INNOVATIVE HIV POINT-OF CARE (POC) CD4, EARLY INFANT DIAGNOSIS (EID) AND VIRAL LOAD (VL) TECHNOLOGIES

Transcription

1 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

2 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 EID Technology Alere Technologies GmbH North-western Global Health Foundation (NWGHF) EID/VL Technology Diagnostics for the Real World Ltd CEPHEID HBDC VL Technology Diagnostics for the Real World Ltd Summary tables

3 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 s 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 highvolume, 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 s. 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 s 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: HIV TECHNOLOGY STRENGTHS PCR TEST/ANTIGEN ASSAY Gold standard for children < 18 months High specificity/sensitivity DBS samples possible Tertiary Health Care Level WEAKNESSES PCR TEST/ANTIGEN ASSAY Complex Weak systems to transport DBS to referral laboratories DBS result reporting can be slow 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 Secondary Health Care Level Primary Health Care Level 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. 2

4 HIV Product profiles These profiles outline the key characteristics of s 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 selection at country level for more strategic and market shaping interventions. Project partners are encouraged to take into consideration all characteristics, discuss them in their context to support an optimal selection and document the rationale for the selection. How to use this information These profiles contain technical information per, 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 s 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 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 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 profiles has been presented for the process of in-country selection. For more information on specifications please contact Bibiana A. Zambrano,bzambrano@unicef.org and for contracting issues Ignacio Gimenez, igimenez@unicef.org. 3

5 List of abbreviations BD CCD CE CHAI DBS EID EUR ISO IVD NEQAS POC PQ QA QC QASI RFP TBD UNICEF SD/PD USD VL WHO Becton Dickinson Charged couple-device Conformité Européenne or European Conformity Clinton Health Access Initiative, Inc. Dried blood spots Early infant diagnosis Euro International Organization for Standardization Light-emitting diode National external quality assessment service - UK Point of care Prequalification Quality assurance Quality control Quality assessment and standardization for immunological measures relevant to HIV/AIDS (QASI) - Canada Request for proposal To be determined United Nations Children s Fund Supply Division/Programme Division United States dollars Viral load World Health Organization 4

6 CD4 Technology 5

7 CD4 Technology Manufactured by: Manufactured in: Web address: Pima Analyser Alere Technologies GmbH 1 Dan st. PO, 360, Yarne, Israel 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 Data storage Approx.1000 test results blood Sample volume 25 µl Connectivity Available 3 different connectivity packages Reading time to results 20 min Power requirements Built in 18V DC battery with V at Hz Throughput (8 hours working day/operator) tests Built-in voltage surge protection Yes. Fuse protection of Battery Operation environment 2-40 C Factory calibrated Yes, with autofocus of the Relative humidity 10-95% (non condensing) Third party supplies to run Reagents storage and quality controls Temp. for transport & storage Shelf life 12 months Compatible with External Quality schemes Ease of use Testing procedure Setting to run optics each time a test is run Consumables for blood collection 2-30 C Internal quality control Bead check consisting of a low and normal cartridge Yes, with NEQAS, QASI scheme 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. Urban and rural across all health care facilities Intended operator to run 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. Validity until ISO 13485: 2012 certified CE 98/79/IVD marked WHO Prequalified in 2012 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 6

8 CD4 Technology Manufactured by: Manufactured in: Web address: BD FACSPresto Near patient CD4 Counter BD International 2350 Qume Drive, San Jose, CA 95131, USA 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 Data storage Approx test results blood Sample volume 20 µl Connectivity TBD Reading time to results 22 min for first sample. Then Power requirements VAC, Hz 4 min per samples (batching) Throughput (8 hours tests Voltage surge protection Yes, built-in working day/operator) Operation environment C Factory calibrated Self-calibration when device switch is on Relative humidity 10-95% Third party supplies to run Consumables for blood collection Reagents storage and quality controls Temp. for transport & Transport C Internal quality control Built-in equipment and storage Storage 4-31 C Shelf life 12 months Compatible with External Quality schemes Ease of use Testing procedure Setting to run cartridge QC Yes, with Multicheck CD4 control and Eurotrol FACSPresto Hb Control 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. Urban and rural, across all health facilities Intended operator to run 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. Validity until ISO 13485:2003 certified CE 98/79/ IVD marked WHO Prequalified in 2014 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 7

