INNOVATIVE HIV POINT-OF-CARE (POC) CD4, EID AND VIRAL LOAD EQUIPMENT PROJECT
CD4 POC/Near POC Technology 2015
Company
CD4 POC/Near POC Technology anticipated for 2016
Orgenics/Alere
Becton Dickinson
Sysmex/Partec
Millipore
Omega Diagnostics
Chipcare
Pima
BD FACSPresto
CyFlow miniPOC
Muse Auto
CD4/CD4% system
Visitect CD4
ChipCare-CD4
Name of product
Analyser
Regulatory status
· ISO 13485: 2012 certified
· CE 98/79/IVD marked
· WHO Prequalified in 2012
· ISO 13485:2003 certified
· CE 98/79/IVD marked
· WHO Prequalified in 2014
· ISO 13485:2012 certified
· CE 98/79/IVD marked
· WHO PQ: Pending
· ISO 13485: 2003 certified ·
Product in development: it has
delayed launch date due to
improvements on the analyser
· ISO 13485: 2012 certified
· CE-IVD: Pending
· WHO PQ: Pending
· Product in development
Format
Portable table top
Portable table top
Portable table top
Portable table top
Disposable with optional reader
Handheld, table top
Weight
2.54 kgs
7 kgs
6.2 kgs
4 Kgs
<1 kgs
Physical dimensions
W 13 × H 16 x D 22 cm
W 25.9 x H 28.5 x D 25.1 cm
W 26.8 x H 24.3 x D 18.6 cm
W 20.62 x H 22.07 x D 28.22 cm
Principle of assay
LED illumination and CCD-based
detection of fluorescent-antibody
labelled cells. Enumeration of CD4
Tlymphocyte absolute per unit of
volume (cells/ul). Cd3+ CD4+ cells/ul
3-color Imaging cytometry with
fluorescent labelled antibodies to
count CD4 and %CD4 in whole blood.
Imaging spectrometer for absorbance
measurement of total
Haemoglobin (Hb)
The CyFlow miniPOC being based on Flow Cytometry
the cell enumeration “gold standard”
technology flow cytometry. It
performs an automatic cleaning cycle
after each measurement
Disposable: 0.300 Kgs;
Reader: 0.800 kgs
Test: W 19x H1.5x D13cm;
Reader: W 19x H19x D18cm
Disposable cartridge containing test
strip (lateral flow) that measures CD4
proteins on T cells- 350 cut-off
Output
Quantitative CD4 Abs count
Sample type
Capillary or venous whole blood
Quantitative CD4 Abs count, CD4 %
and Hb
Capillary or venous whole blood
Quantitative CD4 Abs count and CD4 Quantitative CD4 Abs count
%
Capillary or venous whole blood
Venous whole blood
Semi-quantitative CD4 Abs count
(350/500 cut-off)
Capillary or venous whole blood
Quantitative CD4 Abs count and CD4
%
Capillary or venous whole blood
Sample volume
25 μL
20 µL
20 μL
30 μL
10 µL
Reading time to results
20 minutes
15 minutes
15-20 tests
20 min for first sample. Then 40 –70 3 minutes
seconds per sample
Up to 250 tests
100 tests
40 minutes
Throughput (per 8 hrs working
day/operator)
22 min for first sample. Then 4
minutes per sample
60 - 80 tests
120 tests
24 tests
Batching capabilities
No
Yes
Yes
Yes
Yes
No
Built-in printer
No, external printer
Yes
Yes
No, external printer
No
No, external printer
About 120
42
N/A
Approx. 12000 test results
Approx. 20,000 test results
Approx. 1000 test results on reader
Product features
Number of tests results printed with 100
1 paper roll
Data storage
Approx. 1000 test results
Connectivity
Power requirements
Available 3 different connectivity
TBD
packages
Built in 18V DC battery with 100240V 100-240 VAC, 50-60 Hz
at 47-63 Hz
Not available. Data transfer via USB
drive
100/240 VAC power supply - 50/60
Hz, 66 watts
10 μL
If specified
50/60 Hz, 80 Watts
Handheld reader with a disposable
microfluidic cartridge; 3-color
fluorescence imaging cytometer for
measurements of absolute and
percent CD4 count
Approx. 5000 test results
Available on reader and Android
Available
Smart Phone App
100 - 240 V / 50 Hz., 3 watts, optional
12V battery pack
Orgenics/Alere
Company
Becton Dickinson
Built-in voltage surge protection
Yes. fuse protection of Battery
Yes, built-in
Capacity battery life (in hours and
test runs)
Up to 8 hours or 20 tests in a fully
capacitated, new battery
Approx. 6 hours or 40-60 tests
Alternative charging options: solar
panel, car battery, etc.
