Last Updated on April 9, 2020 by Sagar Aryal
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The world is coming to terms with the current situation of the COVID-19 pandemic. Laboratories and manufacturing companies are working around the clock to find the best, the fastest, easily available, and most accurate diagnostic tests for the causative agent, COVID-19.
Abbott Company based in the United States is among the leading companies in the world designing diagnostic tests that can be used at the Point-of-Care, at the convenience of a Healthcare provider. Working hand in hand with the Food and Drug Administration (FDA), they have designed two techniques for the diagnosis of COVID-19, which have been put under the Emergency Use Authorization (EUA). These diagnostic tests are:
- Abbott RealTime SARS-C0V-2 assay
- Abbott ID NOW COVID-19
Below is a discussion of the Abbott ID NOW COVID-19 Diagnostic test.
Abbott ID NOW COVID-19
ID NOW Test is the fasted diagnostic test for the detection of COVID-19 that uses the ID NOW platform of the Abbott Company. The diagnostic test which runs for 5 minutes for a positive test and for 13-15 minutes for a negative test. However, it has not been approved by the FDA, instead, it has been authorized for the Emergency Use Authorization (EUA) for authorized laboratories and hospital point-of Care settings.
Objectives of Abbott ID NOW COVID-19
- To solely detect the presence of SARS-CoV-2 RNA Nucleic ACid for suspected COVID-19 nasal specimens such as a nasal wash or nasal swabs.
Principle of Abbott ID NOW COVID-19
The test is designed to work on Abbott’s ID NOW platform, which is a rapid instrument-based isothermal system used for the quantitative detection of infectious diseases. The isothermal system has a nucleic amplification technology which enables results in just a few minutes. It is small, lightweight (6.6 pounds) and portable (the size of a small toaster).
Parts of Abbott ID NOW COVID-19
Image Source: Rapid Microbiology
- Lid- it closes and opened the test base holder and sample receiver holder
- Orange Test Base holder – It has the test base where the sample is tested
- Blue Sample receiver Holder – it holds the sample buffer and it is the site for sample inoculation to the buffer
- Transfer cartridge- it has pipettes that collect the sample from the sample receiver to the test base holder
- LCD Color Display Screen – it is the screen that controls the commands of the instrument
- LED Status Indicator
- Audio speaker
- USB Connection
- USB Connection x 2
- Power Connection
- Ether connection
- Power button
- Carrying handle
The procedure of Abbott ID NOW COVID-19
- Power up the Abbott ID NOW at 12V power supply and switch it on.
- Using the user interface, do the necessary operations, such as logins, test types, sample type, Assay test type, run a QC positive and QC negative test before starting the test.
- Select the test to perform and in this case its ID NOW assay.
- Select sample type, nasal swab or nasal wash.
- Enter the patient details on the platform and confirm.
- Load the test base into the test base holder and leave it for 10 minutes to confirm the test.
- Add a sample illusion buffer in a blue sample receiver to the blue sample receiver holder and leave it seated for 3 minutes to warm up. The maximum warm-up time is 10 minutes after which the instrument displays the next command and if it takes longer than 10 minutes, discard the illusion buffer.
- After warming up, remove the seal from the sample receiver, to expose the illusion buffer.
- Take the nasal specimen swab, and vigorously mix the specimen in the illusion buffer for about 10 seconds while pressing the swab on the walls of the sample receiver holder as you mix. Take caution not to splash the sample while mixing which could contaminate the instrument and the working space. If contamination occurs, clean the working space and the instrument with either a 10% bleaching solution or 70% ethyl alcohol or 70% ethanol wipe.
- Discard the specimen nasal swab in the right disposal bin.
- Press OK f the instrument screen.
- Take the white transfer cartridge with attached pipettes, and hold it over the sample receiver, with both hands and press it firmly into the blue sample receiver until you hear a click and the orange indicator button on the cartridge rises up signaling that the sample has been well drawn from the sample receiver into the transfer pipettes on the cartridge.
- Lift the transfer cartridge from the blue sample receiver and attach it to the orange test base and press it down firmly, hearing a series of clicks and until the orange indicator button descends down like it was initially. This ensures the sample has been loaded into the test buffer.
- This prompts a command on the screen to close the lid for 30 seconds.
- The test starts automatically with a display on the screen DO NOT OPEN’ until the test is complete.
- After which the instrument saves the test data and bounces to the test result screen. Up to this moment, do not open the lid until the results are displayed.
- The instrument will print the patient result depending on the configured settings or by pressing the print tab on the screen, and on connection to a printer.
- If there is no result, reboot the machine.
- Then tab the home screen which prompts the open the lid command to discard the used pieces.
Discarding the used pieces
- To dispose of the used pieces, carefully remove the transfer cartridge and test base assembly, and take the assemblage and click it into the sampler receiver. Using a back and forth rocking motion, the assembly connects into the sample receiver.
- Then carefully pull the up the assemblage together, to avoid spillage and contamination of the instrument and the workspace. If contamination occurs, refer above on how to clean the surfaces.
- Wrap the used assemblage pieces with your glove and discard it in the biohazard disposal bin.
- Close the lid of the instrument to allow it to run a self-test.
Results and Interpretation of Abbott ID NOW COVID-19
- For a positive result, the platform detects the presence of the virus nucleic acids within 5 minutes and for a negative result, it takes up to 13-15 minutes.
- Results must be correlated with the patient’s clinical diagnosis, history, and demographic travels prior to the symptoms.
- False-positive and false negatives must be correlated with patient clinical diagnosis, history, and epidemiology prior to the symptoms.
- The testing platform can also be used to check for other infections such as Influenza A and B, strep, and Respiratory syncytial Virus, therefore in case the patient’s result is negative for COVID-19, the health care provider or physician can run the other test to rule our possibilities of their infections as well.
Advantages of Abbott ID NOW COVID-19
- Easy to use with only minimal training requirements
- Large visual touchscreen displays results, eliminating transcription errors and the need for printing
- Small footprint saves you bench space and can be used in any healthcare setting
- Quality Control lock-out
- Bi-directional connectivity
- Offers exceptional performance
- Eliminates interpretation and transcription errors
- Gives you the confidence to make clinical decisions sooner
- Facilitates effective patient management
- Enables prompt initiation of infection control measures
- Aids targeted antiviral therapy and Antimicrobial Stewardship
- Reliable near-patient testing reduces overall healthcare costs
Disadvantages of Abbott ID NOW COVID-19
- There are possibilities of a false positive and false negative result, and therefore health care providers should compare with the clinical diagnosis, history of patient and epidemiological travels of the patient.
- The configurations of the ID NOW Assays on the platform can only be run by the Admin only, therefore in case it spoils or its damaged, it can not be repaired by anyone.
- It requires the correct power supply to maintain the safety and electromagnetic compatibility of the system.
- Risk of electrical shock. Do not operate the instrument or the power supply if it has been opened, damaged or exposed to moisture, condensation or rain.
- The possibilities of contaminations are high if the instrument is moved while running the test.
- To operate and configure the platform, it requires some training and it takes time to configure.
- It can not be used in a setup that does not have a power supply.
- It can only be used to test a single sample at a time.
Applications of Abbott ID NOW COVID-19
- The Assay has been designed to run the COVID-19 Test, however, it is also used to rn Influenza A and B tests, Strep test and Respiratory Syncytial Virus (RSV) test.
Video: COVID-19 Testing Where And When It’s Needed Most
References and Sources