New Born Screening - Current advances and methodologies in the globally

New Born Screening - Current advances and methodologies in the globally

Kalpeshkumar Hegde, 2024

Summary

Newborn screening (NBS) is a critical public health initiative designed to detect rare metabolic, endocrine, and genetic disorders in infants shortly after birth. This proactive approach facilitates early interventions that can prevent severe health complications, disabilities, or death. Since its inception in the 1960s, NBS has evolved from basic testing methods to advanced technologies, including next-generation sequencing (NGS), significantly enhancing its scope and effectiveness.[1][2] As NBS becomes standard practice in many countries, it has garnered attention for its potential to save lives and improve long-term health outcomes.

The historical progression of NBS highlights significant technological advancements, particularly the introduction of tandem mass spectrometry and NGS, which allow for more comprehensive and sensitive testing. NGS, in particular, has revolutionized the field by enabling the detection of genetic conditions that may not be identi-

fied through traditional metabolic screening methods.[3][4] The expansion of NBS programs worldwide is accompanied by community engagement efforts and public health policies aimed at increasing awareness and accessibility, ensuring that these vital services reach diverse populations effectively.[5][6][7]

Despite its successes, NBS faces notable challenges, including the need for stan- dardized methodologies and the complexities associated with interpreting vast genetic data. Ethical considerations also arise regarding informed consent, data pri- vacy, and the implications of genetic testing on family dynamics.[3][8] Additionally, the integration of NGS into existing frameworks presents logistical hurdles, particularly in low- and middle-income countries (LMICs), where access to screening programs remains limited due to infrastructural and educational barriers.[9][10]

The future of NBS lies in continuous technological advancements and international collaborations aimed at refining screening methodologies and improving access. As public health initiatives strive to enhance the effectiveness and reach of NBS, ongoing research and evaluation will be essential to ensure that these innovations translate into improved health outcomes for newborns globally.[4][5][10]

Historical Context

Newborn screening (NBS) has evolved significantly since its inception, transitioning from basic tests to advanced methodologies, including next-generation sequencing (NGS). Initially implemented in the 1960s, NBS programs aimed to identify metabolic disorders that, if left untreated, could lead to severe health issues or death[1][2]. These early programs primarily focused on a limited number of conditions, typically using blood spot testing to assess specific metabolic markers.

As technology progressed, the scope of newborn screening expanded. By the 1980s and 1990s, advances in biochemical assays enabled the detection of more disorders, which contributed to the establishment of standardized screening protocols across various regions[11]. The introduction of tandem mass spectrometry in the late 1990s allowed for simultaneous testing of multiple metabolites, significantly improving the sensitivity and specificity of screening tests[1].

In recent years, the integration of next-generation sequencing into newborn screen- ing has marked a transformative shift in the field. This method enables comprehen- sive genetic testing at a population level, allowing for the early detection of genetic conditions that may not be evident through traditional metabolic screening methods- [3][4]. Studies indicate that NGS can enhance the characterization of Mendelian disorders, providing crucial information for timely interventions[3][11].

The historical development of NBS has also been shaped by public health policies and community engagement efforts aimed at increasing awareness and accessibility of screening programs. Efforts such as regional workshops and educational cam- paigns have encouraged governmental support and community involvement, facili- tating the growth of NBS initiatives globally[5][6][7]. As a result, newborn screening is now a standard practice in many countries, with programs continually evolving to incorporate the latest technological advancements and address the diverse health needs of populations[1][2].

Current Methodologies

Overview of Newborn Screening

Newborn screening (NBS) programs are essential for early detection of rare metabolic, endocrine, and genetic disorders in infants, facilitating timely intervention to prevent severe health issues, disabilities, or death.[2] In the United States, virtually every newborn undergoes screening, which typically includes testing for several conditions through dried blood spots collected within 24 to 48 hours after birth to minimize false negatives.[2] The specifics of the screening process can vary by state, as each state determines the conditions to screen based on population needs and established cutoffs for positive results.[2]

Techniques and Innovations

Dried Blood Spot Screening

Dried blood spot (DBS) screening remains a cornerstone of NBS. Recent advance- ments have focused on enhancing the methodologies used in the extraction and analysis of DNA from DBS, as demonstrated by studies assessing various extraction techniques.[3][6] These improvements aim to increase the reliability and accuracy of test results while reducing false positives and negatives.[6]

Next-Generation Sequencing (NGS)

