CANEA COVID-19 SARS-COV-2 Antigen Lolly- & Saliva Test – BfArM AT323/21 – BfArM Listing (reimbursable) – PZN: 17248862 – PEI evaluated (10 tests per box)

CANEA COVID-19 SARS-COV-2 Antigen Lolly & Saliva Test

For some time, schools and kindergartens have been looking for appropriate ways to ensure the safety of children and educational staff. Regular testing for SARS-COV-2 may be one way to supplement the hygiene concept and break chains of infection. It is especially important that the corona test be easy for children to use and painless to perform. A saliva test offers both of these advantages. It is performed directly in the oral cavity. The ease of sucking makes it easier for younger children, in particular, to accept the test.

Saliva testing is not only excellent for use in schools and kindergartens. It can also be used in other areas with particularly sensitive people. Conceivable examples include nursing homes and facilities for the disabled. In addition, the CANEA COVID-19 SARS-COV-2 Antigen Lolly & Saliva Test facilitates infection control in high-traffic areas such as government offices, retail, food service or the hotel industry.

What to consider when using

Before performing the saliva test, the instructions for use must be read carefully. An error in sample collection or testing may lead to false or invalid results. At least 10 minutes before testing, subjects should not put anything in their mouths. This means not drinking, eating, or smoking during this period. Residues in the mouth could falsify the test result.

Disposable gloves must be worn to collect the sample and perform the test. This prevents contamination of the sample. The testing environment should be clean and provide sufficient space for all components of the saliva test kit. The sample must be analyzed within one hour of collection. Alternatively, it can be stored at 2 °C – 8 °C and used within 12 hours.

Performing the saliva test

In the first step, the test cassette is removed from its packaging and made ready. The extraction tube is prepared according to the instructions for use and the sample collector is removed. A firm sponge is attached to the sample collector. This must not be touched under any circumstances. To take the sample, the sponge is inserted into the mouth. Now it must be moved back and forth in the oral cavity for 1 – 2 minutes until it is completely saturated.

The sponge is then squeezed out in the extraction tube. The saliva mixes with the extraction liquid by gently rotating it. The tube with the dropper attachment then rests for one minute in the stand provided. Finally, test takers place 2 – 3 drops of the saliva sample on the test cassette and read the result after 10 – 15 minutes. The CANEA COVID-19 SARS-COV-2 Antigen Lolly & Saliva Test has a sensitivity of 97.6%, specificity of 99.1%, and accuracy of 98.7% when used correctly.

Scope of supply per box:

• 10 test cassettes for sample analysis
• 10 saliva extraction swabs
• 10 extraction tubes
• 10 dropper attachments
• 10 units of extraction buffer
• 1 tube stand
• 1 instruction leaflet in German and English

This saliva test has been evaluated by the Paul Ehrlich Institute and must be stored between 2 °C and 30 °C. In case of a positive test result, an additional PCR test must be performed.

Product details:

• Sensitivity: 97.6% (161/165); 95% CI* 93.9% -99.3%
• Specificity: 99.1% (542/547); 95% CI* 97.9% -99.7%
• Accuracy: 98.7% (703/712); 95% CI* 97.6% -99.4%
• Bfarm: AT323/21
• PZN: 17248862
• Evaluated by the Paul Ehrlich Institute
• Test evaluation after 10-15 minutes
• Process samples at normal temperature within 1. hour after collection
• If the sample cannot be tested in time after treatment, refrigerate at 2-8° and perform the test within 12 hours after sample collection
• Freezing and thawing of specimens is not permitted
• May be kept until the expiration date indicated
• Available in packs of 10
• STORAGE AND STABILITY: Storage: between 2°C – 30°C
• LIMITATIONS: This test is an in vitro clinical diagnostic. Positive test results must be confirmed by other methods

* Confidence interval

You have questions? Contact us and we will be happy to help you with your request.

Please note:

This offer for a Corona rapid test is intended exclusively for commercial customers (physicians, healthcare professionals, companies) with appropriate qualified personnel. This product is not a layman’s test that may be ordered by private individuals – the purchase of this Corona rapid test is strictly defined according to the Medical Devices Dispensing Ordinance §3.

!!! You confirm with your purchase that you are placing the order for commercial/medical purposes and you are handing over the products to appropriate qualified personnel. Therefore, each order will be carefully checked! Please understand that we unfortunately have to cancel your order if you can not provide proof that you are an authorized person according to MPAV !!!

Note for companies

As a result of an amendment to the Medical Devices Dispensing Ordinance (MPAV), as of February 2, 2021, companies and institutions that provide a service to the general public, the failure or impairment of which would lead to significant supply shortages or endanger public safety, may also obtain and use rapid antigen tests for the detection of the coronavirus SARS-CoV-2.

This means that you are an authorized person under the MPAV.

In concrete terms, this means that these companies and facilities can offer regular testing for their employees and visitors and make these tests part of their hygiene and protection concept, ideally with advice from the respective company medical service or the employers’ liability insurance association.

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