CyFlow Counter® essential

Healthcare

HiV/Aids Monitoring
Aids patient Follow-up

The Complete solution for HiV/Aids Monitoring

01 The Vision

Our Mission: Mobile RELIABLE , COST-EFFICIENT

Cell Analysis and Diagnostics, FOR EVERYONE
Worldwide leading: in 2008 and 2009 Partec’s CyFlow® equipment was used to
­conduct over 5 million HIV/AIDS immune status tests on more than two m
­ illion
patients in 100 countries.

Partec’s Essential Healthcare Division was founded in 2002

to meet an ambi­tious goal: a significant improvement in health
services to patients suffering from the three “global killer
diseases“: HIV/AIDS, tuberculosis and malaria, in particular
in developing and emerging countries. This has been made
possible by the develop­ment of cost-effective, robust, simple,
easy-to-use, and reliable diagnostic equipment that is mobile
and designed especially for the infrastructure in these regions.

Partec’s new series of robust, portable analysis equipment

has ­managed to minimize the existing bottleneck in diag­
nostics. CyFlow® flow cytometry systems and CyScope®
One of Partec’s goals is to make tough, cost-effec­tive flow
fluorescence microscopes prove every day that they represent cytometry and cell analysis equipment available worldwide,
a decisive advantage for global treatment programs. so that as many patients as possible can receive the diag-
noses they urgently need.

By investing all possible efforts, Partec Essential Healthcare

is aiming to bring innovative techniques directly to where they
are needed most, including to those patients far from large
cities living in remote areas which until now have not been re-
ached by the existing health services. Partec has also introdu-
ced mobile laboratories implementing the uniquely portable
and battery/solar panel operated Partec instrumentation.

2 The Vision
02 CyFlow® Counter

THe COMpleTe sOluTiOn: CyFlOw® COunTer

Accurate | Precise | Rapid | Cost-Efficient

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 & cold storage

partec Controlblood - dry

_ dry/lyophilized blood
controls for QC/EQA
_ eliminating any need for
partec After-sales-service &
cold chain & cold storage
user-Training-service
_ locally available
excellent support network

Highlights
_ ultracompact portable / mobile CD4 and CD4% counter _ Partec alignFree™ optical technology
_ dimensions [mm]: L 318 x H 307 x D 264, weight 11.5 kg _ Partec laser technology for highest stability
_ dry reagent kits eliminating any need for cold chain & cold storage _ dedicated CyFlow® Autopreparation &
_ rapid blood preparation protocol: 15 minutes, only Autoloading Station
_ capacity: up to 250 CD4 / CD4% tests per day (optional, capacity up to 400 tests/day)
_ set-up time: < 5 minutes _ minimal requirements for service & maintenance
_ intuitive operation by 8.4” TFT colour touchscreen _ support of QC and EQA programs
_ powered by Intel® computer processor _ for in vitro diagnostic use (IVD)

CyFlow® Counter 3
03 CyFlow® CD4 & CD4% Testing

Get accurate and precise counting results

The CyFlow® Counter for routine adult and pediatric patient
montoring 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
Highlights of CyFlow® Analysis
results for the absolute number of CD4+ T-lymphocytes, the
_ absolute counts with CV≤ 2%
absolute number of total lymphocytes and the percentage of _ CD4+ T-lymphocyte absolute count
CD4+ T-lymphocytes among all lymphocytes (CD4%). (CD4 count)
_ total lymphocyte count (TLC)
_ WBC count (total leukocyte count)
A breakthrough for HIV/AIDS monitoring is reached by the
_ percentage of CD4+ T-lymphocytes
unique and ultimately easy-to-perform rapid Partec blood among all lymphocytes (CD4%
preparation protocol which due to dry reagent tubes and pre- _ percentage of lymphocytes among all leukocytes
filled buffers requires only one pipetting step. _ percentage of CD4+ T-lymphocytes
among all leukocytes

Fig. 1: CD4 Protocol using Partec CD4 easy count kit - dry. Fig. 2: CD4% Protocol using Partec CD4% easy count kit - dry
Analysis of absolute CD4 + T-Lymphocyte cell concentration 2-colour analysis of CD4/TLC/CD45 with CyFlow® Counter
from whole blood. from whole blood.

20 µl fresh whole 410 µl 410 µl

20 µl fresh whole 820 µl
EDTA blood prefilled buffer 1 prefilled buffer 2
EDTA blood prefilled buffer

10 min Connect to the 10 min Immediate

Dry Kit

Dry Kit

Dry Kit
Dry Kit

Dry Kit

incubation CyFlow® and run incubation analysis

at room at room
temperature temperature
in the dark in the dark

Partec CD4%
Partec CD4
easy count kit - dry
easy count kit - dry

4 CyFlow® CD4 & CD4% Testing

 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 lym-
phocyte count (cell population „LYM“), and
total leukocyte count (WBCs - population
„CD45“) as well as CD4 percentage value
(CD4%) for pediatric patients. Due to the
extremely high fluorescence sensitivity and
superior scatter resolution of the CyFlow®,
the cell clusters are well separated from
each other.

