In the years preceding the COVID-19 pandemic, molecular technologies including polymerase chain reaction (PCR) and isothermal amplification were already playing a key role in respiratory infectious disease testing.
The urgent, global nature of the COVID-19 pandemic has thrust molecular and other testing modalities into the spotlight, leading to rapid innovation in the field of diagnostics. More than two years into the pandemic, the U.S. Food and Drug Administration (FDA) has authorized more than 400 novel coronavirus tests1 to help mitigate the spread of the disease.
With molecular-based testing now a cornerstone of COVID-19 diagnosis,2 it is important to understand the differences in various molecular technologies. Lab-based PCR testing has become a common approach to molecular testing over the course of the pandemic,3 having previously been deployed during public health emergencies such as the emergence of SARS-CoV in 2003 and Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012.4 The technology behind PCR testing has been well documented and accepted by scientists and medical staff as robust methodology offering scalability5 and capacity.6
Despite these benefits, however, the COVID-19 pandemic has exposed possible disadvantages to using lab-based PCR technology as a frontline diagnostic tool. The tests require multiple cycles to identify and amplify viral RNA.3 Amplification is performed with thermocycling, a time-consuming process of alternating between heating and cooling, which, combined with the logistical requirements of lab testing, can take from hours to days to yield results – or even longer during periods of intensified demand, as seen during the Omicron surge. Such delays can negatively impact the clinical and infection control decisions made by healthcare providers.
Not Yesterday’s Amplification Method
Although PCR has been widely and routinely deployed during the pandemic, other molecular detection methods offer rapid results at the point of care (POC). Isothermal amplification is cleared for use in a number of commercial molecular diagnostic platforms for sequence specific detection. A variety of isothermal amplification techniques are available, including Loop-mediated Isothermal Amplification (LAMP), Helicase Dependent Amplification (HDA), and Nicking Enzyme Amplification Reaction (NEAR). Although these methods can vary considerably, they do share several common features: all perform amplification with high sensitivity and specificity; all utilize enzymes for separating DNA; and all operate at a single constant temperature to amplify targets, circumventing the need for thermocycling.7 By avoiding this time and energy intensive process, some isothermal amplification tests yield significantly more rapid results compared to PCR tests.8
The Future is Here: Leveraging NEAR in ID NOW™
Abbott’s ID NOW™ testing platform has emerged as an alternative to PCR for more rapid molecular detection of SARS-CoV-2 at the point of care with NEAR detection technology. ID NOW™ COVID-19 tests utilize NEAR isothermal technology, proprietary nicking enzymes, and constant temperature control to achieve the fastest time to completion among available POC molecular tests – returning high-quality results in 13 minutes or less9 and enabling healthcare providers to make evidence-based clinical decisions sooner.
Download Abbott’s ID Now Infographic
ID NOW™ is an automated, instrument-based test for COVID-19 and other infectious diseases that amplifies short sequences of nucleic acids using two primers, a DNA polymerase and a proprietary nicking enzyme to detect small target amounts in minutes. The ID NOW™ platform uses fluorescent beacons to provide a qualitative readout, allowing for adaptation to POC diagnostics.7
How Do ID NOW™ COVID-19 Tests Work?
A direct nasal or nasopharyngeal swab is placed into an acidic liquid solution heated to 56⁰ C (132.8⁰ F), which breaks open the envelope of the SARS-CoV-2 virus, exposing its viral RNA and converting it to DNA through reverse transcription. Then the device amplifies the DNA hundreds of millions of times to make the virus detectable – returning test results in 13 minutes or less.
