ONLINE DAT II Results matter.

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1 From tough questions to reliable answers. ONLINE DAT II Results matter.

2 Patient results matter Reputations are at stake: theirs and yours. Behind every Drugs-of-Abuse Test (DAT) result is a person whose reputation or whose very life, can depend on the specific information provided by your hospital or reference lab. That s why we share your goal to provide timely, accurate DAT results that provide actionable information. Information that can have an immediate impact on a patient s care a job applicant s success or a defendant s case. Because reputations are at stake, we re committed to helping you provide reliable answers to the toughest questions. As DAT testing continues to evolve, we ll be there for trustworthy, reliable results. Information that follows the very latest guidelines set forth by national and global organizations, including The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Substance Abuse & Mental Health Services Administration (SAMHSA) The National Academy of Clinical Biochemistry (NACB) ONLINE DAT II reagents provide actionable information that can have an immediate impact on a patient s care, a job applicant s success, or a defendant s case.

3 Test results matter ONLINE DAT II Reagents: for the precision you demand. With so much at stake, you need to be confident you re using reagents manufactured by a recognized leader in diagnostics technology and customer support. ONLINE DAT II solutions deliver improved performance and easier use with the latest KIMS technology. A new high-performance two-reagent system places the drug conjugate in solution with the antibody on the microparticle surface, for higher antibody/reagent stability than three-reagent Generation I systems. A new generation in reliable technology. As with earlier versions, the exceptional performance of ONLINE DAT II reagents is made possible by drug-specific detection based on KIMS (kinetic interaction of micro-particles in solution) technology. Abs Cocaine II Dose Response Comparison: Roche/Hitachi Calibrator Concentration () H97 H9 H9 H Mod P H Mod DAT The kinetic interaction is indirectly proportional to the amount of drug present in the sample, with accurate results in range up to 000. Optimized for all Roche systems, every ONLINE DAT II reagent relies on proven KIMS technology to deliver High specificity to the target drug with minimized or targeted cross-reactivity High confidence in cut-off ranges Minimized interference from common adulterants Minimized lot-to-lot variability for consistently reliable performance Abs Cocaine II Dose Response Comparison: COBAS INTEGRA I700 I800 I00 Reformulated for even better performance. Using an enhanced variation of KIMS technology, selected ONLINE DAT II reagents have been reformulated to Minimize the need for mixing Minimize viscosity Provide 8-month shelf life stability Produce qualitative and semi-quantitative results with Additional cutoff levels Broader dynamic ranges (expanded up to 0-fold) Higher sensitivity, reducing false positives or negatives Extended onboard stability for greater convenience Calibrator Concentration ()

4 Kinetic interaction of microparticles in solution (KIMS) Easy-to-use, two-reagent formulation eliminates the need for mixing. Aggregation indicates absence of target drug in sample Figure Lack of aggregation indicates presence of target drug in sample Each ONLINE DAT II product combines drug derivatives conjugated to polymer (R) with micro-particles covalently coated with monoclonal antibody and blocking proteins (R). Response to common adulterants High salts No reaction Glutaraldehyde No reaction Chromates No reaction Nitrites No reaction Most adulterants that can produce false negative results with enzyme-based assays have no impact on ONLINE DAT II reagents. Others produce positive results that immediately suggest the need for intervention. Figure Kinetic interaction of micro-particles in solution (KIMS) is induced by binding of the drug conjugate (R) to the monoclonal antibody on the microparticles (R), indicating absence of the target drug in the sample. (Figure ) Conversely, this interaction is inhibited by the presence of the target drug in the sample. (Figure )

5 By integrating DAT, TDM, and clinical chemistries on a single, random-access workstation, lab staff can streamline workflow efficiency. Business results matter Optimizing efficiency is crucial. Today, all labs are challenged to improve efficiency without compromising quality. Fully-automated, random-access Roche systems help meet that challenge, with ONLINE DAT II reagents playing a key role. Minimize hands-on operator time. Convenient, liquid, ready-to-use ONLINE DAT II reagents are available in optimized kit configurations for labs of any size. ONLINE DAT II reagents Minimize prep time while preventing reagent preparation errors Provide superior onboard and calibration stability Enable increased throughput Multi-analyte controls and calibrators save even more time. Eliminate the need to use a control/calibrator for each assay Multi-analyte control ± % at all cutoffs Integration capabilities simplify workflow. By integrating DAT, TDM, and clinical chemistries on a single, random-access workstation, lab staff can Streamline workflow efficiency Decrease turnaround times Reduce costs

