Our product is a test package for cerebrospinal fluid rhinorrhoea. It provides better accuracy and efficiency than options currently available on the market for this purpose. It makes use of the specificity of the beta-2-Transferrin (bTF) for the diagnosis of CSF rhinorrhoea. The niche for this product currently has no competition that can effectively threaten this product, due to their inferior capabilities and pricing. Mainly schools and sport organisations (e.g. clubs) can consider our product, but also other organisations risking from head trauma, spine surgeons can also find our product useful. The profit margins are 800 million units sold. Drawing upon recent research findings and advancements made in our laboratory, we have developed a design that has promising potential for successful market penetration, enabling us to effectively compete with other companies while also ensuring a favourable profit margin.

 

 

Figure 1-3

The test package consists of a test strip and two distinct chambers, namely deletion chamber, and main chamber. The sample is directly sent to deletion chamber, designed for eliminating specific impurity, i.e. sialotransferrin (sTf), which leads to false positive results. Following a waiting period of 2 hours, the purified solution is transferred to the main chamber where it interacts with the AuNP-antibody conjugate. Binding occurs if Beta-2 transferrin is present. After 30 minutes, this solution is added to the test strip. A positive result is indicated by the test line, which turns red in the presence of bTF. The control line serves as an indicator for the reliability of the test. The test package may be defective if the control line fails to exhibit a red color. (The test strip is applied in an analogous manner to COVID-19 Antigen test Packages.)

Detecting spontaneous CSF rhinorrhoea is a noteworthy difficulty owing  to CSF’s absence of colouration in humans, making it challenging to distinguish when mixed with other fluids, mucus being a prominent example due to their similarities in colouration and location of excretion in the body(the nose). bTF serves as a distinctive biomarker for diagnosing CSF rhinorrhoea as it is exclusively present in human CSF and lymph fluid. Yet, distinguishing bTf from sTf, a serum transferrin component, is complicated due to minor differences in their glycan chains. This similarity can result in sTf binding with the anti-Tf antibody, resulting in false positives.

Our strategy for the detection and diagnosis of CSF rhinorrhoea leverages the specificity of a sialic acid-binding lectin, Siglec-1. The package comprises a test strip and two chambers, each serving a unique function.

The deletion chamber involves the utilisation of sialic acid-specific lectin Siglec-1 immobilised onto Nickel Beads to bind with and eliminates sTF from the solution. This process doesn't affect bTF due to the absence of an attached sialo group. A 2 hour stabilisation period is allocated for enhancement of binding effectiveness between lectin and sTF.

In the main chamber, the sample is treated with an anti-transferrin antibody specific to transferrin. This antibody is conjugated to gold nanoparticles (AuNP) and captures bTF. Following a period of 30 minutes for stabilisation, the treated sample is subsequently placed  onto the test strip. This strip consists of a  line with an anti-TF antibody and a control line with an anti-mouse IgG antibody, which serves as a positive control.

The two chambers and test strip will undergo disinfection and will be hermetically enclosed individually in vacuum-sealed plastic packaging in complete isolation, eliminating  any potential for  contamination. Instructions will be printed and contained on biodegradable paper, and components such as the box the package is delivered in and the instructions are made of biodegradable materials. The purpose is to  mitigate our environmental footprint and maximize our production is as sustainable as possible.

✓ ·Cost of biological components include

nitrocellulose membrane, AuNP, Siglec-1, buffer, Anti-transferrin Ab, Nickel Beads.

● ·Cost of non-biological components include

sterile polystyrene tube, biodegradable plastic cover for test strip, vacuum-sealable plastic bag, sustainable cardboard packaging.

In that respect, the estimated cost for the test kit is 10 RMB.

Our promotional strategy incorporates a combination of online and offline channel, inculding promotions on social media or seminars on related topics.

