Implementing gold-standard PCR testing at the point of care

In the global response to the COVID-19 pandemic, healthcare accelerated the deployment of molecular diagnostics, including PCR (polymerase chain reaction) testing, to the point of care (POC). With the expansion and evolution of PCR, healthcare organizations can leverage the advancements in molecular diagnostics and data algorithm development to implement PCR at the point of care, enhancing healthcare workflows and improving patient care, equity, and access.  

Lab leaders have a remarkable opportunity as key stakeholders to get involved in the implementation of PCR at the point of care, by bringing together decision-makers who can improve patient care and drive cost effectiveness through education, collaboration, and communication. 

In a recent discussion on the future of point of care testing, Dr. Payal Patel and Dr. Omai Garner shared their expertise on bringing gold-standard molecular PCR testing closer to the patient.

Molecular diagnostics, especially in respiratory infections, has evolved over time to address the limitations of traditional methods such as blood cultures, which have low sensitivity.¹ The focus has shifted to distinguishing between bacterial and viral disease, emphasizing the need for accurate and timely diagnostics, and reimagining the workflows when implementing PCR in the point of care settings. “Going a step further and trying to have people stop treating viral infections with antibiotics” is critical in curbing infectious diseases, says Dr. Patel. 

With this evolution of molecular diagnostics comes the opportunity to develop respiratory testing algorithms for point of care settings. It’s about providing the right test for the right patient at the right time. Ensuring tests are tailored to patient acuity levels and turnaround time requirements for outpatient, inpatient, and emergency scenarios is also important.²

“You need exquisite sensitivity,” says Dr. Garner, which is one of many positive benefits of implementing gold-standard PCR testing at the point of care. Furthermore, rapid molecular tests influence patient movement and clinical decision-making and are shown to have a positive impact on both patient care³ and on cost⁴.

With new diagnostics and advancements in technology, healthcare organizations need to consider how these can be implemented into their workflows.  

According to Dr. Garner, clinics tend to be intimidated by laboratory and molecular testing because they’re easy to contaminate, are typically more complicated than antigen tests, and involve more steps. All stakeholders, including manufacturers of CLIA-waived and other devices, need to keep this in mind when implementing PCR at the point of care.

He believes making tests easy to use, cost-effective, and not easily contaminated will help with other challenges around reimbursement and costs, with these obstacles further overcome with education and training as well as by publishing data and conducting studies to demonstrate the health economic impact of point of care PCR testing. 

Looking ahead, the potential applications of point of care PCR span across:

• STI Testing

• Multiplex Testing

• Increased Access

With drug resistance being high in STIs, being able to get STI testing in public health clinics, for example, would make a large impact on a global scale. Not only that, but bringing PCR to the point of care can also address global issues such as antimicrobial resistance due to over-prescription and improper use of antibiotics.⁵

“Stewardship programs can work with microbiology labs and diagnostic stewardship teams to help use the test and get the right result,” says Dr. Patel. Implementing bundled approaches for positive and negative results allows for targeted treatments, reducing unnecessary antibiotic prescriptions and contributing to better patient care. 

“I love this notion of equity and access,” says Dr. Garner, explaining that for underserved communities or people experiencing homelessness, making accurate diagnostic testing available without requiring a large laboratory or a lot of money is essential. 

The discussion provided valuable insights into the challenges and opportunities associated with advancing point of care PCR testing. The integration of molecular diagnostics at the point of care holds promise for improving patient care, reducing unnecessary treatments, and addressing healthcare challenges globally while improving patient outcomes, equity, and accessibility.

To listen to the entire discussion, with Dr. Patel and Dr. Garner on the value, challenges, and future of PCR at the point of care, here’s the full presentation.