Overview
- The rapid test is a chromatographic immunoassay test
- Contains the following items to perform the test:
- COVID-19 antigen test cassette
- Instructions for use
- Nasopharyngeal or pharyngeal swab
- Specimen collection tube
- Pipette
- 10-piece rapid test incl. stand for specimen collection tubes
- Test evaluation after 10-15 minutes
- High sensitivity and specificity:
- Sensitivity: 97.5% (78/80); 95% CI* 91.26% - 99.70%.
- Specificity: 100% (90/90); 95% CI* 95.98% - 100.00%
- Accuracy: 98.8% (168/170); 95% CI* 95.81% - 99.86%
(* Confidence interval)
- Store at room temperature
- Do not freeze the test
- Shelf life until the indicated expiration date
- Use test immediately after opening from sealed pouch
- Available in packs of 1 and 10 Units
- Shelf life: 24 months after date of manufacture
- STORAGE AND STABILITY: Store between 2°C - 30°C.
- LIMITATIONS: This test is an in vitro clinical diagnostic test. Positive test results must be confirmed by other methods.
Implementation:
The collection method of the nasopharyngeal swab is shown in Figures 1-4.
The collection method of the pharyngeal swab is shown in Figure 5.
Specimen processing:
Immerse the swab with the specimen into the specimen collection tube and allow the specimen processing solution to completely penetrate the swab. Rotate and squeeze the swab ten times, then remove and discard the swab. Test the retained fluid with the COVID-19 Antigen Rapid Test.
1. Please use swabs to collect the specimen.
2. It is strongly recommended to wear a pair of safety gloves when collecting specimen. This is to avoid contamination.
3. Do not touch the tip (specimen collection area) of the swab. 4.
4. Collect the sample immediately after the presence of symptoms.
5. It is recommended to use the sample immediately after collection. The specimen can be stored at 2°C - 8°C for 72 hours and must be frozen at -20°C for long-term storage. Repeated freezing and thawing should be avoided.
INTERPRETATION OF RESULTS:
Fig. 1: Positive
Fig. 2: Negative
Fig. 3: Invalid
Positive: Control line and T-line appear in the show window.
Negative:Only one line appears in the control area, no line appears in the T area.
Invalid:If no line appears in the control area, the test results are invalid regardless of whether or not there is a line in the T area. The directions may not have been followed correctly or the test may be defective. If the problem persists, stop using the product and contact your local distributor.
Standard scope of delivery:
PZN 16923540: 1-piece test cassette contains: 1 COVID-19 antigen test cassette, 1 nasopharyngeal or throat swab, 1 sample collection tube with processing solution, 1 pipette, 1 instruction manual in German and English.
PZN 16925088: 10-piece test cassette contains: 10 COVID-19 antigen test cassettes, 10 nasopharyngeal or throat swabs, 10 sample collection tubes with processing solution, 10 pipettes, 1 instruction leaflet in German and English.
Return policy
This item is excluded from return.
Distribution:
Canea Pharma GmbH, Tarpenring 12, 22419 Hamburg, Germany
Status of information November 4th, 2020
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