Description
FOR MEDICAL PROFESSIONAL USE ONLY
NASOPHARYNGEAL ANTIGEN RAPID TEST GCCOV- 502A PRODUCED BY MULTINATIONAL COMPANY ZHEJIANG ORIENT GENE BIOTECH CO LTD, LISTED ON THE NASDAQ STOCK EXCHANGE
(one of the world’s largest manufacturers of in vitro tests)
THE PRODUCT IS CE MARKED AND IS DULY REGISTERED WITH THE MINISTRY OF HEALTH AS AN IVD MEDICAL DEVICE UNDER NO. 1984580
The new test based on the Nose Pharyngeal Swab, has the advantage of quick and easy sampling, and an accurate response as early as the first few days after contracting the virus, allowing early detection of the Virus, as early as 24/48 hours after becoming infected.
PRODUCT INFORMATION:
USAGE:
- 15-minute rapid test for SARS-CoV-2 antigen
- Simple procedure
- All the necessary reagents are provided and no other products are needed
- High sensitivity and specificity
PACKAGE CONTENTS:
- 20 Cassette Tests, 20 Sterile Swabs
- 20 Extraction tubes and dropper tips
- 1 Workstation, 2 Buffers, 1 leaflet
PERFORMANCE CHARACTERISTICS:
The rapid cassette test for Coronavirus Antigen (swab) was evaluated with samples obtained from patients.A commercially available molecular testing method was used as the reference method. The results showed that the rapid cassette test for Coronavirus Antigen (swab) has high overall accuracy.
- Relative sensitivity: 96.72% (95%IC*: 88.65-99%-99,60%)
- Relative specificity: 99.22% (95%CI*: 97.21-99%-99,91%)
- Accuracy: 98.74 (95%CI*: 96.80-99%-99,66%)
*confidence intervals