6 Roche/Hitachi Systems: Because efficiency always matters. Whether yours is a dedicated or integrated lab environment, Roche instruments let you consolidate DAT and TDM testing on one platform for maximum workflow efficiency. Roche/Hitachi 9, 9, 97 Systems and MODULAR ANALYTICS modules Create a single, customized, highthroughput workcell that unites and streamlines your DAT, TDM, clinical chemistry, protein testing, and more. Reagents, calibrators, and controls are interchangeable among all Roche/Hitachi analyzers to minimize inventory, purchasing and training costs. MODULAR ANALYTICS SWA Across-the-board service and support. With Roche ONLINE DAT II reagents onboard your Roche Diagnostics system, you can depend on a single, proven resource for expert, responsive, and comprehensive service and support. Roche Diagnostics is the solution provider for labs that want to optimize efficiency. COBAS INTEGRA 00 plus, 700 and 800 Systems With standardized test menus, COBAS INTEGRA analyzers deliver high versatility and ease of operation in a compact design, which makes them ideal for small and mid-size labs. COBAS INTEGRA For more information, contact your Roche Diagnostics representative or visit Roche Diagnostics GmbH Roche Centralized Diagnostics 6898 Mannheim Germany All date from clinical trials on file at Roche Diagnostics. COBAS INTEGRA 700/800 analyzers. Washington G- Reports, Lab Institute Survey, October 00. COBAS, COBAS INTEGRA, MODULAR and ONLINE DAT are trademarks of Roche. 00 Roche Diagnostics. All rights reserved.

7 ONLINE DAT II Calibrators and Controls ONLINE DAT II Calibrators and Controls For use in the qualitative and semi-quantitative detection of drugs of abuse in human urine on automated clinical chemistry analyzers.. Only ONLINE DAT II calibrators and controls are optimized for timesaving flexibility and reliable accuracy when used on COBAS Integra and Roche/Hitachi analyzers: Ready-to-use liquid formulation GC/MS-verified concentrations Human urine matrix Features of new Calibrators and Controls Can be used with current and new drugs of abuse assays on Roche/Hitachi and COBAS Integra analyzers Increased open-bottle stability from 0-60 days (in most cases) Meets SAMHSA requirements Controls are within ± % of the cutoffs Additional cutoffs available The best overall technical support for reagents, systems and instrumentation

8 Product information These new calibrators and controls are a direct replacement for the existing drugs of abuse calibrators and controls on the Roche/Hitachi and COBAS Integra analyzers. CALIBRATORS Calibrator Assay Cutoff 6 (Catalog #) (Calibrator Material) () Preciset DAT Plus I Barbiturates Calibrator (006790) Box of 6 bottles, xml ea (Secobarbital) Benzodiazepines (Nordiazepam) Cocaine Metabolite (Benzoylecgonine) Methadone (d,l-methadone) Opiates (d-morphine) Phencyclidine (Phencyclidine) Propoxyphene (Propoxyphene) Preciset DAT Plus II Benzodiazepines Calibrator (Nordiazepam) ( ) Box of 6 bottles, xml ea Opiates (d-morphine) C.f.a.s. DAT Plus ( ) Box of 6 bottles, xml ea Barbiturates (Secobarbital) Benzodiazepines (Nordiazepam) Cocaine Metabolite (Benzoylecgonine) Methadone (d,l-methadone) Opiates (d-morphine) Phencyclidine (Phencyclidine) Propoxyphene (Propoxyphene) 00 Level Preciset DAT Cannabinoids THC Calibrator ( 9 -THC-COOH) (079690) Box of 6 bottles, xml ea Preciset DAT Cannabinoids THC 0 Calibrator ( 9 -THC-COOH) (079790) Box of bottles, xml ea Preciset DAT Amphetamine Amphetamine (d-amphetamine) Calibrator (00890) Box of 6 bottles, xml ea C.f.a.s. DAT Amphetamine 000 (d-amphetamine) Amphetamine Calibrator (00890) Box of bottles, xml ea