Next-generation sequencing has emerged as a transformative technology in NBS, enabling comprehensive genomic analysis.[4] While the implementation of NGS poses challenges, such as increased data complexity and cost, its potential to identify a broader spectrum of disorders makes it a promising avenue for future research and practice.[3][4] The choice of sequencing type—whole genome sequencing (WGS), whole exome sequencing (WES), or targeted panels—affects data interpretation, multiplexing capacity, and overall cost efficiency.[3] There is ongoing discussion about the need for targeted approaches alongside NGS to maintain effective screen- ing programs.[3]

Second-Tier Testing

Second-tier testing is increasingly utilized to improve the specificity of newborn screenings.These additional tests are designed to further assess positive results and reduce false positives from initial screenings.[6] For example, specialized assays for conditions like Mucopolysaccharidosis (MPS) and Congenital Adrenal Hyperplasia (CAH) have been developed to enhance screening outcomes and the positive predic- tive value of tests.[6][12] These innovations are essential for ensuring that screening processes remain effective and efficient, allowing for the identification of true positive cases while minimizing unnecessary follow-up procedures.

Challenges and Future Directions

Despite these advancements, several challenges remain in the integration of new methodologies into existing NBS frameworks. There is a pressing need to standard- ize and calibrate techniques across laboratories to ensure consistent and reliable results.[12] Additionally, the exploration of artificial intelligence and machine learning in interpreting screening data holds potential for future methodologies, promising further enhancements to the accuracy and efficiency of newborn screening pro- grams.[12] As these technologies evolve, it is crucial to balance the benefits of advanced techniques with the need for established practices that prioritize the health and safety of newborns.

Advances in Technology

Integration of Genomic Technologies

The integration of advanced genomic technologies into newborn screening (NBS) presents both opportunities and challenges. Next-generation sequencing (NGS) technologies, particularly whole-genome sequencing (WGS) and whole-exome se- quencing (WES), are being increasingly considered for their potential to enhance NBS capabilities. However, concerns persist regarding the technical feasibility of these methods, including the accuracy and reliability of the data generated, as well as the interpretation of the results[3].

Challenges of Data Interpretation

Interpreting the vast amount of genetic data produced by WGS and WES is a signif- icant challenge. The complexity of genetic variants, many of which remain classified as variants of unknown significance (VUS), complicates the clinical interpretation
of results[3]. Variations in software and databases across laboratories can lead to inconsistent interpretations[3]. Some researchers advocate for the development of national databases to better characterize genetic variants and improve the under- standing of their significance within specific populations[3].

Technical Approaches to NGS

NGS approaches can vary widely, each presenting unique technical issues. The three primary methods include targeted gene panels, WES, and WGS. While targeted approaches focus on specific genes, they risk missing critical areas, leading to false-negative results. In contrast, WGS does not require gene capture, reducing the likelihood of gaps in data coverage[3]. Nonetheless, the large data output from WGS can be challenging to manage and analyze effectively.

Future Directions in Screening

The continuous evolution of technologies, including the advent of proteomic and metabolomic techniques, may further refine screening strategies, reducing false-pos- itive results and improving pathogenicity predictions[13]. The integration of artificial intelligence (AI) with genomic methodologies is also anticipated to enhance pre- dictive capabilities in NBS, offering a promising avenue for the future of genetic screening[13].

Ethical Considerations

The ethical considerations surrounding newborn screening (NBS) are multifaceted and complex. One primary concern is the balance between genetic determinism and individual autonomy. Supporters of genetic determinism argue that if all genetic information is predetermined, this knowledge can lead to preventive measures, allowing healthcare providers to become "architects" of health rather than passive recipients of fate[1]. This perspective raises questions about the implications for personal choice and freedom, as it suggests a clear path dictated by genetics.

In addition, engaging the private sector in the delivery of quality maternal, new- born, and child health (MNCH) services introduces ethical dimensions regarding accountability and quality. The World Health Organization (WHO) recognizes three categories of private sector engagement: incorporating private actors in public health policy development, influencing private sector behavior through regulatory tools, and attributing private attributes to public sector organizations[8]. Ethical frameworks must ensure that these partnerships maintain high standards of care and do not compromise patient welfare.

Another layer of ethical complexity arises from the accessibility of health services, particularly for children in low- and middle-income countries (LMIC). Barriers to accessing healthcare can stem from various factors, including geographical location, availability of services, financial constraints, and social acceptability[10]. Addressing these barriers ethically requires a comprehensive understanding of both demand and supply-side factors to ensure equitable access to health interventions.

Finally, the sensitivity of genetic data necessitates strict ethical guidelines regarding permissions for access and data interpretation. Currently, clinical and laboratory ge- neticists primarily handle this interpretative burden, but there are discussions about whether medical doctors could take on some aspects of this responsibility[3]. As the landscape of NBS evolves, ethical considerations surrounding informed consent and data privacy remain paramount to safeguard the interests of patients and families.

