CLINICAL PROGRAM UPDATE: TWO KEY STUDIES
CONFIRM RHINOSWAB SUPERIOR PERFORMANCE
TOPLINE
● Nasal Swab Yield study (n=394) confirms Rhinoswab captures statistically significant larger sample than standard of care nasal swab
● Elution Efficiency study confirms Rhinoswab delivers superior elution efficiency when compared to standard of care nasal swab.
May 13, 2021: Melbourne, Australia.
Rhinomed Limited (ASX:RNO; OTCQB:RHNMF) a leader in wearable nasal and respiratory technology is pleased to report an important update on its RhinoswabÔ clinical program.
In December 2020 the company established that the Rhinoswab was comparable to existing standardof care nasal swabs in detecting the SARS-CoV-2 virus in RT-PCR testing. This study wasundertaken at the VIDRL (Peter Doherty Institute).
Since December the company has further refined the swab technology by improving the nylon flock used on the swab. Two studies have now been completed to assess the performance of the Rhinoswab against the current commercially available standard of care nasal swab (Copan eSwabÔ).
Both studies have now confirmed that the Rhinoswab outperforms the standard of care nasal swab (Copan eSwabÔ) in two critical key performance factors: capture (yield) and elution efficiency.
Rhinomed’s new Rhinoswab has recently been approved for sale in the Australian market and is listed on the ARTG and in the US with the FDA. The Rhinoswab standardises the collection process and makes nasal sampling easy and comfortable for users. With production underway in Melbourne, Australia the company is seeking to scale up in order to meet demand. More information on the Rhinoswab is available at https://www.rhinomed.global/about-rhino-med/sample-collection/
NASAL SWAB YIELD STUDY
The objective of the Nasal Swab Yield Study was to compare the mean absorption/sample capture performance of the Rhinoswab against the commercially available standard of care nasal swab (Copan eSwabÔ) at various insertion time points.
Methodology
A randomised trial was conducted where 394 samples were collected from participants over a six week period. Participants were swabbed twice a day with a minimum of five hours between each sample collection. Participants were randomly assigned a nasal swab. Each swab was weighed prior to use and then weighed again post use using a calibrated Sartorius analytical scale.
● Participants were instructed to insert the standard of care nasal swab (Copan eSwabÔ) according to the manufacturer's Instructions for Use (15 seconds, each nostril).
● Participants were asked to insert the Rhinoswab according to the Rhinoswab Instructions for Use. Participants were randomly assigned one of three different time periods for insertion - 15 seconds, 60 seconds and 120 seconds.
Results
The results of the study are displayed below.
Swab | Insertion time period | Mean (g) | 95% CI range |
Standard of Care (Copan eSwabÔ) | 15 secs each nostril | 0.0278 | 0.0231 | 0.0324 |
Rhinoswab | 15 secs | 0.0408 | 0.0341 | 0.0475 |
Rhinoswab | 60 secs | 0.0437 | 0.0369 | 0.0506 |
Rhinoswab | 120 secs | 0.0496 | 0.0417 | 0.0575 |
Conclusion
All Rhinoswabs captured a mean sample larger than the standard of care (Copan eSwabÔ) across all insertion time periods - 15 seconds, 60 seconds and 120 seconds.
| Standard of Care (Copan eSwab) | Rhinoswab | Performance improvement |
15 seconds insertion each nostril | 0.0278g | | |
15 seconds insertion | | 0.0408g | 1.47 times greater than standard of care swab |
60 seconds insertion | | 0.0438g | 1.57 times greater than standard of care swab |
120 seconds insertion | | 0.0496g | 1.78 times greater than standard of care swab |
This study provides statistically powered evidence that the Rhinoswab, in addition to its comfort, ease of use and standardised sample collection procedure, captures a statistically larger sample from the nose than standard of care nasal swab (Copan eSwabÔ).
EVALUATION OF RHINOSWAB ELUTION EFFICIENCY
Independent laboratory, Gnomix (Adelaide, Australia) was engaged to compare the elution efficiency
of the RhinoswabÔ compared to the standard of care nasal swab (Copan eSwabÔ).
Methodology
An aliquot of gamma-irradiated (inactivated) SARS-CoV-2 virus (strain VIC/01/202) was received from the Victorian Infectious Diseases Reference Laboratory (VIDRL) with a nominal CT value of 18 (assay dependent). The SARS-CoV-2 virus was diluted 1/200 in a stock solution of donated saliva to represent a high virus burden sample and 1/2000 in to represent a low virus burden sample.
Two protocols were followed.
1. To reflect the standard of care, the high and low virus burden samples were applied as 4 x 5μl spots (20μl) onto 10 RhinoswabsÔ and 5 standard of care nasal swab (Copan eSwabÔ).
2. To evaluate the inherently greater potential capture area of the RhinoswabÔ in comparison to the standard of care nasal swab (Copan eSwabÔ) 4 x 8μl spots (32μl) were applied onto 10 RhinoswabsÔ.