9 CONTROLS Control Set DAT I (09090) Control Set DAT II (096890) Control Set DAT III (097690) Control Set Amphetamine 00 (008990) Control Set Amphetamine 000 ( ) Assay Cutoff Neg Pos Neg Pos Neg Pos Neg Pos Neg Pos (Control Material) () x0ml x0ml x0ml x0ml x0ml x0ml xml xml xml xml Amphetamines (d-amphetamine) Amphetamines (d-amphetamine) Barbiturates (Secobarbital) Benzodiazepines 00 7 (Nordiazepam) Cocaine Metabolite 0 88 (Benzoylecgonine) 00 7 Methadone (d,l-methadone) 00 7 Opiates 00 7 (d-morphine) Phencyclidine (Phencyclidine) Propoxyphene (Propoxyphene) Cannabinoids 0 ( 9 -THC-COOH) COBAS Integra 00 plus, 700, 800 Systems, and MODULAR ANALYTICS SWA With standardized test menus, these analyzers from Roche Diagnostics deliver maximum versatility and ease of operation in a minimum amount of space, which makes them ideal for small to large labs. MODULAR ANALYTICS SWA COBAS Integra 800

10 Ordering information Assay Cutoff Calibrator Calibrator Control () (Order #) (Order #) (Order #) Amphetamine 00 Preciset DAT AMP Cal (00890) Preciset DAT AMP (00890) Control Set AMP 00 (008990) Amphetamine 000 C.f.a.s. DAT QUAL AMP (00890) Preciset DAT AMP (00890) Control Set AMP 000 ( ) Barbiturates 00 C.f.a.s. DAT QUAL Plus ( ) Preciset DAT Plus I (006790) Control Set DAT I (09090) Benzodiazepines 00 Preciset DAT Plus II Cal ( ) Preciset DAT Plus II ( ) Control Set DAT II (096890) Benzodiazepines 00 Preciset DAT Plus II Cal ( ) Preciset DAT Plus II ( ) Control Set DAT III (097690) Benzodiazepines 00 C.f.a.s. DAT QUAL Plus ( ) Preciset DAT Plus I (006790) Control Set DAT I (09090) Cannabinoids II 0 Preciset DAT THC 0 Cal (079790) Preciset DAT THC 0 (079790) Control Set DAT II (096890) OR Preciset DAT THC Cal (079690) Cannabinoids II 0 Preciset DAT THC (079690) Preciset DAT THC (079690) Control Set DAT I (09090) Cannabinoids II 00 Preciset DAT THC 0 Cal (079790) Preciset DAT THC (079690) Control Set DAT III (097690) OR Preciset DAT THC Cal (079690) Cocaine II 0 C.f.a.s. DAT QUAL Plus ( ) Preciset DAT Plus I (006790) Control Set DAT I (09090) Cocaine II 00 Preciset DAT Plus I Cal (006790) Preciset DAT Plus I (006790) Control Set DAT III (097690) Methadone II 00 C.f.a.s. DAT QUAL Plus ( ) Preciset DAT Plus I (006790) Control Set DAT I (09090) Opiates II 00 Preciset DAT Plus II Cal ( ) Preciset DAT Plus II ( ) Control Set DAT II (096890) Opiates II 000 C.f.a.s. DAT QUAL Plus ( ) Preciset DAT Plus I (006790) Control Set DAT I (09090) Phencyclidine C.f.a.s. DAT QUAL Plus ( ) Preciset DAT Plus I (006790) Control Set DAT I (09090) Propoxyphene 00 C.f.a.s. DAT QUAL Plus ( ) Preciset DAT Plus I (006790) Control Set DAT I (09090) Roche Diagnostics GmbH Roche Centralized Diagnostics 6898 Mannheim Germany For information on additional Calibrators and Controls available, contact your Roche Diagnostics representative. Washington G- Reports, Lab Institute Survey, October 00. COBAS INTEGRA, MODULAR, Preciset and ONLINE DAT are trademarks of Roche. 00 Roche Diagnostics. All rights reserved.