9 CD4 Technology Company: Manufactured in: Web address: OMEGA Diagnostics LTD Omega Diagnostics Ltd House, Hillfoots Business Village, Alva, FK12 5DQ Scotland, UK Specifications- Product available for procurement for evaluation based on supplier response to RFP 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 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 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 Reagents storage and quality controls Consumables for blood collection Temp. for transport & 2 40 C Internal quality control Built in quality control line storage Shelf life 12 months Compatible with External In validation stage Quality schemes 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 Urban and rural, across all health facilities Intended operator to run 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 Packaging Product weight - gross ISO 13485: 2012 certified CE-IVD: pending Disposable test: Kgs Optional reader: kgs Validity until Product volume - gross ISO: 11/01/2015 (URS) Test: W19 x H1.5 x D13 cm Reader: W19 x H19 x D18 cm 8

10 CD4 Technology Manufactured by: Manufactured in: Web address: HumaCount CD4now HUMAN Gesellschaft für Biochemica und Diagnostika mbh Max-Planck-Ring 21 D Wiesbaden, Germany 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 test results Sample volume 40 µl Connectivity Not available. Data transfer via USB drive Reading time to results 8 minutes Power requirements 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 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 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 Shelf life 12 months Compatible with External Quality schemes DailyCheck Control. Counter provides 53 quality checks during each test run 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 Any facility with electricity Intended operator to run 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. ISO 13485:2003 certified CE 98/79/ IVD marked 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 9

11 CD4 Technology Manufactured by: Manufactured in: Web address: CyFlow minipoc Partec GmbH Am Flugplatz 13, Görlitz, Germany 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 Data storage Approx. 20,000 test results blood Sample volume 20 µl blood sample Connectivity Not available. Data transfer via USB drive Reading time to results 20 min for first sample. Then 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 C Factory calibrated Yes, align free optical system Relative humidity 20-85% (non condensing) Third party supplies to run Consumables for blood collection, automatic pipette and hypochlorite solution Reagents storage and quality controls Temp. for transport & Transport: 2-35 C Internal quality control Count Check Beads green storage Storage: 2-8 C Shelf life 6 months Compatible with External Quality schemes Ease of use Testing procedure Setting to run dry as non-biological controls Yes, with German "ring trial" System; NEQAS, QASI 1) Venous blood sample collection; 2) Mix tube 8 times ; 3) EDTA blood is added into ready-touse 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. Any facility with fridge and electricity Intended operator to run 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. Validity until ISO 13485:2012 certified CE 98/79/IVD marked 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 10

12 Early Infant Diagnosis (EID) Technology 11

13 EID Technology Manufactured by: Manufactured in: Web address: Alere Q Alere Technologies GmbH 1 Dan st. PO, 360, Yarne, Israel 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 Data storage Approx test results blood 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 V A/C; Hz. Internal battery as back up to ensure 1 test run Throughput (8 hours 8 tests Built-in voltage surge TBD working day/operator) protection Operation environment 4 30 C Factory calibrated Yes, with autofocus of the Relative humidity % Third party supplies to run Reagents storage and quality controls Temp. for transport & storage optics each time a test is run Consumables for blood collection 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 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 Urban and rural, across all health facilities Intended operator to run Service and Maintenance Maintenance Warranty period: 1 year. After-sales support available. ISO 13485: 2012 certified CE 98/79/IVD marked Validity until TBD Trained health care worker or lab technician 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 12

14 EID Technology Manufactured by: Manufactured in: Web address: LYNX HIV p24 Antigen Test North-western Global Health Foundation (NWGHF) 2707 N. Lincoln Ave, Suit B, IL 60614, USA 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 Data storage N/A blood 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 One sample at a time, but Built-in voltage surge Yes working day/operator) when optimized, 12 tests protection Operation environment Up to 35 C Factory calibrated Self-calibration when device Relative humidity TBD Third party supplies to run Reagents storage and quality controls Temp. for transport & 6 months at 30 C; 3 months Internal quality control storage Shelf life at 45 C; 3 days at 55 C. 6 months at 30 C; 3 months at 45 C; 3 days at 55 C. Compatible with External Quality schemes switch is on Consumables for blood collection Built-in quality control line 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 Urban and rural, across all health facilities Intended operator to run 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. ISO 13485: pending Validity until CE-IVD: pending Packaging Product weight - gross 1,7 Kgs Product volume - gross W 20.2 x H 15.6 x D 13.4 cm 13

