INNOVATIVE HIV POINT-OF CARE (POC) CD4,

EARLY INFANT DIAGNOSIS (EID) AND

VIRAL LOAD (VL) TECHNOLOGIES

HIV PRODUCT PROFILES for Point of Care (PoC) CD4, Early Infant Diagnosis (EID) and Viral Load (VL) technologies for

initial scale –up

October, 2015

1

Content HIV Point of Care Project .................................................................................................................................................. 2

Request for Proposals (RFP) for initial scale-up ................................................................................................................ 2

Selection of technology in the context of the health care system ................................................................................... 2

HIV Product profiles .......................................................................................................................................................... 3

How to use this information ............................................................................................................................................. 3

Rules and responsibilities.................................................................................................................................................. 3

List of abbreviations .......................................................................................................................................................... 4

CD4 Technology ................................................................................................................................................................ 6

Alere Technologies GmbH ............................................................................................................................................. 6

BD International ............................................................................................................................................................ 7

Omega Diagnostics Ltd .................................................................................................................................................. 8

HUMAN ......................................................................................................................................................................... 9

Partec GmbH ............................................................................................................................................................... 10

EID Technology ................................................................................................................................................................ 12

Alere Technologies GmbH ........................................................................................................................................... 12

North-western Global Health Foundation (NWGHF) .................................................................................................. 13

EID/VL Technology .......................................................................................................................................................... 15

Diagnostics for the Real World Ltd ............................................................................................................................. 15

CEPHEID HBDC ............................................................................................................................................................ 16

VL Technology ................................................................................................................................................................. 18

Diagnostics for the Real World Ltd. ............................................................................................................................ 18

Summary tables .............................................................................................................................................................. 19

2

HIV Point of Care Project UNITAID, Clinton Health Access Initiative, Inc. (CHAI) and United Nations Children’s Fund (UNICEF)

have engaged in a tri-party agreement to accelerate access to high-quality Point of Care (PoC) HIV diagnostic

products by addressing market shortcomings and overcoming barriers to entry and uptake for new diagnostics,

in order to maximise the impact of these technologies on patient outcomes. CHAI and UNICEF will undertake

a set of activities which simultaneously engage both the supply and demand sides of the market in 7 high-

volume, early-adopter countries (Ethiopia, Malawi, Mozambique, Kenya, Tanzania, Uganda, and Zimbabwe).

The PoC project has been established to increase access to a new generation of high-quality innovative PoC

HIV diagnostic products. Creating a healthy, dynamic and sustainable market with affordable prices for PoC

technologies, particularly for patients living in remote areas.

Request for Proposals (RFP) for initial scale-up UNICEF launched an RFP for project scale–up in April 2014 to support the procurement of PoC CD4,

PoC/Near-PoC Early Infant Diagnosis (EID) and PoC/Near-PoC Viral Load (VL) technologies for

implementation pilots and initial scale-up, with the objectives of providing the project countries with a range

of high quality HIV PoC products to choose from and facilitating market entry of new manufacturers and

suppliers and increasing competition of innovative HIV PoC diagnostics

Selection of technology in the context of the health care system These innovative technologies can be used strategically at the primary and secondary levels of the health

system, depending on the specific country context; subject to patient load, reagent stability (cold chain or not),

instrument weight (portable vs. bench top), need for additional equipment (centrifuge, etc.), human resources

skills at laboratory and health site, site throughput etc. The following graph describes in general the strengths

and weaknesses of the HIV technologies according to health system level:

Primary Health Care Level

Secondary Health Care Level

Tertiary Health Care Level

STRENGTHS

PCR TEST/ANTIGEN ASSAY

• Gold standard for children

< 18 months

• High specificity/sensitivity

• DBS samples possible

NEAR POC/CONVENTIONAL TECHNOLOGY

• Table top technology

• Higher throughput than

POC

• Use of existence lab set up

POC TECHNOLOGY

• Portable light technology

• Minimal training and

maintenance requirements

• No specialised laboratory

set-up needed

WEAKNESSES

PCR TEST/ANTIGEN ASSAY

• Complex

• Weak systems to transport

DBS to referral laboratories

• DBS result reporting can be

slow

NEAR POC/CONVENTIONAL TECHNOLOGY

• Might need additional

equipment such us

centrifuge

• Reagents might require cold

chain

• Testing procedure might be

more than “plug and play”

POC technology

POC TECHNOLOGY

• May be lower throughput

• More testing sites to

manage the supply chain,

QA, training, service and

maintenance, testing data.

