Globally several potential vaccines are still in development for Covid-19. Such surge has forced drug and pharmaceutical companies to look out for clinical laboratories that are readily available and fully equipped to analyze and manage bioanalytical assays for Covid-19 samples. WHO has designated biosafety level 2 for Covid19. Today the US CDC grants permit to bioanalytical labs that enable method transfer between companies and respective laboratories. Hence, laboratories should be up to date with thorough bioanalytical method validation and method development to safely and effectively support vaccines and treatment options for Covid-19.
How to move ahead with promising bioanalytical assays?
The ongoing pandemic has revealed the importance of diagnostic testing in controlling the outbreak. Ending the pandemic will require a collaborative effort of efficient diagnostic testing and its results to implement appropriate therapeutics rapidly. The implementation of novel diagnostic tests struggles with several initial hurdles. Method development, method validation, bioanalytical assay design, manufacturing and use of emergency approval are some of the challenges faced during the regulatory and developmental phase. Understanding the results and routine challenges faced by diagnostic laboratories, logistic issues, difficulties in setting up, and result optimization were the significant complications encountered during the first Covid-19 wave.
In order to overcome challenges, the diagnostic expansion will play a major role in preventing the community transmission of the pandemic. However, achieving such expansion needs point-of-care tests having specificity and sensitivity closer to actual laboratory tests. Moreover, these point-of-care tests should be easily scalable to meet the rising number of Covid-19 patients. Although it is important to consider the limitations of a diagnostic setup as budget and availability might pose an issue in developing settings.
Testing of high-risk populations such as individuals with rare diseases or organ transplant patients should be a priority. Optimizing patient management will require a clinical examination of patients following point-of-care tests capable of simultaneous detection of several potential pathogens. Bioanalytical labs could also employ multiplex PCR to detect several respiratory pathogens such as influenza A and B viruses, respiratory syncytial virus or other coronavirus strain. Such a multiplex approach will help avoid unnecessary isolation and exploitation of antibiotics.
For Covid-19 patients, additional detection of cardiac and respiratory comorbidities will be crucial in treatment decisions. With such a high volume of medical data, laboratories should be ready to employ artificial intelligence and machine learning initiatives. Currently, several mature and high-end AI solutions are available for bioanalytical laboratory. Furthermore, biomarkers will not only facilitate early and rapid Covid-19 diagnosis, but because they can reduce costs and patient risks and speed up the clinical trial process, biomarkers are crucial in the development of treatment and vaccines for Covid-19.
Bioanalytical assays are continuously developed for Covid-19. If the pandemic hits again or the forthcoming infection wave hits the world again, current tools can be efficiently employed to identify, isolate and treat individual patients. The world health bodies must work together to provide test access and bring forth promising diagnostic and infection control interventions to combat such health disasters successfully.