· Online channel:

WeChat Public Account: Using articles enriched with visual designs and straightforward demographics, we can introduce our product to potential consumers. Diverse content will help readers fully understand  our product and the problems it tackles comprehensively, augmenting readers' awareness of the imperative nature of purchasing our items.

 

Short Videos: With large-scale visual media sharing platforms like WeChat Channels and Bilibili, enable us to produce simple, concise, and appealing videos that raise awareness of the function and applications of our product in daily life and implant subconscious memories of it in the minds of viewers, increasing their likelihood of making a  purchase when come across our product.

· Offline channel:

School Medical Office Promotion: Direct interaction with medical personnel stationed on our campus, one of our targeted customer groups, will increase understanding of and confidence in our product. The establishment of effective working ties and collaboration within this industry will pave the way for a wider outreach to sport club directors, construction site managers, and other organization with comparable needs for our product.

Roadshow Promotion: The roadshow, in conjunction with other educational initiatives, offers a fantastic forum for spreading knowledge about the purposes and significance of CSF as well as the dangers of CSF rhinorrhoea. Promotional materials will be distributed and our team members may engage in direct contact with attendees to enhance the effect of our roadshow presentations.

Given that 80% of CSF leaks result from non-surgical trauma (Friedman, 2001), notably head injuries, our potential customers include sports clubs, construction companies, nursing homes, and small health service providers in rural/marginal areas.

·School Students

As schools have the students getting more involved in sport activities, and for the ‘extra attention that must be given to children’ (Mr. Simon Howells, a 20-year experienced rugby coach in secondary school), there will be attention to students given to their health and safety in their physical education programmes. Any accidents should give a quick diagnosis to suspected health issues to ensure maximum safety.

· Sport Clubs

The nature of competitive sports sometimes entail strenuous physical effort, quick movement, and violent collisions, be it with opposing players, sports equipment, or the ground. Again, from our interview with Mr. Simon Howells and Ms. Rebecca Heddrick (see wiki-IHP), who states that risk evacuation is extremely important in For instance, engaging in high-contact activities like football, rugby, and ice hockey increase the risk of concussions or other serious traumatic injuries. Even in non-contact games or those with little physical contact like soccer or basketball, head injuries can happen through unintentional falls, poorly timed jumps, or collisions that weren't meant. Additionally, participants routinely push their limits to achieve peak performance, occasionally risking their safety. While protective equipments like helmets or head guards are employed in many sports, it is important to note that these measures do not provide an absolute assurance of comprehensive safety. The inherent danger underscores the necessity for sports clubs to be vigilant and proactive in prioritizing safety measures, training, and immediate response to head injuries.

Nevertheless, there are many more potential consumers for CSF rhinorrhoea test kit

· Construction Companies

Construction workers routinely operate in environments characterised by a multitude of hazards, one of the most significant being the threat of head trauma. Several factors contribute to this heightened  risk. Firstly, construction sites are dynamic, constantly evolving landscapes where machinery, tools, and structures change and move frequently. Falling objects, such as tools, materials, or debris, can strike workers from above. Additionally, workers may accidentally bump their heads against fixed or moving objects, or even fall from heights, leading to direct trauma. Uneven or unstable surfaces, as well as the occurrence of  unexpected obstacles further amplify the risks. Moreover, construction tasks often require workers to be in positions where they cannot always see overhead dangers or may not have a stable footing. While helmets and hard hats aim to mitigate these risks, they cannot prevent all potential injuries, making head trauma a persistent threat in the construction industry.

· Nursing Homes (for the elderly)

Elderly individuals, due to factors such as diminished muscular strength, compromised balance, and restricted mobility, are at an increased risk of falls. The falls might pose a particularly dangerous as the ageing process often leads to reduced bone density and fragility, making seniors more susceptible to fractures and injuries from relatively slight incidents. Consequently, the elderly residing in nursing homes, despite being in a care-centric environment, may still confront  the threat of head trauma. While nursing homes aim to provide safe surroundings with necessary precautions like handrails and non-slip flooring, accidental falls can still occur.