15 EID & viral load Technology 14

16 Specifications- Product available for procurement for evaluation, but will require additional lead time to conduct RFQ Product features Principle of assay Sample type Sample volume 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). EID: Capillary or venous whole Data storage Approx. 100,000 test results in the blood; VL: Plasma display module EID: 100 μl of blood sample Connectivity Not available. Data transfer via VL: 200 μl of plasma USB drive and Ethernet EID: 120 min Power requirements Display/assay module: VL: 90 min V, 50Hz.; 20 W/ 80 W EID/VL: 4 tests Built-in voltage surge External UPS and battery back-up protection ºC Factory calibrated Yes Reading time to results Throughput (8 hours working day/operator) Operation environment Relative humidity 5 95% Third party supplies to run Reagents storage and quality controls Temp. for transport & Storage: 2-37 ºC; Internal Quality Control storage Transport: ºC; 1 month (QC) Shelf life 12 months Compatible with External Quality schemes Ease of use Testing procedure Setting to run Consumables for sample collection and for VL: centrifuge Available, requires shipment under dry ice and stored frozen TBD 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. Any facility with fridge/freezer and constant electricity Intended operator to run 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. ISO 13485:2003 certified CE- IVDs/ Validity until ISO:01/06/2017 (UL, UKAS, IAF) Packaging Product weight - gross EID/VL Technology Manufactured by: Manufactured in: Web address: Display module: 1.8 kgs; Assay module: 8.5 kgs SAMBA II Diagnostics for the Real World Ltd Suite 8 Science Village. Chesterford Research Park, Little Chesterford CB10 1XL Product volume - gross Display module: 21.5 x 17 x 18 cm; Assay module: 19 x 33 x 33 cm 15

17 EID/VL Technology Manufactured by: Manufactured in: Web address: Gene Xpert IV CEPHEID HBDC Röntgenvägen 5, Solna, Sweden Specifications- Product available for procurement for EID and VL assay Product features Principle of assay Sample type Nested real-time reverse transcriptase PCR. EID: whole blood Data storage VL: plasma EID: 100ul blood sample; Connectivity DBS (~75ul); VL: 1mL Data is saved in computer Sample volume Ethernet; Wifi; USB ports. Communications protocols for HL7 and ASTM standards Reading time to results 86 min Power requirements V, 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 % Third party supplies to run 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 TBD Quality schemes 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 Any facility with air condition and electricity Service and Maintenance Maintenance Packaging Product weight - gross Intended operator to run Trained health care worker or lab technician 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. ISO 13485: 2003 certified CE 98/79/IVD marked for VL and EID assay 31 kgs with desktop computer 28 kgs with laptop computer Validity until ISO: 28/02/2017 (UKAS, DEKRA, UL) CE: Issued on 19/12/2014 Product volume - gross W x H x D 9.72 cm 16

18 Viral load Technology 17

19 VL Technology Manufactured by: Manufactured in: Web address: SAMBA I Diagnostics for the Real World Ltd. Suite 8 Science Village. Chesterford Research Park, Little Chesterford CB10 1XL 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: V, 50 Hz; 150/ 50 watts Throughput (8 hours tests ( due to multiple Built-in voltage surge working day/operator) sample slots) protection Operation environment ºC Factory calibrated Yes Relative humidity 5 95% Third party supplies to run Reagents storage and quality controls Temp. for transport & storage Storage: 2 37 ºC; Transport: ºC; 1 month Internal quality control Shelf life 12 months Compatible with External Quality schemes Ease of use Testing procedure Setting to run External UPS and battery back-up Consumables for blood collection and centrifuge Available, requires shipment under dry ice and stored frozen TBD 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. Any facility with fridge/freezer and constant electricity Intended operator to run 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. Validity until Packaging Product weight ISO 13485:2003 certified CE-IVD / WHO PQ pending Prep: 50 kgs; Amp: 4.5 kgs Product volume ISO:01/06/2017 (UL, UKAS, IAF) Prep: 68 x 64.5 x 51 cm Amp: 40.5 x 32 x 11.4 cm 18

