NEWGENE saliva antigen test for COVID-19
NEWGENE saliva antigen test for COVID-19
Test result within 15 minutes, determining the presence of SARS-CoV-2 antigen from saliva More
Product code: 5532
from 1,62 € excl. VAT (1,96 € incl. VAT)
Test result within 15 minutes, determining the presence of SARS-CoV-2 antigen from saliva More
Product code: 5532
Variants2
| Variants | Availability | Price excl. VAT | Quantity (ks) | ||
|---|---|---|---|---|---|
 |
Antigen test for COVID-19 from saliva NEWGENE, 1 pc., Code: 17942 | in stock more than 5 pcs | 1,62 € | ||
 |
Antigen test for COVID-19 from saliva NEWGENE, 25 pcs., Code: 17943 | In stock | 38,98 € |
Instructions for Use:
In each package you will find a Czech instruction manual including pictograms
Interpretation of the result:
- Negative(-): The color band appeared only at C
- Positive(+): Two colored bands appeared on the membrane: one at the Ca site and the other at the T site
Invalid: The test result is invalid whenever the color strip at control point C (!) is not colored, even if the color strip is colored at point T. The absence of a color strip at point C indicates that the test was performed incorrectly. Review the test procedure carefully and repeat testing with a new test set. If problems persist, contact your distributor.
Clinical sensitivity and specificity of the test:
Sensitivity: 97.3%
Specificity: 99.2%
Overall Accuracy: 98.3%
Explanation: In general, out of 100 samples with confirmed virus by RT-PCR, approximately 97 positive samples were also positive for this preparation. Approximately 99 out of 100 virus-free samples tested negative for this product. Producer: New Gene (Hangzhou) Bioengineering Co., Ltd. Room 1606, Floor 16, Building 5, 688 Bin'an Road, Changhe Street, Binjiang District, Hangzhou City, Zhejiang Province, P.R. China IVDst diagnostic tool, read the package leaflet. Registration number with SÚKL as IVDst: 01074925 The kit for the detection of the antigen COVID-19 - Saliva is an immunoanalytical test kit intended for the detection of the SARS-CoV-2 virus in saliva samples. This product is suitable for those who have symptoms comparable to COVID-19, such as cough, fever, exhaustion, etc., to help detect SARS-CoV-2 infection early. It can also be used to regularly test people who do not have symptoms of COVID-19 to monitor their health. The result is available within 1-15 minutes after proper sample collection, read the instructions for use. Registered at the SÚKL as an in vitro diagnostic medical device (IVDst) under registration number: 01074925 (https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/ZdravotnickyProstredek/Detail/263724) Marketed as a self-test product, certified by Notified Body No: 1434 (CE 1434), Certificate Number: CE-1434-IVDD-077/2022. Authorized distributor ZP: IVDD for the Czech Republic: RespiLion Distribution (umbrellaline 2010 s.r.o.)