· Small clinics in Rural/Marginal Areas

Numerous rural or marginal areas exhibit a dearth of advanced medical facilities present in urban centres. Hospitals may be sparse, and the presence of specialised diagnostic centres or laboratories may be much more scarce. Also, diagnosing CSF rhinorrhoea requires specialised equipment, which might not be readily accessible  in peripheral areas. Hospitals in these locations might not have the financial means or see the practicality in investing in such equipment if their perception of the demand for this type of equipment is low. Specialist medical staff, such as neurologists or laboratory technicians skilled in detecting CSF rhinorrhoea tend to concentrate in urban or more central locations. Rural areas often struggle with recruiting and maintaining such specialised professionals.

·Spine Surgeons

Spine surgeons must make critical post-operation decisions on patient care quickly regarding to whether the patient has a CSF leak or not (Known et al., 2015), as 16% of CSF rhinorrhoea is caused by surgery (Loew et al, 1984)

The package may be classified as a Class II medical device in China, requiring stringent controls for ensuring its safety and effectiveness.

This non-invasive test package doesn't involve animal testing, so it presents minimal ethical concerns.

Why do we want to make our product?The tests for CSF rhinorrhoea that are currently for sale are either limited reliability (glucose testing yields results with no specificity and sensitivity as low as 80%) or are financially inaccessible to the general population and requires highly skilled labour and specialised capital to run (such as specialised lab equipment and technicians). Both the price and performance for products that currently take up the majority of the market share for this niche is unsatisfactory. Our product aims to remedy this. Through the process of simplification and compression of the requisite test protocols, coupled with a substantial reduction in price attributed to the curtailment of the production process and the elimination of nearly all specialised equipment and labor, our product is uniquely positioned to proffer an unparalleled blend of competitive pricing and remarkable accuracy, the two quintessential facets of test package performance.

· Potential Consumer Base

In China, for primary and secondary school students, there are 293 million (Chinese ministry of Education, 2022). A prominent source of consumers are primary school students in China, thanks to the enforced physical education sessions  compulsory for all students below 16. This puts them all at risk of head injuries, and  when compounded with the fact that they are all adolescents and are therefore undergoing a stage of cerebral growth where cerebral health is particularly important , makes our product particularly important to them. As of now, there is a total of 44.3 million students undergoing education in China, and that number continues to grow. In addition, athletes, manual labourers, and many more labour-intensive and injury-prone professions are all potential major buyers of a test package aiming to indicate a CSF leakage as their activities include heightened risk of traumatic head injury. Hospitals may also consider applying our products in their diagnosis to a certain extent with regards to the urgency and condition of the patient.

Considering the widespread of both amateur or professional sports in China, construction companies, etc. we may consider our product to have a potential consumer base of 400 million.

A large and stable market is one of the fundamental prerequisite for a successful product. Our product caters to those at risk of any type of traumatic head injury as a preventive measure for CSF rhinorrhoea, which may lead to dire consequences. China has annual incidence of traumatic head injury ranging from one to two million recorded cases, a significant number of which  may possibly lead to CSF rhinorrhoea. As a matter of fact, companies with a sizeable manual workforce or sports clubs are both potential major purchasers of our test package due to their high compound risk of rhinorrhoea caused by their substantial amount of individuals at risk. With our products ability to surpass the time required for completion of laboratory testing , it is plausible that hospitals may emerge as significant purchaser, using our product for preliminary prognosis.

· Questionnaire based research

The development of high-quality product requires research and feedback from its target consumers. We carried out a questionnaire about our product’s demographic for research purposes, with over two hundred effective responses. We are able to ascertain several key facts for further improvement of our product. Over 75% of the people believe that head and neck trauma are significant factors of brain health. 88% of the respondents believe our test packages should be available for purchase in pharmacies, and roughly 56% of the participants believe the pricing per package should be between 21 to 50 RMB. Approximately  70% of the respondents only purchase test packages when they suspect they have a corresponding illness, and almost 80% of the participants express contentment with the convenience of current test packages. 83% of the respondents allow the test package a maximum of 15 minutes to provide findings. Ultimately, roughly half of the participants believe the test package should be conducted at their own residence by the consumer, obviating the need for laboratory involvement..