HIV TECHNOLOGY

3

HIV Product profiles These product profiles outline the key characteristics of products for each HIV category: CD4, EID and VL

by supplier. The information is provided to CHAI, UNITAID and Project Countries to facilitate and inform

discussion on product selection at country level for more strategic and market shaping interventions. Project

partners are encouraged to take into consideration all product characteristics, discuss them in their context to

support an optimal product selection and document the rationale for the product selection.

How to use this information

These product profiles contain technical information per product, which have been provided and confirmed

as correct by the suppliers as of date.

Alere (Pima- CD4), BD (FACSPresto- CD4), Alere (Alere Q- EID assay) and.Cepheid (GeneXpert IV- EID

and VL assay) are the manufacturers in this document that are ready for procurement for initial scale-up and

routine use. The rest manufacturers are working towards getting the minimum Quality Assurance (QA)

requirements for procurement. The two CD4 near- PoC suppliers (Partec and Human) equipment were

included in this document as reference, and potential requests can be made from Country Offices outside this

specific project, but these products are not to be procured under this project as they did not meet the

requirements of this particular HIV Point-of-Care project.

Note that from the last RFP-501714 for Innovative HIV PoC CD4, EID and VL equipment for field evaluation,

the following technologies are still available for procurement for field evaluations subject to UNICEF’s

internal approval.

Schedule 1 PoC CD4 (abs), (abs/%), rapid test, optional instrument

Omega

Rules and responsibilities When communicating this document in-country, CHAI and UNICEF Program Division shall work together

with a clear documented approach on how the product profiles are presented to country offices and Ministries

of Health. Meeting minutes should be taken, stating the meeting participants and to whom the information in

the product profiles has been presented for the process of in-country product selection.

For more information on product specifications please contact Bibiana A. Zambrano,bzambrano@unicef.org

and for contracting issues Ignacio Gimenez, igimenez@unicef.org.

4

List of abbreviations

BD Becton Dickinson

CCD Charged couple-device

CE Conformité Européenne or European Conformity

CHAI Clinton Health Access Initiative, Inc.

DBS Dried blood spots

EID Early infant diagnosis

EUR Euro

ISO International Organization for Standardization

IVD Light-emitting diode

NEQAS National external quality assessment service - UK

POC Point of care

PQ Prequalification

QA Quality assurance

QC Quality control

QASI Quality assessment and standardization for immunological measures relevant to

HIV/AIDS (QASI) - Canada

RFP Request for proposal

TBD To be determined

UNICEF SD/PD United Nations Children’s Fund Supply Division/Programme Division

USD United States dollars

VL Viral load

WHO World Health Organization

5

CD4

Technology

6

CD4 Technology Pima Analyser

Manufactured by: Alere Technologies GmbH Manufactured in: 1 Dan st. PO, 360, Yarne, Israel

Web address: www.alere-technologies.com

Specifications- Product available for procurement Product features Principle of assay LED illumination and CCD-based detection of fluorescent-antibody labelled cells. Enumeration

of CD4 T-lymphocyte absolute per unit of volume (cells/ul). CD3+ CD4+ cells/ul.

Sample type Capillary or venous whole blood

Data storage Approx.1000 test results

Sample volume 25 µl Connectivity Available 3 different connectivity packages

Reading time to results 20 min Power requirements Built in 18V DC battery with 100-240 V at 47-63 Hz

Throughput (8 hours working day/operator)

15 -20 tests Built-in voltage surge protection

Yes. Fuse protection of Battery

Operation environment 2-40 °C Factory calibrated Yes, with autofocus of the optics each time a test is run

Relative humidity 10- 95% (non condensing) Third party supplies to run product

Consumables for blood collection

Reagents storage and quality controls Temp. for transport & storage

2-30 °C Internal quality control Bead check consisting of a low and normal cartridge

Shelf life 12 months Compatible with External Quality schemes

Yes, with NEQAS, QASI scheme

Ease of use Testing procedure 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.

Setting to run product Urban and rural across all health care facilities

Intended operator to run product

Trained health care worker

Service and Maintenance 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. Warranty period: 2 years. After-sales support available.