11 ONLINE DAT II Cocaine II Assay ONLINE DAT II Cocaine II Assay For the qualitative and semi-quantitative detection of cocaine in human urine on automated clinical chemistry analyzers (cutoff of 0 or 00 ). Only the ONLINE DAT II Cocaine II assay is optimized for timesaving flexibility and reliable accuracy when used on COBAS INTEGRA and Roche/Hitachi instruments: Ready-to-use liquid formulation Multi-analyte calibrators and controls Dynamic range Accuracy confirmed in worldwide testing Excellent correlation, sensitivity and specificity 9% confidence in results within ± % of cutoff High specificity to benzoylecgonine No interference from more than 0 common drugs Optimized for Roche/Hitachi instruments Increased throughput to 600 tests/hour on COBAS INTEGRA 700/800 Calibration frequency COBAS INTEGRA 00/700/800: each lot and 8 days Roche/Hitachi instruments recommended: After reagent lot change As required following quality control procedure Onboard stability COBAS INTEGRA 00/700/800: 8 days ( weeks) Roche/Hitachi instruments: 6 days (8 weeks) Small and large kit configurations for medium- to high-volume systems The expert overall technical support for reagents and instrumentation Ordering information System Applications Product Catalog# Format Tests/Kit Roche/ Roche/ MODULAR COBAS Hitachi Hitachi ANALYTICS INTEGRA 9/9 97 <P> 00/700/800 Cocaine II x 6/ x 8 ml 0 X X X Cocaine II x 6/ x 9 ml 0 X X Cocaine II x 0/ x 08 ml 900 X Cocaine II Cassette 00 X

12 ONLINE DAT II Cocaine II Assay Specifications Shelf life/storage conditions Onboard reagent stability Roche/Hitachi COBAS INTEGRA 00/700/800 Calibration frequency Roche/Hitachi COBAS INTEGRA 00/700/800 material Precision performance Measuring range Roche/Hitachi (00 assay) Within run To expiration date stored unopened at -8 C 6 days (8 weeks) 8 days ( weeks) After reagent lot change As required following quality control procedure Each lot and 8 days Urine only Cutoff level 0 or 00 Analytical sensitivity (limit of detection) Roche/Hitachi 97 8 COBAS INTEGRA < 7 Imprecision Determined for each analyzer by running a series of calibrator and controls in replicates of 0 for days. Roche/Hitachi (0 assay) Between day Level 8. Level COBAS INTEGRA (0 assay) Cutoff (x) 0.7x x Level Level > 9% negative reading > 9% positive reading Level Level COBAS INTEGRA (00 assay) Cutoff (x) 0.7x.x Within run Between day Method comparison Internal and external method comparisons have shown equivalent performance to industry standard methods. 00 urine samples screened negative in a drug test panel by another technology were evaluated. All 00 samples were negative relative to the 0 and 00 cutoffs. 0 urine samples screened positive by a commercially available enzyme immunoassay and confirmed positive for Cocaine by GC/MS were evaluated. All 0 samples were positive with the ONLINE DAT II Cocaine II assay relative to the 0 and 00 cutoffs. For each cutoff (0 and 00 ), 0 positive samples were diluted with drugfree urine to obtain drug concentrations greater than the respective cutoffs. Data from accuracy studies described above that fell within the near cutoff value ranges were combined with data generated from diluted positive urine samples. The following results were obtained relative to the GC/MS values on both COBAS INTEGRA 700 and Roche/Hitachi 97 analyzers. Ecgonine Cutoff () 0 00 Specificity Level 99.7 Level Level Level > 9% negative reading > 9% positive reading Level Level 7. Negative GC/MS values () s Near Cutoff 88-06, Near Cutoff , The specificity of the ONLINE DAT II Cocaine II assay for structurally similar compounds was determined by generating inhibition curves for each compound listed below at concentrations approximately equivalent in reactivity to the benzoylecgonine assay cutoff. Compound Cocaine Cocaethylene Cocaine Cocaethylene The following compounds were tested at a concentration of 00,000 and were shown to have cross-reactivity values less than 0.0% on both Roche/Hitachi and COBAS INTEGRA instruments. Cross-reactivity Roche/Hitachi COBAS INTEGRA 0 cutoff assay Equivalent to Cutoff Concentration of benzoylecgonine 77,9 8, 67, Approx. % Cross-reactivity Ecgonine methyl ester Equivalent to Cutoff Concentration of benzoylecgonine ,60 00 cutoff assay.7 8, ,08 Norcocaine Approx. % Cross-reactivity More than 0 unrelated drugs commonly found in clinical situations were tested in pooled human urine samples at concentrations of 00,000. All demonstrated cross-reactivity <0.%. For a complete list of drugs tested, refer to package insert Roche Diagnostics GmbH Roche Centralized Diagnostics 6898 Mannheim Germany All data from clinical trials on file at Roche Diagnostics. Comparison methods GC-MS/LC-MS/HPLC or routine IA. Washington G- Reports, Lab Institute Survey, October 00. COBAS INTEGRA and ONLINE DAT are trademarks of a Member of the Roche Group. 00 Roche Diagnostics. All rights reserved.

