INNOVATIVE HIV POINT-OF-CARE (POC) CD4, EID AND VIRAL LOAD EQUIPMENT PROJECT
EID/VL POC/Near POC Technology 2015
Alere
Cepheid
U. Cambridge & DRW
U. Cambridge & DRW
Cepheid
Roche Molecular Systems
Alere Q - EID Assay
Gene Xpert IV - EID/VL Assay
SAMBA I
SAMBA II
Omni
Liat Analyser
Company
Name of product
EID/VL POC/Near POC Technology anticipated for 2016
Instrument picture
Regulatory status
· ISO 13485: 2012 certified
· CE 98/79/IVD marked for EID only
· WHO PQ: Pending
· ISO 13485: 2003 certified
· CE 98/79/IVD marked for EID and VL
· WHO PQ: Pending
· ISO 13485:2003 certified
· CE-IVD: Pending
· WHO PQ: Pending
· ISO 13485:2003 certified
· CE-IVD: Pending
· WHO PQ: Pending
· ISO 13485: 2003 certified
· CE -IVD available in first half of 2016
· WHO PQ: Pending
In development
Format
Portable- table top
Table top
Table top
Table top
Small and Portable / table top
Small handheld / table top
Weight -gross
7.8 Kgs
31 kgs with desktop computer;
28 kgs with laptop computer
Prep: 50 kgs;
Amp: 4.5 kgs
Display module: 2.1 kgs;
Assay module: 9.9 kgs
1.0 kg (2.2 lbs)
3,75 kgs
Physical dimensions - gross
W 20 x H 22 x D 31 cm
W 27.94 x H 30.48 x D 9.72 cm
Prep: 68 x 64.5 x 51 cm
Amp: 40.5 x 32 x 11.4 cm
Display module: 21.5 x 17 x 18 cm Assay W 7.6 cm (3.0”) x H 23.1 cm (9.1”) x D
module: 19 x 33 x 33 cm
10.6 cm (4.2”)
Principle of assay
Real Time PCR for qualitative detection of Nested real-time reverse transcriptase
RNA for HIV-1 (M/N,O) and HIV-2
PCR
Semi quantitative assay, based on
isothermal amplification and visual
detection of nucleic acids. The test
reagents and disposables are provided
with cartridges, which are processed in
SAMBAprep for sample extraction and
SAMBAamp for amplification and
detection.
It is based on isothermal amplification Nested real-time reverse transcriptase
and visual detection of nucleic acids by a PCR
dipstick. It is a qualitative assay for the
detection of HIV-1 RNA and pro-viral
DNA in whole blood samples (EID) and
the HIV-1 Semi-Q assay is a
semiquantitative assay with a cut off at
1,000 copies/ml (VL)
EID: (RT-PCR) Qualitative HIV-1 RNA
and DNA
VL: (RT-PCR) Quantitative HIV-1 RNA
Output
Qualitative HIV p24 (EID)
HIV-1 Viral Load and EID test
Semi-quantitative viral load (1,000
copies/ml cut off) and qualitative early
infant diagnosis
EID and VL
EID and VL
Product features
EID and VL
Sample type
Capillary or venous whole blood
EID: whole blood, DBS
VL: plasma
EID: whole blood
VL: plasma
EID: Capillary or venous whole blood;
VL: Plasma
EID: whole blood, DBS
VL: plasma
EID: whole blood
VL: whole blood or plasma
Sample volume
25 μL
EID: 100ul
1 DBS: approx. 75ul
VL: 1mL
EID: 100 μl VL:
200 μl
EID: 100 μl VL:
200 μl
EID: 100 µL
1 DBS: 60-70 µL
VL: 1 mL
TBD
Reading time to results
52 minutes
EID: 92 minutes
VL: 90 minutes
EID: 120 minutes
VL: 90 minutes
EID: 120 minutes
VL: 90 minutes
EID: 92 minutes
VL: 90 minutes
TBD
Throughput (per 8 hrs working
day/operator)
8 tests
21 tests per 8 hours. System can provide 16 – 24 tests (using one SAMBAprep and 4 tests/assay module/day
higher throughput
one SAMBAamp system, throughput can
be increased with additional SAMBAamp
units)
5 tests per 8 hours. System can provide
higher throughput
TBD
Batching capabilities
No
Not required
Prep up to 6 channels at one time
(batch). Amp up to 4 channels
individually (random access)
modular, random access
Not required
Built-in printer
No, external printer
No, external printer
No, external printer
Yes
No, external printer
Number of tests results printed with 1
paper roll
Approx. 100 test results
N/A
Alere
Company
Cepheid
Approx. 2000 test results
U. Cambridge & DRW
U. Cambridge & DRW
Cepheid
Data storage
Approx. 1000 test results
Data is saved in computer
N/A
Approx. 100,000 test results in the
display module
Connectivity
Pack II: USB modem with 3G card and
booster;
Pack III: USB-Lan adaptor
Ethernet; Wi-Fi; USB ports.
