The document discusses CyFlow®, a portable flow cytometer for HIV/AIDS monitoring and patient follow-up. Some key points:
- CyFlow® uses dry reagent kits that eliminate the need for cold storage, making it suitable for resource-limited areas. It can perform CD4, CD4%, and total lymphocyte counts rapidly from whole blood.
- An optional autopreparation and autoloading station allows processing of up to 400 samples per day.
- Dry reagent kits have a 6-month shelf life and reduce costs by simplifying transport and storage compared to conventional kits.
- Partec also offers dry/lyophilized control blood samples for quality control and external quality
2. 2
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.
01 The Vision
Partec Essential Healthcare Division was founded in 2002
to meet an ambitious 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 equip-
ment optimizes the diagnostic process by minimizing potenti-
al bottleneck. CyFlow®
flow cytometry systems and CyScope®
fluorescence microscopes represent a decisive support for
quality daily routine testing worldwide.
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.
One of Partec’s goals is to make robust, cost-effective flow
cytometry and cell analysis equipment available worldwide,
so that as many patients as possible can access to es-
sential tests.
The Vision
3. CyFlow®
Counter including CyFlow®
Autopre-
paration & 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 Control Blood – dry
_ dry/lyophilized blood
controls for QC/EQA
_ eliminating any need for
cold chain
Partec After-Sales-Service &
User-Training-Service
_ locally available
excellent support network
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)
3
THE COMPLETE SOLUTION: CYFLOW®
COUNTER
Accurate | Precise | Rapid | Cost-Efficient
CyFlow®
Counter
02 CyFlow®
Counter
4. 4 CyFlow®
CD4 & CD4% Testing
ACCURATE AND PRECISE COUNTING RESULTS
The CyFlow®
Counter for routine adult and pediatric patient
immune monitoring within shortest possible time.
03 CyFlow®
CD4 & CD4% Testing
DryKit
DryKit
20 µl fresh whole
EDTA blood
15 min
incubation
at room
temperature
in the dark
Partec CD4%
easy count kit - dry
410 µl
prefilled buffer 1
DryKit
410 µl
prefilled buffer 2
Immediate
analysis
Connect to the
CyFlow®
Counter and run
DryKit
DryKit
20 µl fresh whole
EDTA blood
15 min
incubation
at room
temperature
in the dark
Partec CD4
easy count kit - dry
820 µl
prefilled buffer
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.
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 prepara-
tion 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
5. 5CyFlow®
CD4 CD4% Testing
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).
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.
6. 6 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.
04 CyFlow®
HIV Monitoring
Compact and Affordable
The CyFlow®
Counter is a fully equipped portable and ultra-
compact 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
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 “plugplay” CD4 counter by enabling laboratory
staff to fully concentrate on routine HIV monitoring measure-
ments. 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
make CyFlow®
Counter very cost-effective. Service, techni-
cal 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 enume-
ration are maintained by the extraordinary long lifetime of the
Partec solid state lasers.
7. 7
05 Technical Specifications
For in vitro
diagnostic use.
16 mm
R 430
Length 325 mm
Height330mm
Height124mm
Length 300 mm
Length 265 mm
Height330mm
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 fluorescence channels). It performs both fluore-
scence 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 para-
meters / 2 fluorescence channels (SSC, FL-2,
FL-3). Each parameter is equipped with a photo-
multiplier tube (PMT) and integrated electronic
preamplifier.
Flow System
Synthetic quartz flow cuvette (channel dimen-
sions: 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 volumet-
ric absolute counting, pump speed continuously
adjustable from 0-1200 µl/min, sheath fluid pres-
sure continuously adjustable from 0-500 mbar.
Fluid level indicators for full waste and low sheath
fluid.
Electronics
_ parallel signal processing for each of the optical
channels with selectable linear, 3-decade loga-
rithmic scale
_ precise pulse height measurement
_ 16 bit analog-to-digital converters, trigger on any
parameter or parameter combinations
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)
05-8401
Partec CD4% easy count kit (100 tests)
05-8405
for CyFlow®
Counter
Partec CD8 easy count kit (100 tests)
05-8801
Partec CD3 easy count kit (100 tests)
05-8301
Partec CD4 easy count kit-dry
05-8401-d
Partec CD4% easy count kit-dry
05-8405-d
Technical Specifications
All technical specifications are subject to change without notice.
8. 8 Overview
* For in vitro
diagnostic use.
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.
06 Overview
Order No. Item
CY-S-3022 CyFlow®
Counter*
CY-S-3073 CyFlow®
Counter including CyFlow®
Autopreparation Autoloading Station*
05-8401 Partec CD4 easy count kit (100 tests)*
05-8405 Partec CD4% easy count kit (100 tests)*
05-8401-d Partec CD4 easy count kit-dry (100 tests)*
05-8405-d Partec CD4% easy count kit - dry (100 tests)*
05-8993 Partec Control Blood - dry (50 tests)*
9. Highlights
_ for direct and automatic precise sam-
ple preparation and sample loading
_ for use with CyFlow®
Counter instru-
ments (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
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: 99.9 % @ 250 µl, 99.0 % @ 40 µl
_ Cycle time: 30 sec depending on program mode
Power Supply Dimensions
_ AC adapter (100 – 240 V) 50V AC
_ H x W x D (310 x 380 x 250 mm)
_ Weight 9.6 kg
9
CYFLOW®
AUTOPREPARATION
AUTOLOADING STATION
The only CD4 counter in the market offering the option for fully automized
sample processing and sample loading.
