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Advances in laboratory techniques and the movement to patient-centric services are innovating traditional clinical laboratory services. The history of home-based blood collection is long - home health nurses have been collecting blood samples using venipuncture and sending the samples to clinical laboratories for many years. This column describes innovations in home-based laboratory testing and other home-based tests.
HOME-BASED BLOOD TESTS
Home-based blood glucose monitoring with fingertip blood collection is common now, but it was an innovation in the 1970s (Klimek-Tulwin et al., 2019). Self-testing of prothrombin time using international normalized ratio in the home was an innovation in the 2000s (Gardiner et al., 2005). Newer technologies, called volumetric absorptive microsampling (Dameron, 2018) and advanced microfluidic technology (HemaXis DB10, https://hemaxis.com/products/hemaxis-db10/), are creating the opportunity to run a wider range of commonly used metabolic panels and therapeutic drug-monitoring tests using a finger stick and a collection device. When widely available, these developments will help people in rural areas and those who are homebound be monitored for chronic or acute illnesses.
HOME-BASED BREATH ANALYZER
Scientists working with the National Aeronautics and Space Administration have developed a technology called the E-Nose by innovating technology used to monitor air quality inside spacecrafts (Dark Daily, 2020). The E-Nose technology was designed to run clinical laboratory tests on astronauts living on the International Space Station and for potential space travel to Earth's moon and Mars!
E-Nose is a mobile device, approximately the size of a smartphone, with an array of chemical sensors combined with humidity, temperature, and pressure sensors for real-time breath analysis to detect biomarkers in exhaled breath (Dark Daily, 2020). During the pandemic, the E-Nose was innovated to detect COVID-19 infections by sensing volatile organic particles in exhaled breath (Tavares, 2021). Other examples of E-Nose testing are the detection of ammonia produced by Helicobacter pylori, the pathogen causing stomach ulcers, and the detection of nitrogen oxide concentration in breath indicating worsening asthma. This device is designed to be used at point of care. The laboratory test is run on the device rather than sent to a traditional laboratory and provides results in five minutes.
SALIVA HOME TESTING
Saliva is currently used to measure hormones and drug/alcohol levels (Bosker & Huestis, 2009). COVID-19 tests using saliva samples are showing accurate results and promise for rapid diagnosis of the infection (Ning et al., 2021). However, researchers believe saliva samples can provide biochemical, toxicological, and immunological tests to detect systemic diseases (Chojnowska et al., 2018) and proteomics (Castagnola et al., 2017). Research continues and will ultimately result in home-based tests using saliva samples.
REGULATION
These innovations in clinical laboratory testing are regulated by the Federal Drug Administration (FDA). The FDA has a rigorous review and approval process for new medical devices (FDA, 2020). To find approved medical devices, the FDA has a publicly available database found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
REFERENCES
Bosker W. M., Huestis M. A. (2009). Oral fluid testing for drugs of abuse. Clinical Chemistry, 55(11), 1910-1931. [Context Link]
Castagnola M., Scarano E., Passali G. C., Messana I., Cabras T., Iavarone F., Di Cintio G., Fiorita A., De Corso E., Paludetti G. (2017). Salivary biomarkers and proteomics: Future diagnostic and clinical utilities. Acta Otorhinolaryngologica Italica, 37(2), 94-101. [Context Link]
Chojnowska S., Baran T., Wilinska I., Sienicka P., Cabaj-Wiater I., Knas M. (2018). Human saliva as a diagnostic material. Advances in Medical Sciences, 63(1), 185-191. [Context Link]
Dameron E. (2018). How to create a patient-centered lab with breakthrough blood collection technology: Microsampling takes blood collection out of the clinic [White paper]. Dark Daily. http://www.darkdaily.com/wp-content/uploads/How-to-Create-a-Patient-centered-Lab[Context Link]
Dark Daily. (2020, November 30). NASA develops the 'E-Nose,' a handheld breath analyzer that can measure multiple biomarkers used in medical laboratory tests. https://www.darkdaily.com/nasa-creates-breath-analyzer-to-measure-multiple-bioma[Context Link]
Gardiner C., Williams K., Mackie I. J., Machin S. J., Cohen H. (2005). Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. British Journal of Haematology, 128(2), 242-247. [Context Link]
Klimek-Tulwin M., Knap J., Reda M., Masternak M. (2019). History of glucose monitoring: Past, present, future. Journal of Education, Health and Sport, 9, 222-227. [Context Link]
Ning B., Yu T., Zhang S., Huang Z., Tian D., Lin Z., Niu A., Golden N., Hensley K., Threeton B., Lyon C. J., Yin X.-M., Roy C. J., Saba N. S., Rappaport J., Wei Q., Hu T. Y. (2021). A smartphone-read ultrasensitive and quantitative saliva test for COVID-19. Science Advances, 7(2), eabe3703. [Context Link]
Tavares F. (2021, March 19). NASA's E-Nose device advanced to "sniff" COVID-19 from human breath [Text]. NASA. http://www.nasa.gov/feature/ames/e-nose[Context Link]
U.S. Food Drug Administration (FDA). (2020, October 19). Search for FDA Guidance Documents. https://www.fda.gov/regulatory-information/search-fda-guidance-documents[Context Link]