Point-of-care testing

Point-of-care testing
MeSHD000067716

Point-of-care testing (POCT or bedside testing) is defined as medical diagnostic testing at or near the point of care—that is, at the time and place of patient care.[1][2] This contrasts with the historical pattern in which testing was wholly or mostly confined to the medical laboratory, which entailed sending off specimens away from the point of care and then waiting hours or days to learn the results, during which time care must continue without the desired information.

Technology

HemoScreen CBC analyzer, an example of a portable point-of-care device negating the need to send blood samples to a central lab.

Point-of-care tests are simple medical tests that can be performed at the bedside. In many cases, the simplicity was not achievable until technology developed not only to make a test possible at all but then also to mask its complexity. For example, various kinds of urine test strips have been available for decades, but portable ultrasonography did not reach the stage of being advanced, affordable, and widespread until the 2000s and 2010s. Today, portable ultrasonography is often viewed as a "simple" test, but there was nothing simple about it until the more complex technology was available. Similarly, pulse oximetry can test arterial oxygen saturation in a quick, simple, noninvasive, affordable way today, but in earlier eras this required an intra-arterial needle puncture and a laboratory test; and rapid diagnostic tests such as malaria antigen detection tests or COVID-19 rapid tests that rely on a state of the art in immunology that did not exist until recent decades. Thus, over decades, testing continues to move toward the point of care more than it formerly had been. A recent survey in five countries (Australia, Belgium, the Netherlands, the UK and the US) indicates that general practitioners / family doctors would like to use more POCTs.[3]

The driving notion behind POCT is to bring the test conveniently and immediately to the patient. This increases the likelihood that the patient, physician, and care team will receive the results quicker, which allows for better immediate clinical management decisions to be made. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing (such as COVID-19 rapid tests) and cholesterol screening.[4]

Lab-on-a-chip technologies are one of the main drivers of point-of-care testing, especially in the field of infectious disease diagnosis. These technologies enable different bioassays such as microbiological culture,[5] PCR, ELISA to be used at the point of care.

POCT is often accomplished through the use of transportable, portable, and handheld instruments (e.g., blood glucose meter, nerve conduction study device) and test kits (e.g., CRP, HBA1C, Homocystein, HIV salivary assay, etc.). Small bench analyzers or fixed equipment can also be used when a handheld device is not available—the goal is to collect the specimen and obtain the results in a very short period of time at or near the location of the patient so that the treatment plan can be adjusted as necessary before the patient leaves.[6] Cheaper, faster, and smarter POCT devices have increased the use of POCT approaches by making it cost-effective for many diseases, such as diabetes, carpal tunnel syndrome (CTS)[7] and acute coronary syndrome. Additionally, it is very desirable to measure various analytes simultaneously in the same specimen, allowing a rapid, low-cost, and reliable quantification.[8] Therefore, multiplexed point-of-care testing (xPOCT) has become more important for medical diagnostics in the last decade.[9]

Many point-of-care test systems are realized as easy-to-use membrane-based test strips, often enclosed by a plastic test cassette.[2] This concept often is realized in test systems for detecting pathogens, the most common being COVID-19 rapid tests. Very recently such test systems for rheumatology diagnostics have been developed, too.[10] These tests require only a single drop of whole blood, urine or saliva, and they can be performed and interpreted by any general physician within minutes. Recently, a portable medical diagnostic device called “BioPoC” has been reported which employs free-standing enzyme-modified responsive polymer membrane-based biosensors and a newly devised low-cost transduction principle for the detection of H. Pylori and urea.[11]

During the COVID-19 pandemic, rapid development of POCT occurred, aiming to improve the turnaround time and ease of use compared to the gold standard lab-based PCR test.[12] These have included rapid antigen tests, alternate nucleic acid amplification methods, and novel sensors.[13] A range of test have been developed including smartphone based platforms, and tests targeting blood, saliva, faecal matter, urine, and tears have been proposed.[14] Saliva in particular may offer sufficiently high detection rates in tandem with a non-invasive and user friendly procedure, although reliability requires improvement.[15]

Benefits

The coupling of POCT devices and electronic medical records enable test results to be shared instantly with care providers. The use of mobile devices in the health care setting also enable the health care provider to quickly access patient test results sent from a POCT device.[16][17] A reduction in morbidity and mortality has been associated with such rapid turn around times from a study using the i-STAT to analyze blood lactate levels after congenital heart surgery.[18]

POCT has become established worldwide[19] and finds vital roles in public health.[20] Many monographs in the Thai[21][22] and Indonesian[23] languages emphasize POCT as the normal standard of care in disaster situation.