Extended battery planned with
multiple charging options including
solar
Solar and Car Battery
Operating temperature
2- 40°C
Operating relative humidity (RH)
10- 95% (non condensing)
Factory calibrated
Yes, with autofocus of the optics each Yes, self-calibration when device
time a test is run
switch is on
Sysmex/Partec
Yes, category 3/III; Degree of
protection IP 20
Millipore
Omega Diagnostics
Chipcare
Yes
TBD
Yes
2 hours
Governed by choice of external
battery power bank
8 hours and 30 tests
Rechargeable high efficiency lithium Rechargeable battery option
battery pack for 4-5 hours operation
and a set comprising the battery pack
plus solar panel
Off the shelf battery packs available
or 12v DC car adaptor
Solar and car battery
10- 40 °C
15- 30 °C
10- 35 °C
2- 40 °C
10- 40 °C
10- 95%
20- 85% (non condensing)
5- 85%
20- 70% (non condensing)
10- 90%
Yes, align free optical system
Yes
Yes
Yes equipment performs daily
selfcalibration
Reagents storage, consumables and quality controls
Temperature limits during
transport of all reagents
2- 30°C
45- 60 °C
10- 35 °C (for transportation times ≤ 1- 25 °C
10 days)
2- 40 °C
5- 40 °C
Temperature limits during storage 2 - 30°C
of all reagents
4- 31°C
2- 8°C, do not freeze
Reagent: 4 °C, Lyse reagent is stored
at room temperature
2- 40 °C
5 - 40 °C
Shelf life for unopened tests and all
reagents
12 months
6 months
12 months
12 months
12 months
Third party supplies to run product Consumables for blood collection
Consumables for blood collection
Consumables for blood collection,
automatic pipette of 20μl and
Consumables for blood collection
Consumables for blood collection
Consumables for blood collection
Internal quality control (IQC)
Bead check consisting of a low and
normal cartridge
Built-in and cartridge QC available
The proper functionality of the
instrument is crossed checked daily
by using count check beads green –
dry, which are included in Partec
miniPOC CD4% kit – dry
Yes
Built-in quality control line
Built-in electronic monitoring and
software. Device and cartridge has
internal controls on sample volume,
reagent/cartridge expiry date, and
fluorescence intensities
Compatible with external quality
control scheme(s)
Yes, with Streck CD4 Count, Streck
CD-Check Plus BC, IMMUNO-TROL,
LymphoSure, BD Multi-Check, QASI
and NEQAS
Yes, with CD Check Plus BC
Yes, with non-commercial (i.e.
Governmental German "ring trial"
System) and commercially available
EQA schemes
Yes
In validation stage
Yes
Setting to run product
Any facility with at least sporadic
electricity
Any facility with at least sporadic
electricity
Any health facility with fridge and
electricity
Any health facility with electricity
Urban and rural, across all health
facilities
Any health facility with at least
sporadic electricity
Intended operator to run product
Trained health care worker
Trained health care worker
Laboratory technician, lab staff,
nurses
Trained health care worker
Trained healthcare worker
Trained health care worker
12 months
Ease of use
Company
Orgenics/Alere
Becton Dickinson
Sysmex/Partec
Millipore
Omega Diagnostics
Chipcare
Testing procedure
1) Blood sample collection; 2) Apply
blood sample to cartridge;
3) Incubate cartridge with sample for
18 min;
4) Insert cartridge into analyser;
analysis starts automatically; 5)
Enter patient ID data and read
sample. Result will be displayed on
screen and automatically printed
1)
Venous blood sample
1)
Blood sample collection;
collection;
2)
Mix 8 time the tube;
2)
Mix tube 8 times ;
3)
Place the tube in the
3)
EDTA blood is added into
instrument; 4) Two 15 minute
incubations, run system for three
ready-touse CD4/CD45 dry mAb
minute results 5) Enter patient ID
reagent tube;
data and read result from screen
4)
Shake by hand for approx. 3
seconds, then incubate in the dark for
15 minutes;
5)
Prior to analysis add the readytouse prefilled buffer solution “Buffer
1”; 6) Add the ready-to-use prefilled
buffer solution 2; 7) The sample is
transferred to the sample port by
using a plastic disposable syringe, 8)
Start the analysis of sample and read
the result automatically
One half-day session on user training. Less than one hour user training. No On site end user and maintenance
On site, one to two days session on
No maintenance training
maintenance training required
training; duration 1 day
user training
1) Blood sample collection; 2) Add
blood sample to Well A of test device;
3) After 3 minutes add 1 drop of
buffer to Well A of the test device; 4)
After a further 17 minutes add 3
drops of buffer to Well B of the test
device;
5) Read the results after a further 20
minutes
1) Blood sample collection; 2)
Transfer blood sample to the
cartridge
3) Insert cartridge into device 4)
Press start button and read the
results on the LCD screen or print
out a paper copy
Basic half day user training. Full
training manuals available
One half-day session on user training
Languages of training material
requiredEnglish, French, Portuguese English
English; French; other are available
on request
English, French, Portuguese
English, French, Portuguese
English, French and Portuguese
Training available on site
Yes
Yes
Yes
Yes
Yes
Yes
Service and maintenance
The equipment is designed to be
maintenance free with no user
serviceable parts inside. If damaged,
equipment can be direct swapped out
with a replacement rather than onsite repair. After-sales support
available
The equipment contains an
The CyFlow miniPOC does not
integrated camera and microscope
requires routine preventive
that might be susceptible to damage if maintenance but it is optionally
dropped. If damaged, equipment can available. In case of breakdown,
be direct swapped out with a
either a supplier-trained engineer
replacement rather than on-site
will repair it on site or there will be
repair. After-sales support available an instrument swap. After-sales
support available
Available
Test is disposable and does not
Available
require service/maintenance;
optional reader has no serviceable
parts or maintenance programme,
robust and will be swapped out if it
fails. After-sales support not available
Warranty of product
2 years
3 years
1 year
1 year
1 year
Installation of product on-site
Not needed
Not needed
Installation of product on-site
Yes
Not needed
Training type and duration
1) Blood sample collection; 2) Apply
blood drops to cartridge; 3) Close
cartridge and insert cartridge into
analyser; analysis starts
automatically;
4) Enter patient ID data and read
result from LED screen
Service & Maintenance
No installation required. Ready to use
after opening the box