Negative at 100,000 ng/mL (or highest
level tested). The non-reacting opiate compounds were also tested following the study of M.L. Smith, et. al.
4
Drug free urine samples were spiked with buprenorphine to the
targeted concentrations of 5 ng/mL (50% of the cutoff) and 15 ng/mL (150% of the cutoff). 100 µg/mL of the non-reactive opiate compounds were then added to the
preparation and assayed by MEDTOX Buprenorphine Test. Samples were evaluated in triplicate by in-house operators. None of the non-reactive opiate listed in the following
table affected the expected results.
Buprenorphine-(BUP)
(Buprenorphine) 10ng/mL
Result
Positive at 10 ng/mL
% Cross-Reactive
100%
Buprenorphine-glucuronide
Positive at 7.5 ng/mL
133%
Norbuprenorphine
Positive at 50 ng/mL
20%
Norbuprenorphine-glucuronide
Positive at 75 ng/mL
13%
Codeine
Negative at 100,000 ng/mL
None Detected
Diacetylmorphine
Negative at 100,000 ng/mL
None Detected
Hydrocodone
Negative at 100,000 ng/mL
None Detected
Hydromorphone
Negative at 100,000 ng/mL
None Detected
Levorphanol
Negative at 50,000 ng/mL
None Detected
6-Monoacetylmorphine
Negative at 100,000 ng/mL
None Detected
Morphine
Nalbuphine
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
None Detected
None Detected
Naloxone
Negative at 100,000 ng/mL
None Detected
Naltrexone
Norcodeine
Noroxycodone
Noroxymorphone
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
None Detected
None Detected
None Detected
None Detected
Oxycodone
Negative at 100,000 ng/mL
None Detected
Oxymorphone
Negative at 100,000 ng/mL
None Detected
Thebaine
Negative at 100,000 ng/mL
None Detected
13D. Interference
pH and Specific Gravity:
The MEDTOX Buprenorphine Test was assayed with four negative clinical samples with pH values of 5.0, 6.0, 7.0, and 8.0 ± 0.1. Each sample was assayed in triplicate. The
pH samples were fortified with buprenorphine to the concentrations of 5 ng/mL and 15 ng/mL. All the pH levels gave negative results when fortified to 5 ng/mL,
and all pH levels gave positive results when fortified to 15 ng/mL.
The MEDTOX Buprenorphine Test was assayed with three samples with specific gravity values of 1.003, 1.015, and 1.030 ± 0.001. Each sample was assayed in triplicate.
The specific gravity samples were fortified with buprenorphine to the concentrations of 5 ng/mL and 15 ng/mL. All the specific gravity levels gave negative results when
fortified to 5 ng/mL, and all specific gravity levels gave positive results when fortified to 15 ng/mL.
Common Drugs:
The common drugs were tested following the study of M.L. Smith, et. al.
4
Drug free urine samples were spiked with buprenorphine to the targeted concentrations of 5 ng/mL
(50% of the cutoff) and 15 ng/mL (150% of the cutoff). 100 µg/mL of the common drugs were then added to the preparation and assayed by the MEDTOX Buprenorphine
Test. Samples were evaluated in triplicate by in-house operators. None of the common drugs listed in the following table affected the expected results.
COMMON DRUGS EVALUATED WITH MEDTOX BUPRENORPHINE TEST
Acetylsalicylic Acid
Cocaine
Phenobarbital
Acetaminophen
Dextromethorphan
d-Pseudoephedrine
Amitriptyline
Diphenylhydantoin
Rifampin
Brompheniramine maleate
Doxylamine
Salicylic Acid
Caffeine
Fluoxetine
Vancomycin
Carbamazepine
Ibuprofen
Chlorpheniramine
Morphine
