What do COVID-19 rapid antigen tests do?
Rapid antigen tests can screen COVID-19 virus effectively and have become an effective screening tool for businesses, large factories, schools, and homes due to their easy-to-use feature. Most rapid antigen tests can provide you with the result within 15 minutes with more than 90% accuracy. If you interpret the result as positive within the suggested reading frame, please schedule a PCR molecular test with a local clinic and remain quarantined according to Health Canada policies. Antigen tests are only supposed to be interpreted within the recommended time frame, any reading past 30 minutes will be invalid.
There are many brands of rapid antigen tests that have been approved, different brands could differ in their sensitivity and specificity. Different rapid antigen tests can also differ in detection time, packaging, number of tests, etc. This article will review the most popular and current rapid antigen COVID-19 products available in the Canadian market. All the specifications will be later summarized into a table with each product’s specificity, sensitivity, quantity that comes in each kit. The sample collection method differs by collecting from Anterior Nasal (AN) also known as a shallow nasal swab, and Nasopharyngeal (NP) wherein the swabs go deeper behind the nose above the pharynx. Although NP could be less comfortable to most people, the NP swabs will have higher sensitivity and higher accuracy compared to nasal swabs.
Antigen Tests in the market
1. CovClear COVID-19 Rapid Antigen Test
This rapid antigen kit is developed and manufactured in the USA and is now under interim order (IO#330172) for home-test use. CovClear highlights an easier testing procedure since no reader or cassette is required. It also has high specificity (~100%) as well as sensitivity (~96%) and comes with each test being individually packed, which allows the Business owners to distribute these tests to each of their employees without handing out a whole box. It is a lower nasal test, which is less invasive for the users compared to a nasal-pharyngeal test. The kit has three sizes available: 2 packs, 25 packs, and 50 packs. We are taking preorders at this moment and expect to have them in stock soon.
2. The Rapid Response™ COVID-19 Antigen Rapid Test Device
The BTNX antigen tests are under interim order (IO#321669)and manufactured locally in Canada. The box comes in two different types of packages, a 5 pack and a 25 pack test kit.
The BTNX 25 can collect both Anterior Nasal samples and Nasopharyngeal samples. The Relative Sensitivity is 95.60 % for NP swab; 90.20% for a nasal swab. The Relative Specificity is 100 % for NP swab; 100% for a nasal swab. It is a point-of-care kit intended for health professionals and business use. It comes with 2 bottles of buffers and individually packaged 25 test cassettes, 25 swabs, 25 tubes and nozzles, 1 product insert, 1 tube stand. The package content for buffers may be different depending on lot number, newer updated 25-pack tests come with individually packaged buffers and 2 bottles of buffers in case customers run out of buffer solutions.
The 5-pack Rapid response antigen test is a smaller package compared to the 25 pack, individuals who are in need of a home test can purchase the 5-pack that is less expensive. It includes 5 test cassettes, 5 swabs, 5 tubes and nozzles, 1 product insert, 1 tube stand. All are individually packaged and suitable for individuals who only want to do testing for a small household. Currently, the 5-pack self-test is approved in 4 provinces including Alberta, British Columbia, Ontario, and Saskatchewan. Aurora is only able to ship the 5 pack to these provinces for self-use purposes. Please follow the Health Canada website as the policy may include other provinces in Canada in the future.
3. AssureTech FaStep Antigen test kits
The FaStep Antigen kits are manufactured in Hangzhou, China, it has been CE certified and under interim order (IO#321478). The sample collection method can be either Nasal or Nasopharyngeal swabs. Nasopharyngeal swabs have higher sensitivity compares to Nasal tests, the Relative Sensitivity is 94.3 % (84.6% ~ 98.1%); Relative Specificity: 99.1% (95.1% ~ 99.4%); Overall Agreement: 97.4 % (94.4% ~ 98.48%). The entire package comes in 20 Test cassettes, 20 Individually packed swabs, 20 individual Extraction buffers, 1 Tube stand, 1 Product insert. It can be an ideal package for businesses to screen individual workers constantly. FaStep reads result in 15 minutes, it is overall an efficient and easy-to-use product.
4. Standard Q SD Biosensor
Standard Q is a product manufactured in South Korea that has been recently updated. It was a nasopharyngeal product and was recently revised into a nasal product. Both NP and AN tests are under interim order (IO#328889/313054) that can be used for lab-based and point of care. The relative sensitivity for SD is 97.12%, specificity is 100%. It is a premium product with individual packaging for 25 Test devices, 25 Extraction buffer tubes, 25 Nozzle caps, 25 Sterile swabs, 1 STANDARD COVID-19 Ag Positive Control swab, 1 STANDARD Respiratory Negative Control Swab, 2 Buffer tube racks, 1 Instructions for use. The difference between this product compared to other antigen test is it come with both a positive and a negative control swab for reference. The product can interpret result within 10-30 minutes.
5. Artron COVID-19 Antigen Test
Artron antigen tests are manufactured and distributed in Canada. It is under interim order (IO#327866) for lab-based and point-of-care use. Artron antigen tests are effective for detecting both symptomatic and asymptomatic testing. It has a high sensitivity at 97.22% and specificity at 99.72%. Artron is recently approved for both nasal test and nasopharyngeal test that is more comfortable to perform for some individuals. It comes in 25 Test cassettes, 25 individually packed swabs, 25 extraction tubes, 25 extraction tube caps, 25 sealed sample buffers,1 tube rack, 1 package insert.
6. Abbott PanBio COVID-19 Ag Test Kit
The Abbott Panbio COVID-19 Antigen test is a shallow nasal test manufactured in Germany. It tests and screens for both asymptomatic and symptomatic patients who are suspected to have COVID-19 infection. Abbott has a relative sensitivity at 91.1% and a relative specificity at 99.8%. It comes in 25 tests per box, 25 Extraction tubes, 25 sterilized nasal swabs, 1 tube rack, 1 positive and 1 negative control swab, 1 quick reference, and 25 individual buffers. It is a brand being widely distributed and with one potential flaw, customers usually have a high chance of running out of buffer solutions if they don’t follow the instruction guideline carefully. There will be no additional buffer once you run out.
|Brand||Specificity (%)||Sensitivity (%)||Shelf Life (Months)||Application||Collection Method(s)||Asymptomatic||Synmptomatic||FDA/EUA Authorized|
|Assure Tech FaStep||98.3(NP)/100(AN)||94.3(NP)/92.3(AN)||18||POC||NP/AN||No||Yes||No|
|PBM Status COVID-19/Flu A&B||100||93.1||12||POC||NP||No||Yes||Yes|
|Quidel QuickVue (at home)||99.3||81.3||24||OTC||NP/AN||Yes||Yes||Yes|