In France the economic argument is really strong : if the ratio cost/efficiency is more favorable than any other tests or health care policies, the refund is total. Moreover the public engagement of STD-associations defend the right to people to use free diagnosis test. So, most of the device or molecules that have been recognized for their efficiency are integrally refund by the french medical cover. In the USA, the price as not the same importance than in France. The requirements to allow the american auto test OraQuick® didn't pay attention to the price in the final equation Nevertheless the price is a barrier to access. The low cost may democratize the test worldwide by making it accessible for every buying power.

Finally, The price and the norm are the two greatest barrier to the massive use of a technology all around the world. For instance, OraQuick® is recognize by FDA but didn't receive the CE agreement.

In the case of an auto test, the user has the choice to be alone toe to toe with the diagnosis device and will confront alone to the results. The reaction of the user with his test is unknown. It is up to the user to break this loneliness bubble and to continue his diagnosis process like confirming the results by doing traditional tests. The test has to be enough persuasive to condition the user reaction and the decision after the results. The survey (lien à rajouter vers public acceptation) shows a good dynamic for the reaction (even if it is just a survey) Only 2% of the people wouldn't trust the test. A great majority choose to exchange with other people and breaking their loneliness by speaking with family members or a trusted person. A lot of a answers also look for medical support by going to the diagnosis center or to the primary care physician. In case of false negative test or non persuaded positive person the risk of transmission for the AIDS will be increased and the person will be extremely contagious.

Another interesting question about privacy and the respect of dignity studies the non-acceptance of the diagnosis by refusing to announce the situation to its private circle. What should be the position of the medical staff ? Which values prevails ? The medical secret, which is the root of the trust of the patient to his doctor or the principle of helping person confronted to a danger (in the case of a doctor who knows that a patient risks to transmit the AIDS to his partner who ignore the seropositivity) ?

To study the intimity it's necessary to distinguish the body from the mind.

The test has to preserve the integrity of the user body. Using blood as sample is an appropriate way protect the integrity of the user it is considered as a non invasive test. Intimity of the body was also an argument against the hygienic pad (cf the introduction §). It was a device literally introduced in the body intimity.

The intimity of the mind is considered as anonymity. Can anonymity be guarantee during the whole diagnosis process ? Until where anonymity protect the user and should be necessary ? Anonymity has not to be an obstacle to health care quality and has to be revoked until the health prognostic of the patient is threatened. Two articles in the french public healthcare policies describe the revocation of anonymity. It is possible only with the agreement of the patient in case of therapeutic emergency and it is supposed to improve the diagnosis process and the beginning of the therapy. The diagnosis test is not incompatible with those principe. Moreover anonymity is now considered as an option at diagnosis center. The consultant is free to take the decision for anonymat.

The interviewed doctors do not sense banalization (the risk of a too frequent use after a risk taking) like a nefast consequence of high accessibility. A high acceptability test will be rather used to support the diagnosis in population that do not use classical diagnosis method. Moreover, the risk of a too much intensive use is sense as a positive fact at the condition that the test has to be enough precise, well used, and associate with prevention measure (traditional diagnosis methods and protection).

Nowaday, the banalization risk is clearly not a problem. The priority is to give an access to a fast easy and reliable test to everyone, in order to know its serologic profile.

Biosafety characterize the hazard relative to infectious microorganism. In our project, biosafety deals the biologic materials used in the lab, specially the HIV reverse transcriptase because HIV is rank 3. Biosafety implies the respect of human dignity and vulnerability and the engineer civil responsibilities.

About the engineer civil responsibilities : the device do not present any biosafety risks. No proteins has been indexed as toxic or pathogen. Streptavidin and its cellulose binding domains do not present any toxic hazard.

Furthermore, the matrix has been consulted to take a decision concerning the migration witness. At first, we wanted to use reverse transcriptase on the detection pad. The presence of a such protein in the test has been rejected due to technical issue (what about the risks of false positive due to background noise?) economic issue (the price of production and purification) and ethical issues : even if it is produced by bacteria, is it correct to use some viral protein on the test ? How it will impact the user ? During a test can we risk to get contaminated by HIV protein whereas the test has vocation to prevention and detection ?

