Abbott ID NOW™ is a point-of-care molecular diagnostic method for identifying Covid-19 patients. It allows qualitative identification of SARS-CoV-2 nucleic acid in suspected patients, providing quick results in a range of healthcare locations.
Developed by Abbott, a US-based medical device and healthcare company, the test kit is based on the NOW™ molecular platform, introduced in 2014 for the detection of influenza A and B, strep A and the respiratory syncytial virus in the US.
Regulatory approvals for Abbott ID NOW test
The US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) to use the ID NOW system for Covid-19 detection in March 2020 and ID NOW 2.0 in May 2022. The test meets the criteria for its EUA under Section 564(c) of the Federal Food, Drug and Cosmetic Act.
The authorisation comes from the criteria that SARS-CoV-2 can generate a life-threatening condition, including severe respiratory illness, in humans. The test can diagnose Covid-19 in patients under complete scientific evidence available to the FDA; no other adequate approved alternative is available for emergency use.
The test is also CE-marked in the European Union. Health Canada approved the use of Abbott ID NOW Covid-19 assay in the public health system in October 2020.
The Japanese Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour, and Welfare approved the Abbott ID NOW Covid-19 test system in October 2020 and the ID NOW Covid-19 2.0 in September 2022.
Abbott ID NOW Covid-19 test system features
Abbott ID NOW Covid-19 is a portable, lightweight and compact Covid-19 test device, which can be used in a range of locations including a physician’s office, clinic or mobile units.
The in-vitro diagnostic test is an automated assay that delivers positive results in just five minutes and takes only 13 minutes to show negative results, using the ID NOW molecular platform. The ID NOW molecular platform is an instrument-based, isothermal system for rapid qualitative identification of infectious diseases. Its isothermal nucleic acid amplification technology facilitates accurate test results within a few minutes.
The test detects nucleic acid from the RNA of SARS-CoV-2 virus present in nasal, nasopharyngeal or throat swabs, as well as the swabs eluted in viral transport media, collected by the healthcare providers from the suspected Covid-19 patients.
Abbott ID NOW Covid-19 test platform details
The Covid-19 test system comprises a sample receiver, a test base, a transfer cartridge and the ID NOW instrument.
The sample receiver contains elution or a lysis buffer. The test base has two sealed reaction tubes, each with a lyophilised pellet, while the transfer cartridge sends the eluted sample to the test base.
The sample receiver and test base are placed into the ID NOW instrument, with the specimen kept in the sample receiver. The sample then transports to the test base via transfer cartridge for target amplification. The ID NOW instrument eventually performs heating and mixing activity to detect the virus and furnish the results.
The package also contains external patient swabs, as well as positive control and negative control swabs.
Abbott ID NOW Covid-19 test kit operation
When a sample adds to the system, a chemical solution breaks open the virus, releasing its genetic material. The solution inserts into the ID system, which reads it using molecular testing technology.
If the SARS-CoV-2 virus is present in the sample in any amount, the ID will replicate a small section of the virus’s genetic material to be more detectable, allowing healthcare workers to rapidly identify the virus.
Marketing commentary on Abbott
Abbott focuses on the development of diagnostics and medical devices, as well as nutritional and generic medicines. It currently employs 115,000 people in more than 160 countries.
Abbott ID NOW Covid-19 is the company’s second product for Covid-19 testing that has received EUA in the US. The company’s RealTime SARS-CoV-2 EUA test is a novel coronavirus test, which also received EUA in the US for the detection of Covid-19.
Abbott has delivered over 12 million ID NOW tests across all 50 states of the US, as of October 2020.