20 Summary tables 19

21 Table 1. Summary of HIV POC CD4 technologies Company Alere Product Name Pima Device/ equipment BD Biosciences BD FACSPresto Omega Visitect CD4 Human HumaCount CD4 now Partec CyFlow CD4 mini POC ISO 13485: 2012 certified CE 98/79/IVD marked WHO Prequalified in 2012 Product available for procurement ISO 13485:2003 certified CE 98/79/IVD marked WHO Prequalified in 2014 Product available for procurement ISO 13485: 2012 certified CE-IVD: pending Product available for procurement for evaluation based on supplier response to RFP ISO 13485:2003 certified CE 98/79/IVD marked Product not eligible for procurement for this project ISO 13485:2012 certified CE 98/79/IVD marked Product not eligible for procurement for this project Weight gross 2.54 kgs 7 kgs Disposable: Kgs; 15.8 kgs 6.2 kgs Reader: 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 Capillary or venous whole Venous whole blood Capillary or venous whole blood blood 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 40 minutes 8 minutes 20 min for first sample. Then 40 minutes per sample 70 seconds per sample Throughput (per 8 hrs tests tests 120 tests 50 tests Up to 250 tests working day/operator) Data storage Approx. 1,000 test results Approx. 12,000 test results Approx. 1,000 test results on reader Connectivity Available 3 different connectivity TBD Available on reader and packages Android Smart Phone App Power Supply Built in 18V DC battery with VAC, Hz V / 50 Hz., 3 watts, 240V at Hz optional 12V battery pack Internal quality control (IQC) Bead check consisting of a low Built-in equipment and Buil-int quality control line and normal cartridge cartridge QC Approx. 8,000 test results Approx. 20,000 test results Not available. Data transfer via USB drive Not available. Data transfer via USB drive V/47-63Hz, max /240 VAC power supply - watts, battery optional 50/60 Hz, 66 watts DailyCheck Control. Counter Daily croscheck using count provides 53 quality checks check beads green dry, which during each test run are included in Partec minipoc CD4% kit dry Reagent storage 2-30 C 4-31 C 2-40 C 2-30 C. 2-8 C External QC: 2-8 C Setting Urban and rural across all Urban and rural across all Urban and rural across all Urban and rural across all Any health facility with fridge and health care facilities health care facilities health care facilities health care facilities electricity Intended operator to run 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

22 Table 2. Summary of HIV POC -EID and VL technologies EID EID/VL VL Company Product Name Device/ equipment Alere Alere Q NWGHF LYNX HIV p24 Antigen Test CEPHEID GeneXpert IV-4 DRW- U. Cambridge SAMBA II DRW- U. Cambridge SAMBA I ISO 13485: 2012 certified CE 98/79/IVD marked ISO 13485: pending CE-IVD: pending ISO 13485: 2003 certified CE 98/79/IVD marked ISO 13485:2003 certified CE-IVD: pending ISO 13485:2003 certified CE-IVD: pending Weight -gross Output Product available for procurement for EID assay Product currently not available for procurement Product available for procurement for VL and EID assay 7.8 Kgs 1,7 Kgs 31 kgs with desktop computer 28 kgs with laptop computer Qualitative detection of RNA for Qualitative detection of HIV p24 Quantitative HIV-1 (viral load0 HIV-1 (M/N,O) and HIV-2 antigen. and Qualitative HIV-1 Product available for procurement for evaluation, but will require additional lead time to conduct RFQ Display module: 1.8 kgs; Assay module: 8.5 kgs 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). Sample type Capillary or venous whole blood Capillary or venous whole blood EID: whole blood VL: plasma EID: Capillary or venous whole blood Sample volume 25 µl blood sample 80 ul of blood sample EID: 100ul blood sample; DBS VL: Plasma 200μl (~75ul); VL: 1mL Reading time to results 52 min 51 minutes 86 min EID: 100 μl of blood sample 90 min Throughput (per 8 hrs 8 tests One sample at a time, but when 20 tests. System can provide VL: 200 μl of plasma working day/operator) optimized, 12 tests higher throughput Product available for procurement for evaluation, but will require additional lead time to conduct RFQ Prep: 50 kgs; Amp: 4.5 kgs 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. Plasma tests ( due to multiple sample slots) 1

23 Power Supply 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. Internal quality control (IQC) Yes performed with each test Built-in quality control line run. Device control checks multiple QC parameters for functionality of system Connectivity Pack II: USB modem with 3G Cellular connectivity is in card and booster; Pack III: process. USB-Lan adaptor Setting Urban and rural, across all Urban and rural, across all health health facilities facilities Intended operator to run Trained health care worker or Trained health care worker lab technician A/C power with rechargeable A/C power with rechargeable A/C power with rechargeable battery battery battery 2-28 C 2-37 ºC 2 37 ºC Probe-check controls and internal PCR controls Ethernet; Wifi; USB ports. Communications protocols for HL7 and ASTM standards Any facility with air condition and electricity Trained health care worker or lab technician. Available, requires shipment under dry ice and stored frozen Built-in Ethernet and USB port. Available, requires shipment under dry ice and stored frozen Any facility with fridge/freezer and constant electricity Any facility with fridge/freezer and constant electricity Trained health care worker Trained lab technician, lab assistant Warranty 1 year 1 year 2 years 1 year 1 year N/A UNICEF Supply Division October