Introduction

The SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid  protein in human nasopharyngeal or nasal swab sampled from individuals suspected of COVID-19. Positive results should not be used alone for determining SARS-CoV-2 infection status, but should be combined with clinical  observations, patient history, epidemiological information, and other laboratory evidence. Positive results do not rule out bacterial  infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should not be used as the sole basis for treatment or patient management decisions, including infection control  decisions.

Parameters

• Testing time:  10-15 minutes

• Sensitivity:  98.4%

• Specificity:  98.1%

*no device required

Certificates

CE-IVD

SARS-CoV-2 Antigen-Schnelltestkit (Kolloidales Goldes Method) Analysierte Dokumenten der Leistungsbewertung.pdf

Schneller SARS-CoV-2-Antigen-Test (kolloidale Goldmethode).pdf

Klinischer Bewertungsbericht für SARS-CoV-2-Antigen-Schnelltest (mit Gold-Kolloid).pdf

Clinical Evaluation Report for S3109E SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method).pdf

Analytical performance report for S3109E SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method).pdf

IVD Notification for S3109E SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method).pdf

EAR Certificate_for S3109E SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method).pdf

Manual-S3109E SARS-CoV-2 Rapid Antigen Test(Colloidal Gold Method.pdf

DoC for S3109 SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method).pdf