FAQ
Questions & Answers
A General
- Is ANOSMIC tester authorized by Health Canada for COVID-19 screening?
Yes, ANOSMIC COVID-19 Smell Tester received Health Canada authorization for sale on October 19, 2020, Authorization Reference No: 319520
- Is ANOSMIC COVID-19 Smell Tester any better for checking the loss of smell than smelling coffee or perfume?
The ANOSMIC tester is better than smelling other untested smells for the following reasons:
a) The odorant formulation is designed after research and experimentation to include a combination of ingredients in proper proportions so that the odor stimulates a range of olfactory nerves involved in the sense of smell.
b) This smell has been tested and verified in clinical studies to achieve high accuracy in detecting the loss of smell with COVID-19 patients.
c) Our manufacturing process results in a product that results in a consistent smell.
d) Smells from other products you may use may not have been tested in clinical studies and may be less effective than the 90% accuracy that ANOSMIC® has demonstrated in clinical studies.
e) It is made with all-natural ingredients that are allergen free.
f) It is manufactured in aseptic facility that ensures there are no bacteria or viruses present.
- Is it safe to use ANOSMIC COVID-19 Smell Tester?
To the best of our knowledge, it is safe to use ANOSMIC as it is non-invasive, odorant is made with all-natural ingredients without any chemicals or CBD, it uses non allergen products, and it is manufactured in a sterile facility that is approved by Health Canada and FDA. Health Canada has classified it as a Class I device, which is the least risk.
- How accurate is ANOSMIC in detecting COVID-19 patients?
In clinical studies ANOSMIC is shown to be more than 90% accurate in screening COVID-19 positive and negative subjects.
- Have any Clinical Studies been done on ANOSMIC to determine its efficacy?
So far three clinical studies have been completed in India. The first study was done with 156 persons and sensitivity was 91% in correctly detecting COVID-19 positive patients and specificity was 96% of correctly detecting COVID-19 no false positives. The second study was done with 55 persons and sensitivity was 91% and specificity was 100%. The third study was done with 420 subjects and we were able to detect COVID positive subjects with 92% precision. The comparative gold standard test was an RT-PCR and digital X-ray.
- Is ANOSMIC able to detect asymptomatic COVID-19 patients:
Yes, ANOSMIC test was able to detect 11% COVID-19 patients that were asymptomatic in our third clinical study of asymptomatic subjects. This was confirmed by RT-PCR and digital X-ray tests.
- What percent of COVID-19 infected persons have loss of smell?
Scientific research has shown that loss of smell is a key and reliable indicator for COVID-19. Research studies indicate range for loss of smell from 50% - 98%, many indicating average of 80% - 86% depending how they were conducted. Our clinical studies have shown that 90% COVID infected subjects lose all or some sense of smell.
- Is there a need for ANOSMIC screening even after people get inoculated with the COVID-19 vaccine?
We recommend it. Some scientists suggest that people who have had COVID-19 vaccine may still be able to carry an infection to others.
- Are there any other similar products in the market today?
To the best of our knowledge ANOSMIC® COVID-19 Smell Tester is the only such Class 1 Medical Device authorized for sale by Health Canada.
- Do I get a medical certificate for COVID-19 by using ANOSMIC screening?
No. This is a screening check for smell dysfunction symptom.
B. Product
- What are the ingredients of the ANOSMIC COVID-19 Smell Tester®?
The ingredients of the odorant consist of multiple all-natural products that are proprietary to the company and have a patent pending.
12. Can any of the ingredients cause an allergic reaction?
Clinical studies with over 500 participants showed no allergic reactions with any subjects.
13. How long does the ANOSMIC fluid last in the container?
The 15 ml spray bottle lasts for approximately 75 tests and 100 ml spray bottle lasts for approximately 500 tests. The stated life of the ANOSMIC fluid once opened is 90 days and unopened is 1 year.
14. Is a specific temperature required for the ANOSMIC tester?
No. The ANOSMIC tester may be kept under room temperature or carried in-person.
15. Is the ANOSMIC container recyclable?
Yes
16. Where is ANOSMIC COVID-19 Smell Tester® produced?
The device is produced in a factory located in South West Ontario, Canada that is Good Manufacturing Practices (GMP) compliant and approved by Health Canada and FDA,
C. Directions
17. What distance do I measure from my nostrils for the smell test?
About 4.5 cm or 2 inches
18. What precautions should I take in using the ANOSMIC tester?
One should keep the device away from young children and keep the spray away from the eyes when using it.
