Benefits of Point-of-care testing

The combination of POCT devices and electronic medical records enables test results to be shared immediately with care providers. The use of mobile devices in healthcare settings also enables healthcare providers to quickly access patient test results sent from POCT devices.A study using i-STAT to analyze blood lactate levels after congenital heart surgery showed that reduced morbidity and mortality were associated with such a rapid turnaround time.POCT has been established worldwide and plays an important role in public health.Many monographs in Thai and Indonesian emphasize POCT as the normal standard of care in disaster situations.Potential operational advantages include faster decision-making and triage, reduced operative time, high dependency, post-operative care time, emergency room time, number of outpatient visits, number of hospital beds required, ensuring optimal use of specialty time, and reduced antimicrobials.At-home or POCT testing, providing results within minutes of execution, will allow appropriate action and quick decision-making on the dental patient's care process.The characterization and detection rate of SARS-CoV-2 in dental-associated surrogate sites and specimens has been extensively reviewed.

Regulatory in the U.S. 

The Clinical Laboratory Improvement Amendments (CLIA) regulates any laboratory testing and requires laboratories to be certified to perform any test on human samples for health assessment or diagnosis, prevention or treatment of disease.Three federal agencies collaborate to carry out the responsibilities outlined in the statute: the Food and Drug Administration (FDA), the Centers 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 classifications (Class I, II, and III) as medical devices to ensure safety and efficacy. Regulatory controls and the premarket approval process are determined by this classification, with category I being the lowest risk (least regulated) and category III the highest risk (most regulated).Under CLIA, it is FDA's responsibility to evaluate the complexity of in vitro laboratory diagnostic tests.Score tests only after or upon request for FDA clearance or premarket approval.Manufacturers may apply for a CLIA waiver during this premarket approval/license process.Tests that have been passed or approved for home use or exempted by 42 CRF 293.15(c) are classified as exempt.Otherwise, the test is classified as moderate or high complexity based on the seven classification criteria listed in 42 CFR 493.17.If the test is classified as moderate, the manufacturer may request a waiver of the test through the CLIA Waiver Application.The application must show that the test complies with 42 U.S.C. § 263a(d)(3), that the test is simple and will not cause harm to the patient if performed incorrectly.These test classifications determine the accreditation required for laboratories to perform the above tests. Exempt tests require minimal oversight, while tests of moderate to high complexity require higher oversight and standards within the laboratory.

Centers for Medicaid Services (CMS)

Under CLIA, it is the responsibility of the CMS to issue laboratory certificates and to monitor, inspect and enforce laboratory compliance based on ongoing testing.The CMS covers a total of 260,000 laboratories.

Centers for Disease Control and Prevention (CDC)

CDC focuses on analysis, research, and technical assistance in CLIA partnerships.In particular, the CDC develops technical standards and guidelines, conducts research, monitors practices, and develops resources.In addition, CDC manages the Clinical Laboratory Improvement Advisory Committee (CLIAC). [40] CLIAC is composed of experts from many specialties in clinical and anatomic pathology who provide guidance and advice on general issues in laboratory science.The CDC specifically acknowledges that point-of-care testing only describes where testing is done, not the complexity of the testing itself.As technological innovations will enable more complex tests to be performed at the bedside, these tests may not be CLIA-exempt like some other home point-of-care tests that the FDA has waived, such as urine dipsticks.