Test Antygen
SARS-CoV-2


Certyfikat CE-IVD

OPIS PRODUKTU

PCL COVID19 Ag Rapid FIA

1 - Package Box
2-1 - Kit Pouch
2-2 - Kit
3 - Tube for Specimen
4 - Filter Cap
5 - ID chip


Intended to use

an in vitro diagnostic medical device applying sandwich fluorescent immunoassay to qualitatively detect SARS-CoV-2 antigen in human oropharyngeal / nasopharyngeal specimens and sputum specimens.


PCL COVID19 Ag Rapid FIA

- 10 min Qualitative detection of SARS-CoV-2 Antigens
- Human oropharyngeal swabs and deep sputum samples
- POCT Analyzer Provided
- Limit of Detection : 0.1 ng/ml (r-N protein), 1000 PFU (virus)
- Clinical sensitivity: 100% (27/27)
- Clinical specificity: 97.78% (44/45)

* Two different sites in Korea with 27 positive and 45 negative samples (RT-PCR confirmed).

Specimen


Analyzing


Result Anaysis



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