The letter "P" represents the term "political". The main political obstacle that must be overcome is to the evaluation procedure necessary required to authorise the procurement of our product for purchase by hospitals and medical centres. This process may diminish out momentum in getting our product out on the market due to various bureaucratic hindrances that extended assessment period to be finished. We will counter by applying for the appraisal beforehand so as to coincide the release of the market-ready version of our product with the finish of the appraisal process. Efforts are made to minimise the duration between the product's release for sale and the completion of the evaluation process. Healthcare policies determined by politicians may influence the budget hospitals have, and therefore demand for medical products. After extensive analysis however, we can conclude that the rate of a serious CSF leakage (Risk of irreversible damage/fatal damage) in the population remains largely constant at roughly five individuals per hundred thousand members of the population. With this information in our hands we can roughly estimate that a total of about seventy thousand persons are at risk of losing their lives from CSF leakage, with countless more individuals with leaks that may take a turn for the worse as they are left untreated for ever longer periods of time due to the absence of cheap and reliable testing. Based on the above information, it can be deduced that the demand for our test package is expected to exhibit a stable pattern regardless of the political environment, so we will be largely unaffected by such policy modifications or budgetary alterations.

E for economical. The primary influence of the economic climate will have on our product is price dynamics and demand for comparable products. For example, if a large firm with a higher-cost test package but a more streamlined  PR team pulls off an extremely successful advertising campaign, we may be out-competed due to our constrained advertising budget. As a consequence, our market share will be diminished due to the presence of a product of worse quality. We will circumvent this problem by striking first at the market with our significantly lower price and unparalleled performance to gain as much initial market share as possible, and defend it with new upgraded generations of our product in order to maintain the technical distance between us and our competitors. They will keep bleeding market share to us as long as we can maintain our technical lead over them. A second effect of the economy on our product is economic policies governing medical items. The most favorable course of action is to participate in the China Healthcare Security Program, which opens up the massive customer base that is the Chinese healthcare system to our product, providing us with a financial safety net of sorts.

The letter "S" represents the field of sociology. One significant determinant that plays a part in affecting demand is the awareness of CSF leakage as a prevailing concern. A population characterised by heightened awareness would inevitably have a higher demand for our product owe to their awareness of this health risk. However, an unfortunate fact shown by data from our surveys reveals a concerning reality: Chinese society exhibits a limited level of understanding  about CSF and cerebral health. The polls also exposed the specific areas the general public were most ignorant, providing precision topics for our education program to target. As public awareness of CSF leakage and cerebral health rises demand for our products increases as well. In addition, cultural attitudes and beliefs around medical testing and procedures may influence the adoption rate. Most if not all of the current population are already familiar with using antigen test packages thanks to the COVID-19 pandemic, and by basing our test packag design on that of a COVID antigen test package we will ensure the populace does not have technical issues on the adoption of the package.

T for technological. Advancements in medical technology and diagnostic tools can enable more accurate and efficient testing methods for CSF rhinorrhoea. With the use of our novel protein, we raised the accuracy and precision marginally when compared to solutions available on the market as of now, while maintaining or reducing the associated costs. Moreover, compatibility with existing healthcare systems and electronic health records can facilitate seamless integration and data management. Our new product provides better integration with  pre-existing  systems compared to ELISA or other methods available for purchase with its superior speed and higher volume of testing available.

The letter "L" represents the concept of legality. In order to mitigate any legal inconveniences and obstacles, we are to ensure our end product for widespread distribution is compliant with medical device regulations, quality standards, and data privacy laws. It will be essential to the manufacturing and distribution of the product. We have taken measures to ensure that our product does not infringe on any related patents and intellectual property rights.