It’s No Secret: A Wealth of Clinical Evidence Powers the Utility of the ID NOW™
The proprietary NEAR technology in ID NOW™ has been well-established and used in infectious disease diagnosis since 2014. The FDA initially approved molecular Influenza A & B and Strep A assays for the ID NOW™ platform for POC testing in 2014 and 2015, respectively.10 Both assays were granted Clinical Laboratory Improvement Amendments (CLIA) certificates of waiver, making ID NOW™ the first-ever CLIA-waived POC molecular platform.10 A third assay for Respiratory Syncytial Virus (RSV) was cleared by the FDA in 2016.10
Dozens of peer-reviewed studies have demonstrated the clinical benefits of the ID NOW™ tests. In a pediatric study comparing the ID NOW™ Strep A assay with a rapid antigen POC test, the authors concluded that testing with ID NOW™ led to more appropriate prescribing of antibiotics for group A Streptococcus (GAS) pharyngitis.11 Another study found that rapid POC testing with the ID NOW™ Influenza A & B assay improved healthcare utilization in an Emergency Department (ED) setting. The results showed that patients with flu-like symptoms who were tested with ID NOW™ Influenza A & B in the ED had a shorter length of stay (LOS) compared to patients who received standard of care lab-based testing (mean of four hours vs. six hours), had a lower rate of hospitalizations (9.7% vs. 44.4%) and required fewer additional tests.12
Now, with a robust body of evidence validating the utility of the ID NOW™ platform for near patient testing, Abbott has introduced the ID NOW™ COVID-19 2.0 assay, which offers even more rapid results and high rates of sensitivity. In an analysis of 989 nasal or nasopharyngeal swab specimens from symptomatic patients, the ID NOW™ COVID-19 2.0 test demonstrated Positive Agreement of 93.3% compared with RT-PCR reference testing.13
Precision and Portability: ID NOW™ Meets Patients Where They Are
As a portable, CLIA waived test, ID NOW™ COVID-19 2.0 meets the logistical and personnel challenges associated with SARS-CoV-2 testing. The platform is a lightweight box (6.6 pounds and the size of a small toaster) and does not require preparation of viral transport medium (VTM). With its small size, it can be integrated in nontraditional environments, such as schools, workplaces and airports, and can be brought directly to low-resource communities impacted by COVID-19 that may not have optimal access to healthcare delivery.14
A Matter of Time: Rapid Results Improve Outcomes Across the Healthcare Continuum
Research shows that rapid test results at the POC allows for timely medical assessment, which can lead to improved patient outcomes, better clinical efficiencies, and higher patient satisfaction.15 With the rapid results afforded by the ID NOW™ platform, healthcare providers in the ED, doctors’ offices and urgent care centers can receive clinically actionable results for greater efficiency and faster decision-making. The ID NOW™ platform has several benefits in time-sensitive settings:
- Expedites time to evidence-based treatment, improving patient care and lowering mortality rates16,17
- Supports antimicrobial resistance stewardship16,17
- Supports infection control measures, streamlining isolation procedures and reducing infectious disease outbreaks in the hospital18
- Optimizes workflow and patient throughput, shortening patient wait times and LOS16,17
- Expedites test results to shorten operational time and reduce instrumentation
Rapid Response: Strengthening the Fight Against Respiratory Infectious Disease with POC Molecular Testing
In a comprehensive COVID-19 response plan, different tests serve different needs – from screening large populations to rapidly detecting an active or previous infection in a single individual. Antigen tests, which may serve as an alternative to molecular methods in certain settings, have a place in COVID-19 testing for rapid, high-volume screening of asymptomatic patients. The tests offer other advantages, notably that they’re less expensive to produce and process and have reasonable turnaround times.19
Molecular testing, however, remains the single best method of detecting active symptomatic infection.20 ID NOW™ tests have emerged as critical tools in the COVID-19 arsenal, allowing fast diagnosis – with results in 13 minutes or less9 – in a variety of settings such as physicians’ offices, urgent care clinics, and other POC locations. The tests are cost-efficient not only during the pandemic, but also during respiratory season and year-round – with the ability to detect influenza types A and B in 13 minutes or less,10 Strep A in six minutes or less,10 and RSV in about 13 minutes.21
As molecular diagnostics evolves beyond the lab, clinicians and healthcare workers no longer have to sacrifice accuracy for speed. Isothermal testing with the ID NOW™ platform brings the sensitivity of PCR from the lab to the point of care and offers clinical and cost-effectiveness benefits, establishing a new gold standard in rapid molecular testing.
The ID NOW COVID-19 and ID NOW COVID-19 2.0 products have not been FDA cleared or approved. They have been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories and patient care settings. The tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- US Food and Drug Administration. COVID-19 Tests and Collection Kits Authorized by the FDA. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-and-collection-kits-authorized-fda-infographic. Accessed on March 10, 2022.
