An Easier, more comfortable
way to swab

Rhinoswab is a comfortable, self-administered nasal swab that provides high-yield sampling and fits existing pathology workflows.

Introducing rhinoswab

In response to the COVID-19 pandemic, Rhinomed applied its deep expertise in nasal airway technology to help address the global swab supply shortage.

Through innovative modifications to our existing, proven nasal technology platform, we developed Rhinoswab – a comfortable, easy to use swab that opens up the potential for mass, population-wide sample self-collection.

It was proven to be 100% accurate for the detection of SARS-COV-2 in spiking studies conducted by the Victorian Infectious Diseases Laboratory (VIDRL) when used in rt-PCR testing.

limitations with current swabs

Addressing unmet needs for safe, effective & comfortable sample collection

Small load capacity and limited loading time

May result in low sample yields, which can present an issue in the setting of a low viral load or viral assays with a high limit of detection (LoD).

Pain/discomfort associated with nasopharyngeal (NP) swabs

May contribute to a fear of testing and reluctance to get tested.

Infection risk to healthcare worker (HCW)

Close proximity to patient and risk of sneezing, gagging or coughing during sample collection compromises HCW safety.

Need for skilled healthcare worker to conduct or supervise all sample collections

Increases the burden of testing on the healthcare workforce and personalized protective equipment (PPE) utilization.

THE RHINOSWAB ADVANTAGE

Comfortable & pain free

Rhinoswab is comfortable to use addressing the problems with current nasopharyngeal swabs that are highly invasive and uncomfortable.

Self administered

Rhinoswab is designed for self-collection in the home, at workplaces, clinical settings and anywhere that we need to test frequently and in large numbers.

Dual nostril application for high yield

The new Rhinoswab, with it’s dual swab heads is designed to collect a larger sample from both nostrils simultaneously, offering the potential for a more effective diagnostic sample.

Safer for healthcare workers

Easy self-collection with Rhinoswab reduces the risk to healthcare workers and the cost of personal protection equipment (PPE) required to protect them.

Improved standardization of collection

Less variability in collection technique may help reduce sampling & testing errors.

Works with existing pathology systems and workflows

The swab has been designed to fit into existing vials and work with existing pathology workflows including rt-PCR testing.

A new era in swab technology

Standard nasal swab

Variable placement within nose including anterior nares, mid-turbinate (deep nasal) and nasopharynx; latter can cause pain, discomfort and sneezing

Non-anatomical shape and small surface area of ‘bud’ tip limits contact area with nasal mucosa and sample yield

Composition varies by manufacturer and specimen site, e.g. full-sized or mini-tip made from flocked nylon, round foam or spun fiber (rayon, polyester)

Two insertions required to sample both nostrils

Long, flexible shaft can lead to ‘overshooting’ and ‘brain stab’ discomfort

Break-point enables tip to break off and fit into standard pathology vial

Pencil grip and head tilt required to handle and position tapered shaft

VS

Rhinoswab

Sits comfortably within low-mid nasal turbinates for pain-free sampling

Anatomically designed ‘loop’ tip with large surface area mimics shape of nose to maximize contact area with the nasal mucosa, optimizing sample yield

Nylon-flocked loops for reliable sample uptake and release (latter further supported by hydrophobic treatment of loops)

Two-pronged swab means both nostrils can be sampled simultaneously

Short arms ensure swab goes no further than the low-mid turbinates when fully inserted, irrespective of nose size

Break-point enables loops to break off and fit into standard pathology vial

Handle with ‘thumb print’ allows for
easy, error-free positioning within nose
by patient or healthcare worker at any angle, which standardizes the sampling process

Expert opinion

LEADING BODIES AGREE ANTERIOR OR MID-TURBINATE (DEEP NASAL) SWAB IN ISOLATION IS AN ACCEPTABLE SPECIMEN COLLECTION METHOD FOR DETECTION OF SARS-CoV-2

According to several recent peer-reviewed studies that have compared nasal swabs to NP or OP swabs, self-collected nasal swabs (supervised or at-home) represent a reliable alternative to NP/OP swabs collected by healthcare workers for the detection of SARS-CoV-2.2–5

Based on this evidence, both the US CDC and the FDA have approved self-collected nasal sampling (supervised or at-home) as an acceptable specimen collection method for SARS-CoV-2 testing.6,7

The Office of the Assistant Secretary for Health from the US Public Health Service reports:8

  • Nasal sampling is less invasive and results in less patient discomfort than sampling from other upper respiratory sites
  • A self-administered nasal swab is similar to a NP swab in detecting coronavirus
  • Collection of nasal swab specimens is less technically complex, so can reduce the risk of the spread of infection to healthcare providers, by reducing the duration of the procedure, and allowing the patient to perform self-collection while under supervision
  • Nasal sampling also reduces PPE utilization, given that the patient can perform self-collection under supervision (versus the health care provider performing the collection).