Fig. 4: CD4+ counting Comparison to conventional single platform results Fig. 5: CD4% counting Comparison to conventional dual platform results
employing reference beads. (Data kindly provided by Dr. L.G. Lehman, (National CyFlow Evaluation from NMRL Zimbabwe, CDC Zimbabwe,
University of Douala, Cameroon) African Institute of Biomedical Science and Technology, and Connaught
Clinic, Harare).

CyFlow® CD4 & CD4% Testing 5

03 CyFlow® HIV Monitoring

THe CyFlOw® COunTer: A ClAss OF iTs Own

The CyFlow® Counter provides most accurate and uniquely affordable absolute cell
counts for HIV/AIDS patient monitoring and follow-up diagnostics.

Compact and Affordable 5 minutes. A dramatical cut-down of the cost per CD4 count
and the overall running cost is therefore achieved. Service,
The CyFlow® Counter is a fully equipped portable and ultra- techsupport and maintenance requirements are reduced to a
compact desktop flow cytometer dedicated for routine CD4 neglectible minimum.
and CD4% counting (as well as total lymphocyte and WBC
counting). With its small size and its highest robustness the
CyFlow® Counter is easy to place even in small hospitals and
High precision
laboratories in remote and resource-poor areas such as on The green solid state laser of the CyFlow® Counter developed
provincial and district levels, close to the patients. It is the and manufactured by Partec - also at high room tempera-
perfect device for HIV monitoring to replace more expensive tures - shows a unique short and long term stability superior
and highly service demanding large flow cytometers and CD4 over water and air cooled gas lasers. Highest precision and
counters. most accurate T-cell enumeration are maintained by the
extraordinary long lifetime of the Partec solid state lasers.

alignFree™ Technology
The CyFlow® Counter benefits from the revolutionary Partec
alignFree™ technology. With this important innovation,
difficult and time-consuming optical alignment and laser
adjustment as known from the large conventional systems
are not required anymore, making the CyFlow® Counter the
first and only real “plug&play” CD4 counter. Therefore the lab
can fully concentrate on the routine HIV monitoring measure-
ments. The complete optical system of the CyFlow® Counter
is designed as one solid metal block. Due to the alignFree™
technology, the installation and set-up time of the CyFlow®
Counter is reduced to a minimum. In order to get the first
CD4 cell count results in the morning, it takes not more than

6 CyFlow® HIV Monitoring

04 Technical Specifications
general power requirements Length 318 mm

The CyFlow® Counter is a fully-equipped portable / 100/240 V AC, 60 VA, 50/60 Hz or 12 Volts DC/5A
desktop flow cytometer with laser excitation in
green. It analyses up to three optical parameters dimensions & weight

Height 307 mm
(SSC and 2 fluorescence channels). It performs
325 x 330 x 265 mm, weight: 11.5 kg
both fluorescence analysis and true volumetric
absolute cell counting without the need for refe-
Order numbers

Height 124 mm
rence beads or a haematology counter.
CyFlow® Counter
light source CY-S-3022

The CyFlow® Counter is equipped with a modern

and powerful 532 nm green solid state laser light
reagents Length 300 mm

source. Partec CD4 easy count kit (100 tests)

05-8401 Length 264,1 mm
Optics Partec CD4% easy count kit (100 tests) 16 mm
05-8405
alignFree™ optical system with 3 optical para-
for CyFlow® Counter
meters / 2 fluorescence channels (SSC, FL-1,
FL-2). Each parameter is equipped with a photo-
Height 307 mm

Partec CD8 easy count kit (100 tests)

multiplier tube (PMT) and integrated electronic
05-8801
preamplifier.
Partec CD3 easy count kit (100 tests)
05-8301
Flow system
Synthetic quartz flow cuvette (channel dimen- Partec CD4 easy count kit - dry
sions: 250 µm x 350 µm) for laminar sample flow. 05-8401-d
True Volumetric Absolute Counting based on Partec CD4% easy count kit- dry
precise counting and fluid volume measurement. 05-8405-d
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 R 430

_ 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

All technical specifications are subject to change without notice.

For in vitro
diagnostic use.

Technical Specifications 7
05 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. item

CY-S-3022 Partec 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*

05-8993 Partec ControlBlood - dry*

* For in vitro
diagnostic use.