Global Perspectives

Overview of Newborn Screening Challenges

Newborn screening (NBS) is an essential public health initiative aimed at the early identification and management of conditions that can lead to severe health issues in infants. However, implementing and sustaining NBS programs presents various challenges, particularly in low and middle-income countries (LMICs). These chal- lenges can be categorized into several areas, including logistical issues, coordination of care, and education for healthcare providers [5][7].

Geographic and Logistical Challenges

Geographically isolated and disadvantaged areas (GIDA) often face significant hur- dles in timely specimen submission and recall of screen-positive patients. Remote communities, such as those found in mountainous regions or isolated islands, compli- cate the coordination of necessary acute care management for infants already show- ing symptoms [5]. Ensuring follow-up care and the delivery of essential metabolic foods or medications adds to the logistical burden, sometimes necessitating collab- oration with military resources to navigate these challenges effectively [5].

International Collaborations

To address these challenges, international collaborations have proven beneficial. Examples include partnerships where islands in the Polynesian region access NBS through New Zealand's screening program. Furthermore, specialists from various Southeast Asian countries have participated in training programs based in Australia, and collaborations with European NBS programs have facilitated laboratory services in countries like Laos and Nepal [5]. These partnerships offer valuable insights

into establishing NBS systems in developing contexts and should be considered in planning processes.

Expansion and Policy Development

Successful NBS programs have often expanded their screening panels based on local epidemiology and needs. For instance, the Philippine Newborn Screening Program (PNBSP) expanded its screening panel to include additional conditions as program savings allowed for the procurement of necessary technology [5]. Such expansions reflect the need for continuous policy development and adaptation to local health demands.

Barriers to Implementation

In countries like Indonesia, various barriers impede the implementation of NBS, including insufficient prevalence data, ethical dilemmas, infrastructural challenges, and the need for a comprehensive cost-benefit analysis [9]. Government support, professional advocacy, and a well-established infrastructure are critical to overcom- ing these barriers and ensuring the effective delivery of NBS programs [9].

The Future of Newborn Screening

As the landscape of NBS continues to evolve, it is imperative that both public and private sectors engage in sustainable quality care initiatives. This collaboration is essential for developing systems capable of delivering high-quality care for mothers, newborns, and children at scale, especially in LMICs [8]. Through ongoing training, policy adjustments, and international partnerships, the goal of reducing infant mor- bidity and mortality rates via effective NBS can be achieved globally [7].

Ethical Considerations

The ethical considerations surrounding newborn screening (NBS) are multifaceted and complex. One primary concern is the balance between genetic determinism and individual autonomy. Supporters of genetic determinism argue that if all genetic information is predetermined, this knowledge can lead to preventive measures, allowing healthcare providers to become "architects" of health rather than passive recipients of fate[1]. This perspective raises questions about the implications for personal choice and freedom, as it suggests a clear path dictated by genetics.

In addition, engaging the private sector in the delivery of quality maternal, new- born, and child health (MNCH) services introduces ethical dimensions regarding accountability and quality. The World Health Organization (WHO) recognizes three categories of private sector engagement: incorporating private actors in public health policy development, influencing private sector behavior through regulatory tools, and attributing private attributes to public sector organizations[8]. Ethical frameworks must ensure that these partnerships maintain high standards of care and do not compromise patient welfare.

Another layer of ethical complexity arises from the accessibility of health services, particularly for children in low- and middle-income countries (LMIC). Barriers to accessing healthcare can stem from various factors, including geographical location, availability of services, financial constraints, and social acceptability[10]. Addressing these barriers ethically requires a comprehensive understanding of both demand and supply-side factors to ensure equitable access to health interventions.

Finally, the sensitivity of genetic data necessitates strict ethical guidelines regarding permissions for access and data interpretation. Currently, clinical and laboratory ge- neticists primarily handle this interpretative burden, but there are discussions about whether medical doctors could take on some aspects of this responsibility[3]. As the landscape of NBS evolves, ethical considerations surrounding informed consent and data privacy remain paramount to safeguard the interests of patients and families.

Future Directions

The integration of next-generation sequencing (NGS) into newborn screening (NBS) programs presents promising avenues for advancing pediatric health care. As tech- nology continues to evolve, NGS has the potential to enhance the identification
of genetic disorders in newborns, thereby allowing for earlier interventions and improved outcomes[4][3]. Future developments should focus on refining the criteria for selecting candidate conditions for NGS, ensuring they align with established guidelines like those outlined by the World Health Organization (WHO) and the American College of Medical Genetics (ACMG)[5].