13 ONLINE DAT II Methadone II Assay ONLINE DAT II Methadone II Assay For the qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers (cutoff of 00 ). Only the ONLINE DAT II Methadone II assay is optimized for timesaving flexibility and reliable accuracy when used on COBAS INTEGRA and Roche/Hitachi instruments: Ready-to-use liquid formulation Multi-analyte calibrators and controls Dynamic range Accuracy confirmed in worldwide testing Excellent correlation, sensitivity and specificity 9% confidence in results within ± % of cutoff High specificity to parent drug No interference from more than 80 common drugs Optimized for Roche/Hitachi instruments Increased throughput on COBAS INTEGRA 700/800 to 600 tests/hour Calibration frequency COBAS INTEGRA 00/700/800: each lot and 8 days Roche/Hitachi instruments recommended After reagent lot change As required following quality control procedure Onboard stability COBAS INTEGRA 00/700/800: 8 days ( weeks) Roche/Hitachi instruments: 6 days (8 weeks) Small and large kit configurations for mediumto high-volume systems The expert overall technical support for reagents and instrumentation Ordering information System Applications Product Catalog# Format Tests/Kit Roche/ Roche/ MODULAR COBAS Hitachi Hitachi ANALYTICS INTEGRA 9/9 97 <P> 00/700/800 Methadone II x 6/ x 8 ml 0 X X X Methadone II x 6/ x 9 ml 0 X X Methadone II x 0/ x 08 ml 900 X Methadone II Cassette 00 X

14 ONLINE DAT II Methadone II Assay Specifications Shelf life/storage conditions Onboard reagent stability Roche/Hitachi for Cat. No COBAS INTEGRA 00/700/800 Calibration frequency Roche/Hitachi COBAS INTEGRA 00/700/800 material Precision performance Measuring range 00 7 recovery of controls To expiration date stored unopened at -8 C 6 days (8 weeks), days ( weeks), 8 days ( weeks) After reagent lot change As required following quality control procedure Each lot and 8 days Urine only Cutoff level 00 Analytical sensitivity (limit of detection) Roche/Hitachi 7 COBAS INTEGRA 700 < Imprecision Determined for each analyzer by running a series of calibrator and controls in replicates of 0 for days. Roche/Hitachi Level () >9% negative reading >9% positive reading 00 7 COBAS INTEGRA Cutoff (x) 0.7x.x Within run Between day Level 8 6. Level Level Level Negatives 00% negative Positives 00% positive >9% negative reading >9% positive reading Level 7 8. Level Method comparison Internal and external method comparisons have shown equivalent performance to industry standard methods. 00 urine samples screened negative in a drug test panel by another technology were evaluated. All 00 samples were negative relative to the 00 cutoff. urine samples screened positive by a commercially available enzyme immunoassay and confirmed positive for methadone by GC/MS were evaluated. All samples were positive with the ONLINE DAT II Methadone II assay relative to the 00 cutoff. 0 positive samples were diluted with drug-free urine to obtain drug concentrations greater than the 00 cutoff. Data from the accuracy studies described above that fell within the near cutoff value ranges were combined with data generated from the diluted positive urine samples. The following results were obtained with ONLINE DAT II Methadone II assay relative to the GC/MS values. COBAS INTEGRA 700 and Roche/Hitachi 97 Specificity Compound + Hydroxymethadone Methotrimeprazine Chlorpromazine Thiothixene Clomipramine Promazine Thioridazine Chlorprothixene l- -methadol Promethazine I- -acetylmethadol (LAAM) Trimipramine Cyclobenzaprine Orphenadrine Diphenhydramine Perphenazine Merpenidine Imipramine Cyproheptadine Doxepin * = tested at 00,000 Negative s 0 00 Roche/Hitachi Equivalent to 00 methadone ,07 9,67,77,87 6, 86, 0,88 88,6 70,70, * * * * * * * * <0.0 <0.0 <0.0 <0.0 <0.0 <0.0 <0.0 < Approx. % Cross-reactivity GC/MS Values () Near Cutoff COBAS INTEGRA Equivalent to 00 methadone 7 6 6,09,68 9,767 9,87 09,09 68,9,87 68,9 9,6 9,008 6,0 8,6 9,6,789, 6,6 0,99 8,7 70-0,0 0 The specificity of the ONLINE DAT II Methadone II assay for structurally similar compounds was determined by generating inhibition curves for each compound listed below at concentrations approximately equivalent in reactivity to the assay cutoff. Approx. % Cross-reactivity The following compounds were tested at a concentration of 00,000 and were shown to have cross-reactivity values less than 0.0% on both Roche/Hitachi and COBAS INTEGRA instruments. Amitryptyline Chlorpheniramine Desipramine Nortriptyline Mianserin EDDP (-ethylidene-, -dimethyl-, -diphenylpyrrolidine) Benzphetamine Maprotiline Dextromethorphan Fluoxetine Protriptyline EMDP (-ethyl--methyl-, -diphenylpyrroline) Carbamazepine d-propoxyphene Disopyramide Doxylamine Nordoxepin d-l-verapamil Cross-reactivity More than 80 unrelated drugs commonly found in clinical situations were tested in pooled human urine samples at concentrations of 00,000. All demonstrated cross-reactivity <0.%. For a complete list of drugs tested, refer to package insert. Roche Diagnostics GmbH Roche Centralized Diagnostics 6898 Mannheim Germany All data from clinical trials on file at Roche Diagnostics. Comparison methods GC-MS/LC-MS/HPLC or routine IA. Washington G- Reports, Lab Institute Survey, October 00. COBAS INTEGRA and ONLINE DAT are trademarks of a Member of the Roche Group. 00 Roche Diagnostics. All rights reserved.