Potential operational benefits include more rapid decision making and triage, reduced operating times, high-dependency, postoperative care time, emergency room time, number of outpatient clinic visits, number of hospital beds required, ensuring optimal use of professional time and reduced of antimicrobial medication.

At home or POCT tests, providing results within minutes of being administered, would allow for appropriate measures and rapid decisions about dental patients' care process.[24] Characteristics and detection rate of SARS-CoV-2 in alternative sites and specimens related to dentistry has been extensively reviewed.[25]

Regulatory in the U.S.

The Clinical Laboratory Improvement Amendments (CLIA) regulate any laboratory testing and require laboratories to obtain certificates to do any testing on human specimens for health assessment or to diagnose, prevent, or treat disease.[26] Three federal agencies partner together to cover the responsibilities put forward in the regulations: the Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC).

Food and Drug Administration (FDA)

In vitro diagnostic (IVD) products use the same categorization as medical devices (Class I, II, and III) to assure safety and effectiveness.[27] Regulatory controls and premarket approval process are determined by this classification, with Class I being the lowest risk (least regulated) and Class III being the highest risk (most regulated).

Under the CLIA, it is the role of the FDA to assess the complexity of the in vitro laboratory diagnostic tests.[26] Tests are only scored after the FDA has cleared or approved a premarketing request, or upon request.[28] Manufacturers can apply for CLIA waivers during this premarket approval/clearance process. Tests that are already cleared or approved for home use or are waived by 42 CRF 293.15(c), are classified as waived.[28][29] Otherwise, the tests are either classified as moderate or high complexity based on seven categorization criteria listed in 42 CFR 493.17.[30] If the test is classified as moderate, the manufacturer may request the test be waived through the CLIA Waiver by Application. The application must show that the test meets the criteria in 42 U.S.C. § 263a(d)(3), that the test is simple and will not cause harm to the patient if performed incorrectly.[28]

These test classifications determine the certifications needed for laboratories to perform said tests. Waived tests require the least regulation, while moderate to high complexity tests require higher regulation and standards within the laboratory.

Center for Medicaid Services (CMS)

Under CLIA, it is the role of CMS to issue laboratory certificates and monitor, inspect, and enforce laboratory regulatory compliance based on the tests being performed.[26] In total, CMS covers 260,000 laboratories.[31]

Centers for Disease Control and Prevention (CDC)

The CDC focuses on the analysis, research, and technical assistance within the CLIA partnership.[26] In particular, the CDC establishes technical standards and guidelines, conducting studies, monitoring practices, and developing resources.[32] In addition, the CDC manages the Clinical Laboratory Improvement Advisory Committee (CLIAC).[33] CLIAC is made up of experts in many specialties throughout clinical and anatomic pathology that provide guidance and advice on general issues within laboratory science.

The CDC specifically acknowledges that point-of-care testing simply describes the location at which the testing is performed and not the complexity of the test itself.[34] With technological innovation, more complex tests will be able to be performed at the bedside that may not be CLIA-waived like some other at-home point of care tests that the FDA has waived such as urine dipsticks.

Funding

In the United Kingdom the GP contract leaves the cost of point-of-care testing, which may be substantial, with the individual GP practice, which the cost of medication is met by the clinical commissioning group, which, as the House of Commons Health and Social Care Committee noted in October 2018, creates perverse incentives.[35]