19. How do I do the ANOSMIC Test?
One should shake the spray bottle, then spray a small amount on the wrist, or tissue paper, or cotton swab. Inhale the odor and record the intensity of smell. Dispose the used tissue paper or cotton swab.
20. How do I know if I have a COVID-19 Infection with the ANOSMIC test?
There are two ways of screening a person for COVID-19, first is: regular daily test, and second is: one-time test. In each case the subject should record the intensity of smell from 0 - 10, where 0 is no smell and 10 is maximum smell. Following are the suggestions of how one can determine whether a person is COVID-19 positive or negative:
i) Regular Daily Test: If a person has no sense of smell (0 or 1) or significant degradation in intensity of smell (2-7) or it goes down by 5 points from one day to the next, and there is no nasal congestion or neurological disorder, then the subject is probably COVID-19 positive, otherwise COVID-19 negative. Subjects testing positive must go to a medical test facility for a confirmatory test and self-isolate.
ii) One-Time Test: In addition to recording the intensity of smell, confirmation is done by noticing the physical reaction of the subject to the odor and identification of ingredients of the odorant.
a) If the intensity of smell score is 8-10 and one either physically reacts to the smell or he/she is able to identify any ingredient in the odorant, then subject is most likely COVID-19 negative.
b) If the intensity of smell score is 5-7 and there is no physical reaction and one is not able to identify the ingredients of odorant, there is possibility one has early symptoms of COVID-19, and one should obtain professional medical guidance and test by RT-PCR method.
c) If the intensity of smell score is 0-4 and there is no physical reaction and one is not able to identify the ingredients of odorant, there is good possibility the subject is COVID-19 positive.
d) Subjects testing positive must go to a medical facility for a confirmatory test and self-isolate.
21. What if my smell is okay after testing?
If the smell is okay after testing then one is most likely COVID-19 negative, but one should continue monitoring oneself regularly and follow the local government healthcare precautionary guidelines.
22. What do I do if I have partial smell or complete loss of smell?
If one has partial or full loss of smell then one is most likely COVID-19 positive, and should obtain confirmatory tests at COVID Test Center, such as RT-PCR; consult a medical professional; and isolate themselves as per the local government guidelines.
23. What should I do if I have COVID-19 symptoms such as fever, cough, or diarrhea but the ANOSMIC test is negative?
One should obtain confirmatory tests using RT-PCR method and consult a medical professional.
D. Care & Use
24. Who can use this product and in which applications?
Anyone over 12 years can use this product anywhere. There are multiple applications for screening for coronavirus such as at home, office, factory, school, college, dental and medical office, nursing home, hospital, restaurant, shopping mall, airport, buses, subways, trains, social gathering, wedding, religious congregation etc.
25. At what age can children use ANOSMIC?
It is advised that children over 12 years old can use ANOSMIC independently, however children under 12 years old should use this device with adult supervision as interpretation of test results is subjective. It is advised that children under 3 years should not use ANOSMIC test. Children should wash their wrists or any other part of their arm where the product may have been sprayed.
26. Who should not use ANOSMIC?
The ANOSMIC screening should not be used by the following:
a) Children under 3 years old.
b) Persons who have lost sense of smell for any reason such as autoimmune disorders, undergoing chemotherapeutic treatment, nasal congestion, neurodegenerative diseases etc.
c) If you are using other nasal products, or experience rashes, burning, discomfort, nausea, dizziness, headache and/or hypersensitivity.
d) If you have epilepsy, asthma, chronic cough, or chronic lung conditions.
27. What time of the day should the screening test be performed?
The screening test can be performed at any time of the day.
28. Do I need to clear and clean my nose before testing?
One should clear the nose as far as possible if it has mucus, otherwise it is not required.
29. If I have any pre-existing conditions should I use it?
This device should not be used if someone has lost sense of smell for any reason such as autoimmune disorders, undergoing chemotherapeutic treatment, nasal congestion, neurodegenerative diseases etc.
30. Do I need to test myself every day?
It is a good idea to monitor oneself and record the intensity of smell every day, but it is not necessary.
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31. How long does the smell stay after spraying, and would it create a foul odor in the environment?
The smell does not last for more than one to two minutes. Afterwards there is a soft and subtle fragrance for a few more minutes. The odor is localized if sprayed in proximity of the hand or paper napkin and does not create foul odor in the environment. If sprayed on the hand, wash off thoroughly with soap and water after use.
