At a glance: CanCanea COVID-19 Antigen Suck- & Saliva test
- The test uses nano-colloidal gold technology and the principle of highly specific antibody-antigen reaction and immunochromatographic analysis technique.
- Contains the following items to perform the assay:
- Canea COVID-19 Antigen Saliva test Cassette
- Instruction for use
- Saliva collector
- Extraction tube
- Drip cap
- Sample processing solution
- Tube rack (only for the 10-pack)
- Test evaluation after 15 minutes
- High sensitivity and specificity:
Sensitivity: 97.6% (161/165); 95% KI* 93.9% -99.3%
Specificity: 99.1% (542/547); 95% KI* 97.9% -99.7%
Accuracy: 98.7% (703/712); 95% KI* 97.6% -99.4%
* Confidence interval
- Under normal temperature, samples should be processed within 1 hour after collection.
- If the sample cannot be tested in time after treatment, the processed sample should be refrigerated at 2-8°C and the test should be completed within 12 hours after treatment.
- Freezing and thawing of samples is strictly prohibited.
- Shelf life is until the indicated expiration date.
- Available in pack sizes of 1, 10.
- STORAGE AND STABILITY: Storage: between 2°C - 30°C.
- LIMITATIONS: This test is an in vitro clinical diagnostic test. Positive test results must be confirmed by other methods.
1. The preparation is shown in Figures 1-4.
2. Oral collection method is shown in Figure 5..
3. Specimen processing:
Press the wall of the extraction tube against the sponge of the saliva collector with your hand so that the saliva in the sponge of the saliva collector can flow into the extraction tube. Hold the extraction tube vertically and gently move it back and forth for approx. 5 seconds. The saliva must mix well with the sample preparation solution. Then place the extraction tube in the sample stand for 1. minute. Drop 2-3 drops (approx. 75-100 μl) of the test sample into the sample well of the Canea COVID-19 Antigen Saliva Test Cassette by squeezing the extraction tube.
The result can be read within 10-15 minutes.
Place the extraction tube upright with the opening facing upwards in the sample stand or the punch.
Twist off the cap of the sample preparation solution bottle.
Pour all the sample preparation solution liquid from the bottle into the extraction tube.
Remove the saliva collector from the bag by pushing the stem through the weld. Please do not touch the sponge with your fingers.
The saliva collector is used to take samples and may only be touched at the stem.
Insert only the sponge of the saliva collector into the mouth so that it is well wet by the saliva. Do not insert the saliva collector further if you feel resistance.
Actively move the saliva collector around the inside of the mouth and on the tongue for about 1-2 minutes to collect oral fluid until the sponge is soft and fully saturated. The sponge should be free of hard spots when it is fully saturated.
Remove the saliva collector from your mouth.
Put the saliva collector into the extraction tube.
Press the wall of the extraction tube against the sponge of the saliva collector with your fingers so that the saliva in the sponge of the saliva collector flows into the extraction tube. Try to squeeze out as much sample fluid as possible into the tube.
The two lines on the extraction tube indicate the minimum and maximum filling level of the total liquid. You must add as much saliva fluid to the upright extraction tube until the total fluid is between the marked lines. Do not add less or more saliva fluid.
Remove the saliva collector from the extraction tube and dispose of it properly.
Then close the extraction tube by pressing the drip cap onto the extraction tube with the narrow opening facing upwards.
Hold the extraction tube vertically and gently move it back and forth for about 5 seconds so that the saliva mixes well with the sample preparation solution.
Leave the extraction tube in the sample stand for 1. minute and then use it for the test.
Remove the test cassette from the sealed bag. Place it on a flat, clean and dry surface.
Turn the extraction tube upside down so that the drip cap is facing downwards and add 2-3 drops of the test sample by squeezing the extraction tube into the sample well of the test cassette.
Read the result within 10-15 minutes.
INTERPRETATION OF RESULTS:
Fig. 1: Positive
Fig. 2: Negative
Fig. 3: Invalid
Positive: Control line and Test line appear in the show window.
Negative: Only one line appears in Control area, no line appears in T area.
Invalid: If no line appears in the control area, the test results are invalid regardless of the presence or absence of line in the test area. The direction may not been followed correctly or the test may be deteriorated. It is recommended that repeat the test using a new device. If the problem persist, please stop to use the product and contact local distributor.
Standard scope of delivery:
PZN 17248856: 1 Canea COVID-19 Antigen Saliva Test Cassette, leaflets in English and German language, 1 saliva collector, 1 extraction tube, 1 drip cap, 1 sample processing solution
PZN 17248862: 10 Canea COVID-19 Antigen Saliva Test cassettes, leaflets in English and German language, 10 saliva collectors, 10 extraction tubes, 10 drip caps, 10 sample processing solutions, 1 tube rack
This item is excluded from return.
Canea Pharma GmbH, Tarpenring 12, 22419 Hamburg
Status of information 01 March 2021