Enhancing Screening Criteria

To effectively incorporate NGS into NBS, conditions should demonstrate clear Mendelian inheritance patterns and established genotype-phenotype correlations. Knowledge of known genetic variants, high penetrance, and the availability of effec- tive presymptomatic interventions are essential factors for consideration[4]. Current NBS programs may include conditions that do not meet these stringent criteria; thus, a careful evaluation is required to ensure that only appropriate conditions are added to NGS screening panels[3].

International Collaboration

Collaboration between countries can play a crucial role in the successful implemen- tation of NGS in NBS. Initiatives that involve both commercial and non-commercial partnerships can facilitate training, technology transfer, and the sharing of best prac- tices. For instance, partnerships between developed and developing countries have already proven effective in establishing NBS programs in regions such as Southeast Asia and the Pacific Islands[5]. Learning from these international experiences can guide future efforts and improve the efficiency of NBS systems worldwide.

Addressing Barriers to Access

Despite the potential benefits of NGS, significant barriers to access remain, partic- ularly in low- and middle-income countries (LMICs). To maximize the impact of NBS programs, strategies must address both demand and supply-side challenges con- currently. This includes improving geographical accessibility and delivering services closer to home, as well as enhancing financial incentives for families to participate in screening programs[10]. Evidence suggests that combined interventions, such as using text message reminders and local service delivery, could effectively improve access to NBS in these settings[10].

Continuous Research and Evaluation

Continuous research into the effectiveness of NGS in NBS, including the assessment of intervention combinations and their impacts, will be vital for refining screening methodologies. Evaluating outcomes in diverse contexts will enhance our under- standing of how best to implement NGS in various healthcare systems and popula- tions[10]. As the body of evidence grows, it will inform guidelines and best practices for the integration of NGS into routine newborn screening protocols, ensuring that advances in technology translate into tangible benefits for newborn health globally[- 4][3].

References
[1]: Challenges of using next generation sequencing in newborn screening

[2]: Assessing interstate racial and socioeconomic disparities in newborn ...
[3]: Newborn screening: a review of history, recent advancements, and future ... [4]: Frontiers | Next-Generation Sequencing in Newborn Screening: A Review ... [5]: Next-generation Sequencing in Newborn Screening: A Review on Clinical ... [6]: Overcoming challenges in sustaining newborn screening in low-middle ...

[7]: 2023 APHL and ISNS Newborn Screening Symposium
[8]: Newborn screening progress in developing countries--overcoming internal ... [9]: Current State and Innovations in Newborn Screening: Continuing to Do ... [10]: Current State and Innovations in Newborn Screening: Continuing to Do ... [11]: An Insight into Indonesia's Challenges in Implementing Newborn ...
[12]: Private sector delivery of quality care for maternal, newborn and child ... [13]: A systematic review of strategies to increase access to health services ...

The Latest Insights on Mpox (Monkeypox): August 2024 Update

Mpox, a zoonotic orthopoxvirus previously known as monkeypox, continues to present substantial epidemiological challenges, particularly across the African continent. In 2024, the virus has demonstrated significant persistence and expansion, underscoring the need for continued vigilance and scientific inquiry into its transmission dynamics, pathogenicity, and control measures.

Epidemiological Update

As of mid-2024, Mpox outbreaks have escalated, particularly within the Democratic Republic of the Congo (DRC), which has reported an excess of 14,000 confirmed cases and 511 fatalities. This represents a severe burden on the public health infrastructure, exacerbated by the virus's spread to neighboring countries such as Burundi, Kenya, Rwanda, and Uganda. These nations have documented their first instances of Mpox infection, linked phylogenetically to the ongoing outbreaks in the DRC, highlighting the regional spread of the clade 1b variant.

Globally, the transmission dynamics have shown that while the incidence of Mpox has diminished in non-endemic regions following the 2022 global outbreak, it remains a persistent threat. According to the World Health Organization (WHO), 934 new laboratory-confirmed cases were reported across 26 countries in June 2024 alone, with the African region accounting for the majority of cases.

Molecular and Pathophysiological Insights

Mpox is primarily transmitted via close contact with infected individuals, animals, or contaminated materials, with sexual contact being a significant mode of transmission during recent outbreaks. The clinical presentation typically includes fever, lymphadenopathy, and a characteristic rash that progresses through macular, papular, vesicular, and pustular stages. The virus has been shown to evade host immune responses effectively, leading to varying degrees of morbidity depending on host factors such as immune status and pre-existing conditions.