Communications protocols for HL7 and
ASTM standards
N/A
Not available. Data transfer via USB drive Real-time communications via Wi-Fi or
and Ethernet
cellular connection.
Power requirements
Mains Power 100-240V A/C; 50-60 Hz.
Internal battery as back up to ensure 1
test run
220-240V, 50-60 Hz - 110V
Prep/Amp: 100–250 V, 50 Hz; 150/ 50
watts
Display/assay module: 100 – 250 V,
50Hz.; 20 W/ 80 W
Low Power Consumption
Built-in voltage surge protection
TBD
Separate UPS with surge protection
advised
External UPS and battery back-up
External UPS and battery back-up
Integrated battery and supplemental
battery.
Capacity battery life (in hours and test
Roche Molecular Systems
Data saved on GeneXpert Omni and
Cepheid Cloud Control via automated
data transfer. System-wide data
surveillance available through Cepheid
Cloud Control
External UPS enables test completion in External UPS enables test completion in Integrated Rechargeable Battery: Up to
case of electricity outage
case of electricity outage
four (4) hours operation with
unexpected interruption to power
supply.
Supplemental Rechargeable Battery
Supply (up to 12-hours of battery life):
With variable to no power supply, a
supplemental rechargeable battery
provides freedom to operate for up to
2days of testing.
runs)
Alternative charging options: solar
panel, car battery, etc.
Extended battery planned with multiple
charging options including solar
Prep can be run off a 24vDC power
can be run off 24vDC. e.g. solar panels or Alternative power sources will be
available, including car battery, and
supply e.g. solar panels or batteries. Amp batteries
solar panel
can be run off a 12vDC power supply e.g.
solar panels or batteries
Operating temperature
4- 30 °C
15 - 30 °C
10- 35 °C
10- 38 °C
15 - 40 °C
15– 32 °C
Operating relative humidity (RH)
15- 40 %
10–95 %
5 – 95 %
5- 95 %
10 - 95 %
15 – 80 %
Factory calibrated
Yes, with autofocus of the optics each
time a test is run
Yes, plus annual calibration performed
by the user
Yes
Yes
Yes, plus annual calibration performed
by the user
Temperature limits during transport of 4- 30 °C
all reagents
2 - 28 °C
Transport: 10- 50 °C; 1 month
10- 50 °C; 1 month
2 - 28 °C
Temperature limits during storage of
all reagents
4 - 30 °C
2 - 28 °C
Storage: 2 – 37 °C
2- 37 °C
2 - 28 °C
Shelf life for unopened tests and all
reagents
6 months
Minimum 9 months
12 months
12 months
Minimum 9 months
Third party supplies to run product
Consumables for blood collection
Consumables for blood collection.
Consumables for blood collection.
EID(using DBS): thermomixer and block; For plasma preparation: centrifuge
VL: centrifuge
Consumables for blood collection.
For plasma preparation: centrifuge
Consumables for blood collection.
EID(using DBS): thermomixer and block;
VL: centrifuge
Internal quality control (IQC)
Device control checks each test run,
Probe-check controls and internal PCR
multiple QC parameters for functionality controls
of system
Available, requires shipment under dry
ice and stored frozen
Available, requires shipment under dry
ice and stored frozen
Probe-check controls and internal PCR
controls
Compatible with external quality
control scheme(s)
TBD
TBD
TBD
TBD
Reagents storage, consumables and quality controls
Ease of use
TBD
Sample volume control; internal process
controls
Setting to run product
Urban and rural, across all health
facilities
Any facility with electricity
Alere
Company
Any facility with electricity
Cepheid
Any facility with electricity
U. Cambridge & DRW
U. Cambridge & DRW
Any facility
Urban and rural, across all health
facilities
Cepheid
Roche Molecular Systems
Intended operator to run product
Trained health care worker or lab
technician
Trained health care worker or lab
technician.