Usability

Usability study results

Self collection with rhinoswab is easy and provides consistently reliable samples for testing

In the Rhinoswab usability study, the majority of participants found the device easy to use as part of a self-collection kit for viral testing.1

Rhinoswab’s novel design standardizes its insertion and placement within the nose, facilitating quality sample collection, no matter the user group1.

In a study of swab collection for influenza testing, the majority of participants preferred self-collected swabs over those collected by healthcare workers, with no statistical difference in detecting the virus15.

Rhinoswab is suitable for use across a range of clinical and non-clinical settings

Collection by a healthcare worker or supervised self-collection in a clinical setting

  • COVID-19 testing clinics
  • Hospitals
  • GP clinics
  • Pathology centres

Self collection in a non-clinical setting (where local guidelines permit)

  • At work, especially in high risk occupations requiring high frequency testing
    • Factories
    • Abbatoirs
    • Airlines
  • At place of study
    • Universities/colleges
    • Schools
  • At home

Safety & Tolerability

Superior comfort delivers high patient acceptability

In a usability survey conducted by Rhinomed1:

  • 97.9% of participants reported NO discomfort or pain when using Rhinoswab
  • 77.1% of participants described Rhinoswab as comfortable or very comfortable to use

Rhinoswab’s comfort factor may help reduce testing fears, overcoming reluctance to get tested

Anecdotal reports indicate that some individuals avoid or delay testing due to the pain/discomfort that may be experienced with traditional swabs.10

The superior comfort of Rhinoswab has the potential to improve patients’ willingness to undergo testing, thereby enhancing viral testing rates.

Rhinoswab is a safe alternative to standard of care swabs1

  • There have been no adverse outcomes associated with Rhinoswab to date, other than occasional light nasal spotting when the swab is removed1
  • There are no specific contraindications for collecting samples with Rhinoswab. However, similar to all other swabs11, clinicians should be cautious if the patient has had recent nasal trauma or surgery, has a markedly deviated nasal septum, has a history of chronically blocked nasal passages or severe coagulopathy, or is taking anticoagulant therapy
  • Rhinoswab’s positioning in the low-mid nasal turbinates reduces the likelihood of sneezing during sample collection and avoids the risk of coughing/gagging that comes with NP/OP swabs. This mitigates the risk of aerosol generation at time of sampling, decreasing the infection risk to any healthcare workers in attendance3,12,13

Efficacy

Rhinoswab’s viral load transfer comparable to standard of care1

  • A SARS-CoV-2 spiked study, conducted at the Victorian Infectious Diseases Reference Laboratory (VIDRL) at the Peter Doherty Institute for Infection and Immunity, evaluated the efficacy of Rhinoswab in transferring a viral load for testing compared to a commercially available standard flocked swab (Copan ESwab™)1
  • The study found that there was no difference between the two swabs in the mean cycle threshold (Ct) value for detecting SARS-CoV-2 at both low- and high-burden viral loads1
RhinoswabESwab™
Ct 30 mean ct value low burden viral load29.529.4
Ct 26 mean ct value high burden viral load26.426
  • The study also concluded that the eluted volume from Rhinoswab was comparable to the Copan ESwab™ at both viral load levels1

SARS-CoV-2 detected with 100% accuracy when rt-PCR test applied to infected Rhinoswab samples1

  • In this study, the spiked swabs were tested using reverse transcription-polymerase chain reaction (rt-PCR)1
  • Both Rhinoswab and the Copan ESwab™ reported 100% accurate diagnosis of SARS-CoV-21

Lab considerations

Rhinoswab fits with existing pathology workflows and standard rt-PCR collection vials

