Description
For professional use only.
Coronavirus Ag Rapid Test Cassette (Swab) manufactured by Zhejiang Orient Gene Biotech Co.,Ltd
The Coronavirus Ag Rapid Test Cassette (Swab) is a membrane immunochromatographic test that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-COV-2 in nasopharyngeal swab.
PRODUCT INFORMATION:
The Coronavirus Ag Rapid Test Cassette (swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab samples taken directly from individuals with suspected COVID-19 by health care personnel within the first ten days of symptom onset. The purpose is to aid in the rapid diagnosis of SARS-CoV-2 infections.
USAGE:
- 15-minute rapid test for SARS-CoV-2 antigen
- Simple procedure
- All the necessary reagents are provided and no other products are needed
- Detects suspected cases of COVID-19 in the first few days after the onset of symptoms
PACKAGE CONTENTS:
- 20 Test Cassettes
- 20 Sterile swabs
- 20 Extraction tubes and dropper tips
- 1 Workstation
- 2 Vials of extraction buffer
- 1 Package leaflet
LIMITATIONS:
- Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
- The amount of antigen in a sample may decrease as the duration of the disease increases. Samples collected after day 10 of illness are more likely to be negative than an RT-PCR test.
- Negative results from patients with symptom onset beyond 10 days should be treated as presumptive, and confirmation with a molecular test may be performed if necessary for patient management.
PERFORMANCE CHARACTERISTICS:
- Sensitivity: 96.72% (95%CI*: 88.65-99%-99.60%)
- Specificity: 99.22% (95%CI*: 97.21-99%-99.91%)
- Accuracy: 98.74(95%CI*: 96.80-99%-99.60%)
*confidence intervals
