Blood stream infection (BSI) from bacteria or fungi can lead to inflammatory responses, which is one of the body’s natural defence mechanisms. Without a timely clinical intervention, dysregulated host response to infection leads to sepsis, which is accompanied by life-threatening organ dysfunction, septic shock, multi-organ failure, and death.
Despite advances in the healthcare system, identifying the root cause quickly remains a major challenge globally. In 2017, WHO declared sepsis a healthcare priority as 48.9 million sepsis cases were recorded worldwide and 11 million sepsis-related deaths, representing 19.7% of all global deaths. In India, there were 11.3 million cases and 2.9 million fatalities, accounting for 23% of global burden and 26.4% of all deaths.
In the last two decades, due to indiscriminate use of antibiotics for managing infections, there has been an alarming increase in the rate of antimicrobial resistance (AMR), which has resulted in the emergence of multi-drug-resistant bacterial strains in India. India has one of the highest rates of drug-resistant strains and MDR in the world, which has led to a marked increase in mortality and prolonged hospital stays. Recognising this threat, the Indian government came up with a national action plan in 2017, in coordination with WHO and ICMR, and established the Antimicrobial Resistance Research & Surveillance Network, a network of AMR reporting centres.
A rapid, accurate identification of the agent that causes the disease and the possible antimicrobial resistance profile is essential for the successful management of AMR patients.
The traditional gold standard test is the blood culture test. However, it has disadvantages:
Longer time for diagnosis
Low sensitivity, increased false negatives Growth inhibition in patients receiving antibiotics beforehand
High volume of blood required for reasonable level of sensitivity
Delayed identification of the agent causing sepsis and inappropriate antibiotic therapy are associated with an increase in mortality and morbidity. Several studies show that timely antimicrobial therapy can enhance patient outcomes and that the risk of death rises by 7.6% for every hour of delay.
Molecular diagnostic methods have been gaining importance for pathogen detection due to its speed, specificity, and sensitivity. A rapid, accurate and affordable test for etiological diagnosis directly from the whole blood of patients and identification of AMR profile in positive samples have been a critically unmet diagnostic need in India. This test should be fast, sensitive, specific, accurate and affordable. It may be based on the RT-PCR platform and should cover all critical bacterial and fungal organisms suspected of blood stream infections, as well as AMR genes directly from the patient’s whole blood, making it a powerful tool for diagnosing sepsis.
It could potentially help in reducing sepsis-related mortality, judicious use of antibiotics, thus supporting antimicrobial stewardship programmes in healthcare centres, which are recognised as key strategic intervention programmes aimed at reducing AMR in India.
Dr Aldon Fernandes
(The author is the chief operating officer of GeNei Laboratories which recently forayed into development and manufacturing of RT-PCR-based infectious disease diagnostic kits)