Embed Size (px)
Citation preview
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 : 30 November 2012
Closure date : 16 December 2012
Contact details : [email protected]
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
may return for additional care only later when their disease has progressed significantly and
it is too late for treatment to be fully effective.
2
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 delivery1. 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 resource-
limited 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 UNITAID2 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 approved funding for 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. Key components in this
support are the procurement and donation of instruments, reagents, consumables, and
after-sale services for POC HIV/AIDS diagnostics to each of these 7 countries. UNICEF, with
the support of CHAI, is launching 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 existing and future products, including
instruments, reagents, consumables, and after-sale support.
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, POC diagnostic products must be simple and
easy to use, with testing procedures that require a minimal number of steps from sample
collection to test result and 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 remote rural clinics in which electricity, basic laboratory infrastructure, access to
distilled water and basic laboratory equipment is lacking. Therefore, POC diagnostic
products will also need to be robust and durable, and be able to withstand harsh
environments, including dust, very high and/or low temperatures and high humidity, with
minimal routine service and maintenance requirements. Any POC diagnostic products also 1 WHO Treatment 2.0 website. Accessed July 2012. http://www.who.int/hiv/topics/treatment2/en/
2 UNITAID Website: 2
nd Edition of UNITAID Diagnostics Technology Landscaping Report 25 June 2012.
3
must contain adequate internal quality controls, and must be sufficiently supported by the
supplier with corrective service and maintenance, training, supply chain support, and
distribution in low-resource settings.
Information to be provided
As indicated above, with this Expression of Interest, UNICEF and CHAI seek information on
appropriate POC CD4, EID and VL technologies 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 mentioned
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.
Suppliers are requested to provide a response and indicate the status of information.
We recognize that some of the information may not be available, especially for products
that are not yet commercially available.
Terms
This REOI does not constitute a solicitation. We do not request 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 future tenders (including
requests for quotations or proposals). A response to this REoI does not automatically ensure
that you will be selected to participate in tenders or be selected for procurement. UNICEF
will not be responsible for the costs incurred by you in preparing and submitting your
expression of interest.
UNICEF reserves the right to change or cancel the requirements at any time during the REoI
and/or any future solicitation process. UNICEF also reserves the right to require compliance
with additional conditions as and when issuing any future tender documents.
If you have any additional question about this REoI, please contact Anne Brigitte Lund, e-
mail: [email protected]
Confidential information should be clearly marked as such when submitting your expression
of interest, failing which any information you provide will not be treated as confidential.
Please note that confidential information may be shared with persons advising UNICEF in
relation to the POC Diagnostics Project, including UNITAID as the funder of this project, on a
need-to-know basis, subject to such advisers agreeing to maintain such information
confidential. Any information that is not marked as confidential may be included in future
UNITAID publications on the HIV diagnostics landscape.
Please submit your expression of interest along with documents to [email protected]
4
Information related to POC diagnostic products
Basic Product Information
What is the product name and catalogue number (if applicable)?
Is the product commercially available?
If not, in what stage of development is the product? And what is the projected time line to commercialisation and manufacturing scale-up?
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.)
Product Features – Instrument
What is the test format (e.g. disposable, handheld device, table top)?
What are the dimensions and weight of the instrument, if any?
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 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 it possible to test multiple samples independently of one another (random access)?
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 is the complete range of testing data that can be stored and accessed later? (e.g. quality control results, patient ID, etc.)
Does the instrument have connectivity to transmit testing data remotely? If so, please describe the testing data that can be transmitted and the type of technology that will be
5
used to communicate data.
Does the instrument 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 instrument or the test kit? And in what quantities?
What are the quantities of all reagents, consumables and/or controls that are packaged with each test kit?
What type and quantity of sample collection consumables is required?
What are the quantities of sample collection consumables packaged with each test kit?
Which of these are supplied or plan to be supplied with the instrument 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.
Do any of the 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 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 are expected to be able to perform the testing? How was this determined?
Please describe each step in the process of reagent and control preparation, if any.
Please describe each step in 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? If so, what type and duration? Please differentiate between user training and technical (maintenance) training.
What are the calibration requirements for the instrument, and what level of skill is required to perform calibration?
6
What are the maintenance requirements for the instrument, and what level of skill is required to perform maintenance?
Which additional activities can be performed by a trained end-user (e.g. preventive maintenance, corrective maintenance, calibration, etc.)?
Which of these activities have to be performed by the supplier (or distributor/agent of the supplier)?
Please list the recommended spare parts to be available at remote testing sites.
With normal use, what is the expected 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 instrument.
How is the correct performance of the testing (including assays) assured off-factory?
Describe the risks of cross-contamination between samples, related to human error and to the design of the POC instrument, during sample collection, preparation, and testing. If applicable, how does this risk potentially influence the test results and how is this risk mitigated?
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 the product is not compatible with commercially available quality assurance/control programs, what external quality assurance/ control is recommended?
Further Product Information
Can reagents and all testing consumables required to perform a test 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.
7
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 13485 certified? If not, what other quality management system is in place?
If applicable, please indicate the number of functional production sites, 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 instruments and reagent kits that could be produced each year, or projected to be produced each year (2012, 2013, etc.)?
Please describe the capabilities of your organisation to initiate and/or manage the regulatory aspects of commercialisation of the product.
Please describe your organisation’s relevant commercial strategies that in your opinion could accelerate uptake in resource limited settings. (e.g. partnerships, new financing mechanisms, risk sharing, innovative pricing, etc.)
Please provide additional relevant information about your organisation, as applicable.
After Sale Support
Please describe the capabilities and capacity of your organisation to provide 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 will be the response time to provide preventive and corrective maintenance such as instrument swap-outs 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 instruments, reagents, consumables, controls and spare parts.
8
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 instrument swap-outs are necessary, what inventory of backup instruments will be maintained? Who will maintain this inventory, and where will they be stored?
How much time will it take to provide instrument 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 -