Recent molecular studies have focused on the genomic evolution of the Mpox virus, particularly the clade 1b variant, which has been predominantly circulating in recent outbreaks. The virus's genetic variability and potential recombination events raise concerns about its adaptability and transmissibility, necessitating ongoing genomic surveillance and research.

Vaccination and Therapeutic Challenges

A critical barrier in managing the current Mpox outbreaks is the insufficient availability of vaccines and antiviral therapeutics in regions where the virus is most prevalent. The Africa Centres for Disease Control and Prevention (Africa CDC) has been engaged in efforts to secure 200,000 doses of the Mpox vaccine from Bavarian Nordic. However, this supply is markedly below the estimated requirement of 10 million doses needed to achieve adequate immunization coverage across affected regions.

The existing smallpox vaccine (ACAM2000) and the newer MVA-BN (Imvamune/Imvanex) vaccine have shown cross-protection against Mpox. However, their distribution has been uneven, with low- and middle-income countries facing significant challenges in procurement and deployment. Moreover, antiviral agents such as tecovirimat (ST-246) have demonstrated efficacy against orthopoxviruses, including Mpox, but their availability remains limited.

Conclusion and Future Directions

The persistence and spread of Mpox in 2024 highlight the necessity for robust public health interventions, including enhanced surveillance, equitable vaccine distribution, and intensified research into the virus's molecular biology and immunopathogenesis. The ongoing situation underscores the importance of a coordinated global response to prevent further morbidity and mortality, particularly in regions with limited healthcare resources. 

Future research should focus on understanding the virus's evolution, improving vaccine efficacy and coverage, and developing new antiviral treatments to mitigate the impact of this re-emerging pathogen on global public health.

Standards & Certifications Applicable to Medical Device & Pharma Sector

 

    1: EXCIPACT Certification

    2: EFfCI Certfication

    3: ISO 13485:2015 Quality Management Systems for Medical Devices

    4: GMP Pharma for Good Manufacturing Practices

    5: GDP - Good Distribution Practices

    6: ISO 135378:2017 - Packaging for Medical Devices

    7: CE - Medical Devices including 

    8: Invitro Diagnostic Medical device Regulation (EU) 2017/746 (IVDR)

Face Masks to Combat Coronavirus (COVID-19)-Processing, Roles, Requirements, Efficacy, Risk and Sustainability

Face Masks to Combat Coronavirus (COVID-19)-Processing, Roles, Requirements, Efficacy, Risk and Sustainability    

Rahman MZ, Hoque ME, Alam MR, Rouf MA, Khan SI, Xu H, Ramakrishna S. Face Masks to Combat Coronavirus (COVID-19)-Processing, Roles, Requirements, Efficacy, Risk and Sustainability. Polymers (Basel). 

2022 Mar 23;14(7):1296. doi: 10.3390/polym14071296. PMID: 35406172; PMCID: PMC9003287.

ABSTRACT: 

Increasingly prevalent respiratory infectious diseases (e.g., COVID-19) have posed severe threats to public health. Viruses including coronavirus, influenza, and so on can cause respiratory infections. A pandemic may potentially emerge owing to the worldwide spread of the virus through persistent human-to-human transmission. However, transmission pathways may vary; respiratory droplets or airborne virus-carrying particles can have a key role in transmitting infections to humans. In conjunction with social distancing, hand cleanliness, and other preventative measures, the use of face masks is considered to be another scientific approach to combat ubiquitous coronavirus. Different types of face masks are produced using a range of materials (e.g., polypropylene, polyacrylonitrile, polycarbonate, polyurethane, polystyrene, polyester and polyethylene) and manufacturing techniques (woven, knitted, and non-woven) that provide different levels of protection to the users. However, the efficacy and proper disposal/management of the used face masks, particularly the ones made of non-biodegradable polymers, pose great environmental concerns. This review compiles the recent advancements of face masks, covering their requirements, materials and techniques used, efficacy, challenges, risks, and sustainability towards further enhancement of the quality and performance of face masks.

AFFILIATIONS:

• 1Department of Mechanical Engineering, Ahsanullah University of Science and Technology (AUST), Dhaka 1208, Bangladesh.
• 2Department of Biomedical Engineering, Military Institute of Science and Technology (MIST), Dhaka 1216, Bangladesh.
• 3Department of Knitwear Manufacturing and Technology, BGMEA University of Fashion and Technology (BUFT), Dhaka 1230, Bangladesh.
• 4Department of Biobased Materials Science, Kyoto Institute of Technology (KIT), Matsugasaki Hashikamicho 1, Sakyoku, Kyoto 606-8585, Japan.
• 5Department of Mechanical Engineering, National University of Singapore (NUS), Singapore 117575, Singapore.
• 
  

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