Regulatory status Regulatory status ISO 13485: 2012 certified

CE 98/79/IVD marked WHO Prequalified in 2012

Validity until ISO: 30/07/2018 (MDC, ZLG) CE: Issued on 01/28//2014

Packaging Product weight -gross 2.54 kgs Product volume- gross W 13 × H 16 x D 22 cm

7

CD4 Technology BD FACSPresto Near patient CD4 Counter Manufactured by: BD International Manufactured in: 2350 Qume Drive, San Jose, CA 95131, USA

Web address: www.bd.com

Specifications - Product available for procurement Product features Principle of assay 3-color Imaging cytometry with fluorescent labelled antibodies to count CD4 and %CD4 in whole

blood. Imaging spectrometer for absorbance measurement of total Haemoglobin.

Sample type Capillary or venous whole blood

Data storage Approx.12000 test results

Sample volume 20 µl Connectivity TBD

Reading time to results 22 min for first sample. Then 4 min per samples (batching)

Power requirements 100-240 VAC, 50-60 Hz

Throughput (8 hours working day/operator)

60- 80 tests Voltage surge protection Yes, built-in

Operation environment 10- 40 °C Factory calibrated Self-calibration when device switch is on

Relative humidity 10- 95% Third party supplies to run product

Consumables for blood collection

Reagents storage and quality controls Temp. for transport & storage

Transport 45- 60 °C Storage 4- 31 °C

Internal quality control Built-in equipment and cartridge QC

Shelf life 12 months Compatible with External Quality schemes

Yes, with Multicheck CD4 control and Eurotrol FACSPresto Hb Control

Ease of use 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.

Setting to run product Urban and rural, across all health facilities

Intended operator to run product

Trained health care worker

Service and Maintenance Maintenance The equipment contains an integrated camera and microscope that might be susceptible to

damage if dropped. If damaged, equipment can be direct swapped out with a replacement rather than on-site repair. Warranty period: 3 years. After-sales support available.

Regulatory status Regulatory status ISO 13485:2003 certified

CE 98/79/ IVD marked WHO Prequalified in 2014

Validity until ISO: 03/11/2016 (BSI, CMDCAS) CE: Issued on 28/03/2014

Packaging Product weight - gross 7 kgs Product volume - gross W 26 x H 28.5 x D 25 cm

8

CD4 Technology OMEGA Diagnostics LTD

Company: Omega Diagnostics Ltd Manufactured in: House, Hillfoots Business Village, Alva, FK12

5DQ Scotland, UK

Web address: www.omegadiagnostics.com

Specifications- Product available for procurement for evaluation based on supplier response to RFP 501714 Product features Principle of assay Disposable cartridge containing test strip (lateral flow) that measures CD4 proteins on T cells-

350 cut-off.

Sample type Capillary or venous whole blood

Data storage Approx. 1000 test results on reader

Sample volume 30 µl Connectivity Available on reader and Android Smart Phone App

Reading time to results 40 min Power requirements 100 - 240 V / 50 Hz., 3 Watts Optional 12V battery pack

Throughput (8 hours working day/operator)

120 tests Built-in voltage surge protection

TBD

Operation environment 2 – 40 °C Factory calibrated Yes

Relative humidity 20- 70% (non condensing) Third party supplies to run product

Consumables for blood collection

Reagents storage and quality controls Temp. for transport & storage

2– 40 °C Internal quality control Built in quality control line

Shelf life 12 months Compatible with External Quality schemes

In validation stage

Ease of use Testing procedure 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.

Setting to run product Urban and rural, across all health facilities

Intended operator to run product

Trained health care worker

Service and Maintenance Maintenance Test is disposable and does not require service/maintenance; optional reader has no serviceable

parts or maintenance programme, robust and will be swapped out if it fails. Warranty period of the optional reader: 1 year. After-sales support not available.

Regulatory approvals Regulatory approvals ISO 13485: 2012 certified

CE-IVD: pending WHO PQ: pending

Validity until ISO: 11/01/2015 (URS)

Packaging Product weight - gross Disposable test: 0.300 Kgs

Optional reader: 0.800 kgs Product volume - gross Test: W19 x H1.5 x D13 cm

Reader: W19 x H19 x D18 cm

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CD4 Technology HumaCount CD4now Manufactured by: HUMAN Gesellschaft für Biochemica und

Diagnostika mbH

Manufactured in: Max-Planck-Ring 21 D 65205 Wiesbaden, Germany

Web address: www.human.de/en/index.php

Specifications- Product not eligible for procurement for this project Product features Principle of assay Automatic CD4 / CD4% and haematology analyser. Gold-labelling of CD4+ cells.