In both instances each swab was then placed into a 5ml tube containing 1ml of Saline, vortexed vigorously for 30 seconds and left to elute for 1 hour at room temperature. Standard curve samples were prepared by spiking 32μl, 20μl, 15μl, 10μl and 5μl of the respective high and low virus burden samples into a 5ml tube containing 1ml of Saline, vortexed vigorously for 30 seconds and left to sit for1 hour at room temperature.
Assay
Following elution, 140μl of eluate was extracted using the QIAamp Viral RNA Mini Kit (QIAGEN) according to the manufacturer's instructions. The QuantiNova IC RNA was included in all samples as an extraction control. Reverse transcription and qPCR were performed using the QuantiNova Pathogen +IC Kit (QIAGEN) in combination with the SARS-CoV-2 N1+N2 assay kit (QIAGEN) according to the manufacturer's instructions. A 6μl volume of input viral RNA was used in the QuantiNova Pathogen Assay and thermal cycling was performed on a Rotorgene Q qPCR instrument using the conditions in the QuantiNova Pathogen +IC Kit handbook. The QuantiNova IC RNA, extraction negative control and PCR negative control were included on each run.
Results:
Standard load
1. 20μl at High Virus burden
Sample loading of 20μl of the high virus burden sample yielded an average of 16.34μl recovery (82%) for the RhinoswabÔ and an average of 14.5μl (73%) for the comparable standard of care nasal swab (Copan eSwabÔ). This suggests a superior elution efficiency for the RhinoswabÔ when comparing identical initial loadings of the high virus burden sample.
| High Virus Burden 20 μl (1ml Elution) Average Ct | Average μl recovered |
RhinoswabÔ | 25.45 (+/- 0.24) | 16.34 μl (82%) |
Standard of Care nasal swab (Copan eSwabÔ) | 25.75 (+- 0.43) | 14.50 μl (73%) |
20μl at Low Virus burden
Sample loading of 20μl of the low virus burden sample yielded an average of 21.8μl recovery (~100% taking into account experimental deviation) for the RhinoswabÔ and an average of 14.5μl (73%) for the comparable standard of care nasal swab (Copan eSwabÔ). This suggests superior elution efficiency for the RhinoswabÔ when comparing identical initial loadings of the low virus burden sample.
| Low Virus Burden 20 μl (1ml Elution) Average Ct | Average μl recovered |
RhinoswabÔ | 29.15 (±0.24) | 21.80 μl (~100%) |
Standard of Care nasal swab (Copan eSwabÔ) | 30.39 (±1.03) | 17.33μl (87%) |
2. Greater load potential
32μl at High Virus burden A sample loading of 32μl of the high virus burden on the RhinoswabÔ was also tested to evaluate the inherently greater potential capture area of the RhinoswabÔ in comparison to the standard of care nasal swab (Copan eSwabÔ). This yielded an average of 21.0μl recovery (66%) for the RhinoswabÔ. This indicates that it is possible to recover more virus from the extra loading capacity, although there appears to be slightly diminished overall efficiency.
| High Virus Burden 32 μl (1ml Elution) Average Ct | Average μl recovered |
RhinoswabÔ | 24.94 (±0.17) | 21 μl (66%) |
32μl at Low Virus burden
A sample loading of 32μl of the low virus burden on the RhinoswabÔ was also tested to evaluate the inherently greater potential capture area of the RhinoswabÔ in comparison to the Standard of Care nasal swab (Copan eSwabÔ). This yielded an average of 28.7μl recovery (90%) for the RhinoswabÔ. This indicates that it is possible to recover more virus from the extra loading capacity, although there appears to be slightly diminished overall efficiency.
| Low Virus Burden 32 μl (1ml Elution) Average Ct | Average μl recovered |
RhinoswabÔ | 28.5 (±0.49) | 28.7 μl (90%) |
Conclusion
Under the conditions tested and with the materials supplied, the RhinoswabÔ demonstrated not only a comparable but also a superior elution efficiency to the commercially available Standard of Care nasal swab (Copan eSwabÔ).
This report has been authorised for release to the market by the Board.
Company | Investor and Media Relations |
Michael Johnson, CEO & Director +61 (0) 3 8416 0900 mjohnson@rhinomed.global Follow us on Twitter @rhinomedceo | Rudi Michelson Monsoon Communications +61(0) 411 402 737 rudim@monsoon.com.au |
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Rhinomed Global (https://www.rhinomed.global) is an Australian-based medical technology company with a patented nasal technology platform whose first products are used by consumers in the global sleep, respiration, and nasal congestion markets. These products, sold at major US retailers, support the development, acceptance, and adoption of a pipeline of future wearable, sensor, diagnostic, and drug delivery opportunities. The company has recently secured FDA class 1 registration for its Rhinoswab, a dual nostril swab designed to collect nasal specimens for diagnostic testing for respiratory diseases, particularly COVID-19. Since its formation six years ago, Rhinomed has built the necessary foundation to accelerate its already increasing revenue
growth. The company trades on the ASX:RNO and the OTCQB:RHNMF