COVID-19 detection test kit
Qualitative detection of SARS-CoV-2 virus nucleic acid in COVID-19 patient
Authorised under FDA’s Emergency Use Authorisation (EUA)
Abbott ID NOW COVID-19 is a molecular point-of-care test system for the detection of patients infected with Covid-19. It facilitates qualitative detection of the nucleic acid of SARS-CoV-2 virus in Covid-19 suspected patient.
Developed by Abbott, the test kit is based on ID NOW™ molecular platform, introduced in 2014 for the detection of Influenza A & B, Strep A and respiratory syncytial virus (RSV) in the US.
The US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) to use the system for Covid-19 detection in March 2020. The test meets the criteria for its EUA, under Section 564(c) of the Federal Food, Drug and Cosmetic Act.
The authorisation comes from criteria that SARS-CoV-2 can generate a life-threatening condition, including severe respiratory illness to 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 company is preparing to deliver 50,000 tests a day to the healthcare system.
Abbott ID NOW COVID-19 test features
Abbott ID NOW COVID-19 is a portable, light-weight (3kg), small toaster sized COVID-19 test device, which can be used in various locations including physician’s office, clinic or mobile units.
The test is an automated assay that delivers positive results in just five minutes and takes only 13 minutes to show the negative results, using the ID NOW™ molecular platform. The ID NOW™ molecular platform of the test is an instrument-based, isothermal system for rapid qualitative identification of infectious diseases. Its isothermal nucleic acid amplification technology facilitates accurate test results in 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.
Details of Abbott ID NOW COVID-19 test platform
The Covid-19 test system comprises a sample receiver, a test base, a transfer cartridge and the ID NOW instrument.
Sample receiver contains elution or 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.
Operation of Abbott ID NOW COVID-19 test kit
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 SARS-CoV-2 virus is present in the sample in any amount, ID will replicate a small section of the virus’ genetic material to be more detectable, allowing healthcare workers to rapidly identify the virus in patients to fight against the coronavirus pandemic.
Marketing commentary on Abbott
Abbott is a medical device company based in the US. The company focuses on the development of diagnostics and medical devices, as well as nutritional and generic medicines.
Abbott ID NOW COVID-19 is the company’s second product for Covid-19 test that 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.
Approximately 150,000 test kits have been shipped to hospitals and medical centre labs in 18 states and the company aims to ramp up its capacity to supply one million test kits per week.
Abbott currently employs approximately 107,000 people in over 160 countries.