- Binnicker MJ. Challenges and controversies to testing for COVID-19. J Clin Microbiol. 2020; 58:e01695-20.
- Gangulia A, Mostafa A, Berger J, et al. Rapid isothermal amplification and portable detection system for SARS-CoV-2. PNAS. 2020;117:22727-22735.
- Vandenberg O, Martiny D, Rochas O, et al. Considerations for diagnostic COVID-19 tests. Nat Rev Microbiol. 2021;19:171-183.
- Yu J, Huang Y, Shen Z-J. Optimizing and evaluating PCR based pooled screening during COVID 19 pandemics. Sci Rep. 2021;11:21460.
- National Institutes of Health (2020 September 2). NIH continues to boost national COVID-19 testing capacity [Press release]. https://www.nih.gov/news-events/news-releases/nih-continues-boost-national-covid-19-testing-capacity. Accessed on March 11, 2022.
- Khan P, Aufdembrink LM, Engelhart AE. Isothermal SARS-CoV 2 diagnostics: tools for enabling distributed pandemic testing as a means of supporting safe reopenings. ACS Synth Biol. 2020;20;9(11):2861-2880.
- Oliveira BB, Veigas B, Viana Baptista P, et al. Isothermal amplification of nucleic acids: the race for the next “gold standard”. Front Sens. 2021;2:752600.
- Abbott (2020 March 27). Abbott launches molecular point-of-care test to detect novel coronavirus in as little as five minutes. [Press release]. https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes#:~:text=in%20outbreak%20hotspots.%22-,Abbott%20will%20be%20making%20ID%20NOW%20COVID%2D19%20tests%20available,can%20have%20the%20greatest%20impact. Accessed on March 13, 2022.
- Abbott (2018 October 25). Abbott introduces the next generation of influenza A & B and strep A assays with fastest-ever time to molecular results. [Press release]. https://abbott.mediaroom.com/2018-10-25-Abbott-Introduces-the-Next-Generation-of-Influenza-A-B-and-Strep-A-Assays-with-Fastest-Ever-Time-to-Molecular-Results#:~:text=The%20enhanced%20Influenza%20A%20%26%20B,of%20all%20test%20components%2C%20simplifying. Accessed on March 11, 2022.
- Berry GJ, Miller CR, Moreno Prats M, et al. Comparison of the Alere i Strep A test and the BD Veritor system in the detection of group A Streptococcus and the hypothetical impact of results on antibiotic utilization. J Clin Microbiol. 2018;56:e01310-17.
- Trabattoni E, Le V, Pilmis B, et al. Implementation of Alere i Influenza A & B point of care test for the diagnosis of influenza in an ED. Am J Emerg Med. 2018;36:916-921. [Note: need to purchase article for full access]
- Data on file. ID NOW COVID-19 2.0 Product Information sheet.
- Trenti T. Synergy between point-of-care testing and laboratory consolidations. EJIFCC. 2021;32(3):328-336.
- Barenfager J, Drake C, Leon N, et al. Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000;38(8):2824-2828.
- Mackie PLK, Joannidis PAM, Beattie J. Evaluation of an acute point-of-care system screening for respiratory syncytial virus infection. J Hosp Infect. 2001;48:66-71. [Need to purchase for access]
- Bonner AB, Monroe KW, Talley LI, et al. Impact of the rapid diagnosis of influenza on physician decision-making and patient management in the pediatric ED: results of a randomized, prospective, controlled trial. Pediatrics. 2003;112:363-367. [Need to purchase for access]
- Mills JM, Harper J, Broomfield D, et al. Rapid testing for respiratory syncytial virus in a paediatric emergency department: benefits for infection control and bed management. J Hosp Infect. 2011;77:248-251. [Need to purchase for access]
- High-Throughput, Laboratory-Based Antigen Tests Address an Unmet Need in the Global COVID-19 Pandemic. Health Affairs Forefront, February 11, 2022. https://www.healthaffairs.org/do/10.1377/forefront.20220209.825156/. Accessed on March 14, 2022.
- US Food and Drug Administration. Coronavirus Testing Basics. April 2021. https://www.fda.gov/media/140161/download. Accessed on March 14, 2022.
- ID NOW™ Strep A 2 [package insert]. Scarborough, ME: Abbott Diagnostics Scarborough, Inc.; 2020.