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SARS-CoV-2 Ag Diagnostic Test kit (Colloidal Gold)

 

 

More details

Reliable and cost-effective SARS CoV-2 antigen rapid test

The easy-to-use test, utilising the standard lateral flow test cassette for the detection of SARS-CoV-2 virus antigen, provides reliable visual results after 10 minutes. The test kit is based on colloidal gold immunoassay technology.   

It is an Ideal solution for fast and qualitative results in patients with onset of symptoms between 0-7 days

The collection of the specimen, using either a naso-/oropharyngeal sample or a saliva swab is very simple.  

The sample is applied to the buffer tube and, afterwards, the prepared solution will be dripped onto the test strip.

After the incubation time, results are read manually by the operator.

The test was evaluated by Paul-Ehrlich-Institute (Germany)

 

Test interpretation

Technical specifications
Technology Lateral flow sandwich immunoassay
Sample type Saliva, naso-/oropharyngeal swab
Buffer volume

26 x 500 μL
(ready-to-use buffer and mixing tube)

Sample volume 100 μL (3 drops)/test

Sensitivity
(supplier information)

Naso-/oropharyngeal sample:
87.0 % (RT-PCR CT value ≤ 36);
95.15 % (≤ 7 days symptom onset)
Saliva sample:
90.45% % (RT-PCR CT value ≤ 36);
95.51%  (≤ 7 days symptom onset)

Specificity
(supplier information)

Naso-/oropharyngeal sample: 99.12%
Saliva sample: 99.45%
Packaging specification 25 tests/kit

 

for more details please refer to the IFU

Contact

Sysmex Europe GmbH

Bornbarch 1

22848 Norderstedt

Germany

+49 (40) 527 26 0

+49 (40) 527 26 100

Documents

Product documents

Regulatory Documents

Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:

Go to My Sysmex

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