Asian Scientist Magazine (Dec. 5, 2022) — Research has estimated that 1.27 million deaths worldwide in 2019 were directly attributable to antimicrobial resistance (AMR), which the World Health Organization has classified as a global health concern. A 2017 study also highlighted Southeast Asia as among the regions with the highest risk of AMR spreading across the human population.
AMR refers to the resistance that pathogens, such as bacteria and fungi, have developed over time against the drugs designed to counter them. This scenario creates drug-resistant diseases or superbugs that no longer respond to available treatment, putting a strain on healthcare systems. Patients’ lives are also at risk as infections—even simple ones—would become increasingly challenging to treat. While AMR is a natural phenomenon, its spread has accelerated in recent years primarily because of the overuse and misuse of antimicrobials, particularly antibiotics.
Committed to addressing AMR, bioMérieux, with its BioFire® products, offers rapid diagnostic solutions to identify pathogens faster and more accurately to reduce the improper use of antibiotics. In the 2000s, BioFire, a US-based company, started developing polymerase chain reaction (PCR) technologies to offer syndromic testing—a novel approach of using a single test to identify multiple infectious diseases that present similar symptoms. In 2014, it was acquired by bioMérieux, a global leading provider of in vitro diagnostic solutions.
The BioFire technology consists of six multiplex PCR panels covering six different syndromes: upper respiratory, lower respiratory, bloodstream, gastrointestinal, meningitis/encephalitis and joint infections. CE-marked and approved by the US Food and Drug Administration, the easy-to-use tests can identify multiple diseases within an hour and have robust performance, with a sensitivity range between 91.7 and 99.0 percent and a specificity range between 97.3 and 99.8 percent.
“Traditional methods take up to 72 hours to identify the cause of an infectious disease, often relying on culture or techniques that are neither sensitive nor specific. Additionally, molecular methods require skilled expertise and usually cannot be processed during night shifts or on weekends. A long turnaround time to receive definitive results for a patient can lead to the overuse of antimicrobials and, in turn, AMR,” explained Laura Balestra, Product Manager for BioFire at bioMérieux Asia Pacific.
For example, a physician wanting to check for meningitis will collect cerebrospinal fluid (CSF) from the patient and send it for various assessments. These include biochemistry analysis, bacteria culture, PCR and antigen tests. This traditional process will take days for the results to be ready, hence, delaying proper treatment for the patient. In contrast, the BioFire test takes only an hour to identify 14 bacteria, viruses and yeast associated with meningitis/encephalitis from 200 microliters of CSF.
With minimal training, the BioFire test can be operated within two minutes (hands-on time) and in three steps. Firstly, an unprocessed sample is inserted into a pouch containing freeze-dried reagents for sample preparation, PCR and detection. The pouch is then placed in the system, which will isolate and purify nucleic acids from the sample, and carry out nested multiplex PCR. This two-stage process involves producing an overall multiplex reaction before performing single-plex reactions on individual components. In the final step, the system will automatically analyze the sample, detect the presence of targeted pathogens and generate the results within an hour.
“Our solution is faster, more comprehensive and accurate than traditional testing methods. Compared to other multiplex PCR assays available in the market, our system has a broader panels menu,” said Balestra. “We also have an extensive database of published studies—over 1,000—supporting the performance and utility of our syndromic molecular assays.”
On a business trip to India in April 2022, Balestra was told of a young boy who was admitted into a hospital after experiencing stomach pain, fever and blood in his urine. Physicians initially treated him with multiple broad-spectrum antibiotics and antifungal drugs, and subjected him to various tests that were inconclusive after 40 hours. When the boy’s blood culture turned positive (indicating bacterial infection), they ran it through the BioFire Blood Culture Identification 2 (BCID2) Panel, which can identify 43 bloodstream-related targets. Within an hour, the BCID2 Panel confirmed Salmonella as the cause of the boy’s symptoms. The physicians could then stop the broad-spectrum antibiotics and antifungal drugs, and keep only the targeted therapy (piperacillin/tazobactam).
The BCID2 Panel is one of the six multiplex PCR panels that are part of the BioFire technology. All panels have multiple targets, and three are able to detect the AMR genes of pathogens as well. Among the clinical advantages that these panels have demonstrated include reducing overall hospital costs as a faster diagnosis leads to shorter patient stays. However, as these panels function primarily to identify the cause of a disease, it is necessary to use them as a complementary test to other methods, such as antimicrobial susceptibility testing, and interpret their results in light of clinical findings.
Ever forward-looking, bioMérieux is constantly improving its BioFire panels to align with advancements in epidemiology and to address new disease outbreaks. The BioFire Respiratory 2.1 (RP2.1) Panel, for example, now has an expanded target list to cover SARS-CoV-2 or COVID-19. In addition, the company seeks to increase public awareness about new and faster ways to diagnose infectious diseases. It is working towards making its solutions eligible for national reimbursement plans in Japan and Taiwan.
With AMR growing as a threat to public health, accurate and rapid diagnostic testing has become all the more necessary. Ordering multiple tests to determine a cause of a disease and waiting days for the results are no longer ideal.
“AMR is a silent pandemic, and we believe that effective diagnostics are vital in the fight against it. Timely diagnostic answers can help reduce the use of unnecessary antibiotics and, when antibiotics are needed, help ensure they are appropriately targeted,” expressed Balestra.
Discover BioFire® and request a free demo here.
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Source: BioFire ; Images: BioFire
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