Sold only under the conditions of law number 4737/2020. EOF notification number 2830000616813.
THE PRODUCT IS NOT AVAILABLE TO INDIVIDUALS
Orders that do not comply with the above conditions will be cancelled.
The Realy Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of specific antigens in Sars-Cov-2 present in the human nasopharynx.
Allow test, sample, extraction buffer to come to room temperature
(15-30 ° C) before testing.
1.Remove the tester from the sealed aluminum case and use it
as soon as possible. Place the tester on a clean and flat surface. The
better results will be obtained if the analysis is performed immediately after opening
of the aluminum case.
2. Unscrew the entire cap of the sample collection tube
3. Take out 1 bottle of sample extraction buffer, remove the bottle cap,
add all of the extraction buffer to the extraction tube.
4.Place the sterile swab specimen in the specimen extraction buffer.
Rotate the stylus for about 10 seconds while pressing the head in
of the tube to release the antigen on the swab.
5.Remove the sterile swab while pressing the sterile swab head into
inside the tube as you remove it to expel as much liquid as possible
from the stylus. Dispose of the sterile swab according to the disposal protocol
6. Screw and tighten the cap on the sample collection tube, then
vigorously shake the sample collection tube to mix the sample and the
sample extraction buffer. See figure 4.
7.Add 3 drops of solution (about 80μl) to the sample port of the device and to
then start the timer. Read the result in 10~20 minutes. Do not interpret
result after 20 minutes.
- For in vitro diagnostic use only.
•Do not use after the expiry date.
• Make sure the test package is not damaged before opening for use.
•Perform the test at room temperature 15 to 30°C.
•Wear gloves when handling samples, avoid touching membrane
reagent and the sample window.
• All samples and used components should be treated as
infectious and to be disposed of according to local regulations.
•Avoid the use of blood samples.
A clinical evaluation was performed to compare the results obtained from
the Novel Coronavirus (SARS-Cov-2) Rapid Antigen Test Cassette (Pen) and PCR. The
results are summarized below:
Table: : Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) vs. PCR
|Method||2019 Test K-nCoV it (RT-NPCR ucleic ) Acid|| Total|
|The Novel Coronavirus|
(SARS-Cov-2) Antigen Rapid
Test Cassette (Swab)
Clinical sensitivity = 201/209=96.17 % (95%CI* 92.51% to 98.17%)
Clinical specificity = 450/450＞99.9% (95%CI* 98.98% to 100%)
Accuracy: (201+450)/ (201+0+8+450) *100%=98.79% (95%CI* 97.58% to 99.43%)
Limit of Detection (LoD)
|2019-nCoV Strain Tested |
|Realy Tech product|
|Stock 2019-nCoV Concentration |
|1 X 106 TCID50/mL|
|Concentration in Dilution tested (TCID50/ml) |
|Call rates of 20 replicates near cut-off |
|Limit of detection (LoD) per Virus Strain||1.25 X 103 TCID50/mL|
Instructions for use in Greek: Instruction for use GR
EC Declaration of Conformity: CE-DOC
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