CyFlow Counter. The Complete Solution for HIV/AIDS Monitoring. Essential Healthcare. HIV/AIDS Monitoring Patient Follow-up

Transcription

1 CyFlow Counter Essential Healthcare HIV/AIDS Monitoring Patient Follow-up The Complete Solution for HIV/AIDS Monitoring

2 01 The Vision OUR MISSION: MOBILE, RELIABLE, COST-EFFICIENT CELL ANALYSIS AND DIAGNOSTICS, FOR EVERYONE World leading: in 2008 and 2009 Partec CyFlow equipment was used to conduct over 5 million HIV/AIDS immune status tests for more than two million patients in 100 countries. Partec Essential Healthcare Division was founded in 2002 to meet an ambi tious goal of significantly improving the quality of laboratory services in developing and emerging countries, especially in regard to the three global killer diseases HIV/AIDS, tuberculosis, and malaria. Partec achieved this goal through cost-effective, robust, simple, easy-to-use, and reliable diagnostic equipment designed especially for the infrastructure in these regions. The new series of Partec robust, portable analytical equipment optimizes the diagnostic process by minimizing potential bottleneck. CyFlow flow cytometry systems and CyScope fluorescence microscopes represent a decisive support for quality daily routine testing worldwide. One of Partec s goals is to make robust, cost-effec tive flow cytometry and cell analysis equipment available worldwide, so that as many patients as possible can access to essential tests. Partec Essential Healthcare focuses its efforts on innovative techniques by bringing diagnostics where they are needed the most, including hard-to-reach communities living in remote areas with very limited access to basic health care services. To improve diagnostic accessibility, Partec has introduced mobile laboratories CyLab and CyLab mini and adopted portable, battery/solar panel operated instrumentation. 2 The Vision

3 02 CyFlow Counter THE COMPLETE SOLUTION: CYFLOW COUNTER Accurate Precise Rapid Cost-Efficient CyFlow Counter including CyFlow Autopreparation & Autoloading Station _ results: CD4 absolute and CD4% among lymphocytes for adult and pediatric patients _ blood preparation time: 15 minutes, only _ max. capacity: 250 tests/day without automat 400 tests/day with automat _ ideal also for mobile use Partec CD4 and CD4% _ dry mab reagents _ eliminating any need for cold chain Partec After-Sales-Service & User-Training-Service _ locally available excellent support network Partec Control Blood dry _ dry/lyophilized blood controls for QC/EQA _ eliminating any need for cold chain Highlights _ ultracompact portable/mobile CD4 and CD4% counter _ dimensions [mm]: L 325 x H 330 x D 265, weight 11.5 kg _ dry reagent kits eliminating any need for cold chain _ rapid blood preparation protocol: 15 minutes, only _ capacity: up to 250 CD4 / CD4% tests per day _ set-up time: < 5 minutes _ intuitive operation by 8.4 TFT colour touchscreen _ powered by Intel Celeron Computer processor _ Partec alignfree optical technology _ Partec laser technology for highest stability _ dedicated CyFlow Autopreparation & Autoloading Station (optional, capacity up to 400 tests/day) _ minimal requirements for service & maintenance _ support of QC and EQA programs _ for in vitro diagnostic use (IVD) CyFlow Counter 3

4 03 CyFlow CD4 & CD4% Testing ACCURATE AND PRECISE COUNTING RESULTS The CyFlow Counter for routine adult and pediatric patient immune monitoring within shortest possible time. The CyFlow Counter is designed to perform any dedicated cell analysis in routine HIV/AIDS follow-up diagnostic. Out of only one sample tube, the CyFlow Counter delivers precise results for the absolute number of CD4+ T-lymphocytes, the absolute number of total lymphocytes and the percentage of CD4+ T-lymphocytes among all lymphocytes (CD4%). The unique and easy-to-perform rapid Partec blood preparation protocol which requires only one pipetting step due to dry reagent tubes and pre-filled buffers is a breakthrough in HIV/AIDS immune status monitoring. Highlights of CyFlow Analysis _ absolute counts with CV 2% _ CD4+ T-lymphocyte absolute count (CD4 count) _ total lymphocyte count (TLC) _ WBC count (total leukocyte count) _ percentage of CD4+ T-lymphocytes of all lymphocytes (CD4%) _ percentage of lymphocytes among all leukocytes _ percentage of CD4+ T-lymphocytes among all leukocytes Fig. 1: CD4 Protocol using Partec CD4 easy count kit - dry. Analysis of absolute CD4+ T-lymphocytes cell concentration from whole blood. Fig. 2: CD4% Protocol using Partec CD4% easy count kit - dry 2-colour analysis of CD4/TLC/CD45 with CyFlow Counter from whole blood. 20 µl fresh whole EDTA blood 820 µl prefilled buffer 20 µl fresh whole EDTA blood 410 µl prefilled buffer µl prefilled buffer 2 Dry Kit 15 min incubation at room temperature in the dark Dry Kit Connect to the CyFlow Counter and run Dry Kit 15 min incubation at room temperature in the dark Dry Kit Dry Kit Immediate analysis Partec CD4 easy count kit - dry Partec CD4% easy count kit - dry 4 CyFlow CD4 & CD4% Testing