8 Overview
06 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

_ 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 Performance
Tray versions _ Positionning: (X, Z) < 0.1 mm and (Y) < 0.3 mm
_ 10, 20, 30, 40 samples plus pipette tips _ cross contamination: < 1.0 %
_ 96 well microplate _ Dispensing precision and
_ Cleaning and washing solution reservoirs accuracy: >99.9 % @ 250 µl, > 99.0 % @ 40 µl
_ 2 large buffer reservoirs with _ Cycle time: 30 sec depending on program mode
Order No. Product
2 precision syringe pumps CY-S-3053 Partec CyFlow® Autoprepara-
Programming Power Supply & Dimensions tion- and Autoloading Station
_ User selectable preparation _ AC adapter (100 – 240 V) 50V AC
CY-S-3073 Partec CyFlow® Counter inclu-
or autoloading modes _ H x W x D (310 x 380 x 250 mm)
ding CyFlow® Autopreparation
_ User definition for incubation _ Weight 9.6 kg
& Autoloading Station
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

Sample Automation 9
07 Reagents

pArTeC dry reAgenT KiTs

For CD4 and CD4% counting, eliminating any need for cold chain and cold storage

Cost reduction and improved Accuracy

In addition, a significant cost reduction is achieved due to much
easier transport and storage of reagent kits. Another important
advantage is the improved accuracy of the test as all pipetting
steps besides the transfer of the primary blood sample into the
test tubes are eliminated. Hence, the new “dry” kits from Partec
lead to a tremendous improvement for monitoring the immune
status of HIV/AIDS patients worldwide.

Highlights dry reagent Kit

_ Identification and enumeration of the CD4+ helper/

partec “dry” reagent Kit inducer T-lymphocyte subset (and CD45+ leukocytes)
in human blood samples
_ No lyse - no wash reagent kit based on ready-prepared
innovative solution
test tubes containing “dry”, lyophilized CD4-PE (and CD45-
Partec is introducing an innovative and unique solution for CD4 PE-Dy647 mAbs) for volumetric absolute counting of CD4+
absolute and CD4% counting. In combination with the CyFlow® T-cells (and CD4% among lymphocytes) in HIV monitoring
and for follow-up diagnostics of adult and pediatric
instruments, reagents for HIV monitoring and AIDS patient AIDS patients – for CyFlow® Counter and CyFlow® SL_3
follow-up are now available ready-prepared in dry/lyophilized
form in ready-to-use test tubes. This new product is a significant
breakthrough for patient support programmes, especially in
Order no. product
resource-constrained settings, because it eliminates any need
05-8401-d Partec CD4 easy count kit - dry
for a cold chain and refrigeration as necessary for conventional
test kits. The CD4 / CD4% “dry” kits can be stored at high room 05-8405-d Partec CD4% easy count kit - dry
temperatures and have a shelf life of 12 months.

10 Reagents
pArTeC COnTrOlblOOd – dry
Quality Control and External Quality Assessment with Dry Stabilized Blood Samples

in Germany has developed freeze-dried (lyophilized) blood

samples with superior features. These samples serve as per-
fect tool for leukocyte immunophenotyping, differential cell
counting and all other testing applications. Logistics and sto-
rage are now safely possible without any needs for cold chain
and refrigeration. Instrument calibration and quality control
procedures are possible in any laboratory without degradation
of the cellular material and function.

partec Controlblood - dry

Highlights Controlblood – dry

Applications
Modern clinical routine laboratories require state-of-the-art
_ ideal for immunophenotyping, for example
laboratory tests for many clinical parameters. Quality control HIV monitoring and AIDS patient follow-up
routines therefore play an increasingly important role for _ perfect material for multinational surveys
and clinical multisite studies
applications like immunophenotyping and CD4+ T-cell / CD4%
_ quality control (QC) | external quality assessment (EQA)
counting in HIV/AIDS programs. Internal quality control and
external quality assessment procedures need reliable stan-
dard reference materials which are utmost stabile, easy to
ship and most easy-to-use.

The German Reference Institute for Bioanalytics (RfB) of

Order no. product
the German Society for Clinical Chemistry and Laboratory
05-8993 Partec ControlBlood - dry
Medicine e. V. (DGKL, www.dgkl-rfb.de) together with the
Institute for Laboratory Medicine and Transfusion Medicine
of the University Hospital at the Ruhr University Bochum

Reagents 11
Contact

Partec GmbH Partec GmbH Partec North America, Inc. Partec Japan, Inc. Partec S.A.R.L.
Am Flugplatz 13 Otto-Hahn-Straße 32 603 Heron Dr., Unit 9 3628-46 Kandatsu 14/16 rue Gallieni
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[email protected] [email protected] Fax 856 467 0188 [email protected] Fax +33 1 69 04 90 38
[email protected] [email protected]

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[email protected]
Phone +44 1227 811711
Fax +44 1227 811712
[email protected]

Partec Afrique Centrale Partec East Africa Ltd Partec Southern Africa Complete list of subsidiaries and distributors:
SARL N.H.I.F. Building, 2nd Floor (Pty) Ltd
Rue Bebey Elame—AKWA Ragati Road Unit IF
www.partec.com
Douala Code 00517—Uhuru Plot 119
B.P. 2326 Gardens Millenium Park
Douala Nairobi Gaborone
Cameroon Kenya Botswana
07.10

Phone +237 33 42 76 12 Phone +254 20 272 7355 Phone +267 318 1844
Phone +237 77 65 41 89 Fax +254 20 272 7358 Fax +267 318 1841
Fax +237 33 42 76 12 [email protected] [email protected]
www.cyclos-design.de

[email protected]