About the respect of the others : precautions are essential about the management and the treatments of the blooded contaminated wastes. It is necessary to deliver with the diagnosis test a special waste bag and a single-use self pricker and to collect it at drugstores. In case of a medical use the central waste-collect remove this problem. The case of the plastic device will be explained in section 4

The rapid diagnosis test are additional and complementary tools for the traditional diagnosis tests. No matter how the rapid diagnosis test can be reliable, the results has to be confirmed. It exists two risks for a diagnosis test : the false positive and the false negative.
According to the virologist Prof. Chidiac, the risk of false negative has to be strictly nul. In case of false negative, the infected people will not be aware of its positivity and can’t take the good measure to protect itself and its other partners. For the AIDS, the early stage of infection corresponds to a high transmission rate period. The engineer alone to carry the responsibility, so the false negative has to be eradicate at all cost. The risk of false positive has less ethicals requirements because after confirmation by a traditional tests it is a happy-ending.

However, the use of such a test present some hard ethical requirements in matter of engineer civil responsibilities and protection of the human integrity. It implies precautions taking by the healthcare authority in numerous domains : informations, medical or para medical support, juridical protection, free access, evaluation, accessibility limited to drugstore ?

The test can be easily misused : for instance use on animals (before unconventional practise ?) or be used as a contraceptive tools ( the early detection can be sense as security) or as an a incomplete prevention tools before an unprotected practise . Nevertheless, misuses under bad conditions (alcoholed-altered behaviour) or without the respect of the correct practices described in the usernote lead to erroneous diagnosis. Is it the responsibility of the developers and/or the retailers to assume the usernote respect ? So the retail of the diagnosis tests has to be correlated to a good support and with some quality informations for the good use. The redaction of a user note is fully part of that approach.

The accompaniment question is contains three aspects. The accompaniment during the retail, it contains all the informations accessible to the potential user (usernote, advice of the para-medical staff, advertisement, comments on forum networks). The accompaniment ante/post test delivered by the medical staff or associative members.

STDs are severe consequences diseases which engage the health pronostic in the long run and carry very serious secondary effects like sterility, opportunistic infections and indirectly death. Informations about the meaning of the diseases, the treatments and the consequences has to be given objectively and with the respect of everyone's sensitivity. For instance the AIDS diagnosis implies the prognostic medical of the patient and its future on familial, professional and social points of view. The accompaniment delivered by doctor has to place the patient in a situation of informed consent. The patient has to exercise his free individual choices in order to plan his future. The role of the accompaniment is also to aware the patient about hygiene rules and protection measure about the others.

According to the diversity of patient sensitivity and thoughts path to the acceptation of the diseases, a psycholog can be required and also a social assistant to ensure the administrative procedure.
The familial accompaniment has also consequences on the user. The opinions are subjective according two directions : the risk minoration ou the hyperbolization. The judgement of the close relatives is influenced by the affection for the patient and their will to answer at all cost to every sollicitations. Sometimes the relatives don’t have the knowledge and the pedagogy quality of a health professional. Accompany someone his not to be behind nor before nor to be at his place, it is to stand asides and to give support. It requires some scientifics knowledge and practical and being manners. It cannot be improvised.
A useful accompaniment consist in rassure the user and encourage him to consult a healthcare professional or a diagnosis center.

The diagnosis test reconfigure the relationships between the medical staff and the users. How can we manage to reduce the loneliness of the user concerning the test and the results self interpretation ? The design of the user note has to bring some answers. It has to be ergonomic as much as possible, to reassure the user and to help in in the post results decision taking. (lien vers la user note). A call center also can be available to deliver advices to the users.

The question of the medical support has been asked in the survey.(lien vers) The answers show that an accompaniment is needed mainly during the test execution and during the results interpretation. This question reveals the limits of the matrix which is “only” a help tool for decision taking. How interacts the accessibility with medical support ? Is prescription a sufficient accompaniment ? Is medical support an barrier to accessibility are a needed lock to ensure a correct use of the diagnosis test ?