See also

References

  1. ↑ Kost GJ (2002). "1. Goals, guidelines and principles for point-of-care testing". Principles & practice of point-of-care testing. Hagerstwon, MD: Lippincott Williams & Wilkins. pp. 3–12. ISBN 978-0-7817-3156-0.
  2. 1 2 Quesada-González D, Merkoçi A (July 2018). "Nanomaterial-based devices for point-of-care diagnostic applications". Chemical Society Reviews. 47 (13): 4697–4709. doi:10.1039/C7CS00837F. PMID 29770813.
  3. ↑ Howick J, Cals JW, Jones C, Price CP, Plüddemann A, Heneghan C, et al. (August 2014). "Current and future use of point-of-care tests in primary care: an international survey in Australia, Belgium, The Netherlands, the UK and the USA". BMJ Open. 4 (8): e005611. doi:10.1136/bmjopen-2014-005611. PMC 4127935. PMID 25107438. open access
  4. ↑ "Point of Care Diagnostic Testing World Markets". TriMark Publications.
  5. ↑ Iseri E, Biggel M, Goossens H, Moons P, van der Wijngaart W (November 2020). "Digital dipstick: miniaturized bacteria detection and digital quantification for the point-of-care". Lab on a Chip. 20 (23): 4349–4356. doi:10.1039/D0LC00793E. PMID 33169747.
  6. ↑ "College of American Pathologists POCT toolkit". Archived from the original on 2010-12-22. Retrieved 2012-02-11.
  7. ↑ Tolonen U, Kallio M, Ryhänen J, Raatikainen T, Honkala V, Lesonen V (June 2007). "A handheld nerve conduction measuring device in carpal tunnel syndrome". Acta Neurologica Scandinavica. 115 (6): 390–7. doi:10.1111/j.1600-0404.2007.00799.x. PMID 17511847. S2CID 18119311.
  8. ↑ Spindel S, Sapsford KE (November 2014). "Evaluation of optical detection platforms for multiplexed detection of proteins and the need for point-of-care biosensors for clinical use". Sensors. 14 (12): 22313–41. Bibcode:2014Senso..1422313S. doi:10.3390/s141222313. PMC 4299016. PMID 25429414.
  9. ↑ Dincer C, Bruch R, Kling A, Dittrich PS, Urban GA (August 2017). "Multiplexed Point-of-Care Testing - xPOCT". Trends in Biotechnology. 35 (8): 728–742. doi:10.1016/j.tibtech.2017.03.013. PMC 5538621. PMID 28456344.
  10. ↑ Egerer K, Feist E, Burmester GR (March 2009). "The serological diagnosis of rheumatoid arthritis: antibodies to citrullinated antigens". Deutsches Ärzteblatt International. 106 (10): 159–63. doi:10.3238/arztebl.2009.0159. PMC 2695367. PMID 19578391.
  11. ↑ Tzianni, Eleni I.; Hrbac, Jan; Christodoulou, Dimitrios K.; Prodromidis, Mamas I. (2020). "A portable medical diagnostic device utilizing free-standing responsive polymer film-based biosensors and low-cost transducer for point-of-care applications". Sensors and Actuators B: Chemical. 304: 127356. doi:10.1016/j.snb.2019.127356. S2CID 209716454.
  12. ↑ Qin, Zhen; Peng, Ran; Baravik, Ilina Kolker; Liu, Xinyu (September 2020). "Fighting COVID-19: Integrated Micro- and Nanosystems for Viral Infection Diagnostics". Matter. 3 (3): 628–651. doi:10.1016/j.matt.2020.06.015. PMC 7346839. PMID 32838297.
  13. ↑ Song, Qi; Sun, Xindi; Dai, Ziyi; Gao, Yibo; Gong, Xiuqing; Zhou, Bingpu; Wu, Jinbo; Wen, Weijia (2021). "Point-of-care testing detection methods for COVID-19". Lab on a Chip. 21 (9): 1634–1660. doi:10.1039/D0LC01156H. PMID 33705507.
  14. ↑ Azzi, L.; Maurino, V.; Baj, A.; Dani, M.; d’Aiuto, A.; Fasano, M.; Lualdi, M.; Sessa, F.; Alberio, T. (February 2021). "Diagnostic Salivary Tests for SARS-CoV-2". Journal of Dental Research. 100 (2): 115–123. doi:10.1177/0022034520969670. ISSN 0022-0345. PMC 7604673. PMID 33131360.
  15. ↑ Kevadiya, Bhavesh D.; Machhi, Jatin; Herskovitz, Jonathan; Oleynikov, Maxim D.; Blomberg, Wilson R.; Bajwa, Neha; Soni, Dhruvkumar; Das, Srijanee; Hasan, Mahmudul; Patel, Milankumar; Senan, Ahmed M.; Gorantla, Santhi; McMillan, JoEllyn; Edagwa, Benson; Eisenberg, Robert; Gurumurthy, Channabasavaiah B.; Reid, St Patrick M.; Punyadeera, Chamindie; Chang, Linda; Gendelman, Howard E. (May 2021). "Diagnostics for SARS-CoV-2 infections". Nature Materials. 20 (5): 593–605. Bibcode:2021NatMa..20..593K. doi:10.1038/s41563-020-00906-z. PMC 8264308. PMID 33589798.
