Abbott ID Now for Rapid COVID-19 Point of Care Testing: Introduction, Principle, Test Requirements, Testing Procedure, and Result Interpretation and Keynotes

Introduction of Abbott ID Now for Rapid COVID-19 Point of Care Testing

The ID Now (Abbott) COVID-19 Test performed on the ID Now Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of COVID-19 RNA in direct specimens like nasal or throat for COVID-19 swabs from patients with signs and symptoms of respiratory infection. The system is planned for use as an assist diagnosis of COVID-19 viral infections in concurrence with clinical and epidemiological risk factors. Negative results do not rule out severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and should not be used as the sole basis for diagnosis, treatment, or other patient management settlements.

Principle of Abbott ID Now

The ID Now COVID-19 test is automated multiplex tests that utilize isothermal nucleic acid amplification technology. The system contains Sample Receiver, containing elution buffer, a Test Base, comprising two sealed reaction tubes, each containing a lyophilized pellet, a Transfer Cartridge for transfer of the eluted sample to the Test Base, and the ID Now Instrument. The in The COVID-19 Test Base having reaction tubes contain the reagents required for amplification of SARS-CoV-2, as well as an internal control (IC).

The templates (similar to primers) designed to target SARS-CoV-2 RNA amplify a unique region of the RNA dependent RNA polymerase (RdRp) segment. Fluorescently-labeled molecular beacons are used to specifically identify each of the amplified RNA targets. To Run the test, the Sample Receiver and Test Base are inserted into the ID Now Instrument. The sample is put to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, initiating target amplification. Heating, mixing, and detection are done by the instrument, with results automatically reported.

Test Requirements for Abbott ID Now for Rapid COVID-19 Testing

1. Equipment (ID Now)
2. Test specimens-A nasal swab or a throat swab should be collected with an Abbott ID Now dry swab is provided with the test kits.
3. Reagents, Calibrants and Internal Quality Control (IQC) Materials

• Test Bases: Orange plastic components containing two reaction tubes of lyophilized reagents for the targeted amplification of Influenza A and B viral RNA or SARS-CoV-2 RNA (storable at room temperature 15-30ºC)
• Sample Receivers: Blue plastic components containing 2.5 mL of elution buffer (storable at room temperature 15-30ºC
• Transfer Cartridges: White plastic components used to transfer 2 x 100 μL of sample extract from the Sample Receiver to the Test Base (storable at room temperature 15-30ºC). Note-It is very crucial when handling the transfer cartridge that the lower section (circled) does not come into contact with any surfaces or hands. The transfer cartridge should remain in its packaging until immediately earlier to use.
• Positive Control Swab: The positive control swab is coated with inactivated influenza A and B viruses (for Influenza) for COVID-19. These swabs must be handled as though they could transmit disease (storable at room temperature 15-30ºC

4. For Environmental, Health & Safety Controls: Use appropriate PPE

Test Procedure of Abbott ID Now

Sign in and Enter Test Details

1. Take on a fresh pair of gloves and turn on the ID Now Instrument (if it is switched off) – thumb the power button on the side of the instrument.
2. Enter User ID – Press after entry.
3. Touch ‘Run Test’ – This will be the test process.
4. Touch ‘COVID-19’ – This begins a COVID-19 test.
5. Enter Patient MRN – using the on-screen keyboard or barcode scanner.
6. Touch.
7. Verify that the ID was entered correctly, and then touch to confirm entry.
8. If the patient details do not pop up on the screen check that the patient’s hospital number has been entered correctly prior to proceeding.

Loading the Test base

1. Open the lid and insert Orange Test Base into Orange Test Base holder.
2. Confirm that the correct test is displayed on the screen – Touch ‘OK’ to proceed.
3. We will have 10 minutes from now to confirm the test and complete all steps of pre-analysis.

Loading the Sample Receiver and Adding Sample

1. Open foil pack 2 and remove just the blue base.
2. Insert Blue Sample Receiver into the Blue Sample Receiver holder.
3. Wait for the Sample Receiver to Warm-Up (3 minutes) before moving to Step 4. Do not remove the Sample Receiver from the instrument once Warm-Up begins. Do not remove the foil seal until shown by the instrument. Do not close the lid or insert the sample until reminded by the instrument.

Removal of the foil seal and addition of the patient swab to the Sample receiver.

1. When prompted (after 3 minutes) place two fingers along the outer edge of the Sample Receiver to hold it in place then peel off the foil seal.
2. Take out the swab from its packaging and vigorously mix the swab in the elution buffer for 10 seconds.
3. Press the swab head against the side of the Sample Receiver as you mix it. This assists remove the sample from the swab.
4. Once the swab is removed, touch ‘OK’ to proceed. Be careful not to cause any splashing of the elution buffer in the sample receiver.
5. Discard the swab in a yellow Burn-bin or sharps bin.

Transfer of Sample into the Test Base

1. Remove the white transfer cartridge from foil pack 2.
2. Press the White Transfer Cartridge into the Blue Sample Receiver – listen for a click. The orange indicator on the Transfer Cartridge will then be in the rise position.
3. If the orange indicator does not stand up, continue pushing onto the Sample Receiver until it does.
4. Lift the white transfer cartridge onto the orange test base.
5. Push the transfer cartridge firmly until the orange indicator descends.
6. If the orange indicator does not descend, continue pushing onto the Test Base until it does.
7. Close the lid within 30 seconds.

