Buprenorphine Homogeneous Enzyme Immunoassay (HEIA™)

FDA Cleared

Formula: C29H41NO4 Accurate and Reliable

Systematic Name: (2S)-2-[(5R,6R,7R,14S)-9α-cyclopropylmethyl-4,5-epoxy-6, 14-ethano-3-hydroxy-6-methoxymorphinan-7-yl]-3,3-dimethylbutan-2-ol Ready to Use

Brand Names: Suboxone®, Subutex®, Buprenex®, Temgesic®, Transtec®

About Buprenorphine: Buprenorphine is a semi-synthetic opiate with partial agonist and antagonist actions. It is a powerful analgesic, 25 to 40 times more potent than Morphine. It is used for the treatment of moderate to severe pain, peri-operative analgesia and opioid dependence. Overdose symptoms of the drug include confusion, dizziness, pinpoint pupils, hallucinations, hypotension, respiratory difficulty, seizures and coma.1

Administration: Injection, infusion, transdermal patch, or sublingual tablet.

Elimination: Buprenorphine is metabolized by N-dealkylation to Norbuprenorphine, followed by glucuronide conjugation of both Buprenorphine (BUP) and Norbuprenorphine (nor-BUP) for excretion in urine. The amount of Norbuprenorphine metabolite excreted in urine generally exceeds that of conjugated Buprenorphine.2

1. R.C. Baselt and R. H. Cravey. Disposition of Toxic Abuse Potential: Buprenorphine is subject to abuse and diversion. It is Drugs and Chemicals in Man. 4th edition. 93. 2. E.J. Cone, C.W. Gorodetzky, D. Yousefnejad et al. often used recreationally by insufflation, and is commonly used by illicit The Metabolism and Excretion of Buprenorphine in Humans. Drug Met Disp 12: 577-581 1983. users to prevent withdrawals in-between doses of their opiate of choice. Suboxone®, Subutex®, Temgesic® and Buprenex® are registered trademarks of Reckitt Benckiser. Transtec® is a registered trademark of Grünenthal

Tel 909.482.0840 | Toll Free 888.664.8378 | Fax 909.482.0850 ISO13485:2003 www.immunalysis.com CERTIFIED Buprenorphine (HEIA™)

Assay Specifications Cross-Reactivity

Methodology: Homogeneous Enzyme Immunoassay Analyte Analyte Buprenorphine Cross- Concentration Equivalent Reactivity Cutoff: 5 ng/mL (ng/mL) (ng/mL) (%)

Calibration Range: 0-40 ng/mL Buprenorphine 5.0 5.0 100.00

Norbuprenorphine 5.5 5.3 90.91 Overlap: Buprenorphine (5 ng/mL Cutoff)

0.25% Buprenorphine 3,000 5.3 0.17 Glucuronide -‐25% Cutoﬀ +25% 0.20% Norbuprenorphine 4,000 5.5 0.13 Glucuronide 0.15%

0.10% ND = Cross-Reactivity < 0.05% Nomial Distribu.on % Nomial Distribu.on

Nominal DistributionNominal % The following analytes were tested for cross-reactivity at 100,000 ng/mL and none 0.05% were detected: 6-acetyl Morphine, Codeine, Dihydrocodeine, EDDP, EMDP, Ethyl Morphine, Heroin, Hydrocodone, Hydromorphone, LAAM, Levorphanol, Methadone,

0.00% Meperidine, Morphine-3-gluc., Morphine, Morphine-6-gluc., Nalorphine, Naloxone, 350 360 370 380 390 400 410 Naltrexone, Norpropoxyphene, Oxycodone, and Oxymorphone. Rate (ΔmA/min)

Analytical Recovery: Buprenorphine 45 LC-MS Confirmation 40 (5 ng/mL) 35 30 Positive Negative 25 20 HEIA Positive 40 0 15 (5 ng/mL) Recovered Conc. (ng/mL) (ng/mL) Recovered Conc. 10 Negative 0 40

0 0 5 10 15 20 25 30 35 40 45

Spiked Concentra8on Buprenorphine (ng/mL)

ORDER - Buprenorphine (HEIA) Semi-Quantitative Precision at 5 ng/mL Catalog # Description Precision (n=80) 336UR-0025 / -0100 / -0500 25 mL / 100 mL / 500 mL Kit Concentration Mean SD CV% C336UR-10-1 5 ng/mL Calibrator (ng/mL) (mA/min) C336UR-10-2 3.75 and 6.25 ng/mL Controls C336UR-10-5 0, 5, 10, 20 and 40 ng/mL 3.75 Control LOW 3.3 0.2 5.3 Calibrators 5 Calibrator 4.9 0.3 5.8 Neg-10-1 10 mL Negative Urine Control 6.25 Control HIGH 6.5 0.4 5.6