E for in Environmental. Considerations may relate to the disposal of medical waste generated during testing or the sustainability of manufacturing processes. Practically we can have our plastic covers made of bio-degenerative plastic. Geographic factors, such as climate or regional healthcare disparities, may influence the demand and distribution of the test package.

The test package's strengths lie in its ability to accurately detect CSF-related antigens, i.e. beta-2 transferrin, providing a non-invasive and convenient diagnostic tool for healthcare professionals. It offers the potential to improve diagnostic accuracy and facilitate prompt response. However, it is important to acknowledge that weaknesses may include potential limitations in detecting infrequent or atypical cases of CSF leakage.

Opportunities for the test package include a growing demand for improved diagnostic solutions in the field of CSF rhinorrhoea, expanding healthcare accessibility, and potential collaborations with medical professionals, sport-related organisations, construction companies, etc.. Threats include competition from alternative diagnostic methods, as well as the possibility of rivals developing comparable items.

Our main competitor, which also provides a test on beta-2 transferrin is commercial ELISA test, for which examples of these companies producing it are Shanghai Keshenghan , Aosilai, Youbosen, etc.. Their ELISA test package utilises sandwich ELISA and they also have high accuracy to 97% and 99% respectively for sensitivity and specificity as the test also aims for the specificity of a protein to accurately determine the presence of CSF and its rhinorrhoea.

The domestically produced ELISA test package has a price spanning from 800 to 2240 RMB, while imported ones are overall more costly, with price ranges varying from 1190 to 2340 RMB. There are two prevalent test kinds, namely 48T and 96T (where 'T' denotes  the number of samples can be accommodated in single test package), the latter being more expensive than the former. It requires storage temperature of 2-8 degrees away from light. During testing, the required concentration must be larger than 1.0 pg/mL, and its effective testing range is from 1 to 120 pg/mL. The duration of validity for this term is six months. This ELISA test requires a set of numerous, complex procedures for those carrying it out, including pretreatment procedures for the test sample. Thus, it is inevitable that samples need to be sent to laboratories and professional technicians, which incurs supplementary expenses that exhibit regional disparities around cities. Currently, this ELISA test package is not applied clinically but only for research purposes, which shows that beta-2 transferrin ELISA has not yet established significant dominance in ordinary medicinal applications to capture a substantial market share from both public hospital/government purchases nor ordinary consumer consumption.

In conclusion, the current ELISA test demonstrates a high level of accuracy, which they usually promise a 0.99 accuracy. Nevertheless, lab-requiring ELISA is costly, resource consuming from its storage to executing from the supplier’s perspective, time consuming waiting for the sample to be tested. Consequently, it is not a prevalent test for the general population.

The cost for ELISA test, though one package can test for maximum of either 48 or 96 tests, the average price for one test varies between 15 RMB to 25 RMB. YBio’s ELISA package for beta-transferrin, for example, is 1900 RMB one package, 96T, i.e. 96 samples can be done so optimistically one consumer pays 20 RMB for paying the package. In addition, ELISA test requires quite stringent storage conditions, which include significant energy costs for continuous refrigeration, as well as the allocation of laboratory resources and staffs for its production. Moreover, the use of laboratory  resources services necessitates, a delivery fee from places is also included. Most importantly, researches (Kwon et al, 2015) emphasised the importance of pretreatment of sample to remove an impurity, sTf that may lead to false positive. To achieve this, again laboratory equipments such as multiple centrifuges (Known et al., 2019) is applied, which increases the cost of product by a large amount. If a comprehensive diagnosis including ELISA is promoted for medical uses, we may consider that the the cost of conducting a single test is not only about compromising the package itself, but all those subtle costs, resulting in an estimated cost of 90-110 RMB per sample.

A bTF ELISA test has a shelf life of  6 months. Long-term storage is not possible due to the wastage of unsold samples when the supply exceeds the demand. Antigen tests averagely can still be used in 15 months, thus in terms of bearing the time of storage, our solution demonstrates superiority.