15 ONLINE Opiates 00/000 Assay ONLINE Opiates 00/000 Assay For the qualitative and semi-quantitative detection of opiates in human urine on automated clinical chemistry analyzers (cutoff of 00 or 000 ). Only the ONLINE Opiates 00/000 assay is optimized for timesaving flexibility and reliable accuracy when used on COBAS INTEGRA and Roche/Hitachi instruments: Ready-to-use liquid formulation Multi-analyte calibrators and controls Dynamic range Accuracy confirmed in worldwide testing Excellent correlation, sensitivity and specificity 9% confidence in results within ± % of cutoff High specificity to morphine No interference from more than 80 common drugs Optimized for Roche/Hitachi instruments Increased throughput on COBAS INTEGRA 700/800 to 600 tests/hour Calibration frequency COBAS INTEGRA 00: each lot and 8 days COBAS INTEGRA 700/800: each lot and days Roche/Hitachi instruments recommended After reagent lot change As required following quality control procedure Onboard stability COBAS INTEGRA 00: 8 days ( weeks) COBAS INTEGRA 700/800: 8 days (6 weeks) Roche/Hitachi instruments: 6 days (8 weeks) Small and large kit configurations for medium- to high-volume systems The expert overall technical support for reagents and instrumentation Ordering information System Applications Product Catalog# Format Tests/Kit Roche/ Roche/ MODULAR COBAS Hitachi Hitachi ANALYTICS INTEGRA 9/9 97 <P> 00/700/800 Opiates 00/ x 9/ x 9 ml 00 X X X Opiates 00/ x 9/ x 6 ml X X Opiates 00/ x 0/ x 00 ml 00 X Opiates 00/ Cassette 00 X