Trained lab technician, lab assistant, task
shifting studies to train lower cadres of
health care workers and community
workers will be carried out
Trained health care worker. Task
Any trained health care worker or lab
shifting studies conducted in Zimbabwe technician.
and Uganda show that lower cadres of
health care workers like midwives,
counsellors and microscopists can
operate SAMBA II
Trained health care worker (training
approx. 30 minutes)
Testing procedure
1) Blood sample collection; 2) Add
blood sample in the sample collector
attached to the cartridge (the flow of
blood into the sample window is
verified before the sample collector is
discarded and cartridge capped); 3)
The cartridge is loaded into the
equipment and the test begun;
4) Enter patient ID data and read result
from screen
EID whole blood; 1) Sample collection:
2) Transfer 750μL of reagent buffer
into cartridge; 3) Mix the tube 7 times;
4) Transfer 100μL of blood into
cartridge and close; 5) Cartridge is
loaded in the equipment and result is
read.
EID DBS: 1) Place a DBS into the sample
reagent buffer tube; 2) incubate in the
thermomixer for 15 min at 56 °C; rotate
at 500rpm 3) transfer 1ml of the liquid
to the cartridge and close; 5) Cartridge is
loaded in the equipment and result is
read.
VL Plasma: 1) Centrifuge sample to
separate plasma, 2) add 1ml of plasma
into the cartridge and close; 4) Cartridge
is loaded in the equipment and result is
read
1)
Blood sample collection;
2)
Centrifuge sample to extract
plasma
(VL test only);
3)
Insert sample and cartridges into
SAMBAprep machine;
4)
Press start button and place tube
containing extracted sample into
SAMBAamp;
5)
Load SAMBAamp cartridge and
transfer extracted sample into
amplification cartridge;
6)
Press start button and at
completion of amplification step (beep
will sound); 7) Rotate cartridge
manually, plunge detection buffer and
read test results visually at end of
detection
1)
Blood sample collection;
2)
Centrifuge sample to extract
plasma
(VL only);
3)
Add sample to the cartridge; 4)
Add the cartridge into the equipment; 5)
Press start button and select 'print' for
printed results if desired, the data is
automatically stored and displayed
EID whole blood: 1) Sample collection:
2) Transfer 750 μL of reagent buffer
into cartridge; 3) Mix the tube 7 times;
4) Transfer 100 μL of blood into
cartridge and close; 5) Cartridge is
loaded in the equipment and result is
read.
EID DBS: 1) Place a DBS into the sample
reagent buffer tube; 2) incubate in the
thermomixer for 15 min at 56 °C; rotate
at 500rpm 3) transfer 1 ml of the liquid
to the cartridge and close; 5) Cartridge is
loaded in the equipment and result is
read.
VL Plasma: 1) Centrifuge sample to
separate plasma, 2) add 1 ml of plasma
into the cartridge and close; 4) Cartridge
is loaded in the equipment and result is
read
1)
Blood sample collection;
2)
Apply blood to Liat tube;
3)
Insert tube into Liat analyser; the
analyser will start assay and the result
will be reported automatically
Training type and duration
One half-day session on user training. No One half-day session on user training
maintenance training required
1 day
4 hours total training
On-board videos and self-instruction.
One half-day session on user training
available
Languages of training material
English, French, Portuguese
Portuguese, Spanish, English, French,
Russian
English
English
Portuguese, Spanish, English, French,
Russian
Training available on site
Yes
Yes
Yes
Yes
Yes at central sites, train the trainer
available for decentralization
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 on-site
repair. After-sales support available
The GeneXpert IV-4 requires routine
preventative maintenance. In case of
breakdown, supplier-trained engineer
will repair it. After-sales support
available
The equipment does not require routine Any faulty equipment will be swapped
maintenance. In case of failure the
out with a replacement. After-sales
instrument will be swapped out.
support available
Aftersales support available
The Omni requires routine preventative Through Roche offices worldwide
maintenance. In case of breakdown,
supplier-trained engineer will replace it.
After-sales support available
Warranty of product
1 year
2 years
1 year
1 year
2 years, extended 5 year warranty
available
Installation of product on-site
No
Yes by local supplier-trained engineers
Yes
Not anticipated
Not required, available if needed
Service & Maintenance