Upon examining the comparing metrics, our product is not based on the sophisticated ELISA but a very simple, in terms of practical using, antigen test. (A good analogy is the COVID-19 antigen test) The general public can execute the test in the comfort of their own home, therefore significantly reducing the time required for sample transportation to laboratories. Our price is set at around 80 RMB when commencing our product selling, which is rather low considering that an ELISA test’s cost not only consists of the basic cost itself, but also consumers’ chronological cost, etc.. Hence our products, when introduced into market, are expected to rapidly acquire a significant market share considering their unique features, including heir simplicity and time efficiency testing for CSF rhinorrhoea, which is presently not offered by any other comparable products. 

When considering the population affected by traumatic brain injury, which exceeds one to two million individuals, a large proportion of this group has CSF leakage, not to mention when the product is promoted to evident in situations involving vigorous sports, manual labour, or any other activities where such leaking poses an obvious hazard.  Hence we can say more than 400 million users will buy our products, which each person is expected to use at least two test packages, resulting in a total market demand of at least 800 million units. Considering the global awareness of  antigen test  during  the pandemic in 2023,  it can be anticipated that  Consumer Acquisition Cost (CAC) will be lowered as consumers increased familiarity and trust in antigen test so less effort required  to convince them the reliability and safety of our antigen test.

The causes of CSF rhinorrhoea, such as sports injury, is constant in amount over time, thus the consumer base remains in a large and stable quantity, which our product is advantageous in Customer Lifetime Value (ClTV).

Sunk cost: A research and development cost per cycle will be estimated around 10,000 RMB, 5 cycles every year and clinical (animal) trials, estimating 3 cycles per year cost 100,000 RMB per round, the fixed cost will be 350,000 RMB in total.

Operation expenses can be set as 200,000 RMB per staff per year and 20 staffs are employed, its sum 4,000,000 RMB per year.

The annual allocation for promotional costs amounts to 3,000,000 RMB. Considering the potential future situation, it is deemed appropriate to modify the aforementioned figure, potentially amounting to an annual sum of 2,000,000 RMB for the second and third years. 

Upon examination of the first year, a comprehensive summation of all expenditures yields a total of 7,850,000 RMB. With each test sold at 20 RMB for the first year and production cost for each test to be 10 RMB, the total revenue can be calculated as 10 RMB times quantity sold. To achieve full cost coverage, 785,000 tests need to be sold. This target is readily attainable given our substantial prospective demand of  800 million tests and our product will capture a significant share. It is very plausible that we may exceed this target by a considerable margin. Therefore, it is feasible to achieve a substantial profit margin.  

 

Perception map:

 

1. Radiological diagnosis (e.g. CT minimum 240RMB)

2. lumbar puncture 100-200RMB

3. laboratory analysis (sample delivery, pretreatment & ELISA, etc.)

4. Ordinary doctor visual analysis (22RMB once, but usually patients go to ENT before neurology doctor thus need several appointment being made)

5. glucose strip test (Cheap but low accuracy, 80% sensitivity and 0 specificity) (Chan et al., 2004)

6. Our product is low in price, convenient, has high accuracy

Figure 4

· Production Procedure

Having assessed the influence of our product on the market, we can formulate a comprehensive strategy and plan for our product. The fundamental nature of our product is a test package for CSF rhinorrhoea. Through utilisation of an innovative protein, we are able to distill the test into a 15 minute test which only requires a nasal swab instead of an assay that takes over a day to run and requires expensive lab equipment as well as professionals for its execution.

 

The following section provides a comprehensive overview of the manufacturing process for our CSF test package (for nasal discharge).