16 ONLINE Opiates 00/000 Assay Specifications Shelf life/storage conditions Onboard reagent stability Roche/Hitachi COBAS INTEGRA 00 COBAS INTEGRA 700/800 Calibration frequency Roche/Hitachi COBAS INTEGRA 00 COBAS INTEGRA 700/800 material To expiration date stored unopened at -8 C 6 days (8 weeks) 8 days ( weeks) 8 days (6 weeks) After reagent lot change As required following quality control procedure Each lot and 8 days Each lot and days Urine only Precision performance Measuring range Cutoff level 00 or 000 Analytical sensitivity (limit of detection): 00 cutoff 000 cutoff Roche/Hitachi 6 0 COBAS INTEGRA 9 7 Imprecision Determined for each analyzer by running a series of calibrator and controls in replicates of 0 for days. Roche/Hitachi (00 assay) Level () Roche/Hitachi (000 assay) Level () >9% negative reading >9% positive reading >9% negative reading >9% positive reading COBAS INTEGRA (00 assay) Cutoff (x) 0.8x (0 ).x (60 ) Within run Between day.8. COBAS INTEGRA (000 assay) Cutoff (x) 0.8x (600 ).x (00 ) Within run Between day >9% negative reading >9% positive reading >9% negative reading >9% positive reading recovery Negatives 00% negative of controls Positives 00% positive Method comparison Internal and external method comparisons have shown equivalent performance to industry standard methods. 00 urine samples screened negative in a drug test panel by another technology were evaluated. All 00 samples were negative relative to the 00 and 000 cutoffs. 0 urine samples screened positive by a commercially available enzyme immunoassay and confirmed positive for opiates by GC/MS were evaluated. All 0 samples were positive with the Opiates 00/000 assay relative to the 00 and 000 cutoffs. The following results were obtained relative to the GC/MS values on a COBAS 700 analyzer. GC/MS 00 cutoff 000 cutoff + + COBAS INTEGRA Specificity The specificity of the ONLINE Opiates 00/000 assay for structurally similar compounds was determined by generating inhibition curves for each compound listed below at concentrations approximately equivalent in reactivity to the morphine assay cutoff. Roche/Hitachi COBAS INTEGRA Compound Cutoff Equivalent to Cutoff Concentration of Morphine and Cross-reactivity % Codeine Ethyl morphine Diacetylmorphine 6-Acetylmorphine Dihydrocodeine Dihydromorphine Morphine-- glucoronide Hydrocodone Thebaine Hydromorphone n-norcodeine n/a ,90 % n/a n/a ,768 99,6 % n/a Oxycodone Mepheridine >7,000 >00,000 <0. <0. >670,000 <0. >670,000 <0. Fentanyl n/a n/a n/a n/a = not tested for specificity on Roche/Hitachi instrument Cross-reactivity ,078 6,7 6,7 7,000 % % ,9 0. 6,6 0. 6,767 0.,000, More than 80 unrelated drugs commonly found in clinical situations were tested in pooled human urine samples at concentrations of 00,000. All demonstrated cross-reactivity <0.%. For a complete list of drugs tested, refer to package insert. Roche Diagnostics GmbH Roche Centralized Diagnostics 6898 Mannheim Germany All data from clinical trials on file at Roche Diagnostics. Roche/Hitachi and 000 cutoff qualitative; 000 cutoff semi-quantitative only. Comparison methods GC-MS/LC-MS/HPLC or routine IA. Washington G- Reports, Lab Institute Survey, October 00. COBAS INTEGRA and ONLINE DAT are trademarks of a Member of the Roche Group. 00 Roche Diagnostics. All rights reserved.

17 ONLINE DAT II THC II Assay ONLINE DAT II THC II Assay For the qualitative and semi-quantitative detection of THC in human urine on automated clinical chemistry analyzers (cutoff of 0, 0, or 00 ). Only the ONLINE DAT II THC II assay is optimized for timesaving flexibility and reliable accuracy when used on Roche/Hitachi and COBAS Integra instruments: Ready-to-use liquid formulation Multi-analyte controls Dynamic range 0-00 Accuracy confirmed in worldwide testing Excellent correlation, sensitivity and specificity 9% confidence in results within ± % of cutoff No significant interference from more than 90 common drugs Optimized for Roche/Hitachi and COBAS Integra instruments Calibration frequency COBAS Integra 00/700/800: each lot and 8 Days Roche/Hitachi instruments recommended: After reagent lot change As required following quality control procedure On-board stability COBAS Integra instruments: 8 Days ( weeks) Roche/Hitachi and COBAS Integra instruments: 6 days (8 weeks) Small and large kit configurations for small- to high-volume systems The best overall technical support for reagents and instrumentation Ordering information System Applications Product Catalog# Format Tests/Kit Roche/ Roche/ Roche/ MODULAR MODULAR COBAS Hitachi Hitachi Hitachi ANALYTICS ANALYTICS INTEGRA 77 9/9 97 <P> <DAT> 00/700/800 THC II x 6/ x 8 ml 0 X X X THC II x 6/ x 9 ml 0 X X THC II x 0/ x 08 ml 900 X THC II x / x ml 9,000 X X THC II not available yet Cassette 00 X

18 ONLINE DAT II THC II Assay Specifications Shelf life/storage conditions Onboard reagent stability Roche/Hitachi Onboard reagent stability COBAS Integra Calibration frequency Roche/Hitachi COBAS Integra material Precision performance To expiration date stored unopened at -8 C 6 days (8 weeks) 8 days ( weeks) After reagent lot change As required following quality control procedure Each lot and 8 days Urine only Measuring range/cutoff level 0-00 for 0 Cutoff level 0-00 for 0, or 00 Analytical sensitivity (limit of detection) Instrument Cutoff () Lower limit () Roche/Hitachi COBAS Integra 0 < 0 < 00 <6 Imprecision Determined for each analyzer by running a series of calibrators and controls in replicates of 0 for days on a Roche/Hitachi 97 analyzer. Roche Hitachi 0 assay Level () assay Level () >9% negative reading >9% positive reading >9% negative reading >9% positive reading assay Level () recovery of controls COBAS Integra 0 assay Level () 0.7x.x assay Level () 0.7x.x assay Level () 0.7x.x Negatives 00% negative Positives 00% positive >9% negative reading >9% positive reading >9% negative reading >9% positive reading >9% negative reading >9% positive reading >9% negative reading >9% positive reading

