Molecular Lateral Flow Diagnostics- A New Era for Point-of-Care Testing

If you’re like many physicians and Point of Care (POC) laboratories, you may be dealing with suboptimal performance from some of your current diagnostic methods. For example, conventional Rapid Influenza Diagnostics Tests (RIDTs) vary in terms of sensitivity and specificity when compared with viral culture or reverse transcription-polymerase chain reaction (RT-PCR). Product insert information and research publications indicate that in general, RIDTs sensitivities are approximately 50-70%.

But the technology of point-of-care diagnostics is changing.

One particular evolving technology is molecular diagnostics, which detects specific sequences in DNA or RNA that may (or may not) be associated with disease. At present, there are molecular applications in infectious diseases, oncology, pharmacogenomics, genetic disease screening and coagulation, among others.

PCR: The Gold Standard, but Not Feasible in POC

Polymerase chain reaction (PCR) has long been considered a diagnostic gold standard due to the high accuracy of the technology, which accounts for its use in core or reference labs. It can detect disease with as few as several copies of a gene. But due to complicated workflows, complex procedures, cold chain storage, and time & economic costs, PCR hasn’t been feasible in a point-of-care setting.

PCR Now in the Palm of Your Hand

Laboratories love the accuracy of results from molecular tests, though many still prefer the workflow of a traditional lateral flow test.  By combining top-performing PCR technology with state-of-the-art microfluidic testing – and merging it into a POC-friendly workflow – physician office labs finally get cutting-edge molecular lateral flow systems with the best of both worlds: PCR-quality results and the ease of use of conventional lateral flow rapid diagnostics.

For physicians, this provides the convenience and procedural familiarity of traditional POC rapid immunoassays - while providing the superior sensitivity, specificity and information provided by laboratory-based PCR testing.

Advantages of Molecular Lateral Flow Technology

Compared to other methods, molecular lateral flow technology has significant point-of-care advantages:

• Laboratory PCR performance.
• No cold chain storage – the test and its components can be stored in ambient environments.
• Easy to use – each test needs less than 2 minutes of hands-on time.
• Affordability – with a single test diagnosis, reducing send out lab costs for confirmatory testing.
• State-of-the-art microfluidic cassette technology with a compact portable Dock allows for true molecular PCR testing to be performed anywhere testing is needed.

Sekisui Diagnostics Silaris™ Platform

The Silaris™ platform allows urgent care, physician offices, hospitals and other facilities to implement an affordable, CLIA Waived, molecular testing option to diagnose and treat patients quickly - which is key to minimizing the spread of the virus. Silaris™ offers the simplicity, convenience and procedural familiarity of traditional visual read rapid tests, while providing the superior sensitivity and specificity of laboratory‐based PCR testing.

Since the U.S. FDA reclassified antigen-based Rapid Influenza Diagnostic Tests (RIDTs) requiring increased sensitivity, specificity and annual strain testing quality controls for RIDTs, the value of molecular testing has become more widely recognized. With the Silaris Influenza A&B Test, hospitals and physician office laboratories can step up to molecular testing and benefit from a simplified workflow and greater performance for early detection & proper management of influenza.