PROPOSED IMPLEMENTATION

Introduction

SPYKE is a detection system that could, for instance, detect GHB directly in your glass. Through a simple cup, this quick test will enable both clubs and individual users to check for GHB passively and continuously. However, before SPYKE may be used in the real world, legislation, certifications, data regulation, safety concerns, clinical trials, scaling-up procedures, and environmental effects must be addressed. Here, the recommended method for carrying out our project is outlined, and the problems we tackled are addressed. In addition, other applications were explored, as well as, their safety aspects and challenges.

Application and End-Users

This section outlines our concept for SPYKE's use and how end-users will be involved. It also shows how other parties, such as the police and medical institutions, interact with SPYKE. A graphic illustration of these suggested applications can be found in Figure 2.

Production

Since we are more aware of the issue in the Netherlands and because the safety precautions and quality controls are governed by European law, SPYKE's manufacture will take place in this area [1] . To ensure the best possible communication between the clubs—our key customers—and our business, we intend to open multiple distribution and collection points close to major cities like Amsterdam, Rotterdam, and The Hague. This is essential to guarantee that our product is recycled properly and that the cup is reusable. In essence, our plan is to collect the cups from the clubs the morning after, restock the biological components, refresh the sensor as necessary, and then deliver the glasses to the hospitality establishment. To do this, distribution and transportation logistics are essential. In order to prevent any miscommunication and give the end-users the most reliable biosensor we can, we intend to rely on established distribution services and communicate directly with our clients. We also plan to use rPET, a recyclable plastic that is suitable for food, to prevent environmental pollution and health hazards [2] . The overview of our company can be found on the entrepreneurship page.

Hospitality Businesses

The majority of SPYKE's clients are hospitality businesses (see empathy map in entrepreneurship ). These are the primary locations where spiking happens, so they would be keen to purchase our equipment to guarantee a secure atmosphere for their customers [TU Delft, see club interviews ]. Whenever spiking occurs, the businesses become linked to the negative stigma of a location that permits spiking [TU Delft, interview Perron ]. This is unfair because these businesses cannot be held accountable for other people's conduct. This causes them to feel victimized throughout the entire process. Given that they are our target audience, we must guarantee a clear communication with them in order to ensure proper waste disposal, proper function of the device and recyclable goods. We would need to use an indistinguishable glass, which would make it impossible to tell a SPYKE glass apart from a regular glass, to assure everyone's safety. This is due to the fact that not everyone might want to purchase the good, but they should not become the target of spiking due to them not having an additional safety measure provided by our glass.

Also, the consumer at the establishment will have to pay a slightly higher price for the first glass at the beginning of the night before continuing to pay the regular costs once they have their own product. This procedure has been used for some time to lessen plastic waste, not only in the Netherlands but also in other nations, particularly at festivals [3] . Because of this, we don't anticipate this deployment will affect our sales and the customer's safety.

End-users

Our end-users are part of the nightlife audience [TU Delft, see empathy map ]. They desire a product that is trustworthy, quick, affordable, passive, and discrete [TU Delft, see survey users and focus group ]. We chose a biosensor in a glass that continuously (thus passively) measures the GHB concentration in their drink and emits light if in contact with GHB so that they can enjoy the night as much as possible without having to worry about potentially getting spiked. We made the decision to work together with the hospitality establishment to maintain a safe atmosphere overall in order to make it as effective and accessible to everyone as possible. The end-user can simply purchase the cup directly at the venue without additional burdens.

In addition to speaking with many stakeholders throughout our interviews, we also had a dialogue with a victim who proposed we implement an additional gadget [TU Delft, interview victim without proof ]. After being spiked, they claimed they became overly conscious of their surroundings, thus having a device that they could buy themselves would provide them with that required added safety. This way, they could also actively check it at all locations if necessary. Moreover, we had a conversation with a high ranking police man, and he confirmed that a supplementary gadget would be a great addition [TU Delft, interview with Aaldrik Krol ]. We are therefore going to create a device that the user can insert into the beverage as often as they deem appropriate to ensure everyone is safe.

