POINT OF CARE DIAGNOSTICS

Transcription

1 ENSURING ACCESS TO POINT OF CARE DIAGNOSTICS IN DECENTRALISED HIV AIDS PROGRAMMES REQUEST FOR EXPRESSION OF INTEREST Technology : Point of Care HIV diagnostic and treatment monitoring devices for Early Infant Diagnosis (EID) and Viral load assessment, and CD4 enumeration. Publish date : 27 August 2012 Closure date : 27 September 2012 Contact details : alund@unicef.org Innovative CD4 and Viral Load measurement and Early Infant Diagnosis (EID) at Point of Care Despite the progress that has been made in recent years in the fight against HIV/AIDS, there are still 1.8 million AIDS-related deaths and 2.7 million new infections each year. People living in resource-limited settings are disproportionately affected by the AIDS epidemic, and rural populations are the hardest hit. ART can dramatically extend the lives of patients living with HIV and reduce disease transmission to uninfected individuals. Over the last decade, access to ART has improved dramatically, but more than half of those in need are still without treatment, particularly among patients in difficult-to-reach places. Additionally, those with access typically initiate treatment too late, leading to poorer health outcomes, higher treatment costs, and further spread of disease. The availability and appropriate use of diagnostic testing is one of the major bottlenecks to timely, high-quality HIV treatment for adults and children, and prophylaxis for pregnant women. The three most critical diagnostic tests for effective HIV treatment all exhibit major bottlenecks that need to be addressed: (1) Late ART initiation among adults due to limited access to CD4 to determine ART eligibility; (2) Late ART initiation among infants due to limited access to Early Infant Diagnosis (EID) testing; and (3) Late switching to second-line ART due to limited access to Viral Load (VL) testing to identify first-line treatment failure. For each of these tests, patients often wait weeks or months for results, forcing multiple trips to the clinic to receive care. Many patients are lost at various steps in the process, and 1

2 may return for additional care only later when their disease has progressed significantly and it is too late for treatment to be fully effective. The WHO/UNAIDS strategy Treatment 2.0, launched in 2010, promotes the optimisation of treatment regimens and efficiency gains, and calls for improved diagnosis, task shifting, and decentralisation of service delivery 1. There is growing demand to improve the efficiency of services for HIV/AIDS while maintaining the quality of patient care. At the same time, there is growing need to increase access to more robust and high quality diagnostics in resourcelimited settings. Access to Point of Care (POC) diagnostics is highlighted as one of the pillars of the Treatment 2.0 strategy. A recent landscape analysis commissioned by UNITAID 2 revealed that there are several innovative technologies that could facilitate treatment initiation and monitoring at the point of care. In light of this, UNITAID has funded a partnership between the United Nations Children s Fund (UNICEF) and the Clinton Health Access Initiative (CHAI) to support programmes in 7 countries (Ethiopia, Kenya, Malawi, Mozambique, Tanzania, Uganda and Zimbabwe) to accelerate the uptake of new POC HIV diagnostics. Through this partnership, UNITAID will procure and donate equipment, reagents, consumables, and after-sale support for POC HIV diagnostics to each of the 7 countries. In close collaboration with UNITAID and other partners, UNICEF and CHAI launch this Request for Expression of Interest (REoI) calling upon the industry, academia and others engaged in the development of point of care products for CD4, EID and VL to (i) express their interest in becoming a future supplier of these product categories, and (ii) provide information about their concepts and products. We are interested to learn of appropriate existing and new technology developments, suitable for improving access to HIV diagnostics, at the point of care, in low-resource settings. Product Requirements POC HIV diagnostics will ultimately be used across a number of cadres of health care workers and across a variety of settings. The intended users for these technologies range from laboratory staff, medical officers and nurses at higher-level health facilities to lab assistants, lay counsellors and community health workers at the more decentralised levels of the health system in low-income settings. At the lower level of education, staff expected to use POC diagnostics will have no formal healthcare qualifications, and the level of health training they receive will be limited. Therefore, the technical sophistication of POC diagnostics must be minimal, with procedures for reagent, control, and sample preparation and testing that do not require a laboratory technician. Likewise, the settings in which POC diagnostics are intended to be used range greatly from larger urban health facilities to 1 WHO Treatment 2.0 website. Accessed July UNITAID Website: 2 nd Edition of UNITAID Diagnostics Technology Landscaping Report 25 June

3 remote rural clinics in which electricity, basic laboratory infrastructure, access to distilled water and basic laboratory equipment is lacking. POC diagnostics will also need to withstand harsh environments, including dust, very high and/or low temperatures and high humidity. Any diagnostic products also must contain adequate internal quality controls, and must be sufficiently supported with available service and maintenance, supply chain, and distribution in low-resource settings. The REOI is designed to better understand the range of technologies, concepts and products under development, and to identify those that meet the requirements above. Information to be provided Together with this expression of interest, UNICEF and CHAI seek information on appropriate POC CD4, EID and VL technologies, concepts and products that can work across a range of settings and cadres of health care workers in low-resource settings, and the organisations developing and manufacturing them. In the context of the targeted settings and end-users that these products are designed to serve, as well as the minimum requirements above, below are important aspects that will guide future procurement. Kindly provide responses to each of the questions below, and provide supporting documentation where possible. Information related to appropriate technologies, concepts or products Basic Product Information What is the name and the product reference? Is the product commercially available? If not, in what stage of development is the product? And what is the projected time line to commercialisation? What is the current regulatory status of the product? What test parameters are measured? (e.g. CD4 count and/or percentage, EID, VL, Hb, or a combination of these. For each parameter, describe whether the result provided is quantitative, semi-quantitative or qualitative.) Responses Kindly provide supporting documentation where possible Product Features Equipment What is the test format (e.g. disposable, handheld device, table top)? What are the dimensions and weight of the testing equipment? What throughput (number of tests) can be achieved in an 8-hour work day? What is the total test turn-around time for each sample? If applicable, what is the primary power source used for the testing? Are there alternative power sources available or planned? If so, please 3

