c16000 Line Balancing July 2007 Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois

c16000 Line Balancing Document Control Number Revision or Release Date The information, documents and related graphics published herein (the "Information") are the sole property of Abbott Laboratories. Permission to use the Information is granted, provided that the copyright notice appears on all copies; use of the information is for operation of ABBOTT products by Abbott trained personnel or information use only; the information is not modified in any way; and no graphics are used separate from accompanying text. All samples (printouts, graphics, displays, screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results. The information was developed to be used by Abbott Laboratories-trained personnel, by other persons knowledgeable or experienced with the operation and service of the product identified, under the supervision and with cooperation from Abbott Laboratories technical support or service representatives. In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with or arising from the use of the information by persons not fully trained by Abbott Laboratories. This limitation shall not apply to those persons knowledgeable or experienced with the operation and service of the product identified, under the supervision and with cooperation from Abbott Laboratories technical sales or service representatives. No part of this media may be reproduced, stored, retrieved, or transmitted in any form or by any means without the prior written permission of Abbott Laboratories. Updates to the Information may be provided in either paper or electronic format. Always refer to the latest documents for the most current information. ABBOTT LABORATORIES MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE WITH RESPECT TO THE INFORMATION. ABBOTT LABORATORIES HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NON-INFRINGEMENT. Each person assumes full responsibility and all risks arising from use of the Information. The Information is presented "AS IS" and may include technical inaccuracies or typographical errors. Abbott Laboratories reserves the right to make additions, deletions, or modifications to the Information at any time without any prior notification. AEROSET, ARCHITECT and c 8000 are registered trademarks. c 16000 and SmartWash are trademarks of Abbott Laboratories. All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade dress, or product name may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the property of their respective companies. All rights reserved. Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark, or other proprietary right of Abbott Laboratories. Document Control Number Revision or Release Date Content or Pages Revised, Added, or Deleted 204129-101 07/2007 New Release Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