Police

When we identified our stakeholders, we also considered contacting the police to learn more about what typically occurs when someone wants to report being spiked and what features our sensor would need to have in order to be used as evidence in court [TU Delft, interview with Aaldrik Krol, Cornelis Villerius and the page human practices ]. He described the procedure to us and provided us with a guarantee that the police would become involved if the outcome of the test was positive.

Improving Data

Governmental and medical institutions have been attempting to comprehend how frequently spikes occur. This issue has received significant media attention, however, unfortunately, the reported case and the proven ones do not match [4] , [5] , [TU Delft, see human practices and local context ]. This is because the GHB molecule degrades quickly and because testing processes are ineffective [TU Delft, see human practices and market analysis ]. It is crucial to have access to current, reliable data on the prevalence of this issue in order to strengthen intervention tactics and direct governments in the process of eradicating GHB spikes. One of SPYKE’s goals is to increase the available data on GHB spiking incidents.

In order to accomplish this, we intend to make the detection system’s data accessible to health organizations by utilizing already-existing databases like the National Alcohol and Drug Information System (LADIS) [6] . Data security will be assured by the police department and law enforcement institutes. Health organizations will be able to determine which areas are more likely to experience an increase in GHB spiking and where they need to take action to solve the issue by studying this data. As a result, health organizations would be better able to advise governments and healthcare networks on intervention program ideas, resulting in the effective use of (financial) resources and a healthier and safer population.

Other Applications

As discovered from stakeholder interactions during the integrated human practices , SPYKE can be used for more applications than only countering GHB spiking. At the moment, there is no reliable quick GHB test available on the market [TU Delft, see market analysis ]. We discovered that hospitals, the forensic institute, and law enforcement are in need of a quick GHB test.

• Hospitals: As hospitals hardly ever test for GHB at this moment, medical experts informed us that hospitals urgently need a rapid GHB test. Currently, hospitals use a complex GC-MS test that must be performed by a professional to detect GHB. A fast GHB test could help determine the root of the symptoms and help decide on the best course of action. Blood is a suitable sample because the test must be simple to perform, even on comatose patients.
• Forensic institute: We were informed by employees from the forensic institute that they also long for a fast GHB test when determining one’s cause of death. Now, it takes a long time to screen for GHB because a blood sample needs to be sent to the Dutch Forensic Institute (NFI). The rapid identification of GHB in blood could expedite the investigation and reduce the required work. Nonetheless, after a positive result, blood must still be sent to the NFI to confirm that GHB was present.
• Law enforcement: The police and the Public Prosecution Service don’t have a quick GHB test to identify GHB intoxication for violent incidents, driving under influence, and spiking. At the moment law enforcement has to take the same steps as the forensic institute, which again requires a lot of effort and time. According to Erik Izaks , it will be almost impossible to create a test that would stand up in court. For this reasein, the test should serve as a first screening after which the NFI should confirm the test for legal relevance.

To be useful for all these applications, the mechanism of SPYKE should be used to create a quick GHB blood test. Nienke le Fever mentioned that the test has to be validated following European guidelines before it can be used. The steps that have to be taken can be found here. Aaldrik Krol mentioned the police was interested in helping us achieve this. We also heard from Femke Gresnigt that for the test to be viable in hospitals, a sensitivity and specificity of 95% would be required. To be viable for these uses the sensor has to pass these criteria. If not, further improvement of SPYKE is required.

Safety

The various areas of safety and security were investigated, discussed, and incorporated into the suggested implementation and research during the creation of SPYKE. The following proposed implementations and research were made in order to achieve safety and minimize any potential issues arising associated with SPYKE:

• Migration tests and BlcR safety: The ministry of Health, Wellfare and Sport (VWS) explained that migration tests must be carried out to ascertain whether the filter we use does, in fact, retain BlcR well. Migration tests determine whether excessive amounts of a certain food contact material are present in the food [7] .
• Data security: Using a light instead of our initial idea, a Bluetooth output, lowers the possibility of data exploitation. The information is gathered by the police and stored in their safe database [8] .
• More drugs: Research should be done to incorporate current electronic rape drug testing into the SPYKE glass to safeguard the user from other drugs.
• Selling to individuals: We offer the opportunity to purchase SPYKE individually to people who prefer to be in charge dont have to rely on the nightlife establishment.
• Needle spiking: The existence of SPYKE might make needle spiking the preferable method of spiking. Our further use of SPYKE as a test for the presence of GHB in the body may be able to shed light on the controversial subject of needle spiking.
• Recycling: We chose to recycle SPYKE in the factory rather than on-site because we wanted to ensure its trustworthiness.
• Biocontamination: We choose to purify the BlcR protein inside the factory to ensure the ampicillin restistence plasmid doesn’t leave the factory.

