![Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Kore
a
PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com
pclchip@pclchip.com
biz@pclchip.com
1. Introduction
2. Kit Components
3. Manual
4. IFU
5. Performance Summary
[COV04S] PCL
COVID19 Ag Gold](https://image.slidesharecdn.com/pclcov04spresentation210413-2-221214181939-77b4dc58/85/PCL_COV04S_Presentation_210413-2-pdf-1-320.jpg)
![Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Kore
a
PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com
pclchip@pclchip.com
biz@pclchip.com
[COV04S] PCL
COVID19 Ag Gold
How To Use & Result
Introduction
- 10 min Qualitative Specific Detection of SARS-CoV-2 Antigens
in human saliva and nasopharyngeal specimens
Performance Summary
- Limit of Detection (Saliva)
5.62 x 102 TCID50/ml
- Clinical sensitivity: 90.83 % (109/120)
- Clinical specificity: 99.50 % (199/200)
Intended Use
In vitro diagnostic medical device applying sandwich fluorescent
immunoassay to qualitatively detect N protein (nucleocapsid
protein) of SARS-CoV-2 antigen in human saliva and
nasopharyngeal specimens.
Negative Positive Invalid Invalid](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
Recommended
More Related Content
More from Schnelltestskaufen24.de
More from Schnelltestskaufen24.de (8)
Recently uploaded
Recently uploaded (20)
PCL_COV04S_Presentation_210413-2.pdf
- 1. Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Kore a PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com pclchip@pclchip.com biz@pclchip.com 1. Introduction 2. Kit Components 3. Manual 4. IFU 5. Performance Summary [COV04S] PCL COVID19 Ag Gold
- 2. Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Kore a PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com pclchip@pclchip.com biz@pclchip.com [COV04S] PCL COVID19 Ag Gold How To Use & Result Introduction - 10 min Qualitative Specific Detection of SARS-CoV-2 Antigens in human saliva and nasopharyngeal specimens Performance Summary - Limit of Detection (Saliva) 5.62 x 102 TCID50/ml - Clinical sensitivity: 90.83 % (109/120) - Clinical specificity: 99.50 % (199/200) Intended Use In vitro diagnostic medical device applying sandwich fluorescent immunoassay to qualitatively detect N protein (nucleocapsid protein) of SARS-CoV-2 antigen in human saliva and nasopharyngeal specimens. Negative Positive Invalid Invalid
- 3. Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Kore a PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com pclchip@pclchip.com biz@pclchip.com Kit Components 100 100 ea 50 ea 5 ea 1 ea 8 bottles to aliquot 50 ea 5 ea 1 ea 100 ea 50 ea 5 ea 1 ea 1 ea 1 ea 1 ea 1 ea 100 Test COVID19 Ag Gold 1 Test
- 4. a PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com pclchip@pclchip.com biz@pclchip.com Certificate & Record [COV04S] PCL COVID19 Ag Gold CE-IVD MFDS FSC Austria Germany BfArM Italy ISS India ICMR Validation Serbia Montenegro Bosnia Hercegovina Guatemala Peru Indonesia Process Supplied Approval https://www.bfarm.de/DE/Medizinprodukte/Antigentests/_node.html Self Test Approval Spain Pakistan Self Test Approval
- 5. Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Kore a PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com pclchip@pclchip.com biz@pclchip.com [COV04S] PCL COVID19 Ag Gold Self Test Approval in Austria https://www.basg.gv.at/en/medical-devices/covid-19 Self Test Approval in Pakistan
- 6. Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Kore a PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com pclchip@pclchip.com biz@pclchip.com [COV04S] PCL COVID19 Ag Gold Independent Testing Report from DE https://www.gfeblut.de/wp-content/uploads/2021/01/ Comparison-Rapid-Assays-SARS-FRA.pdf