Molecular Testing in Point-of-Care (POC)

More testing that has traditionally been performed in the main laboratory is moving to point-of-care POC. These types of testing, allow for the most sensitive (POC) molecular assays to be performed in doctor’s offices, emergency rooms, urgent care clinics, nursing homes, schools and more. Having molecular assays allows for accurate disease diagnosis and expedited patient treatment. Sample collection and transportation are significantly improved since some POC methodologies allow for simplified sample collection, including patient self-collection. Samples no longer need to be transported to a central lab since POC assays bring the testing to the patient. This is especially useful in rural areas and areas where patients may not return to the provider’s office to receive their test results and treatment.

History of molecular POC testing

The COVID-19 pandemic created a greater demand for molecular POC tests.

The accelerated production of nucleic acid amplification tests began in 2009 during a flu pandemic and in 2015, the first molecular test for influenza A & B was classified as CLIA waived by the FDA.¹ Tests were later developed for RSV, group A Strep and sexually transmitted infections (STIs).² Then, during the COVID-19 pandemic, molecular POC tests needed to be developed rapidly, resulting in the production of more than 200 tests using methods such as real-time PCR, loop-mediated isothermal amplification (LAMP) and clustered regularly interspaced short palindromic repeats (CRISPR).²

Emerging POC methodologies

Using microfluidic technologies, “lab-on-a-chip” POC assays have been developed which allow for an even more portable test that requires a small amount of reagent to perform the test.³ These assays retain sensitivity and specificity while reducing costs and turnaround times.³ There is also equipment-free molecular POC testing. Staying up to date on emerging technologies will help us offer suggestions and educate others.

Fig. 1 Example of lab-on-a-chip assay. Jenkins, Lee. 2024. "Key Breakthroughs in Molecular POC Testing." Cytiva News Center, April 4, 2024. https://www.cytivalifesciences.com/en/us/news-center/advances-in-molecular-poc-testing-10001.

Considerations

Each institution will have a slightly different need for molecular POC testing. When deciding whether or not molecular POC is appropriate, key considerations should be made, including the sensitivity and specificity of the assay, turnaround time, shipping and storage requirements, product shelf-life, sample type and sample collection and cost.² POC specialists will also want to consider the regulatory requirements and the feasibility of implementing molecular POC testing. Are there staff who can run this test, and is there ample space to place an instrument? What are the infection control requirements?

What is needed?

There is a need to have a coordinated effort between researchers, healthcare professionals and policymakers in order to maximize the benefits of molecular point of care testing.⁴ Developing innovative platforms that improve accuracy, user-ease and turnaround time should be a focus for researchers.⁴ Test developer collaboration will healthcare professionals will help to find solutions that meet healthcare needs.4 Provider investment in staff training will allow these new technologies to be implemented successfully.⁴ Policymakers may be able to address environmental concerns and offer incentives such as grants or tax benefits for POC research.⁴ As POC specialists, we play a key role in POC molecular testing by helping to select the best POC molecular test for our institution, developing a training program and providing on-going quality assurance monitoring to ensure regulatory compliance.

Molecular testing resources

Molecular Point-of-Care Testing in Clinical Laboratories | myadlm.org

Upcoming continuing education in Molecular POC testing:

KEYPOCC meeting – Hagerstown, MD on Friday, October 24, 2025

https://artery.myadlm.org/discussion/keypocc-meetings-july-11-wilmington-de-oct-24-hagerstown-md#bm408d2532-4cd8-4d31-a970-7befaf16a197

Reference

1. Azar, Marwan M., and Marie L. Landry. 2018. "Detection of Influenza A and B Viruses and Respiratory Syncytial Virus by Use of Clinical Laboratory Improvement Amendments of 1988 (CLIA)-Waived Point-of-Care Assays: A Paradigm Shift to Molecular Tests." Journal of Clinical Microbiology 56 (7): e00367–18. https://doi.org/10.1128/JCM.00367-18.
2. Hassman, Ashley, Colby Rouchka, Diego Sunino, Felix Veloz Espinal, Mona Youssef, and Renee Richie Casey. 2024. "Molecular Point-of-Care Assay Development: Design and Considerations." Current Protocols 4 (6): e1058. https://doi.org/10.1002/cpz1.1058.
3. Jenkins, Lee. 2024. "Key Breakthroughs in Molecular POC Testing." Cytiva News Center, April 4, 2024. https://www.cytivalifesciences.com/en/us/news-center/advances-in-molecular-poc-testing-10001.
4. Zu, Yanbing, Hong Chang, and Zhanfeng Cui. "Molecular Point-of-Care Testing Technologies: Current Status and Challenges." DOAJ Nexus 2, no. 2 (June 2025): 100059.