Sample type Venous whole blood Data storage Approx. 8000 test results

Sample volume 40 µl Connectivity Not available. Data transfer via USB drive

Reading time to results 8 minutes Power requirements 110-230 V/47-63Hz, 110 VA. Battery optional

Throughput (8 hours working day/operator)

50 tests Built-in voltage surge protection

Yes, power safety socket, plus UPS or battery system

Operation environment 18 - 34 °C Factory calibrated Calibration/alignment is done during installation and then during annual maintenance by local engineer

Relative humidity < 80% Third party supplies to run product

Consumables for blood collection, roller and vortex

Reagents storage and quality controls Temp. for transport & storage

Storage: 2 to 30 ° C Transport: 10 days at 50 °C

Internal quality control DailyCheck Control. Counter provides 53 quality checks during each test run

Shelf life 12 months Compatible with External Quality schemes

Yes, with Streck Check Plus CD4 control

Ease of use Testing procedure 1) Venous blood sample collection; 2) Mix tube 8 times; 3) Place the tube in the instrument; 4)

Enter patient ID data and read result from screen.

Setting to run product Any facility with electricity Intended operator to run product

Trained health care worker

Service and Maintenance Maintenance The HumaCount CD4 now requires routine preventative maintenance. In case of breakdown,

supplier-trained engineer will repair it. Warranty period: 1 year. After-sales support available.

Regulatory status Regulatory status ISO 13485:2003 certified

CE 98/79/ IVD marked WHO PQ: pending

Validity until ISO:11/03/2019 (MDC, ZLG) CE: Issued on 19/03/2014

Packaging Product weight - gross 15.8 kgs Product volume - gross W 51 x H 40 x D 47 cm

10

CD4 Technology CyFlow miniPOC Manufactured by: Partec GmbH Manufactured in: Am Flugplatz 13, 02828 Görlitz, Germany

Web address: www.partec.com

Specifications - Product not eligible for procurement for this project Product features Principle of assay The CyFlow® miniPOC being based on the cell enumeration “gold standard” technology flow

cytometry. It performs an automatic cleaning cycle after each measurement.

Sample type Capillary or venous whole blood

Data storage Approx. 20,000 test results

Sample volume 20 µl blood sample Connectivity Not available. Data transfer via USB drive

Reading time to results 20 min for first sample. Then 40 –70 sec/sample (batching)

Power requirements 100/240 VAC power supply - 50/60 Hz, 66 watts

Throughput (8 hours working day/operator)

Up to 250 tests Built-in voltage surge protection

Yes, category 3/III; Degree of protection IP 20

Operation environment 15-30 °C Factory calibrated Yes, align free optical system

Relative humidity 20- 85% (non condensing) Third party supplies to run product

Consumables for blood collection, automatic pipette and hypochlorite solution

Reagents storage and quality controls Temp. for transport & storage

Transport: 2- 35 °C Storage: 2-8 °C

Internal quality control Count Check Beads green –dry as non-biological controls

Shelf life 6 months Compatible with External Quality schemes

Yes, with German "ring trial" System; NEQAS, QASI

Ease of use Testing procedure 1) Venous blood sample collection; 2) Mix tube 8 times ; 3) EDTA blood is added into ready-to-

use CD4/CD45 dry mAb reagent tube; 4) Shake by hand for approx. 3 seconds, then incubate in the dark for 15 minutes; 5) Prior to analysis add the ready-to-use 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 displayed.

Setting to run product Any facility with fridge and electricity

Intended operator to run product

Laboratory technician, lab staff, nurses

Service and Maintenance Maintenance The CyFlow® miniPOC does not requires routine preventive maintenance but it is optionally

available. In case of breakdown, either a supplier-trained engineer will repair it on site or there will be an instrument swap. Warranty period: 1 year. After-sales support available.