  • Rhinoswab does not require any change to your pathology workflows and can be immediately integrated with your existing transport media and collection tubes
  • Rhinoswab can be included in your self-collection kits, with easy-to-follow written and video instructions
  • Rhinoswab samples are also suitable for many rapid antigen tests that can accommodate Rhinoswab’s unique design

Reliable supplier, comparable pricing1

  • Medical grade quality (including gamma-ray sterilization); polycarbonate handle with flocked nylon tips
  • Comparable price to standard of care swabs
  • FDA registered (Class I)
  • Suitable for individuals 16 years or older; pediatric size available in near future
  • Available in boxes of 50 units with outer cartons containing 24 boxes (total of 1200 RHINOSWABs)
  • Further resources such as technical specifications and datasheets to support the procurement process within your hospital, health service or organization are available upon request or can be downloaded here.

FAQs

Is Rhinoswab a COVID test?

No. Rhinoswab is not a test.
There are three stages to conducting a covid test; 1) Collect a sample 2) analyse the sample 3) report the results. Rhinoswab provides a comfortable alternative to standard nasopharyngeal swabs for collecting the sample. Once Rhinoswab collects a sample from the nose, the swab is placed in a standard vial containing saline transport media and sent to a lab for testing. The test is conducted within the pathology laboratory using rt-PCR testing equipment.

Can Rhinoswab be used with rt-PCR testing?

Yes. Rhinoswab can be used with rt-PCR testing.
Rhinoswab is designed to be used with standard vials and transport media, fit seamlessly into pathology laboratory workflows and used on existing rt- PCR testing equipment.  

Is nasal swabbing a valid sample collection method?

Yes, nasal swabbing is a valid sample collection method.
Swabbing only the nose is a valid sample collection approach. Scientific literature and guidance provided by the FDA, CDC (Center for Disease Control) and WHO support the efficacy and reliability of nasal swabs that access just the front of the nose rather than the depth of the nasal cavity. 

Does Rhinoswab need to be administered by health care workers?

No Rhinoswab is self administered.
Rhinoswab is designed to be self administered to minimise risk to health care workers. Health care workers may supervise the sample collection process if necessary for those who are under 16 years of age or those who have cognitive or other challenges, but they will not be required to handle the swabs. 

Why is nasal swabbing safer for Health Care Workers?

The Office of the Assistant Secretary of Health SARS – Co-V2 (COVID-19) Fact Sheet states: “Collection of nasal swab specimens is less technically complex, so can reduce the risk of the spread of infection to healthcare providers, by (1) reducing the duration of the procedure, and (2) allowing the patient to perform self-collection while under supervision.”

What are the benefits of self collection of nasal samples?

Self collection of nasal swab samples are safer for Health Care Workers who can supervise patients performing self collection from a distance rather than the HCW performing the collection.
The Office of the Assistant Secretary of Health SARS – Co-V2 (COVID-19) Fact Sheet recognizes that self collection of nasal samples “… also lessens PPE utilization, given that the patient can perform self-collection under supervision (versus the health care provider performing the collection).”

Is Rhinoswab registered with health regulators?

Yes. Rhinoswab is registered as a 510K exempt medical device in the US and as a Class 1 medical device with the TGA in Australia. We are currently awaiting CE Mark registration for Europe.

Who can use Rhinoswab?

Rhinoswab is registered for use by anyone over the age of 16 years.

Is Rhinoswab comfortable?

Yes. A usability study showed that 77.1% of participants found the swab to be very comfortable or comfortable and a further 20.8% found it to be neither comfortable nor uncomfortable.

Is Rhinoswab painful?

No. A usability study showed that 97.9% of participants (47 out of 48 participants who took part in the trial) reported that they experienced no pain at all when using the swab.

How does Rhinoswab compare to other swabs in terms of efficacy?

In a spiking study undertaken by the Victorian Infectious Diseases Reference Laboratory, Rhinoswab was shown to be 100% a for the diagnosis of SARS-CoV-2 and equal to the current standard of care at both low and high viral loads.

Is Rhinoswab compatible with all rt-PCR test equipment?