What is Line Balancing? R2 R1 The c16000 has two R1 reagent probes and two R2 reagent probes. The dual probes allow the c16000 to process up to twice as many photometric tests as the c8000. This occurs because the probes can simultaneously aspirate reagents for two different assays in each 4.5 second cycle. Each pair of probes has an A-line probe that can only access the outer ring (segments A, B, and C) of the carousel and a B-line probe that can only access the inner ring (segment D) of the carousel. Each probe then dispenses into the corresponding A-line or B-line cuvette of each cuvette pair. Outer ring A-line R2 Inner ring B-line R1 Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Why is Line Balancing Important? If reagents are loaded optimally between the Outer (A-line) and Inner (B-line) carousels, the c16000 will fill cuvettes more efficiently and maximize throughput. If reagents for a common panel are loaded more heavily on one line versus the other, the system will leave empty cuvettes and the throughput is decreased. Line balancing involves more than ensuring an even number of reagents are loaded on the inner and outer carousels. The example on the next page demonstrates the impact of uneven line balancing. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Example In the following example, there are two panels that are frequently ordered: Panel 1 – Na, K, Cl, CO2, Glu, Ca, Urea, Creat, TP, and Alb Panel 2 – Alb, AST, ALT, T Bili, and AlkP Here are two different ways you could load the reagent carousels Example 1 Example 2 Reagents # A-line (Outer) ICT, Glu, Urea, TP, T Bili, AST, AlkP 7 B-line (Inner) CO2, Ca, Alb, Creat, ALT 5 Reagents # A-line (Outer) ICT, Glu, CO2, Urea. Creat, Ca 6 B-line (Inner) T Bili, Alb, AST, ALT, AlkP, TP It would seem that the reagents are more balanced in Example 2. Is this confirmed when the system dispenses the tests for the frequently ordered panels? Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Example Frequently ordered panels: Panel 1 – Na, K, Cl, CO2, Glu, Ca, Urea, Creat, TP, and Alb Panel 2 – Alb, AST, ALT, T Bili, and AlkP Reagent Loading Example 1 Reagent Loading Example 2 Reagents # A-line (Outer) ICT, Glu, Urea, TP, AST, T Bili, AlkP 7 B-line (Inner) CO2, Ca, Creat, Alb, ALT 5 Reagents # A-line (Outer) ICT, CO2, Glu, Ca , Urea, Creat 6 B-line (Inner) TP, Alb, AST, ALT, T Bili, AlkP System Dispense Results System Dispense Results Panel 1 Panel 2 Panel 1 Panel 2 Cuvettes A-line B-line ICT Gluc CO2 Urea Ca TP Alb Creat Cuvettes A-line B-line T Bili AST ALT AlkP Alb Cuvettes A-line B-line ICT CO2 TP Glu Alb Ca Urea Creat Cuvettes A-line B-line Alb AST ALT T Bili AlkP Cycles = 3 Empty Cuv. = 1 Cycles = 5 Empty Cuv. = 2 Cycles = 5 Empty Cuv. = 5 Cycles = 6 Empty Cuv. = 4 Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Example As you can see from the previous pages, with the reagents loaded as in Example 1, the system generated fewer empty cuvettes and needed fewer cycles to run the assays Leading to a FASTER THROUGHPUT!!! Now it’s time to maximize your customer’s throughput. Use the reagent configuration shown on pages 8 and 9 as a starting point. This configuration is based on commonly ordered chemistry panels and tests To further optimize the configuration for a specific customer’s assay menu, you can use the detailed instructions on pages 10 - 16. Information required to perform the analysis: The most frequently ordered panels and/or assays for the lab The menu of assays that will be run on the c16000 Bonus – the assay package inserts allow you to further refine the line balancing by reducing the need for SmartWashes. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Typical Arrangement – Reagent Carousel View The following is an example of how you might load the reagent carousels for a typical laboratory work list. NOTE: Some assays are available outside the US only. The illustration above is provided as an example and is intended for informational use only. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Typical Arrangement List A-Line (Outer) Detergent A 10% Dtg B 0.5% Acid Wash Saline (dilution) Water Bath Additive ICT Sample Diluent Glucose Urea Total Protein AST Total Bilirubin Lipase Phosphorus GGT LD Neonatal Bilirubin HDL-Ultra Amylase ApoA ApoB C3 C4 IgA IgM IgG Prealbumin RF Transferrin Haptoglobin Microalbumin CRP Iron Lactic Acid Acid Phos Saline-HIL A -1-Acid Glycoprotein A -1-Antitrypsin Amylase (pancreatic) ASO b-2-Microglobulin Bile Acids Ceruloplasmin Cholinesterase "Cholinesterase (Dibucaine) " CK-MB Copper D-Dimer Digitoxin Ferritin Fructosamine HBDH IgE K Light Chains λ Light Chains Lp(a) Myoglobin B-Line (Inner) Detergent A 10% Dtg B 0.5% Acid Wash Saline (dilution, R1 only) CO2 Calcium Creat AlbG/AlbP ALT Alk Phos Triglyceride Cholesterol Direct LDL Uric Direct Bilirubin Urine Protein Magnesium CK UIBC Ammonia NOTE: Some assays are available outside the US only. The table above is provided as an example and is intended for informational use only. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Detailed Line Balancing Instructions Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Instructions – Atypical Assays The following assays require special processing: The ICT assay always dispenses in the A-line (outer). The system cannot use the B-line cuvette in the same cycle. Therefore the B-line cuvette remains empty when an ICT test is processed. When an assay requires a sample volume greater than 8 µL, the system cannot aspirate and dispense sample into both the A-Line and B-Line cuvettes in the same cycle. These assays, (such as Creatinine and Iron), can be loaded in either the A-Line (outer) or B-Line (inner) reagent carousels. However, when these assays are dispensed the corresponding B-Line or A-Line cuvette remains empty. When an assay requires an onboard dilution, the system cannot aspirate and dispense sample into both the A-Line and B-Line cuvettes in the same cycle. These assays, (such as IgA and IgM), can be loaded in either the A-Line (outer) or B-line (inner) reagent carousels. However, when these assays are dispensed, the corresponding B-Line or A-line cuvette remains empty. Although these atypical assays may impact system throughput, they should not be evaluated when determining if the A and B lines are evenly balanced. The following example illustrates how the system leaves some cuvettes empty when running these atypical assays. Cuvettes A-line B-line ICT empty Gluc CO2 Urea Ca TP Alb Creat Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Instructions – Step 1 Wash Solution and Diluents Load all the wash solutions on both the A-line and B-line Load the saline used for sample dilution on both the A-line and B-line (R1 only) Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Instructions – Step 2 Determine if the customer is running Lipase? There are several reagents that significantly interfere with lipase and require SmartWashes. Placing these assays on opposite lines minimizes the potential for interference and reduces the need for extra SmartWashes. Use the assays from the Lipase package insert that require line separation on the AEROSET System as a guideline for configuring the c16000. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Instructions – Step 3 Identify the most frequently ordered panels Distribute the assays from the frequently ordered panels between the two lines. You may have to move assays several times to ensure you have the best balance for the frequently ordered tests. Remember ICT and Creat are atypical assays that are not evaluated when determining line balancing. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Instructions – Step 4 Distribute individual test(s) Individual tests that are ordered frequently but are not part of any panels, are distributed evenly in the remaining positions. Once you have filled the 20 positions of the B-line (Inner) carousel, the remaining tests are loaded in the A-line (Outer) carousel. These should be the less commonly ordered assays. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

Line Balancing Instructions – Step 5 To further refine line balancing, review the reagent SmartWash definitions in the assay package inserts. A SmartWash is defined when one reagent interferes with another. If these reagents are loaded on opposite lines, the system never pipettes the reagents from the same probe so the SmartWash is never required. Line separation of assays requiring a wash reduces the amount of wash solution used and increases throughput. If you move reagents to eliminate washing, ensure your common panels remain balanced. The distribution of common tests is more important than eliminating a few SmartWashes because the system will rearrange the aspiration order of tests to avoid performing a SmartWash. Document Control Number 204129-101 ©2007, Abbott Laboratories, Abbott Park, Illinois Company Confidential Not for customer distribution

EOD