To read more about the details of the safety consideration of SPYKE and to see the design changes based on the safe-by-design approach, go to the safety page.

Challenges

Improve performance

We developed a prototype of the cup including our GHB sensor. The electronic circuit incorporated inside was able to detect SSA, but the full system failed due to leakage, faulty electrodes, and bad wire connections. To make SPYKE viable these problems should first be overcome. On the hardware page , we describe the prototype and propose ways to improve its performance.

Cleaning

One of the greatest challenges in the application of SPYKE is the cleaning of the glasses by the clubs. To reduce waste and lower costs, the glasses should be reused multiple times during the night. The cleaning procedure usually used by bars involves chemicals [9] which could be harmful to the SPYKE system.

Governmental approval

As identified by the five food safety institutions, it could be difficult to get governmental approval for SPYKE as it could be a food safety risk. Through various interviews [TU Delft, see integrated human practices], we identified that SPYKE could be classified as a food contact material[10]. This would make the BlcR protein, produced by a GMO, not be considered a GMO, which reduces the number of regulations significantly. To be sure SPYKE identifies as a food-contact material, migration tests for the BlcR protein should be done. Also, the rest of the sensor should adhere to the food-contact material regulations [10] which means that all the materials should be approved. In the safe-by-design approach, we made design changes to make sure that all the materials that would possibly come in contact with the beverage were food safe. For non-food-safe materials like the electronic components and the battery, it is not necessary that they are changed if they are not in contact with the beverage. The case is similar for the intelligent packaging material with non-food-safe acid fuchsin [11]. Eventually, we should submit an application with all our research to the EFSA who will do a risk assessment to decide if SPYKE will be approved [TU Delft, see compliace ], [12].

Scaling up

Currently, SPYKE is still a prototype. To go from this prototype to an actual marketable product, the production process must be scaled-up. This comes with its own hurdles to overcome. For example, although scaling-up results in a reduction in material costs due to bulk consumption, many substantial one-time purchases must be made. These include molds for the hardware and glasses and reactors for the in-house production of the BlcR through the use of microorganisms. Therefore, funding must be acquired and partners should be found to assist in these processes [TU Delft, see internal operations ].

Environmental impact

A final challenge that SPYKE faces upon implementation is the environmental impact of the product. To ensure a reliable SPYKE, the DNA, electrodes, protein, and filter must be replaced each night as they can lose their functionality after one night. This, however, affects the environment in a negative way. To relieve this pressure on the surroundings, biodegradable plastics and recycled materials should be considered to be used in all other components of the test that allow for it.

Diclofenac

As mentioned in human practices , diclofenac could be a possible antidote to a GHB overdose [13]. If this would indeed be the case, diclofenac could be used as a preventive measure if SPYKE indicates that the user has been drugged. Nightlife establishments and first aid doctors could have diclofenac ready to save people from a GHB overdose. The paper only presents the use of diclofenac as a GHB antidote when given prior to GHB intoxication. More research should be done to investigate if diclofenac also works when given after GHB intoxication.

More drugs

Future research should be done to test whether biosensors for other possible rape drugs could be implemented with our GHB sensor. Electrochemical detection of benzodiazepines [14] and ketamine [14], two other common rape drugs [16], has already been proven possible. These detection mechanisms could possibly be combined with our electrical sensor. Due to time constraints, we could not test this, but this possibility should be investigated. A paper from 2019 [17] suggested the possibility of using directed evolution to create novel allosteric transcription factors. Further research could be done to create allosteric transcription factors for possible rape drugs. These transcription factors could possibly be added to our sensor to screen for more drugs.