Canea COVID-19 Antigen Suck- & Saliva test

Important note:
In vitro diagnostic medical device – for healthcare professionals only.

Canea COVID-19 Antigen Saliva is used for qualitative detection of the antigen of COVID-19 in human saliva sample. The test has high sensitivity and specificity and provides the result in 10-15 minutes.

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Canea COVID-19 Antigen
Suck- & Saliva test

Important note:
In vitro diagnostic medical device – for healthcare professionals only.

Canea COVID-19 Antigen Saliva is used for qualitative detection of the antigen of COVID-19 in human saliva sample.
The test has high sensitivity and specificity and provides the result in 10-15 minutes.

Jetzt online bestellen!

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.
Ergebnis in 15 Minuten ablesbar

Durchführung

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.

Durchführung: COVID-19 Canea Schnelltest

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

Return policy
This item is excluded from return.

Vertrieb:
Canea Pharma GmbH, Tarpenring 12, 22419 Hamburg
Status of information 01 March 2021

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