19 Method comparison Roche/Hitachi 97 Analyzer Internal and external method comparisons have shown equivalent performance to standard methods. 00 urine samples screened negative in a drug test panel by another technology were evaluated. All 00 samples were negative relative to the 0, 0, and 00 cutoffs. urine samples screened positive by a commercially available enzyme immunoassay and confirmed positive for THC by GC/MS were evaluated. All samples were positive with the THC II assay relative to the 0, 0, and 00 cutoffs. For each cutoff, 0 positive samples were diluted with drug-free urine to obtain drug concentrations greater than the representative cutoffs. Data from accuracy studies described above that fell within the near cutoff value ranges were combined with data generated from diluted positive urine samples. The following results were obtained relative to the GC/MS values using ONLINE DAT II THC II assay on a Roche/Hitachi 97 analyzer. Cutoff () Negative s GC/MS values () Near Cutoff Near Cutoff Near Cutoff COBAS Integra Analyzer 00 hundred urine samples, obtained from a clinical laboratory where they screened negative in a drug test panel by another technology, were evaluated for cannabinoids on a COBAS INTEGRA 700. All 00 clinical samples were negative relative to the 0, 0, and 00 cutoffs. 0 urine samples, obtained from clinical laboratories where they screened positive by a commercially available enzyme immunoassay and confirmed positive for cannabinoids by GC/MS ( cutoff) were also evaluated on a COBAS INTEGRA samples were positive with the COBAS INTEGRA THC assay relative to the 0 cutoff; 0 samples were positive with the assay relative to the 0 cutoff; 0 samples were positive with the assay relative to the 00 cutoff. Specificity The specificity of the ONLINE DAT II THC II assay for structurally similar compounds was determined by using Roche/Hitachi instruments to generate inhibition curves for each compound listed below at concentrations approximately equivalent in reactivity to the 9 COOH-THC assay cutoff. Compound Cutoff 9-carboxy--nor- 9 THC 9-carboxy--nor- 9 THC glucuronide 8-β--dihydroxy- 9 THC 8-α--hydroxy- 9 THC -hydroxy- 9 THC Cannabinol 9 THC The specificity of the COBAS Integra Cannabinoids II assay was determined by generating inhibition curves for each of the compounds listed and determining the approximate quantity of each compound that is equivalent in assay reactivity to the 0, 0 and 00 THC assay cutoffs. Compound Cutoff 9-carboxy--nor- 8 THC 9-carboxy--nor- 9 THC glucuronide 8-β--dihydroxy- 9 THC 8-α-hydroxy- 9 THC -hydroxy- 9 THC Cannabinol 9 THC Cross-reactivity Equivalent to Cutoff Concentration of 9 COOH-THC and Cross-Reactivity % % ,000 % ,000, Equivalent to Cutoff Concentration of 9 COOH-THC and Cross-Reactivity % % % % % More than 90 unrelated drugs commonly found in clinical situations were tested in pooled human urine samples at concentrations of 00,000. All demonstrated negligible cross-reactivity. For a complete list of drugs tested, refer to package insert or method sheet. In addition, 0 samples were diluted to a 9 COOH-THC concentration of 7-00% of the cutoff concentration for each cutoff; and 0 samples were diluted to a 9 COOH- THC concentration of 00-% of the cutoff concentration for each cutoff. Data from the accuracy studies described above that fell within the near cutoff value ranges were combined with data generated from the diluted positive urine samples. The following results were obtained with Cannabinoids II on a COBAS INTEGRA 700 relative to the GC/MS values. Cutoff () Negative s GC/MS values () Near Cutoff Near Cutoff Near Cutoff

20 Roche Diagnostics GmbH Roche Centralized Diagnostics 6898 Mannheim Germany All data from clinical trials on file at Roche Diagnostics. Washington G- Reports, Lab Institute Survey, October 00. COBAS INTEGRA, MODULAR, Preciset and ONLINE DAT are trademarks of Roche. 00 Roche Diagnostics. All rights reserved.

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