Regulatory status Regulatory status ISO 13485:2012 certified

CE 98/79/IVD marked WHO PQ: pending

Validity until ISO: 28/06/2014 (TUV Rheinland, ZLG) CE: Issued on 29/08/2014

Packaging Product weight - gross 6.2 kgs Product volume - gross W 26.8 x H 24.3 x D 18.6 cm

11

Early Infant Diagnosis (EID) Technology

12

EID Technology Alere Q Manufactured by: Alere Technologies GmbH Manufactured in: 1 Dan st. PO, 360, Yarne, Israel

Web address: www.alere-technologies.com

Specifications- Product available for procurement for EID assay Product features Principle of assay Real Time PCR for qualitative detection of RNA for HIV-1 (M/N,O) and HIV-2.

Sample type Capillary or venous whole blood

Data storage Approx. 1000 test results

Sample volume 25 µL Connectivity Pack II: USB modem with 3G card and booster; Pack III: USB-Lan adaptor

Reading time to results 52 min Power requirements Mains Power 100-240V A/C; 50-60 Hz. Internal battery as back up to ensure 1 test run

Throughput (8 hours working day/operator)

8 tests Built-in voltage surge protection

TBD

Operation environment 4 – 30 °C Factory calibrated Yes, with autofocus of the optics each time a test is run

Relative humidity 15– 40 % Third party supplies to run product

Consumables for blood collection

Reagents storage and quality controls Temp. for transport & storage

4 – 30 °C Internal quality control Device control checks each test run, multiple QC parameters for functionality of system

Shelf life 6 months Compatible with External Quality schemes

TBD

Ease of use 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.

Setting to run product Urban and rural, across all health facilities

Intended operator to run product

Trained health care worker or lab technician

Service and Maintenance Maintenance Warranty period: 1 year. After-sales support available.

Regulatory status Regulatory status ISO 13485: 2012 certified

CE 98/79/IVD marked WHO PQ: pending

Validity until ISO: 30/07/2018 (MDC, ZLG) CE: Issued on 21/07/2014

Packaging Product weight - gross 7.8 Kgs Product volume - gross W 20 x H 22 x D 31 cm

13

Specifications- Product currently not available for procurement Product features Principle of assay In vitro immunochromatographic assay for the qualitative detection of HIV p24 antigen.

Sample type Capillary or venous whole blood

Data storage N/A

Sample volume 80 ul Connectivity TBD

Reading time to results 51 minutes Power requirements AC/DC adapter itself is rated for 39.6 W (12 V at 3.3 A)

Throughput (8 hours working day/operator)

One sample at a time, but when optimized, 12 tests

Built-in voltage surge protection

Yes

Operation environment Up to 35 °C Factory calibrated Self-calibration when device switch is on

Relative humidity TBD Third party supplies to run product

Consumables for blood collection

Reagents storage and quality controls Temp. for transport & storage

6 months at 30 °C; 3 months at 45 °C; 3 days at 55°C.

Internal quality control Built-in quality control line

Shelf life 6 months at 30 °C; 3 months at 45 °C; 3 days at 55°C.

Compatible with External Quality schemes

Yes, with WHO standard (HIV1 isolate, code NISBC 90/636)

Ease of use Testing procedure 1) Blood sample collection; 2) Separate plasma from red blood cells with plasma separator; 3)

Add buffer and heat sample in processor; 4) Insert test strip into processor and read the test result.

Setting to run product Urban and rural, across all health facilities

Intended operator to run product

Trained health care worker

Service and Maintenance Maintenance The equipment does not require routine maintenance. It will be swapped out if it fails. Warranty

period: 1 year. After-sales support available.

Regulatory status Regulatory status ISO 13485: pending

CE-IVD: pending WHO PQ: pending

Validity until

Packaging Product weight - gross 1,7 Kgs Product volume - gross W 20.2 x H 15.6 x D 13.4

cm

EID Technology LYNX HIV p24 Antigen Test Manufactured by: North-western Global Health Foundation

(NWGHF) Manufactured in: 2707 N. Lincoln Ave, Suit B, IL 60614, USA

Web address: www.nwghf.org

14

EID & viral load

Technology

15

Specifications- Product available for procurement for evaluation, but will require additional lead time to conduct RFQ Product features Principle of assay It is based on isothermal amplification and visual detection of nucleic acids by a 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 semi-quantitative assay with a cut off at 1,000 copies/ml (VL).