Sample Automation
07 Sample Automation
Order No. Product
CY-S-3053 CyFlow®
Autopreparation and
Autoloading Station
CY-S-3073 CyFlow®
Counter including
CyFlow®
Autopreparation
Autoloading Station
10. 10 Reagents
PARTEC DRY REAGENT KITS
For CD4 and CD4% counting, eliminating any need for cold chain
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 follow-
up 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.
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 pati-
ents worldwide.
Partec “Dry” Reagent Kit
Order No. Product
05-8401-d Partec CD4 easy count kit-dry
05-8405-d Partec CD4% easy count kit-dry
Highlights Dry Reagent Kit
_ 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
08 Reagents
11. 11
PARTEC CONTROL BLOOD – DRY
Quality Control and External Quality Assessment with Dry Stabilized Blood Samples
Reagents
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.
Partec has developed freeze-dried (lyophilized) blood samp-
les with superior features. These samples serve as reference
material for leukocyte immunophenotyping, differential cell
counting and all other testing applications. Logistics and sto-
rage 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.
Order No. Product
05-8993 Partec Control Blood - dry
Partec Control Blood - dry
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)
12. Contact
www.cyclos-design.de02.13
Partec Southern Africa
(Pty) Ltd
Unit IF, Plot 119
Gaborone International
Finance Park
Gaborone
Botswana
Phone +267 318 1844
Fax +267 318 1841
psa@partec.com
Partec East Africa Ltd
N.H.I.F. Building, 2nd Floor
Ragati Road
Code 00517—Uhuru
Gardens
Nairobi
Kenya
Phone +254 20 272 7355
Fax +254 20 272 7358
pea@partec.com
Partec Afrique Centrale
SARL
Rue Bebey Elame—AKWA
Douala
B.P. 2326
Douala
Cameroon
Phone +237 33 42 76 12
Phone +237 77 65 41 89
Fax +237 33 42 76 12
pac@partec.com
Partec Nordic AB
Industrigatan 44 B
571 38 Nässjö
Sweden
Phone +46 380 16464
Fax +46 380 16466
partecnordic@partec.com
Partec Southern Africa
(Malawi) Ltd
Amina House, Area 6/14
Off Paul Kagame
(Chirambula) Highway
Ground Floor - Unit 10
Lilongwe
Malawi
Phone +265 1 753 199
Fax +265 1 753 198
psa@partec.com
Partec GmbH
Otto-Hahn-Straße 32
D-48161 Münster
Germany
Phone +49 (0) 2534 8008-0
Fax +49 (0) 2534 8008-90
info@partec.com
Partec GmbH
Am Flugplatz 13
D-02828 Görlitz
Germany
Phone +49 (0) 3581 8746-0
Fax +49 (0) 3581 8746-70
mail@partec.com
Partec North America, Inc.
603 Heron Dr., Unit 9
Swedesboro, NJ 08085
USA
Phone 856 467 0018
US toll-free 888 808 0067
Fax 856 467 0188
partecna@partec.com
Partec Japan, Inc.
3628-46 Kandatsu
Tsuchiura 300-0013
Japan
Phone +81 29 834 7788
Fax +81 29 834 7772
partecjapan@partec.com
Partec Nederland BV
Middenweg 591 B
1704 BH Heerhugowaard
Nederland
Phone +31 72 5742427
Fax +31 72 5710756
partecnederland@partec.com
Partec West Africa SARL
01 BP 1323
Ouagadougou
Burkina Faso
Phone +226 50 30 45 59
Fax +226 50 30 45 59
pwa@partec.com
Partec S.A.R.L.
14/16 rue Gallieni
91700 Sainte Geneviève
des Bois
France
Phone +33 1 69 04 87 12
Fax +33 1 69 04 90 38
partecfrance@partec.com
Partec Healthcare Limited
No 16 Mafemi Crescent
Utako – District
Abuja
Nigeria
Phone +234 9 8761891
Fax +234 9 8761891
partecnigeria@partec.com
Complete list of subsidiaries and distributors:
www.partec.com
Partec Private Limited
E-135, Ground Floor
Lajpat Nagar—I
New Delhi—110 024
India
Phone +91 11 4101 8787
Fax +91 11 4650 2659
partecindia@partec.com
Partec UK Ltd
Unit 44
Canterbury Innovation
Centre
University Road
Canterbury
Kent CT2 7FG
United Kingdom
Phone +44 1227 811711
Fax +44 1227 811712
partecuk@partec.com
Partec Italia S.r.l.
Via. G. Mascherpa 14
20841 Carate Brianza (MB)
Italia
Phone +39 0362 909 143
Fax +39 0362 909 157
partecitalia@partec.com
Partec South East Asia
1747/31 Chan Road
Sathorn
10120 Bangkok
Thailand
Phone +66 26 787 663
Fax +66 26 787 663
partecsea@partec.com
MADE IN GERMANY