In such case, it can be interesting to compare the issues with other diagnosis test like pregnancy tests or the genetics test. In France, pregnancy tests are available both with or without medical prescription. Hosting a child has certainly not the same consequences as hosting a STDs, in the first case it is to give birth to new human, it will surely impacts on the future of the future parents. In the other case it’s affecting the life of the person on a negative way. However in both cases, it impacts the future of the both partners. On the long run, the model of the retail of diagnosis tests will probably converge to a pregnancy tests like model.

The diagnosis test as to be integrated on a sustainable perspective. The ethics matrices has guided our environmental conscience and gave us a rigorous anatomic thought path to environmentally optimize each part of the device.
At the early stage of the cycle of life the biosourced materials has been privileged to reduce the rarefaction petrol and rare ore.
For instance, we used latex beads which are potentially biosourced with rubber tree (Hevea brasiliensis) than nanoparticles of gold which is a common support to work with aptamer.
Here is some other choices to reduce the impact of the diagnosis test on the environment. The support of the paper consists in recycled cellulose. The plastic device is made of bio-sourced plastic or recyclable resin. As often as possible, we used cell-produced biological materials instead of chemically produced ones.
To conclude the project conciliate technical aspects and environmental specifications.

After the use the management of the biological trashed has to be investigated. Indeed STDs can survive during a long run in a liquid solution or six hours at the air. The goal is to protect the other person to get infected by contaminated materials. The paper is a pertinent solution has it can be easily burn or autoclaved to be recycled. It is the same specifications for the plastic device which has to be collected and recycled. Models of trashs collect can be practicable : the test can be returned to the drugstore and be centralized before being treated. The tests aim to modify the behaviour of the users, they have to be aware about the risk of contamination after use.

Furthermore, the matrix has been consulted to take a decision concerning the migration witness. At first, we wanted to use reverse transcriptase on the detection pad. The presence of a such protein in the test has been rejected due to technical issue (what about the risks of false positive due to background noise?) economic issue (the price of production and purification) and ethical issues : even if it is produced by bacteria, is it correct to use some viral protein on the test ? How it will impact the user ? During a test can we risk to get contaminated by HIV protein whereas the test has vocation to prevention and detection ?

On one hand the diagnosis test has to be usable to every people without any medical skills or knowledges. This condition is necessary to the test democratization : the right of the people to have an access to a diagnosis test. On the other hand, the simplicity of use contribute to reduce the mistake due to the manipulations during the test. The principal levers are the usernote and the easy handled design.

However, the use of such a test present some hard ethical requirements in matter of engineer civil responsibilities and protection of the human integrity. It implies precautions taking by the healthcare authority in numerous domains : informations, medical or para medical support, juridical protection, free access, evaluation, accessibility limited to drugstore ?

Outside the hospital, the prescription of a diagnosis test has be realized with the verbal agreements of the consultant.

Reinforcing the accessibility of the diagnosis test is encouraging the voluntary approach to get diagnosticate. This approach illustrate the expression of the free will. The easy access is the number one reason according to the men which go to free diagnosis center. The personal initiative to get diagnosticate is the motor of prevention by diagnosis. For some people, going at the hospital or a the free diagnosis center is mentally difficult. This problem can be deleted by the release in drugstore or in self service. The self service is questioning about the intimity and privacy. In super market, the abundance of the people can increase the feeling of being anonymous : I’m someone in the middle of the mass or at the opposite as meetings have a higher probability : How to stand the regard of someone when grabbing an autotest ? How should I react or how can a relative react if he or she see me buying an autotest ? Besides, the tellers do not have any medical skills and are not under medical secret. Furthermore, an accompaniment has to be provided (like condoms) because of the incompatibility of the self service and the informational procedure delivered by the medical staff. In case of internet self-service, the privacy seems to be well protected, for instance thanks to the use of avatars, intermediate bank account platform and privacy policies even if the datas own can escape very easily to the users.

Finally it will be pertinent to design a neutral and difficulty recognizable packing to protect the privacy of the users when buying an auto test.

Easy access is the key to ensure the largest use of the diagnosis test so it has to offer good condition : privacy and informations when buying it.