b'Chapter 3 How is the menu of molecular diagnostics expanding after COVID-19?An interview with Esther Babady, PhDMolecular testing has been launched into the stratosphereThe pandemic has put so much emphasis on because of the COVID-19 pandemic. Clinical laboratories arounddeveloping PCR testing. How will this change the types the world have invested billions of dollars not only in test kits forof tests and instruments clinical laboratories consider SARS-CoV-2, but in new instruments, staff, and other resourcesgoing forward?to support the enormous volume of testing required. The pandemic has brought knowledge of advanced, high-According to COVID-19 Response Advisors, monthly capacity forcomplexity testing into everyday life. Now people outside molecular SARS-CoV-2 testing in the U.S. was estimated to bemedicine talk about PCR testing like its something everyone 128 million in May 2022, although about a quarter of that includesshould understand.point-of-care and over-the-counter molecular systems (Figure 1). This awareness has opened up a future for performing more testing, particularly infectious disease testing, at home. Before 200 the pandemic, it would have blown my mind that in some cases molecular testing would be simplified to the point that a layperson 180 could do it at home. This new reality is going to create a new set 160 of challenges, but that door is now open, and we have to figure 140 out how we walk through it.Tests (in millions)120What kinds of challenges do you mean?100The demand for SARS-CoV-2 tests has shown some of the 80 limitations with molecular testing. One of the most controversial 60 discussions around COVID-19 and molecular testing is cycle 40 threshold, or C, value and being able to understand viral load. t20 C tvalues aim to capture information not only about how much virus is present in a sample but sometimes to infer how infectious 0a person might be.Nov 21 Dec 21 Jan 22 Feb 22 March 22 April 22 May 22POC and LabLab PCRMolecular And the issue becomes that just detecting nucleic acids is not OTC PCRwith pooling totalgoing to be enough to make at-home molecular tests as useful Figure 1. Monthly SARS-CoV-2 testing capacity estimates peras we might want them to be. We need to figure out which American Association for Clinical Chemistry (AACC). Recreated with permission.molecular markeror something elsewill identify when a person is actually infectious.The new focus on molecular capability also has spurredIn the pandemic, we discovered both the promise and the innovation, as laboratorians determine what other areas couldlimitations of current PCR testing: We figured out that we can benefit from a molecular testing capacity boost, while alsomake things simple and reliable enough for patients to perform figuring out what to do with instruments bought to satisfy thethem at home, but now were left with questions on how to make demands of peak pandemic testing. things a bit more advanced in order to capture the information we Clinical Laboratory News talked to Esther Babady, PhD, chief ofreally want about who is infectious and who is not.Clinical Microbiology Service at Memorial Sloan Kettering, about what she sees.10 Molecular testing thermofisher.com/infectiousdisease Contents'