Starting the Analysis

1. The lid should be closed within 30 seconds of the transfer cartridge being detected to start the analysis.
2. Analysis runs for up to 13 minutes.
3. When amplification and detection are complete, the instrument will automatically save the data before advancing to the results screen.
4. Note: Do not open the lid until the results are shown or the test will be canceled
5. The Test Results screen displays either a Negative or Positive result for a successfully completed test.
6. If a test error occurs, the display will read ‘Invalid’.

Finishing the Test and Removal of Test Pieces

1. From the results screen Press New Test to run another test, or Press Home to return to the Home screen.
2. We will be prompt to open the lid and discard the test pieces.
3. Remove test pieces by lifting the Transfer Cartridge attached to the Test Base, and clicking it into the Sample Receiver; this may need a gentle rock to clip both edges of the orange into the blue.
4. All test pieces will be connected and can now be removed from the instrument/ ID Now, wrapped inside a disposable glove as it is removed from the hand, and disposed of in the yellow Burn bin or sharp bin.
5. Put on a fresh pair of gloves and wipe the inside areas of the instrument with a 70% alcohol wipe .
6. Close the lid.
7. The instrument will then run a Self-Test before showing the Home screen or Enter Patient ID screen, depending on which previously selected.
8. Clean the external areas of the device with a 70% alcohol wipe.
9. Remove gloves and discard them in clinical waste.
10. Wash hands as per hand hygiene procedure.

Quality Control for Abbott ID Now for Rapid COVID-19 Point of Care Testing

Performing a Quality Control (QC) Assay-

• Turn on and log in to the analyzer.
• From the Home Screen Touch ‘Run QC Test’
• Touch ‘COVID-19’.
• Select the QC Test to be Run; Positive QC Test or Negative QC Test.
• Press ‘edit QC Sample ID’ and enter the QC lot number, then press the tick to confirm – failure to do so will hold back the QC results in POCcelerator.
• Confirm the information entered for the QC sample by touching ‘OK’.
• Continue from Step 2 above for running the swab.

Maintenance of ID Now Instrument

1. It is the maintenance-free and has no serviceable parts. In the case of instrument failure or damage, contact Abbott Technical Support.
2. It should be wiped using 70% ethanol. Do not spray or pour the solution directly onto the instrument when cleaning.
3. Ignore using excess liquid during cleaning since it may damage the instrument.
4. The device must be cleaned following every test performed.
5. A daily clean should also be done and recorded on the QC and Maintenance Logs
6. Abbott recommends that the exterior instrument surfaces and the surfaces visible under the open lid be cleaned daily.
7. Clean the surrounding bench area.
8. Always clean instrument and surrounding areas immediately after possible patient sample contamination.

Results Interpretation of Abbott ID Now

• Test Negative: It will take 13 minutes.
• Test Positive: The result will show within 5 to 13 minutes.
• Quality Control samples: Negativ control shows negative while positive control shows a positive result.
• Invalid Result: Repeat the test.

Keynotes on Abbott ID Now for Rapid COVID-19 Point of Care Testing

• A blank sterile patient swab should be used as a negative control for the COVID-19 test kits.
• Always process the negative control swab first
• Positive results are available within 5 to 13 min and negative results within 13 min.
• Nasal or Throat Swabs: Sterile swabs for use with the ID Now COVID-19 Test these are supplied with the test kits (store at Room temperature 15-30ºC).
• VTM swabs are not allowed for processing on the ID Now.

Limitations and Interferences of the Method

1. The performance of the ID NOW COVID-19 was evaluated using the procedures provided in this product insert only. Modifications to these procedures may alter the performance of the test.
2. Negative results should be treated as presumptive and tested with an alternative authorized molecular assay, if necessary for clinical management, including infection control. This is not routinely being performed and is covered in the risk assessment.
3. If a specimen is improperly collected, transported or handled, false-negative results may occur.
4. False-negative results may also occur if amplification inhibitors are present in the specimen or if inadequate levels of viruses are present in the specimen. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
5. As with any molecular test, mutations within the target regions of the Abbott ID NOW COVID-19 test could affect primer and/or probe binding resulting in failure to detect the presence of the virus.
6. The test cannot rule out diseases caused by other bacterial or viral pathogens.
7. Id Now COVID-19 is intended for testing a swab directly without elution in viral transport media as dilution will result in decreased detection of low positive samples that is near the limit of detection of the test.
8. Id Now does not allow to assay swab samples eluted in VTM as it is not appropriate for use in this test.
9. The assay is a qualitative test and does not provide the quantitative value of detected organism present.

Further Readings

• https://www.ruh.nhs.uk/pathology/documents/poct/SOP_Abbot_ID_Now_COVID_POCT.pdf?t=60262
• https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes
• https://www.microsensdx.com/lamp-vs-pcr-choosing-the-appropriate-sars-cov-2-covid-19-diagnostic-test/
• https://journals.asm.org/doi/full/10.1128/JCM.01136
• https://www.medicaldevice-network.com/projects/abbott-id-now-covid-19/