Sample type EID: Capillary or venous whole blood; VL: Plasma

Data storage Approx. 100,000 test results in the display module

Sample volume EID: 100 μl of blood sample VL: 200 μl of plasma

Connectivity Not available. Data transfer via USB drive and Ethernet

Reading time to results

EID: 120 min VL: 90 min

Power requirements Display/assay module: 100 – 250 V, 50Hz.; 20 W/ 80 W

Throughput (8 hours working day/operator)

EID/VL: 4 tests Built-in voltage surge protection

External UPS and battery back-up

Operation environment

10- 38 ºC

Factory calibrated Yes

Relative humidity 5 – 95% Third party supplies to run product

Consumables for sample collection and for VL: centrifuge

Reagents storage and quality controls Temp. for transport & storage

Storage: 2- 37 ºC; Transport: 10- 50 ºC; 1 month

Internal Quality Control (QC)

Available, requires shipment under dry ice and stored frozen

Shelf life 12 months Compatible with External Quality schemes

TBD

Ease of use Testing procedure 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.

Setting to run product Any facility with fridge/freezer and constant electricity

Intended operator to run product

Trained health care worker

Service and Maintenance Maintenance If damaged, equipment can be direct swapped out with a replacement rather than on-site repair.

Warranty period: 1 year. After-sales support available.

Regulatory status Regulatory status ISO 13485:2003 certified

CE- IVDs/ WHO PQ: pending WHO PQ: pending

Validity until ISO:01/06/2017 (UL, UKAS, IAF)

Packaging Product weight - gross

Display module: 1.8 kgs; Assay module: 8.5 kgs

Product volume - gross Display module: 21.5 x 17 x 18 cm; Assay module: 19 x 33 x 33 cm

EID/VL Technology SAMBA II

Manufactured by: Diagnostics for the Real World Ltd Manufactured in: Suite 8 Science Village. Chesterford Research Park,

Little Chesterford CB10 1XL

Web address: www.drw-ltd.com

16

EID/VL Technology Gene Xpert IV Manufactured by: CEPHEID HBDC Manufactured in: Röntgenvägen 5, 171 54 Solna, Sweden

Web address: www.cepheidcares.com

Specifications- Product available for procurement for EID and VL assay Product features Principle of assay Nested real-time reverse transcriptase PCR.

Sample type EID: whole blood VL: plasma

Data storage Data is saved in computer

Sample volume EID: 100ul blood sample; DBS (~75ul); VL: 1mL

Connectivity Ethernet; Wifi; USB ports. Communications protocols for HL7 and ASTM standards

Reading time to results 86 min Power requirements 220-240V, 50-60 Hz - 110V

Throughput (8 hours working day/operator)

20 tests. System can provide higher throughput

Built-in voltage surge protection

Separate UPS with surge protection advised

Operation environment 15°C - 30°C Factory calibrated Yes, plus annual calibration performed by the user

Relative humidity 10–95 % Third party supplies to run product

Consumables for blood collection and for EID and DBS: theromixer and block; and for VL: centrifuge

Reagents storage and quality controls Temp. for transport & storage

2 - 28°C Internal quality control Probe-check controls and internal PCR controls

Shelf life Minimum 6 months Compatible with External Quality schemes

TBD

Ease of use Testing procedure 1) Blood sample collection; 2) Transfer 750 μL of the sample reagent, into the cartridge; 3) Mix

7 times the vacuum tube; 4) Transfer 100 μL into the cartridge (DBS: place a DBS on the sample reagent; then to the thermomixer, incubate for 15 min at 56 °C; rotate at 500 rpm and transfer 1ml of the liquid to the cartridge. Plasma: Centrifuge sample to extract plasma, add 1 ml of plasma into the cartridge); 5) Close the cartridge; 6) The cartridge is loaded into the equipment and read the test result.

Setting to run product Any facility with air condition and electricity

Intended operator to run product

Trained health care worker or lab technician

Service and Maintenance Maintenance The GeneXpert IV-4 requires routine preventative maintenance. In case of breakdown,

supplier-trained engineer will repair it. Warranty period: 2 years. After-sales support available.

Regulatory status Regulatory status ISO 13485: 2003 certified

CE 98/79/IVD marked for VL and EID assay WHO PQ: pending

Validity until ISO: 28/02/2017 (UKAS, DEKRA, UL) CE: Issued on 19/12/2014

Packaging Product weight - gross 31 kgs with desktop computer

28 kgs with laptop computer

Product volume - gross W 27.94 x H 30.48 x D 9.72 cm

17

Viral load

Technology

18

VL Technology SAMBA I

Manufactured by: Diagnostics for the Real World Ltd. Manufactured in: Suite 8 Science Village. Chesterford Research Park,

Little Chesterford CB10 1XL

Web address: www.drw-ltd.com

Specifications- Product available for procurement for evaluation, but will require additional lead time to conduct RFQ Product features Principle of assay 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.

