This consistently translates in lower diagnostic sensitivity, or positive agreement with NAATs. In general, the analytical sensitivity, or lower limit of detection of rapid antigen tests is several logs less than that of the most sensitive NAATs. Rapid antigen tests with US FDA EUA as of 4 April 2021, for use in patient care settings operating under a CLIA certificate of waiver are listed in Table 1. But affordability, test accuracy and rapid time to result are attributes of POC that are important universally. Some of these criteria, such as equipment-free, are more relevant for resource-limited, remote settings with unreliable electrical power. The ASSURED criteria describe the most desirable attributes of POC tests, and are Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users. These criteria can be applied to POC tests for all infectious diseases, including COVID-19. The World Health Organization (WHO) developed the ASSURED criteria as a standard for rapid tests for detection of sexually transmitted infections in resource-limited settings. Rapid, single-use tests are often used at the POC. Ĭommercially available SARS-CoV-2 NAATs and antigen tests are available in both high throughput batch-based format often employing large instrumentation, and single-use portable sample-to-answer format that can be performed on demand for fast results. †Information from manufacturers' instructions for use available at. Microfluidic immunofluorescence instrument read Lateral flow fluorescence instrument read ![]() ![]() Lateral flow immunoluminescent instrument read Additional FDA authorizations for at-home use are described separately.īD Veritor SARS-CoV-2 BD Veritor SARS-CoV-2 & Flu A + Bĭigital chromatographic immunoassay instrument read For a list of SARS-CoV-2 antigen tests with EUA for settings operating under a CLIA Certificate of Waiver, see Table 1. However, some accreditation agencies in the US and local or state governments may have more strict quality requirements for POC sites that perform testing for SARS-CoV-2. Under CLIA, testing sites with a certificate of waiver are generally exempt from most US regulatory oversight requirements for non-waived laboratories, including personnel qualifications, training, test method verification and proficiency testing or external quality assessment. But the complexity of tests performed at a testing site is determined by its type of CLIA certificate a testing site with a certificate of waiver can perform only waived tests. Both waived and non-waived tests can be performed at the POC. Waived tests can be performed without the need for the conduct of more stringent quality standards imposed by CLIA for non-waived testing. Waived testing is defined by CLIA as simple tests that carry a low risk for an incorrect result. Some SARS-CoV-2 tests have received Emergency Use Authorization (EUA) from the US FDA for use in CLIA-waived testing sites. Recently, the COVID-19 pandemic has shined a spotlight on Clinical and Laboratory Improvement Amendments (CLIA)-waived diagnostic testing. Some POC tests are approved, cleared or authorized by regulatory bodies to be performed by non-laboratory professionals. ![]() POC tests are performed in a variety of settings including physician offices, emergency department, urgent care facilities, school health clinics and pharmacies. The current widely accepted definition of point of care (POC) testing includes testing that occurs at or near the point of patient care, such that the results drive patient care decisions made during that encounter. Point-of-care laboratory tests for SARS-CoV-2 & their regulation in USA Antivirals and monoclonal antibody therapies are available for COVID-19, and their initiation is dependent upon positive results of SARS-CoV-2 testing. Testing identifies infected individuals to be quarantined or isolated for infection control purposes, (1) impacts patient management decisions (2), and guides therapeutic strategies ( ). Testing for SARS-CoV-2 infection is a critical component of the public health response to COVID-19, in part because asymptomatic infections are common and contribute to COVID-19 transmission. As of 20 April 2021, over 140 million confirmed COVID-19 cases and over 3 million deaths have been reported globally ( ). The rapid increase and spread in reported cases triggered the World Health Organization to declare COVID-19 to be a global pandemic on 11 March 2020. Severe acute respiratory syndrome coronavirus (SARS-CoV-2), the etiologic agent of COVID-19, was first detected in Wuhan, Hubei Province, China in December of 2019. Current global COVID-19 situation, & role of laboratory testing
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