Rhinoswab has been tested by the Victorian Infectious Diseases Reference Laboratory, part of the Peter Doherty Institute for Infection and Immunity (the Doherty) one of Australia’s preeminent covid-19 research and testing facilities.
Trials of Rhinoswab will continue to take place with diagnostic companies and laboratories and we welcome the opportunity to trial Rhinoswab on any rt-PCR testing equipment. Please contact Peter Jordan, SVP Business Development, at [email protected] to arrange a trial.

Will Rhinoswab work with our diagnostic equipment?

If you would like to trial Rhinoswab to determine how well it performs on your equipment or in your laboratory, please contact Peter Jordan, SVP Business Development, at [email protected] to arrange a trial.

REquest a sample

RHINOSWAB by RHINOMED is FDA and TGA registered and available for trial or purchase. 

If you would like to trial Rhinoswab, please complete this form to request samples.

Or contact us to discuss how Rhinoswab may help deliver a better sampling solution for your needs.

References

  1. Rhinomed Pty Ltd. Data on file 2020/21. 
  2. Tu YP et al. Swabs collected by patients or health care workers for SARS-CoV-2 testing [Letter to the Editor]. N Engl J Med; 3 June 2020. 
  3. McCulloch D. Comparison of unsupervised home self-collected midnasal swabs with clinician-collected nasopharyngeal swabs for detection of SARS-CoV-2 infection. JAMA Network Open 2020;3(7):e2016382. doi:10.1001/jamanetworkopen.2020.16382. 
  4. Wehrhahn M et al. Self collection: an appropriate alternative during the SARS-CoV-2 pandemic. J Clin Virol 2020;128:104417. doi: https://doi. org/10.1016/j.jcv.2020.104417. 
  5. Altamirano J et al. Assessment of sensitivity and specificity of patient-collected lower nasal specimens for severe acute respiratory syndrome coronavirus 2 testing. JAMA NetwOpen 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005. 
  6. Centers for Disease Control and Prevention (CDC), US Department of Health & Human Services. Interim guidelines for collecting, handling and testing clinical specimens for COVID-19 (last updated 6 Jan 2021). Available at: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html#specimen (last accessed February 2021). 
  7. US Food and Drug Administration (FDA). Coronavirus (COVID-19) update: daily roundup (published March 23, 2020). Available at: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup (last accessed February 2021). 
  8. Office of the Assistant Secretary for Health, US Public Health Service. Nasal (Anterior nasal) specimen collection for SARS-CoV-2 diagnostic testing. Fact sheet. 11 Nov 2020. Available at: https://www.cdc.gov/coronavirus/2019-ncov/downloads/lab/OASH-nasal-specimen-collection-fact- sheet_updates_2020_11_11_508.pdf (last accessed February 2021). 
  9. Chicago Sun Times, 10 April 2020. COVID-19 tests: What it feels like to have one. Available at https://chicago.suntimes.com/coronavirus/2020/4/10/21216845/coronavirus-covid19-abbott-rapid-swab-test-nose-nasal-how-it- feels-jayant-pinto-molly-erickson (last accessed February 2021). 
  10. ABC News, 27 August 2020. Coronavirus testing in Melbourne went down — here’s why some Aussies are avoiding the swab. Available at https://www.abc.net.au/news/2020-08-27/coronavirus-covid-19-test-victoria-queensland- nsw-why-not/12601334?nw=0 (last accessed February 2021). 
  11. Marty FM, Chen K and Verrill KA. How to obtain a nasopharyngeal swab specimen. N Engl J Med 2020;382:e76. doi: 10.1056/NEJMvcm2010260. 
  12. Palmas G et al. Nasal swab as preferred clinical specimen for COVID-19 testing in children. Pediatr Infect Dis J 2020;39(9):e267−270. doi: 10.1097/INF.0000000000002812. 
  13. Harding H et al. Aerosol-generating procedures and infective risk to healthcare workers from SARS-CoV-2: the limits of the evidence. J Hosp Infect 2020;105(4):717–725. doi:10.1016/j.jhin.2020.05.037 
  14. Arnaout R et al. SARS-CoV2 testing: the limit of detection matters. bioRxiv (preprint); 4 June 2020. doi: 10.1101/2020.06.02.131144.
  15. Dhiman N et al. Effectiveness of patient-collected swabs for influenza testing. Mayo Clin Proc 2012;87(6):548–554. doi:10.1016/j.mayocp.2012.02.011.