 

First, the essential constituents, including test cartridges, sample collection swabs, buffer solutions, reagents, and packaging materials are produced or procured. These components are subsequently assembled to form the test cartridges, incorporating various layers and components in a precise manner to ensure proper fluid flow and accurate results. Reagents, including the bTF protein indicative of CSF leakage, are prepared and immobilised onto designated regions within the test cartridge. Rigorous quality control measures are implemented throughout the manufacturing process, including sensitivity and specificity validation using known positive and negative samples. The finalised test packages are packaged, labeled with instructions, lot numbers, and expiry dates, and may undergo sterilisation to ensure safety. Proper storage conditions are maintained until the packages are ready for distribution. In addition to the CSF rhinorrhoea antigen test package, there are several complementary services that can enhance the overall diagnostic and treatment experience for patients. One important complementary service is diagnostic consultation, where medical experts or healthcare professionals provide personalised guidance and expertise in interpreting test results and recommending appropriate treatment options based on the findings. This service ensures that patients receive comprehensive and individualised care, addressing their specific needs and circumstances. Another valuable complementary service is collaborating with imaging centres or radiology facilities to offer medical imaging services, such as MRI or CT scans. These imaging techniques provide detailed visual information about the site and extent of CSF leakage, aiding in accurate diagnosis and treatment planning. By integrating these imaging services with the antigen test results, healthcare providers can obtain a more comprehensive understanding of the condition, facilitating targeted and effective treatment approaches. Establishing a robust referral network is crucial to ensure that patients with CSF rhinorrhoea have access to specialised care beyond the initial diagnostic phase. This network can include specialists such as otolaryngologists, neurologists, or neurosurgeons who have expertise in managing CSF rhinorrhoea. Referrals to these specialists can be made based on the test results and individual patient needs, enabling a multidisciplinary approach and seamless coordination of care throughout the treatment journey. Patient education and support services play a vital role in empowering individuals with CSF rhinorrhoea and their families to make informed decisions about their health. Developing comprehensive educational materials and online resources that explain CSF rhinorrhoea, its symptoms, causes, available treatment options, and preventive measures can increase awareness and enable patients to actively participate in their care. Additionally, offering support services such as helplines or online communities creates a platform where patients can seek guidance, share experiences, and find emotional support from others facing similar challenges. Effective treatment coordination services streamline the process of care for patients with CSF rhinorrhoea. This includes facilitating communication and collaboration between patients, primary care providers, specialists, and other healthcare professionals involved in their treatment. Coordinating appointments, organising follow-up care, and ensuring the seamless flow of information between different healthcare providers helps optimise the patient's experience and ensures continuity of care. Investing in research and development efforts is essential to continuously improve the accuracy, sensitivity, and specificity of the CSF rhinorrhoea antigen test package. By staying at the forefront of advancements in diagnostic technologies, healthcare providers can enhance the reliability and performance of the test, leading to more accurate and timely detection of CSF leakage. Additionally, ongoing research can help identify potential biomarkers or innovative approaches for diagnosing and managing CSF rhinorrhoea, driving advancements in the field and improving patient outcomes. By integrating these comprehensive complementary services, healthcare providers can offer a holistic and patient-centred approach to individuals with CSF rhinorrhoea. This approach not only focuses on accurate diagnosis but also emphasises personalised treatment plans, education, support, coordination of care, and continuous improvement through research and development.

 

There are several potential substitutes for a CSF-Rhinorrhoea antigen test package. One option is laboratory analysis of cerebrospinal fluid (CSF) through tests that assess protein levels, glucose levels, cell counts, and the presence of specific markers related to CSF leakage. Medical imaging techniques such as MRI or CT scans can also be utilised to visualise structural abnormalities or meningocele, which can indicate CSF rhinorrhoea. Another substitute is sending CSF samples to a laboratory for bTF analysis, a specific protein found in CSF and not in other body fluids, using techniques like immunoassays or electrophoresis. Additionally, healthcare professionals can rely on a comprehensive clinical evaluation, including a detailed medical history, physical examination, and assessment of symptoms associated with CSF leakage. However, they either do not have perfect accuracy/specificity or friendly prices and subtle costs such as the time used to deliver sample to hospital.

