Nasopharyngeal Oropharyngeal Nasal Three-In-One COVID-19 Antigen Test Kit
- Wizbiotech
- CE
- China
SARS-CoV-2 Antigen Rapid Test is intended for the qualitave detecon of SARS-CoV-2 Antigen (Nucleocapsid protein) in oropharyngeal swab, nasopharyngeal swab and anterior nasal swab specimen in vitro. It only needs 15~20 minutes to get results.
Intended Use
The novel coronavirus testing kit is a tool used to detect the presence of the coronavirus.The testing kit is designed to provide rapid and accurate results, enabling medical professionals to diagnose and treat patients promptly. By detecting the virus early, it is possible to isolate and treat infected individuals, limiting the spread of the virus. The testing kit has proven to be a crucial tool in the global fight against COVID-19, helping to control the pandemic and save lives.
Benefits
Oral pharyngeal/nasopharyngeal/nasal swabs are used as test samples to meet various clinical requirements.
The operation is simple, and the test results can be obtained in 15 to 20 minutes
Without the aid of instruments, the results can be interpreted directly by the naked eye.
Product Specifications
Method | Colloidal Gold |
| Sample Type | Oropharyngeal swab/Nasopharyngeal swab/ Anterior nasal swab |
| Time to Result | 15~20mins |
| Storage | 24 months from date of manufacture |
Shelf Life | 24 months from date of manufacture |
Kit Size | 1/5/20/25 tests |
※ Refer to Package Insert for additional product information.
Product Performance
| WIZ’s Results(Nasopharyngeal swab) | Reference PCR Results | Sensitivity: 97.92%（95% C.I.94.05%~99.29%） Specificity: 100.00%（95% C.I.98.88%~100.00%） Overall Percent Agreement: 99.38%（95% C.I.98.19%~99.79%） | ||
Positive | Negative | Total | ||
| Positive | 141 | 0 | 141 | |
| Negative | 3 | 338 | 341 | |
| Total | 144 | 338 | 482 | |
| WIZ’s Results(Oropharyngeal swab) | Reference PCR Results | Sensitivity: 97.92% (95% C.I.94.05%~99.29%) Specificity: 100.00% (95% C.I.98.88%~100.00%) Overall Percent Agreement: 99.38% (95% C.I.98.19%~99.79%) | ||
Positive | Negative | Total | ||
| Positive | 141 | 0 | 141 | |
| Negative | 3 | 338 | 341 | |
| Total | 144 | 338 | 482 | |
| WIZ’s Results(Anterior nasal swab) | Reference PCR Results | Sensitivity: 98.26% (95%C.I.93.86%~99.79%) Specificity: 100.00% (95%C.I. 99.19%~100.00%) Overall Percent Agreement: 99.65% (95%C.I. 98.74~99.96%) | ||
Positive | Negative | Total | ||
| Positive | 113 | 0 | 113 | |
| Negative | 2 | 456 | 458 | |
| Total | 115 | 456 | 571 | |
Applications
Outpatient Emergency Laboratory
Clinical Departments
Community Hospital
Laboratory Departments
Health Management Center
Clinic
Certifications
