05 Aug 2021: Information regarding ReCIVA® & COVID-19

Owlstone Medical Ltd would like to draw Breath Biopsy® users’ attention to the following guidelines and recommendations on how to safely use the ReCIVA® Breath Sampler whilst there is continued concern over the spread of COVID-19.

ReCIVA already provides biological filtration and independent tests have shown it provides over 99% filtration in standard bacterial and viral load tests. This exceeds the biological filtration requirements of a Type III surgical mask and hence sigificantly reduces the risk of aerosol exposure from the exhaled breath. Note: as with all protective masks there is the possibility of leaks around the face and the use of ReCIVA should not be considered a substitute for any standard PPE.

In addition to the protection afforded from this biological filtration, and in line with WHO and CDC recommendations, we advise that a low-level disinfection (protocol link below) is performed on ReCIVA before using ReCIVA on another study subject and (ideally) as soon as possible after each breath collection.

ReCIVA disinfection protocol: VIEW PROTOCOL

The disinfection protocol has been developed specifically for ReCIVA and has been formally validated by Nelson Laboratories LLC (https://www.nelsonlabs.com/testing/disinfection-validation-for-reusable-devices/) as effective in exceeding the 6 log (i.e. greater than 99.9999%) reduction required for low-level disinfection in accordance with international guidelines concerning the use of non-critical equipment in healthcare facilities.

Please note that the disinfection protocol linked above replaces the general cleaning instructions provided in the ReCIVA user manual. The following precautionary measures are also recommended:

  • If not already required to do so, operators should consider wearing additional PPE when interacting with study subjects in accordance with a suitable risk assessment and local context.
  • Provide clean nitrile gloves for the study subjects to wear, so that they can hold or touch ReCIVA without additional risk of introducing contamination. Note: the ReCIVA user manual requires the operator, but not the subject, to wear clean nitrile gloves.
  • Ensure that the sorbent tube assembly containing the breath sample is removed from ReCIVA and bagged as soon as possible after completing the breath collection. The sorbent tubes are exposed to the subject’s breath so it is particularly imperative to follow our existing advice to always handle them with gloves. Take precautions when handling potentially contaminated materials accord to local guidelines. DO NOT attempt to clean the sorbent tubes as this will affect the quality of the breath sample. The outer zip lock bag used to contain the tubes can be cleaned with a disinfectant wipe once the bag has been properly sealed.
  • Ensure that the disposable mask (including its integral biological filter) and the yellow exhaust valve are disposed of as soon as possible after completing the breath collection in accordance with local guidelines for disposing of infectious waste. A replacement valve will be shipped with each Breath Biopsy Kit. Please contact us if you require additional valves.
  • Consider using a clean head strap for each study subject. Head straps can be bagged and washed in warm soapy water before re-use. Please contact us if you require additional head straps.
  • Clean the outer surface of the air supply tubing connecting ReCIVA to the CASPER™ Portable Air Supply between breath collections using the supplied disinfection wipes. Use additional wipes as necessary to ensure that surface remains wet for at least 5 minutes and allow at least 30 minutes for the tubing to air dry after cleaning before collecting further study samples.
  • All other breath collection equipment (CASPER Portable Air Supply, trolley, laptop etc.) should be periodically cleaned with disinfection wipes according to their Instruction for Use documents, and local requirements. Allow at least 30 minutes for the equipment to air dry after cleaning before collecting further study samples.

Please refer to expert medical opinion and the latest official advice on COVID-19 in your location when assessing whether ReCIVA is suitable for your population of interest.

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