 

The prototype and packaging of a CSF Rhinorrhoea Antigen test package play crucial roles in ensuring the effectiveness, usability, and safety of the diagnostic tool. Here's a description of the prototype and packaging considerations: The prototype of a CSF Rhinorrhoea Antigen test package involves the development of a functional model that showcases the key components and features of the final product. This includes the test cartridges, sample collection swabs, reagents, and any necessary accessories. The prototype allows for testing and refinement of the package's design, functionality, and performance before mass production. During the prototyping phase, it is important to evaluate factors such as the sensitivity and specificity of the package in detecting the specific CSF-related antigen, as well as the overall ease of use. The prototype should be optimised for accuracy, reliability, and user-friendliness, ensuring that healthcare professionals can obtain accurate results with minimal effort. Iterative testing and feedback from medical experts and potential end-users can help refine the prototype and address any issues or improvements needed. The packaging of a CSF Rhinorrhoea Antigen test package serves multiple purposes, including product protection, information dissemination, and regulatory compliance. The packaging should be designed to maintain the integrity and stability of the components throughout transportation, storage, and usage. It should safeguard the package from moisture, temperature variations, and potential contamination, ensuring that the reagents and other materials remain viable and effective. The packaging should prominently display important information such as the name of the test package, instructions for use, lot number, expiration date, and relevant regulatory compliance details. Clear and concise instructions enable healthcare professionals to properly conduct the test and interpret the results. Additionally, incorporating user-friendly elements such as illustrations, diagrams, or QR codes for access to digital resources can further enhance the usability and convenience of the package. Consideration should also be given to the environmental impact of the packaging. Utilising sustainable materials or incorporating eco-friendly practices in packaging design aligns with current environmental standards and contributes to responsible manufacturing. Overall, the prototype and packaging of a CSF Rhinorrhoea Antigen test package should prioritise accuracy, ease of use, product protection, regulatory compliance, and environmental consciousness. Through careful development and refinement, an effective and user-friendly test package can be created to assist healthcare professionals in the accurate diagnosis of CSF rhinorrhoea.

 

As mentioned, our product will be initially sell at a unit price of 20 RMB. This is to ensure the revenue is sufficient to maintain a profit margin. Furthermore, given the absence of any direct competitors offering commercial Point-of-Care (POC) test package for CSF rhinorrhoea, the pricing of such a product would not be a disadvantage.

 

[1] 28. Kwon SJ, Zhang F, Dordick JS, Sonstein WJ, Linhardt RJ. Detection of cerebrospinal fluid leakage by specific measurement of transferrin glycoforms. Electrophoresis. 2015;36:2425-2432

 

[2]Oh, J., Kwon, S.J., Dordick, J.S., Sonstein, W.J., Linhardt, R.J., Kim, M.G. (2019). Determination of cerebrospinal fluid leakage by selective deletion of transferrin glycoform using an immunochromatographic assay. Theranostics, 9(14), 4182-4191. https://doi.org/10.7150/thno.34411.  

 

[3] Friedman JA, Ebersold MJ, Quast LM. Post-traumatic Cerebrospinal Fluid Leakage. World J Surg. 2001; 25: 1062-1066.

 

[4]  Loew F, Pertuiset B, Chaumier E, Jaksche H. Traumatic, spontaneous and postoperative CSF rhinorrhea. Adv Tech Stand Neurosurg. 1984; 11: 169-207

 

[5]2022年全国教育事业发展统计公报, 2023.7.5

 

[6]Chan DT, Poon WS, Ip CP, Chiu PW, Goh KY. How useful is glucose de- tection in diagnosing cerebrospinal fluid leak. The rational use of CT and beta-2 transferrin assay in detection of cerebrospinal fluid fistula. Asian J Surg. 2004;27:39-42. https://doi.org/10.1016/s1015-9584(09)60242-6