Sample type Plasma Data storage N/A

Sample volume 200μl Connectivity N/A

Reading time to results 90 min Power requirements Prep/Amp: 100–250 V, 50 Hz; 150/ 50 watts

Throughput (8 hours working day/operator)

16 – 20 tests ( due to multiple sample slots)

Built-in voltage surge protection

External UPS and battery back-up

Operation environment 10- 35 ºC

Factory calibrated Yes

Relative humidity 5 – 95% Third party supplies to run product

Consumables for blood collection and centrifuge

Reagents storage and quality controls Temp. for transport & storage

Storage: 2 – 37 ºC; Transport: 10- 50 ºC; 1 month

Internal quality control Available, requires shipment under dry ice and stored frozen

Shelf life 12 months Compatible with External Quality schemes

TBD

Ease of use Testing procedure 1) Blood sample collection; 2) Centrifuge sample to extract plasma; 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 ampfication step (beep will sound); 7) Rotate cartridge manually, plunge detection buffer and read test results visually at end of detection.

Setting to run product Any facility with fridge/freezer and constant electricity

Intended operator to run product

Trained lab technician, lab assistant

Service and Maintenance Maintenance The equipment does not require routine maintenance. It will be swapped out if it fails. Warranty

period: 1 year. After-sales support available.

Regulatory status Regulatory status ISO 13485:2003 certified

CE-IVD / WHO PQ pending Validity until ISO:01/06/2017 (UL, UKAS,

IAF)

Packaging Product weight Prep: 50 kgs;

Amp: 4.5 kgs Product volume Prep: 68 x 64.5 x 51 cm

Amp: 40.5 x 32 x 11.4 cm

19

Summary tables

Table 1. Summary of HIV POC CD4 technologies

Company Product Name

Alere Pima

BD Biosciences BD FACSPresto

Omega Visitect CD4

Human HumaCount CD4 now

Partec CyFlow CD4 mini POC

Device/ equipment

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-IVD: pending WHO PQ: pending

ISO 13485:2003 certified CE 98/79/IVD marked WHO PQ: pending

ISO 13485:2012 certified CE 98/79/IVD marked WHO PQ: pending

Product available for procurement

Product available for procurement

Product available for procurement for evaluation based on supplier response to RFP 501714

Product not eligible for procurement for this project

Product not eligible for procurement for this project

Weight –gross 2.54 kgs 7 kgs Disposable: 0.300 Kgs;

Reader: 0.800 kgs 15.8 kgs 6.2 kgs

Output Quantitative CD4 Abs count Quantitative CD4 Abs count, CD4 percentage and Hb

Semi-quantitative CD4 Abs count (350/500 cut-off)

Quantitative CD4 Abs count and full blood count (FBC)

Quantitative CD4 Abs count and CD4 percentage

Sample type Capillary or venous whole blood Capillary or venous whole blood

Capillary or venous whole blood

Venous whole blood Capillary or venous whole blood

Sample volume 25 μL 20 µL 30 μL 40 μL 20 μL

Reading time to results 20 minutes 22 min for first sample. Then 4

minutes per sample 40 minutes 8 minutes 20 min for first sample. Then 40

–70 seconds per sample

Throughput (per 8 hrs working day/operator)

15-20 tests 60 - 80 tests 120 tests 50 tests Up to 250 tests

Data storage Approx. 1,000 test results Approx. 12,000 test results Approx. 1,000 test results on

reader Approx. 8,000 test results Approx. 20,000 test results

Connectivity Available 3 different connectivity packages

TBD Available on reader and Android Smart Phone App

Not available. Data transfer via USB drive

Not available. Data transfer via USB drive

Power Supply Built in 18V DC battery with 100-240V at 47-63 Hz

100-240 VAC, 50-60 Hz 100 - 240 V / 50 Hz., 3 watts, optional 12V battery pack

110-230V/47-63Hz, max 110 watts, battery optional

100/240 VAC power supply - 50/60 Hz, 66 watts

Internal quality control (IQC) Bead check consisting of a low and normal cartridge

