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COVID-19 testing machine Abbott ID now SOP

Contents

  1. Aim
  2. Scope
  3. Link to overarching policy
  4. Procedure
  5. Appendices

1 Aim

To provide clear written instructions to colleagues so that they can safely use the COVID-19 testing machine which helps prevent person-to-person transmission of COVID-19.

2 Scope

All colleagues using the COVID-19 testing machine.

3 Link to overarching policy

The overarching policy for this standard operating procedure is the medical devices management policy.

Other associated documents that should be read in conjunction with the procedure are:

4 Procedure

4.1 Intended use

This medical device is for use by healthcare professionals for the qualitative detection and diagnosis of SARS-CoV-2 from nasal, nasopharyngeal and throat swabs.

4.2 Test procedure

  1. Decontaminate hands and don personal protective equipment (PPE) appropriate to the procedure.
  2. Widely open the package by pulling from the top down. Carefully remove the swab and perform nasal sample collection.
  3. Swabs should be tested as soon as possible after collection. If this is not possible, it can be kept at room temperature for up to 2 hours. It can also be refrigerated at 2 to 8 degrees and tested within 24 hours. The swab must be kept in its original packaging if not tested immediately. If the swab is from another ward/area it must be transported in an approved transport container (red bucket).
  4. Press the Power Button on the side of the machine, enter User ID and press the tick symbol.
  5. Touch ‘Run test’, then touch ‘COVID-19 test’. Select swab sample type if prompted. Enter patient ID using the keyboard then press the tick symbol. Verify ID by pressing the tick symbol again.
  6. Open the machine lid. Check that a reagent pellet is visible at the bottom of each reaction tube prior to inserting the orange test base in the machine. The blue sample receiver and orange test base are then inserted into the ID now machine. Do not open the sample receiver before placing in the instrument.
  7. Confirm that the correct test is displayed on the screen and press ‘OK’. There is then only 10 minutes to complete the test, after which time the test base and sample receiver must be removed and discarded. The sample receiver will become ready for use, and prompt the user to remove the foil seal from the sample receiver. Ensure the sample receiver remains in the machine when removing the foil seal, by placing 2 fingers along the outer edge of the sample receiver to hold it in place.
  8. The swab is added to the sample receiver. Mix the swab in the liquid for 10 seconds. Lift the swab out of the liquid and press the swab head against the side of the sample receiver to remove excess liquid. Once the swab is removed, press ‘OK’ to proceed. Discard the swab into an infectious waste (orange) bag.
  9. Press the white transfer cartridge into the blue sample receiver until a click is heard. The orange indicator on the transfer cartridge will rise. If the indicator does not fully rise, the transfer cartridge may not have collected enough sample.
  10. Lift and connect the white transfer cartridge to the orange test base. The orange indicator on the transfer cartridge will now descend. If the orange indicator does not fully descend, not enough sample has been dispensed.
  11. Close the lid. Do not open the lid until the ‘test complete’ message appears on the screen. If a test error occurs, the display will read ‘Invalid’.
  12. If ‘Invalid’, one additional test may be run using the same sample receiver. Remove the connected test base and transfer cartridge and
    connect the test base portion to an open, unused sample receiver. The connected test base and transfer cartridge must be attached to a sample receiver before disposal. The sample receiver from a new transfer cartridge package may be used for this. Remove the blue sample receiver separately, and carefully from the machine. The sample receiver should be retained and kept upright to avoid spilling the liquid contents. From the home screen, start a new test. Follow the screen prompts, however, when asked to insert the sample receiver, reuse the sample receiver and do not re-elute the swab.
  13. Remove PPE and discard into appropriate waste stream.
  14. Decontaminate hands.

4.3 Recording on SystmOne clinical records

Record date, device type, batch number and expiry date, result on SystmOne. Inform Senior colleague of test result (negative or positive).

4.4 Actions following results of tests

  • COVID-19 positive, inform Infection Prevention and Control team, document on the template on SystmOne, commence observations if symptomatic, inform clinical lead and commence isolation procedure as per respiratory management procedure in the infection prevention and control manual.
  • COVID-19 negative, document on the template on SystmOne.

4.5 Training requirements

Read the operator’s manual and practice the testing procedures before using the meter. The device can be used by any suitably trained member of a trust Healthcare team as part of their clinical activity.

4.6 Safety warnings

Don't

  • do not mix components from different kit lots or from other ID NOW assays
  • do not if any components are dropped, cracked or found to be damaged
  • do not use scissors or sharp objects to open foil pouches as damage can occur
  • do not use more than once, all test pieces are single-use items

4.7 Control swab procedure

This should be done with each new set of swabs and with each new user. If used infrequently, this should be done before use or monthly:

  • decontaminate hands
  • follow the run QC test instructions on the ID now machine. A positive control swab is included with the kit, and a sterile swab can
    be used as the negative control swab
  • results will be reported as Pass or Fail accordingly. If the correct control results are now obtained, do not perform patient tests. contact technical support during normal business hours on 0161 483 9032

4.8 Machine storage temperature

  • 2 to 30 degrees C.

4.9 Incident reporting

  • If there is an incident or fault whilst using this machine, this should be reported on an IR1 in accordance with the incident reporting policy.

5 Appendices

Appendix A Manufacturer’s instruction

Document control

  • Version: 1.
  • Unique reference number: 1063.
  • Date approved: 5 September 2023.
  • Approved by: Clinical policy review and approval group.
  • Name of originator or author: Medical devices and duty of candour officer Hawthorn ward.
  • Name of responsible individual: Executive director of nursing and AHP.
  • Date issued: 2 October 2023.
  • Review date: 31 October 2025 (new document).
  • Target audience: All users.

Page last reviewed: May 13, 2024
Next review due: May 13, 2025

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