5 Fig. 3: CD4 Absolute & CD4% Counting Automatically generated report display from CD4% analysis with CyFlow Counter: Direct result display of absolute CD4+ T-cell count (cell population CD4 ), total lymphocyte count (cell population LYM ), as well as CD4 percentage value (CD4%) for pediatric patients. Due to the extremely high fluorescence sensitivity and superior scatter resolution of the CyFlow Counter, the cell clusters are well separated from each other. Fig. 4: CD4+ counting Comparison to conventional single platform results employing reference beads. (Data kindly provided by Dr. L.G. Lehman, University of Douala, Cameroon) Fig. 5: CD4% counting Comparison to conventional dual platform results (National CyFlow Evaluation from NMRL Zimbabwe, CDC Zimbabwe, African Institute of Biomedical Science and Technology, and Connaught Clinic, Harare). CyFlow CD4 & CD4% Testing 5

6 04 CyFlow HIV Monitoring THE CYFLOW COUNTER: A CLASS OF ITS OWN The CyFlow Counter provides the most accurate and affordable absolute cell counts for HIV/AIDS patient monitoring and follow-up diagnostics. Compact and Affordable The CyFlow Counter is a fully equipped portable and ultracompact desktop flow cytometer dedicated for routine CD4 and CD4% counting (as well as total lymphocyte and WBC counting). With its small size and its robustness the CyFlow Counter is easy to place close to the patients such as in small hospitals at district and provincial level and laboratories in remote areas. It is the ideal device to replace more expensive and highly service demanding large flow cytometers and CD4 counters used for HIV monitoring. alignfree Technology make CyFlow Counter very cost-effective. Service, technical support, and maintenance requirements are kept to a minimum. High Precision CyFlow Counter is equipped with green solid state laser entirely developed and manufactured by Partec. Also at high room temperatures Partec laser shows unique short and long term stability superior to other green solid state laser brands. Both higher precision and more accurate CD4 T-cell enumeration are maintained by the extraordinary long lifetime of the Partec solid state lasers. The CyFlow Counter benefits from the revolutionary Partec alignfreetm technology. Due to this important innovation, difficult and time-consuming optical alignment and laser adjustment typical of large conventional systems are no longer necessary. This makes the CyFlow Counter the first and only real plug&play CD4 counter by enabling laboratory staff to fully concentrate on routine HIV monitoring measurements. The complete optical system of the CyFlow Counter is designed as one solid metal block. AlignFreeTM technology reduces to a minimum the installation and set-up time of the CyFlow Counter. This rapid set up enables the user to obtain CD4 results in less than 5 minutes. The dramatic decrease of cost per CD4 test and the minimum overall running costs 6 CyFlow HIV Monitoring

7 05 Technical Specifications General The CyFlow Counter is a fully-equipped portable / desktop flow cytometer with green laser excitation. It analyses up to three optical parameters (SSC and 2 fluores cence channels). It performs both fluorescence analysis and true volumetric absolute cell counting without the need of reference beads or a haematology counter. Light Source The CyFlow Counter is equipped with a powerful state-of-the-art 532 nm green solid state laser as light source. Optics alignfree optical system with 3 optical parameters / 2 fluorescence channels (SSC, FL-2, FL-3). Each parameter is equipped with a photomulti plier tube (PMT) and integrated electronic preamplifier. Flow System Synthetic quartz flow cuvette (channel dimensions: 250 µm x 350 µm) for laminar sample flow. True Volumetric Absolute Counting based on precise counting and fluid volume measurement. Computer controlled precision syringe pump for contamination-free sample transport and volumetric absolute counting, pump speed continuously adjustable from µl/min, sheath fluid pressure continuously adjustable from mbar. Fluid level indicators for full waste and low sheath fluid. Power Requirements 100/240 V AC, 60 VA, 50/60 Hz or 12 Volts DC/5A Dimensions & Weight 325 x 330 x 265 mm, weight: 11.5 kg Order Numbers CyFlow Counter CY-S-3022 Reagents Partec CD4 easy count kit (100 tests) Partec CD4% easy count kit (100 tests) for CyFlow Counter Partec CD8 easy count kit (100 tests) Partec CD3 easy count kit (100 tests) Partec CD4 easy count kit - dry d Partec CD4% easy count kit- dry d Height 330 mm Height 330 mm Length 325 mm Length 300 mm Length 265 mm Height 124 mm 16 mm Electronics R 430 _ parallel signal processing for each of the optical channels with selectable linear, 3-decade logarithmic scale _ precise pulse height measurement _ 16 bit analog-to-digital converters, trigger on any parameter or parameter combinations All technical specifications are subject to change without notice. For in vitro diagnostic use. Technical Specifications 7

8 06 Overview HIV MONITORING WITH CYFLOW COUNTER. Partec Essential Healthcare provides a unique diagnostic package for dedicated, accurate and most cost-efficient CD4 absolute and CD4% counting. Order No. CY-S-3022 Item CyFlow Counter* CY-S-3073 CyFlow Counter including CyFlow Autopreparation & Autoloading Station* Partec CD4 easy count kit (100 tests)* Partec CD4% easy count kit (100 tests)* d Partec CD4 easy count kit - dry (100 tests)* d Partec CD4% easy count kit - dry (100 tests)* Partec Control Blood - dry (50 tests)* 8 Overview * For in vitro diagnostic use.