Built-in equipment and cartridge QC

Buil-int quality control line DailyCheck Control. Counter provides 53 quality checks during each test run

Daily croscheck using count check beads green – dry, which are included in Partec miniPOC CD4% kit – dry

Reagent storage 2 - 30°C 4- 31°C 2- 40 °C 2- 30 °C. External QC: 2- 8°C

2- 8°C

Setting Urban and rural across all health care facilities

Urban and rural across all health care facilities

Urban and rural across all health care facilities

Urban and rural across all health care facilities

Any health facility with fridge and electricity

Intended operator to run product

Trained health care worker Trained health care worker Trained healthcare worker Trained health care worker Laboratory technician, nurse, lab staff

Warranty period 2 years 3 years Optional reader: 1 year 1 year 1 year

1

Table 2. Summary of HIV POC -EID and VL technologies

EID EID/VL VL

Company Product Name

Alere Alere Q

NWGHF LYNX HIV p24 Antigen Test

CEPHEID GeneXpert IV-4

DRW- U. Cambridge SAMBA II

DRW- U. Cambridge SAMBA I

Device/ equipment

Regulatory status ISO 13485: 2012 certified CE 98/79/IVD marked WHO PQ: pending

ISO 13485: pending CE-IVD: pending WHO PQ: pending

ISO 13485: 2003 certified CE 98/79/IVD marked WHO PQ: pending

ISO 13485:2003 certified CE-IVD: pending WHO PQ: pending

ISO 13485:2003 certified CE-IVD: pending WHO PQ: pending

Product available for procurement for EID assay

Product currently not available for procurement

Product available for procurement for VL and EID assay

Product available for procurement for evaluation, but will require additional lead time to conduct RFQ

Product available for procurement for evaluation, but will require additional lead time to conduct RFQ

Weight -gross 7.8 Kgs 1,7 Kgs 31 kgs with desktop computer

28 kgs with laptop computer Display module: 1.8 kgs; Assay module: 8.5 kgs

Prep: 50 kgs; Amp: 4.5 kgs

Output Qualitative detection of RNA for HIV-1 (M/N,O) and HIV-2

Qualitative detection of HIV p24 antigen.

Quantitative HIV-1 (viral load0 and Qualitative HIV-1

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 semi-quantitative assay with a cut off at 1,000 copies/ml (VL).

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.

Sample type Capillary or venous whole blood Capillary or venous whole blood EID: whole blood VL: plasma

EID: Capillary or venous whole blood

Plasma

Sample volume 25 µL blood sample 80 ul of blood sample EID: 100ul blood sample; DBS

(~75ul); VL: 1mL VL: Plasma 200μl

Reading time to results 52 min 51 minutes 86 min EID: 100 μl of blood sample 90 min

Throughput (per 8 hrs working day/operator)

8 tests One sample at a time, but when optimized, 12 tests

20 tests. System can provide higher throughput

VL: 200 μl of plasma 16 – 20 tests ( due to multiple sample slots)

2

Power Supply A/C power with rechargeable battery

A/C power with rechargeable battery

A/C power with rechargeable battery

A/C power with rechargeable battery

A/C power with rechargeable battery

Reagent storage 4 – 30 °C 6 months at 30 °C; 3 months at 45 °C; 3 days at 55°C.

2 - 28°C 2- 37 ºC 2 – 37 ºC

Internal quality control (IQC) Yes performed with each test run. Device control checks multiple QC parameters for functionality of system

Built-in quality control line Probe-check controls and internal PCR controls

Available, requires shipment under dry ice and stored frozen

Available, requires shipment under dry ice and stored frozen

Connectivity Pack II: USB modem with 3G card and booster; Pack III: USB-Lan adaptor

Cellular connectivity is in process.

Ethernet; Wifi; USB ports. Communications protocols for HL7 and ASTM standards

Built-in Ethernet and USB port. N/A

Setting Urban and rural, across all health facilities

Urban and rural, across all health facilities

Any facility with air condition and electricity

Any facility with fridge/freezer and constant electricity

Any facility with fridge/freezer and constant electricity

Intended operator to run product

Trained health care worker or lab technician

Trained health care worker Trained health care worker or lab technician.

Trained health care worker Trained lab technician, lab assistant

Warranty 1 year 1 year 2 years 1 year 1 year

UNICEF Supply Division

October 2015