(PharmaNewsWire.Com, October 15, 2021 ) According to a study conducted by ClinicalTrials.gov, to prevent screening shortages, an innovative PCR-free alternative strategy was developed based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status based on the analysis of their saliva. It is also used as a tool for the identification of respiratory viruses from cell culture supernatants. MALDI-TOF MS is one of the major technologies used in microbial identification.
The COVID-19 pandemic has had a major impact on the US, China, India, as well as many major European countries. Since most of these countries are major manufacturers of the instruments and consumables used for microbial identification, the pandemic and nationwide lockdowns have caused a decline in the sales of these products. This has negatively affected the microbial identification market. However, the market is expected to recover in the next one to two years.
Microbial identification is mainly used for human disease diagnosis. It delivers rapid and reliable results that help in the timely adoption of appropriate therapies. Microbial identification products can improve the management of infectious diseases, especially in areas with inadequate healthcare infrastructure. It is estimated that approximately 1,400 pathogens can cause human diseases.
Pathogenic bacteria alone cause about 350 million cases of foodborne diseases. About 48 million foodborne illnesses occur annually in the US alone, which leads to approximately 128,000 hospitalizations and 3,000 deaths every year. Poor water hygiene can cause 1.7 million deaths a year worldwide, and 9 out of 10 deaths occur in children. Most of these deaths, however, are observed in developing countries (NCBI).
According to the WHO, TB is one of the top 10 causes of death. A total of 1.5 million people died from TB in 2018 worldwide. Between 2000–2018, an estimated 58 million lives were saved through TB diagnosis and treatment. ccording to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2019, globally, 1.7 million people were newly infected with HIV, 38 million people are living with HIV, and 690,000 people died of AIDS-related illnesses.
Furthermore, incidents such as the Zika epidemic (2016), Ebola epidemic (2014), H1N1 swine flu pandemic (2009), H5N1 Avian flu pandemic (2004), Severe Acute Respiratory Syndrome (SARS) pandemic (2003), and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic (2019–2020) have caused serious health concerns. They also lead to an increased demand for diagnostic products, including those for microbial identification.
Automated microbial identification systems are priced within the range of USD 50,000 to USD 75,000. Pharmaceutical companies require many such systems and, hence, the capital cost increases significantly. Academic research laboratories generally cannot afford such systems as they have limited budgets. In addition, the maintenance costs and several other indirect expenses result in an overall increase in the total cost of ownership of these instruments. This hinders the mass adoption of automated microbial identification systems, especially by relatively small institutions.
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