9 07 Sample Automation CYFLOW AUTOPREPARATION & AUTOLOADING STATION The only CD4 counter in the market offering the option for fully automized sample processing and sample loading. Highlights Capacity Tray versions _ 10, 20, 30, 40 samples plus pipette tips _ 96 well microplate _ Cleaning and washing solution reservoirs _ 2 large buffer reservoirs with 2 precision syringe pumps Programming _ User selectable preparation or autoloading modes _ User definition for incubation times and order of analysis _ Single tube or complete batch analysis _ Easy programming with CyView MPE software module _ Bar code reader for sample tray and primary tubes Performance _ Positioning: (X, Z) < 0.1 mm and (Y) < 0.3 mm _ Cross contamination: < 1.0 % _ Dispensing precision and accuracy: > µl, > µl _ Cycle time: 30 sec depending on program mode Power Supply & Dimensions _ AC adapter ( V) 50V AC _ H x W x D (310 x 380 x 250 mm) _ Weight 9.6 kg _ for direct and automatic precise sample preparation and sample loading _ for use with CyFlow Counter instruments (Article No. CY-S-3022) _ acquisition of up to 400 samples per day _ automated change of pipette-tip for every sample, no cross contamination _ operated and controlled by CyFlow Counter _ for use with new CD4/CD4% dry reagents _ self cleaning modes and automatic shut down procedure Order No. Product CY-S-3053 CY-S-3073 CyFlow Autopreparation and Autoloading Station CyFlow Counter including CyFlow Autopreparation & Autoloading Station Sample Automation 9

10 08 Reagents PARTEC DRY REAGENT KITS For CD4 and CD4% counting, eliminating any need for cold chain Cost Reduction and Improved Accuracy In addition, easier transport and storage conditions of reagent kits drastically contribute to the overall costs reduction. Another important advantage of the dry kits is the improved accuracy of the test since all pipetting steps except for the transfer of blood sample into the test tube are eliminated. Hence, the new dry kits from Partec lead to a remarkable improvement in the routine monitoring of the immune status of HIV/AIDS patients worldwide. Highlights Dry Reagent Kit Partec Dry Reagent Kit Innovative Solution Partec has introduced an innovative and unique solution for CD4 absolute and CD4% counting. In combination with the CyFlow instruments, reagents for HIV monitoring and patient followup are now available ready-prepared in dry/lyophilized form in ready-to-use test tubes. This new product is a significant break-through for patient support programmes, especially in resource-constrained settings, because it eliminates any need for cold chain and refrigeration as required with conventional test kits. The CD4 / CD4% dry kits have a shelf life of 6 months. _ identification and enumeration of the CD4+ helper/ inducer T-lymphocyte subset (and CD45+ leukocytes) in human blood samples _ no lyse - no wash reagent kit based on ready-prepared test tubes containing dry, lyophilized CD4-PE (and CD45- PE-Dy647 mabs) for volumetric absolute counting of CD4+ T-cells (and CD4% among lymphocytes) in HIV monitoring and for follow-up diagnostics of adult and pediatric AIDS patients for CyFlow Counter and CyFlow SL_3 Order No d d Product Partec CD4 easy count kit - dry Partec CD4% easy count kit - dry 10 Reagents

11 PARTEC CONTROL BLOOD DRY Quality Control and External Quality Assessment with Dry Stabilized Blood Samples Partec has developed freeze-dried (lyophilized) blood samples with superior features. These samples serve as reference material for leukocyte immunophenotyping, differential cell counting and all other testing applications. Logistics and storage are now safely possible without any need for cold chain. Instrument calibration and quality control procedures are possible in any laboratory without degradation of the cellular material and function. Partec Control Blood - dry Applications As integrating part of the Laboratory Quality Management System, routine analysis of quality controls is crucial to ensure high quality of testing. For immunophenotyping and CD4+ T-cell / CD4% counting in HIV/AIDS programs this can be achieved and maintained overtime using Partec Control Blood dry. It offers reliable standard reference materials to be used as daily Internal Quality Controls and for periodical External Quality Assessment as well. Partec Control Blood dry samples are stable, easy-to-use, with no limitations for transport and shipment. Highlights Control Blood Dry _ ideal for immunophenotyping, for example HIV monitoring and AIDS patient follow-up _ perfect material for multinational surveys and clinical multisite studies _ quality control (QC) external quality assessment (EQA) Order No. Product Partec Control Blood - dry Reagents 11

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