Covid-19 Antigen Professional Use

Intended Use

The product is intended for the qualitative detection of antigen against COVID-19 in clinical samples (nasal swab & Oropharyngeal swab).





Test Method

1. Insert the sample tube into the sample tube rack to ensure that the sample tube is vertical .Take one sample treatment solution and add all sample treatment solution into the sample tube.

2. Put swab sample into prepared sample tube and rotate at least 10 times. Standing all the materials 1 minute for well-extracting.

3.Throw the used swab as medical waste.

4.Cover dripper tightly on the top of sample tube.

5.Add 80μL or 3 drops processed sample into the sampling well of cassette.


covid-19 Ag test IFU_1.png




Clinical Procedure

The test kit only detects the N protein, and cannot detect the S protein and its mutation structure. Coronavirus, as a large virus family, is a single positive stranded RNA virus with envelope. The virus is known to cause major illnesses such as colds, Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome (SARS). The core protein of COVID-19 is the N protein (Nucleocapsid), which is a protein component located inside the virus. It is relatively conserved among β-coronaviruses and is often used as a tool for the diagnosis of coronaviruses.




Specification


Specimen
Oropharyngeal swabNasal Swab
Test Time
15 minutes15 minutes
Sensitivity
94.74%
93.98%
Specificity99.44%99.44%
Storage Condition2 years, Room Temperature2 years, Room Temperature





Video

0ef1178e914408d62fd2d722078a23a.png

Scan the QR code to watch the video




More Information

Catagory   20 tests/kit

Cat No.   PMD 202/204

product   Covid-19 Antigen Rapid Detection kit (Colloidal Gold) nasal swab & Oropharyngeal swab








Documents Download
普迈德新冠抗原Pro-med Covid-19 Antigen Test-2021.09.10.pdf
6.6MBDownload
antigen professional IFU.pdf
12.72MBDownload
LOD.pdf
98.4KBDownload
Clinical evalureport nasal swab.pdf
229.41KBDownload
covid-19 Ag test IFU.pdf
5.81MBDownload
Prev 1 Next
Login
Login
Login by:
leave a message
back to the top