  16. ↑ Ventola CL (May 2014). "Mobile devices and apps for health care professionals: uses and benefits". P & T. 39 (5): 356–64. PMC 4029126. PMID 24883008.
  17. ↑ Quesada-González D, Merkoçi A (June 2017). "Mobile phone-based biosensing: An emerging "diagnostic and communication" technology". Biosensors & Bioelectronics. 92: 549–562. doi:10.1016/j.bios.2016.10.062. hdl:10261/160220. PMID 27836593.
  18. ↑ Rossi AF, Khan D (June 2004). "Point of care testing: improving pediatric outcomes". Clinical Biochemistry. 37 (6): 456–61. doi:10.1016/j.clinbiochem.2004.04.004. PMID 15183294.
  19. ↑ Tran NK, Kost GJ (2006). "Worldwide point-of-care testing: compendiums of POCT for mobile, emergency, critical, and primary care and of infectious diseases tests". Point of Care: The Journal of Near-Patient Testing & Technology. 5 (2): 84–92. doi:10.1097/00134384-200606000-00010.
  20. ↑ "Special Edition in Public Health". Point of Care: The Journal of Near-Patient Testing & Technology. December 2006.
  21. ↑ Kost GJ (2006). "1. Overview of point-of-care testing: Goals, guidelines, and principles". In Charuruks N (ed.). Point of Care Testing for Thailand (in Thai). Bangkok. pp. 1–28.
  22. ↑ Kost GJ (2006). "10. Point-of-care testing in province hospitals and primary care units (PCUs): Optimizing critical care and disaster response". In Charuruks N (ed.). Point of Care Testing for Thailand (in Thai). Bangkok. pp. 159–177.
  23. ↑ Kost GJ, Tran NK, Tuntideelert M, Kulrattanamaneeporn S, Peungposop N (October 2006). "Katrina, the tsunami, and point-of-care testing: optimizing rapid response diagnosis in disasters". American Journal of Clinical Pathology. 126 (4): 513–20. doi:10.1309/NWU5E6T0L4PFCBD9. PMID 16938656.
  24. ↑ Shirazi, Sajjad; Stanford, Clark M.; Cooper, Lyndon F. (May 2021). "Testing for COVID-19 in dental offices: mechanism of action, application and interpretation of laboratory and point-of-care screening tests". The Journal of the American Dental Association. 152 (7): 514–525.e8. doi:10.1016/j.adaj.2021.04.019. ISSN 0002-8177. PMC 8096195. PMID 34176567.
  25. ↑ Shirazi S, Stanford CM, Cooper LF (March 2021). "Characteristics and Detection Rate of SARS-CoV-2 in Alternative Sites and Specimens Pertaining to Dental Practice: An Evidence Summary". Journal of Clinical Medicine. 10 (6): 1158. doi:10.3390/jcm10061158. PMC 8000787. PMID 33802043.
  26. 1 2 3 4 Health, Center for Devices and Radiological (2021-09-13). "Clinical Laboratory Improvement Amendments (CLIA)". FDA.
  27. ↑ Health, Center for Devices and Radiological (2021-10-18). "Overview of IVD Regulation". FDA.
  28. 1 2 3 Health, Center for Devices and Radiological (2020-02-25). "CLIA Waiver by Application". FDA.
  29. ↑ "42 CFR § 493.15 - Laboratories performing waived tests". LII / Legal Information Institute. Retrieved 2021-10-22.
  30. ↑ Health, Center for Devices and Radiological (2020-02-27). "CLIA Categorizations". FDA.
  31. ↑ "Clinical Laboratory Improvement Amendments (CLIA) | CMS". www.cms.gov. Retrieved 2021-10-22.
  32. ↑ "About CLIA | CDC". www.cdc.gov. 2018-09-14. Retrieved 2021-10-22.
  33. ↑ "Clinical Laboratory Improvement Advisory Committee (CLIAC) | DLS |CDC". www.cdc.gov. 2021-10-21. Retrieved 2021-10-22.
  34. ↑ "CLIA Test Complexities | CDC". www.cdc.gov. 2020-08-05. Retrieved 2021-10-22.
  35. ↑ "MPs demand end to 'perverse' cost to GPs of testing before antibiotic prescribing". Pulse. 22 October 2018. Retrieved 30 November 2018.
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