The Path Forward for COVID-19 Diagnostics
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COMMENTARY
The Path Forward for COVID‑19 Diagnostics Thomas Usherwood1 · Lei Zhang1 · Anubhav Tripathi1
© Springer Nature Switzerland AG 2020
The sudden onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; COVID-19) pandemic created an initial vacuum for in vitro diagnostics (IVDs). With commercial assays now available, the research and development of COVID-19 IVDs should focus on improving reaction sensitivity, reducing reagent usage, and minimizing testing time. At the time of writing, 41 COVID-19 IVD assays have been granted emergency use authorization (EUA) by the US FDA, 37 of which are nucleic acid based [1]. Serological tests offer much shorter detection time than nucleic acid-based approaches; however, their antibody affinity and specificity require significant periods of validation. The predictability of polymerase chain reaction (PCR)-based assays make them more suitable during this stage of viral testing. Since lockdown of the general public has ended in the USA, and the screening of individuals for work resumption has begun, the volume of COVID-19 tests needed has increased drastically. Therefore, rapid, sensitive, and—most importantly—accurate IVD assays are needed to address the expanded global screening. Point-of-care (POC) testing has great potential for widespread diagnosis of COVID-19 because of its rapidity, low cost, and easy distribution. Currently, the most common techniques involve reverse transcriptase PCR (RT-PCR), but many recent POC approaches involve using loop-mediated isothermal amplification (LAMP). LAMP is attractive because of its sensitivity and short run time and because it does not require a thermocycler [2]. Other nucleic acidbased tests, such as those involving digital droplet PCR and nanoparticle-based DNA amplification, are also being examined because of their superior limit of detection (LOD), sensitivity, and specificity. Antibody tests for immunoglobulin G and M also exist, using lateral flow assays for a POC approach [3]. Lab-on-a-chip (LOC) and microfluidic devices
* Anubhav Tripathi [email protected] 1
Center for Biomedical Engineering, Brown University, Providence, RI 02912, USA
show particular promise. As LOC devices can be miniaturized and easily automated, they are an excellent platform for POC diagnostics, and this is already being realized in the literature [4–6]. Innovations such as 3D printing have the potential to revolutionize LOC technologies and increase accessibility [7]. The use of various biological fluids has been proposed to test for COVID-19. Perhaps the most prominent of these is saliva, which has been shown to contain SARS-CoV-2 RNA [8, 9]. SARS-CoV-2 has also been detected in blood [10, 11] and fecal samples [11, 12], whereas several studies have shown it is not detectable in urine [13, 14]. There is potential for diagnostic tests to use any of these fluids that contain SARS-CoV-2, and development of these tests could allow for cross-verification between assays to ensure patients are diagnosed correctly. The re
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