4 describe. To obtain a test result, does the product require supporting devices (such as pipettes, centrifuge, etc.) that are not supplied with the product? If so, please describe. Is random access of samples possible? Is it possible to test multiple samples simultaneously (batching) to increase throughput? If so, please describe. How are the results displayed? (e.g. printed, displayed on screen, disposable, etc.) Can test results be stored and accessed later? If so, how many? What other testing data can be stored and accessed later? (e.g. quality control results, patient ID, etc.) Does the equipment have connectivity to transmit testing data remotely? If so, please describe the testing data that can be transmitted and communication method. Does the equipment require installation from the supplier at each testing site? Product Features Reagents, Consumables, and Controls What reagents, consumables and/or controls are supplied with the equipment or the test kit? And in what quantities? What type and quantity of sample collection consumables is required? Which of these are supplied or plan to be supplied with the equipment or the test? To obtain a test result, does the product require supporting chemicals or reagents (such as buffer, quality control kits, calibration kits, distilled water, etc.) that are not supplied with the product? If so, please describe. Does the product or any of its reagents, consumables, or controls require controlled temperature or humidity during transport or storage? If so, please describe the temperature and humidity range. What is the shelf life of the product and/or each of the reagents, consumables and controls required? Are there additional storage requirements for any reagents, consumables, and controls? Ease of Use Based on the level of technical sophistication of the product, what cadres of healthcare worker could perform the testing? Please describe the process of reagent and control preparation, if any. Please describe the process of sample collection, sample preparation, and testing. What type(s) of sample can be used for testing, and what minimum volume is required? Are there requirements for the sample or any testing reagents to be precisely measured? If so, please describe. Does the use of the product require training? Please differentiate between user training and technical (maintenance) training. 4

5 What are the calibration requirements for the testing equipment, and what level of skill is required to perform calibration? What are the maintenance requirements for the testing equipment, and what level of skill is required to perform maintenance? Which of these can be performed by a trained end-user (e.g. preventive maintenance, corrective maintenance, calibration, etc.)? Which of these have to be performed by the supplier? Please list the recommended spare parts to be available at the end-user site. With normal use, what is the frequency of interventions such as calibration, cleaning, preventive maintenance, repair and/or exchange? What type and amount of waste is generated from testing? Quality Control Please describe the calibration off-factory for the equipment. How is the correct performance of the testing (including assays) assured off-factory? Are there internal quality controls available for the product? If so, please describe. Is the product compatible with commercially available external quality assurance/ control programs? If so, please describe. If not, what external quality assurance/ control is recommended? Further Product Information Can reagents and all testing consumables required be bundled to simplify supply chain? If so, how many tests are in each bundle? Please provide a list of countries where the product is registered or where the product dossier has been submitted for registration (if applicable). Please provide a list of current regulatory approvals for the product (if applicable). Please provide a list of countries where the product has been procured and at what volumes (if applicable). Are there operational leasing possibilities for this product? If so, please describe. If available please attach product testing literature, published studies, and reported trials of the product. Information related to your organisation (company, academy, etc.) Basic Organisation Information Please provide the name and a short description of your organisation. Please provide the name and contact details of your organisation focal point. Is your organisation ISO certified? If not, what other quality management system is in place? If applicable, please indicate the number of functional production sites, 5

6 and the accreditation achieved for each site. Please describe existing and future plans for a distribution and support network. Please provide an indicative number of equipment/reagent kits produced per year, or projected to be produced per year? Please describe the capabilities of your organisation to initiate and/or manage the regulatory aspects of commercialisation of the product. Please describe relevant commercial strategic options, that in your opinion could accelerate uptake in resource limited settings. Please provide additional relevant information about your organisation, as applicable. After Sale Support Please describe the capabilities and capacity of your organisation to provide with after sale support, such as maintenance, replenishment, and provision of spare parts. If necessary, can installation and training be provided at remote testing sites? If so, please describe how you will support these sites, including availability of current training programs, and future plans. If necessary, can regular preventive and corrective maintenance be provided at remote testing sites? If so, please describe how you will support these sites. How much time will it take to provide preventive and corrective maintenance at remote testing sites? If necessary, can supplies be distributed (supply chain) to remote testing sites or at a central warehouse? If so, please describe your current distribution network (supply chain) for equipment, reagents, consumables, controls and spare parts. What is the expected lead time for deliveries after orders are placed? Kindly list the available spare parts, excluding the ones recommended to be available on-site with the end-user. If equipment swap-outs are necessary, what inventory of backup equipment will be maintained? How much time will it take to provide equipment swap-outs? Please specify whether swap-outs will be to the remote testing site or to a central warehouse. How are such swaps organised in terms of logistics and expenses? - Thank you for your cooperation - In Summary This REOI does not constitute a solicitation. We do not require bids or proposals at this stage; we merely seek information on your technologies either available on the market or in development and your expression of interest in participating in a future tenders (including requests for quotations or proposals). A response to this Request for Expression of Interest does not automatically ensure that you will be selected to participate in our tenders. 6

7 CHAI-UNICEF reserves the right to change or cancel the requirements at any time during the REoI and/or solicitation process. CHAI-UNICEF also reserves the right to require compliance with additional conditions as and when issuing the final tender document. If you have any additional question about this REoI, please contact Anne Birgitte Lund, e- mail: Confidential information should be clearly marked as such. Please submit your expression of interest along with documents to indicating Innovative POC CD4, Viral Load and EID testing in the subject line. 7